Evaluating Point-of-care Ultrasound to Improve Tuberculosis Diagnosis in Children
Conditions: Tuberculosis
Sponsor: Medecins Sans Frontieres, Spain

   
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EVALUATING POINT 
OF CARE 
ULTRASOUND TO 
IMPROVE TB 
DIAGNOSIS IN 
CHILDREN 
 
STUDY PROTOCOL – VERSION 1.13     November 
2021 
MÉDECINS SANS 
FRONTIÈRES & 
MINISTRY OF 
HEALTH 

   
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Abbreviations 
 
 
 
 
 
 
AIDS 
Acquired Immunodeficiency Syndrome  
ART 
Antiretroviral treatment 
ATT 
Antituberculosis treatment 
CHW 
Community health worker 
CSF 
Cerebral spinal fluid 
CRF 
Clinical report form 
DST 
Drug susceptibility testing 
EPTB 
Extrapulmonary tuberculosis 
IDP 
Internal displaced population 
IPD 
In-patient department 
ITFC 
Inpatient Therapeutic Feeding Centre 
HIV 
Human immunodeficiency virus 
MSF 
Médecins Sans Frontières 
MoH 
Ministry of Health  
MTB/RIF 
Mycobacterium tuberculosis / Rifampicin resistance 
OCBA 
Operational Centre Barcelona-Athens 
OPD 
Out-patient department 
NICU 
Neonatal intensive care unit 
PICU 
Paediatric Intensive Care Unit 
POCUS 
Point-of-care ultrasound 
SAM 
Severe acute malnutrition 
SOP 
Standard operating procedures 
TB 
Tuberculosis 
US 
Ultrasound 

   
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Table of content 
1. 
Summary .......................................................................................................................................................4 
2. 
General Information......................................................................................................................................5 
3. 
Background ...................................................................................................................................................7 
a. 
Tuberculosis in children ............................................................................................................................7 
b. 
TB diagnosis in children .............................................................................................................................7 
c. 
Use of Xpert MTB / RIF for TB diagnosis ...................................................................................................8 
d. 
Point-of-Care Ultrasound (POCUS) for TB diagnosis .................................................................................8 
e. 
Differential diagnosis for childhood TB  ....................................................................................................9 
4. 
Rationale for this study .................................................................................................................................9 
5. 
Context ....................................................................................................................................................... 10 
6. 
Objectives ................................................................................................................................................... 11 
a. 
Main objective ....................................................................................................................................... 11 
b. 
Secondary objective ............................................................................................................................... 11 
7. 
Patients and Methodology ......................................................................................................................... 12 
a. 
Study design ........................................................................................................................................... 12 
d. 
Study participants and sample size ........................................................................................................ 12 
1. 
Research population .............................................................................................................................. 12 
2. 
Participants: inclusion criteria ................................................................................................................ 12 
3. 
Participants: exclusion criteria ............................................................................................................... 12 
4. 
Sample size ............................................................................................................................................. 13 
e. 
Definitions .............................................................................................................................................. 13 
8. 
Study procedures ....................................................................................................................................... 15 
a. 
Identification of participants .................................................................................................................. 15 
b. 
Laboratory .............................................................................................................................................. 15 
c. 
POCUS assessment ................................................................................................................................. 16 
d. 
Linkage to care for HIV/TB patients ....................................................................................................... 16 
e. 
Follow-up patients and tracing of defaulters ......................................................................................... 16 
f. 
Data collection ....................................................................................................................................... 17 
9. 
Safety Considerations ................................................................................................................................ 19 
10. 
Data Management and Analysis ............................................................................................................ 20 
11. 
Ethical Considerations ............................................................................................................................ 20 
a. 
Informed consent ................................................................................................................................... 21 
b. 
Confidentiality ........................................................................................................................................ 21 
c. 
Benefits .................................................................................................................................................. 22 

   
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d. 
Risks ........................................................................................................................................................ 22 
12. 
Timeline .................................................................................................................................................. 22 
13. 
Dissemination of Results and Publication Policy ................................................................................... 22 
14. 
Budget needs ......................................................................................................................................... 23 
15. 
References.............................................................................................................................................. 24 
16. 
Appendixes ............................................................................................................................................. 27 
Appendix 1:  Study Information Sheet POCUS ............................................................................................... 28 
Appendix 1a:  Study Information Sheet POCUS in Arabic (South Sudan) .......... Error! Bookmark not defined. 
Appendix 1b:  Study Information Sheet POCUS in Creole (Guinea Bissau) ....... Error! Bookmark not defined. 
Appendix 2: Informed consent form POCUS .................................................................................................. 31 
Appendix 3: CRF clinical form ........................................................................................................................ 32 
Appendix 4: TB diagnostic algorithm ............................................................................................................. 34 
Appendix 5: SOP for naso-pharyngeal aspirate ............................................................................................. 36 
Appendix 6: SOP for gastric lavage ................................................................................................................ 37 
Appendix 7: SOP for pulmonary sample collection, storage and shipment .................................................. 38 
Appendix 8: SOP for lymph node puncture and Xpert MTB/RIF assay .......................................................... 41 
Appendix 9: SOP for Xpert MTB/RIF assay performance ............................................................................... 42 
Appendix 10: SOP for the diagnosis of HIV in children .................................................................................. 45 
Appendix 11: Checklist for adherence counselling (HIV and TB) ................................................................... 47 
Appendix 12: Anti-TB dosages for children .................................................................................................... 52 
Appendix 13a: Weight for height in children from 5 to 10 year old .............................................................. 54 
Appendix 13b: Weight for height in adolescents ........................................................................................... 55 
Appendix 14: POCUS report form .................................................................................................................. 56 
 
 
 
 

   
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1. Summary 
 
 
Title 
EVALUATING POINT OF CARE ULTRASOUND TO IMPROVE TB DIAGNOSIS IN CHILDREN 
Design 
Multicentric study (South Sudan and Guinea Bissau).   
Longitudinal prospective cohort study.  
Rationale 
TB diagnosis in children is particularly challenging in low-resource and conflict-affected 
settings, and a high number of children remain undiagnosed and untreated. A delay in TB 
diagnosis can lead to an increase in preventable morbidity and mortality.  
Data from pilot studies in South Africa suggest that TB-focused POCUS improves timely 
diagnosis of childhood TB and is a valuable tool for monitoring treatment response while 
being a non-invasive and low cost bedside tool. Moreover, POCUS is widely distributed in 
MSF missions. The study aims to refine and adapt TB-focused POCUS protocols (i.e. FASH, 
Chest) for children with presumptive TB living in different TB endemic settings and with 
differing co-morbidities (i.e. HIV, malnutrition) and differential diagnoses (i.e. Cystic 
Echinococcosis). 
Main 
objectives 
To describe the findings obtained by POCUS methodology for pulmonary and extra-
pulmonary tuberculosis in children per TB category. 
Secondary 
objectives   
1. To establish the sensitivity, specificity, positive predictive value (PPV) and negative 
predictive value (NPV) of POCUS positive (any of 8 pre-established sonographic signs) as a 
composite   against a composite reference of the final diagnosis (confirmed TB, 
unconfirmed TB or unlikely TB)2.   To describe the sonographic signs according to HIV 
status (positive, negative) and to nutritional status (SAM or not SAM) 
3. To determine the proportion of children with improvement or resolution of sonographic 
signs and the proportion without improvement of sonographic signs at 2 months of follow-
up in children with and without TB 
4. To describe operational aspects of POCUS: compliance with POCUS examination; quality 
of POCUS; duration of POCUS; mean time to definitive diagnostic in POCUS positive results 
compared to POCUS negative results; proportion of children who started TB treatment on 
basis of POCUS positive results. 
Population 
Children with presumptive TB in Malakal (South Sudan) and in Bissau (Guinea Bissau). 
Timeframe 
January 2019 to July 2021 
Expected 
results 
Identification of main POCUS determinants for TB diagnosis in children and include them 
in TB algorithms while adapting and simplifying the POCUS protocol to better adjust it to 
the local context. 
Partnership 
Ministry of Health in South Sudan 
Ministry of Health in Guinea Bissau 

   
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2. General Information 
Title and date 
EVALUATING POINT OF CARE ULTRASOUND TO IMPROVE TB DIAGNOSIS IN CHILDREN, 
March 2019 
Name and address 
of MSF-OCBAs 
mission HQ 
Médecins sans Frontières South Sudan mission, Juba 
Médecins sans Frontières Headquarters, Barcelona 
Principal 
Investigators  
Laura Moretó Planas, HIV/TB Referent 
MSF OCBA, Medical Department 
Tel: +34 93 304 6168 
Email: laura.moreto@barcelona.msf.org 
Sabine Bélard 
Department of Paediatrics, Charité - University Medicine, Berlin 
E-mail: sabine.belard@charite.de 
Co-investigators 
for the study in 
Malakal (South 
Sudan) 
Maria José Sagrado, Epidemiologist Referent, MSF OCBA 
E-mail: mariajose.sagrado@barcelona.msf.org 
 
Erin Stratta 
Diagnostic Imaging Advisor/Ultrasound, MSF International 
E-mail: Erin.Stratta@amsterdam.msf.org 
Adi Nadimpalli 
Project Coordinator POCUS, MSF USA  
E-mail: adi.nadimpalli@newyork.msf.org 
Endashaw Mengistu, Medical Coordinator in South Sudan 
E-mail: msfe-juba-medco@barcelona.msf.org 
Godwin Ohisa, National TB, Leprosy and Buruli Ulcer Control Programme Manager, 
Ministry of Health, Republic of South Sudan 
E-mail: ssntptraining1@gmail.com 
Mohamed Eltom, Health Advisor Cell 5 (South Sudan, Sudan, Ethiopia, Somalia), MSF 
OCBA, Nairobi Unit  
E-mail: mohamed.eltom@barcelona.msf.org 
Partner 
organizations for 
the study in 
Malakal (South 
Sudan) 
 
MoH of South Sudan 
 

   
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Co-investigators 
for the study in 
Bissau (Guinea 
Bissau) 
Jonathan Gallo, Mission Epidemiologist in Guinea Bissau 
E-mail: msfe-bissau-epidem@barcelona.msf.org 
Maria José Sagrado, Epidemiologist Referent, MSF OCBA 
E-mail: mariajose.sagrado@barcelona.msf.org 
Erin Stratta 
Diagnostic Imaging Advisor/Ultrasound, MSF International 
E-mail: Erin.Stratta@amsterdam.msf.org 
Adi Nadimpalli 
Project Coordinator POCUS, MSF USA  
E-mail: adi.nadimpalli@newyork.msf.org 
Pablo Nuozzi, Medical Coordinator in Guinea Bissau 
E-mail: msfe-bissau-medco@barcelona.msf.org 
Jamila Vieira Fonseca  
Director of Paediatric department of Simão Mendes National Hospital, Guinea Bissau 
 
Cándida Redina Rodrigues  
Responsible of Ambulatory Care Centre at Simão Mendes National Hospital 
 
Armando Sifna 
General Director of  Raoul Follereau Hospital, Guinea Bissau 
 
Miguel Camará 
Director of National TB Programme, Ministry of Health, Guinea Bissau 
E-mail: miguelcamara68@hotmail.com 
 
Mercè Rocaspana, Health Advisor Cell 2 (Guinea Bissau, Niger, Nigeria, Mali), MSF OCBA 
E-mail: merce.rocaspana@barcelona.msf.org 
Partner 
organizations for 
the study in Bissau 
(Guinea Bissau) 
Ministry of Health (MoH) Guinea Bissau 
 
 
 

   
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3. Background  
 
a. Tuberculosis in children 
Despite the increased availability of diagnostic tests as well as a curative and preventive therapy, 
tuberculosis (TB) remains an important cause of morbidity and mortality. TB is the main infectious disease 
killer in the world and remains an important burden in resource-limited settings. WHO estimates that 10.4 
million people suffered from TB in 2016, of which 1.7 million people died (1). Developing countries account 
for more than 90% of these cases and deaths.  
 
Tuberculosis is also a major cause of morbidity and mortality among children: in 2016, 1,000,000 children 
became ill from TB, of which 250,000 died -80% of them were under 5 years old (2). Childhood TB has been a 
largely neglected subject for organizations dedicated to TB or child health. 
 
Active TB in children is also a serious and frequent co-infection of HIV or a co-morbidity of malnutrition in 
endemic environments (3-6). Malnutrition is an independent risk factor for both development of TB and 
mortality due to TB (7-9), and is associated with more severe forms of TB (8). It is essential to better 
integrate the diagnosis of tuberculosis into vertical programs for non-infectious diseases, especially for 
malnutrition services (5,6,10,11). 
b. TB diagnosis in children 
According to WHO, the TB diagnostic gap world-wide is still enormous: 39% of all patients suffering from TB 
remained undiagnosed in 2016 (1). This gap is even higher when it comes to paediatric TB. In some African 
settings, only 20% of estimated cases were diagnosed (12).  
 
The diagnosis of tuberculosis in children is particularly difficult and is essentially based on clinical symptoms. 
TB scoring systems have not proven to be effective and young children have difficulty expectorating 
adequate samples for microbiologic investigation. Even if samples are obtained by partly invasive procedures 
such as naso-pharyngeal aspiration or gastric lavage, the positivity rate in smear or culture is low (13,14). 
Similarly, radiographs and skin tests of tuberculin give only very limited information in children and are rarely 
available in contexts where Médecins sans Frontières (MSF) works.  
 
In addition, TB cultures and Xpert MTB / RIF® (Cepheid, Inc.) are often not available in endemic areas. 
Traditionally, TB culture has been considered as the gold standard for TB diagnosis. However, access to 
culture and time till final result make culture not feasible as a regular test in most of the contexts where MSF 
works. This is the reason why an international expert panel established that the case definition of “confirmed 
tuberculosis” includes a positive WHO-endorsed nucleic acid amplification test (Xpert MTB/RIF) in addition to 
culture confirmation using a valid respiratory specimen for microbiologic examination, irrespective of the 
culture result (13). 
 
Even when there is access to TB culture or Xpert MTB/RIF, we are confronted with the challenge of getting an 
appropriate sample from children. Clinical signs and symptoms alone are often variable and therefore 
considered too inaccurate for TB screening. This is particularly true for children under 5 years old, children 
with HIV and for children with severe acute malnutrition. TB suggestive signs and symptoms such as cough, 
fever and low weight gain are also common in other childhood diseases, further complicating diagnosis (15).  
 
It is therefore essential to continue research that may improve the diagnosis of tuberculosis in children.  
Timely initiation of appropriate treatment reduces morbidity and mortality. As such, there is an urgent need 

   
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for appropriate tools which allow reliable and timely diagnosis of childhood tuberculosis. Improving 
childhood diagnosis will also reduce over-diagnosis and over-treatment, which exposes children to 
unnecessary toxicity and wastes resources.  
c. Use of Xpert MTB / RIF for TB diagnosis 
Xpert MTB/RIF is widely used for TB diagnosis in pulmonary samples. A recent meta-analysis (16) showed 
that, compared with microscopy, Xpert offers better sensitivity (increased by 36-44%) for the diagnosis of 
pulmonary tuberculosis in children. However, its sensitivity remains suboptimal compared with culture tests 
(pooled sensitivity of 62-66% in respiratory samples, specificity 98%).  Xpert scale-up can improve access to 
tuberculosis diagnostics for children. Culture remains the gold standard but, in the mentioned meta-analysis, 
among all samples analysed, only 12% had a culture positive. 
 
The use of Xpert MTB/RIF has also been extended to extra-pulmonary TB forms. Recent meta-analysis and 
literature review (17,18,19) on the diagnostic accuracy of Xpert MTB/RIF in extra pulmonary samples, 
showed that Xpert sensitivity differed substantially between sample types, with higher sensitivity for lymph 
nodes (pooled sensitivity ranged between 87 and 96%) and CSF (pooled sensitivity ranged between 80.5 and 
85%), and had a high specificity (pooled specificity between 97 and 98.7%). These findings led the WHO 
recommend Xpert MTB/RIF as the primary diagnosis test for lymph node and meningitis TB (20). 
d. Point-of-Care Ultrasound (POCUS) for TB diagnosis 
The use of POCUS has been extended into daily clinical practice throughout various medical specialties and is 
well acknowledged as a useful bedside diagnostic tool. POCUS is meant to be an efficient tool to reduce time 
to diagnosis and management decisions. Further, it is an inexpensive, safe and portable imaging tool with a 
special utility in resource-limited settings (21). Focused Assessment with Sonography for HIV-associated 
Tuberculosis (FASH) is the most widely studied and implemented application of POCUS in infectious diseases 
to date (22-28) and pulmonary POCUS is increasingly being used to diagnose pneumonia.  
 
The value of US for diagnosing extra-pulmonary tuberculosis in adults has long been recognized. The 
sonographic features suggestive of extra-pulmonary tuberculosis in populations with a high prevalence of 
tuberculosis (and HIV co-infection) include: 
 
• 
Pleural effusion, particularly when unilateral. In a study from sub-Saharan Africa, unilateral pleural 
effusion was caused by tuberculosis in over 90% of cases and was highly associated with HIV 
infection (29);  
• 
Pericardial effusion, which is consistently reported to be due to tuberculosis and to be associated 
with HIV co-infection in the vast majority of cases in Africa (30). Pericardial fluid can easily be 
identified by POCUS (31). POCUS can additionally be used to assess hemodynamic significance of the 
pericardial effusion, which aids in the decision to perform a pericardiocentesis (32).   
• 
Enlarged abdominal lymph nodes and splenic micro-abscesses have been repeatedly reported as 
characteristic findings of abdominal tuberculosis not only in HIV-infected patients, but also in HIV-
uninfected patients (33,34,36). 
 
Despite this evidence, the impact of POCUS on clinical decision-making for paediatric TB in low-resource 
settings has not yet been well studied. POCUS is especially attractive for children as a bedside and non-
invasive procedure. In addition, the high proportion of extra-pulmonary TB in children can be translated into 
high yield US findings, which are easily recognizable with basic US training (35). POCUS can then have a role 
in contributing to a timely diagnosis of paediatric TB and in monitoring the treatment response (36). 

   
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However, more studies to define the characteristic ultrasound findings in different endemic settings, at 
different health care levels or in different co-morbidities (such as malnutrition) need to be done for an 
informed application of POCUS for TB in routine patient management.  
 
The abnormal findings on FASH ultrasound exam may have various aetiologies. However, in a high-
prevalence setting, certain sonographic findings can justify initiation of tuberculosis treatment as 
tuberculosis is the first differential diagnosis (37). 
 
Many studies have shown the excellent performance of lung ultrasound to diagnose pneumonia (38). Few 
studies looking at lung POCUS performance to diagnose pulmonary TB (39,40) have shown that POCUS can 
be a complementary tool in evaluating patients with suspected lung TB. POCUS scanning of the mediastinum 
can detect mediastinal lymphadenopathy, a common manifestation of childhood tuberculosis (41). Lung and 
mediastinal findings suggestive of childhood TB are traditionally visualized by CXR. However, CXR is often not 
available or affordable in resource-limited settings (42). In addition, there is high inter-reader variability 
(43,44,45) and unwanted exposure to ionizing radiation. Lung ultrasound for TB appears to be a promising 
imaging tool in the absence of CXR or in addition to CXR. It allows clinicians to visualize features compatible 
with either childhood TB or pneumonia, part of the differential diagnosis for TB. Finally, it allows for 
monitoring treatment response in children diagnosed with TB or with pneumonia. More data on lung 
ultrasound in paediatric TB suspects is needed. 
 
In regards with equipment, there are good quality low cost devices [36] which require two transducers 
(linear and convex) at a total approximate cost of 2.500$. US devices have batteries available and the running 
costs comprise ultrasound gel (0.1$ per exam) and maintenance. Regarding staff training, POCUS for EPTB 
(FASH) can be taught to clinicians efficiently in 2-day courses [32] and POCUS for pneumonia can be taught to 
clinicians efficiently in 1 hour training [54]. 
e. Differential diagnosis for childhood TB  
The main differential diagnoses to be considered for children with TB suspicion are: 
 
• 
Visceral Leishmaniosis (in South Sudan, not endemic in Guinea Bissau) 
• 
HIV (with lymphoid interstitial pneumonia or PCP) 
• 
Non Tuberculosis Mycobacteria Infection 
• 
Lymphoma 
• 
Hydatid disease 
4. Rationale for this study 
 
As described above, TB diagnosis in children is challenging in low-resource and conflict-affected settings, and 
a high number of children remain undiagnosed and untreated. A delay in TB diagnosis can lead to an increase 
in preventable morbidity and mortality.  
 
Data from pilot studies in South Africa suggest that TB-focused POCUS improves timely diagnosis of 
childhood TB and is a valuable tool for monitoring treatment response. POCUS is widely distributed in MSF 
missions. POCUS as a non-invasive and low-cost imaging modality therefore has high potential to support TB 
diagnosis and monitoring of treatment in children. The study aims to refine and adapt TB-focused POCUS 

   
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protocols (i.e. FASH, Lung) for children with presumptive TB living in different TB endemic settings and with 
differing co-morbidities (i.e. HIV, malnutrition) and differential diagnoses (i.e. Cystic Echinococcosis). 
 
Our future ambition is to incorporate POCUS in diagnostic algorithms for TB diagnosis in childhood, while 
adapting and simplifying the POCUS protocol to better adjust it to the local context. 
5. Context  
In 2016, 2.5 million people fell ill with TB in the African region, accounting for a quarter of new TB cases 
worldwide. An estimated 417,000 people died from the disease in the African region (1.7 million globally) in 
2016. Over 25% of TB deaths occur in the African Region (46,47).  
a. Malakal (South Sudan) 
In South Sudan, TB remains a major public health problem. According to 2016 WHO data, the estimated TB 
incidence (all forms of TB) in South Sudan was 146 per 100.000 population (11% affecting children) in 2016, 
with an overall treatment coverage of 54%. HIV prevalence in the country and in Upper Nile region is 2.7%. 
Estimated rate of MDR TB in new and already treated cases is estimated to be 3 and 13% respectively (48). 
People living in IDP camps, have an increased risk to develop TB (49), and the estimated incidence in Malakal 
is 3.5 times higher than in the country, with high HIV co-infection (11%). 
Médecins sans Frontières (MSF) started the intervention in Malakal (figure 1) by the end of 2013 due to a 
conflict crisis in the area which required big humanitarian needs. MSF is currently supporting primary and 
secondary health care in Malakal Protection of Civilians (POC) and Town, and supporting the rural area 
through a decentralised model of care. HIV/TB support started in 2015 and is currently supporting a cohort 
of around 100 HIV patients and is currently providing TB-DRTB integrated care. All components of the 
program (diagnostic, medical care, counselling and health promotion-community engagement) are 
supported by MSF, even if all data is reported to National TB Program according to MoH requirements. 
Figure 1: 
 
In 2017, a total number of 236 patients were diagnosed of TB and started on treatment. Among them, 34 
(14%) were children, 14 among them under 5 years old. In 2018, the MoH placed Xpert MTB/RIF machine in 
MSF supported laboratory in Malakal POC. Improved diagnostic skills and community strategy with active 
case finding have increased the TB diagnosis by 25%, with 28 cases in the first 8 months of the year. POCUS 
was implemented by a specialized team during 2018 with specific training on FASH and Lung.  
 
Malakal 
Upper 
Nile 
South Sudan 

   
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a. Bissau (Guinea Bissau) 
In Guinea Bissau, TB remains a major public health problem. According to 2017 WHO data (50), the 
estimated TB incidence (all forms of TB) in Guinea Bissau was 374 per 100.000 population (15% affecting 
children) in 2017, with an overall treatment coverage of 32%. HIV prevalence in the country is 3.4% according 
to UNAIDS (51) and HIV coinfection in TB patients is as high as 32%. Estimated rate of MDR TB in new and 
already treated cases is estimated to be 2.5 and 14% respectively. The treatment success for new and relapse 
TB cases is 76 and 43% respectively. According to National TB Program data, in 2018 2200 persons were 
started on TB treatment and 45% among them were ≤ 15 years old. 
MSF OCBA launched the permanent mission in Guinea Bissau (figure 2) in 2016 as a strategic choice with the 
objective to test and develop innovative medical strategies in paediatric care to decrease childhood mortality 
and which will ultimately help to overcome operational challenges, by being capitalized and exported to 
more unstable settings. MSF supports several departments in the Simão Mendes National Hospital in 
collaboration with MoH: paediatric intensive care unit (PICU), neonatal intensive care (NICU), in-patient 
therapeutic feeding centre (ITFC) and few beds in the paediatric ward. MSF is currently diagnosing TB in 
children and referring them to MoH / National TB program to initiate and continue treatment. 
Figure 2: 
 
POCUS was implemented during 2018 at Simão Mendes National Hospital and all training was provided by 
specialized team, including FASH and lung ultrasound.  
6. Objectives 
a. Main objective  
To describe the findings obtained by POCUS methodology for pulmonary and extra-pulmonary tuberculosis in 
children per TB category.  
b. Secondary objective 
1) To establish the sensitivity, specificity, positive predictive value (PPV) and negative predictive value 
(NPV) of POCUS positive (any of 8 pre-established sonographic signs) as a composite against a 
composite reference of the final diagnosis (confirmed TB, unconfirmed TB or unlikely TB) 
2) To describe the sonographic signs according to HIV status (positive, negative) and to nutritional 
status (SAM or not SAM) 
3) To determine the proportion of children with improvement / resolution of sonographic signs and the 
proportion without improvement of sonographic signs at 2 months of follow-up in children with and 
without TB 
Bissau 
Guinea Bissau 

   
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4) To describe operational aspects of POCUS: compliance with POCUS examination; quality of POCUS; 
duration of POCUS; mean time to definitive diagnostic in POCUS positive results compared to POCUS 
negative results; proportion of children who started TB treatment on basis of POCUS positive results. 
7. Patients and Methodology 
a. Study design  
We plan to conduct a multicentric study in 2 different centres: Malakal (South Sudan) and Bissau (Guinea 
Bissau). The methodology for the evaluation of POCUS for the diagnosis of TB in children will be longitudinal 
case series with diagnostic test evaluation.  
 
b. Study sites 
This study will be conducted in South Sudan in two different sites, the Malakal POC and the Malakal town, 
and in Bissau in one site, the Simão Mendes National Hospital. 
 
c. Partnership and study coordination 
In South Sudan, this study will be conducted in partnership between Médecins sans Frontières Operational 
Centre Barcelona-Athens (OCBA) and the Ministry of Health of South Sudan, in collaboration with the 
National TB Program. The MoH is willing to provide administrative and political support. The Xpert MTB/RIF 
machine was procured by MoH as well. No academic institutions have been involved in the study. 
 
In Guinea Bissau, this study will be conducted in partnership between MSF OCBA and the MoH of Guinea 
Bissau, in close collaboration with the National TB Program. MSF works closely with MoH in Simão Mendes 
hospital, and the General Director of the TB hospital (Raoul Follereau Hospital), as well as the Responsible of 
the TB ambulatory care at Simão Mendes, are co-authors of the study and willing to provide technical 
support.  
d. Study participants and sample size 
1. Research population 
The research population are children with presumptive TB in Malakal (town and POC hospitals) or in Bissau 
(Simão Mendes National Hospital).  
 
Note that the same population will be offered to participate in the study “Evaluating Xpert MTB/RIF in stools 
and urine to improve TB diagnosis in children” which will be submitted in a separate protocol. Note that all 
participants will be asked to sign 2 separate consent forms. 
2. Participants: inclusion criteria 
• 
Any child from 6 months of life to 15 years old 
• 
TB suspected according to diagnostic criteria  
• 
Informed consent provided by legal responsible or companion 
3. Participants: exclusion criteria 
• 
Patients who have received TB treatment for > 1 day in the last 3 months 

   
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4. Sample size 
The primary objective is to describe the findings obtained by POCUS methodology for pulmonary and extra-
pulmonary tuberculosis in children per TB category. According to literature, POCUS positive as a composite 
(FASH and chest) have a sensitivity between 60 and 75% in EPTB and a sensitivity of 30 to 50% in PTB. An 
initial sample size was estimated assuming a sensitivity of 30% and precision of 12%, obtaining an initial 
sample size of 95 patients with TB (confirmed and unconfirmed); assuming that TB cases represented 60% of 
the cases, the global sample size of suspected TB was estimated in 158 patients. 
In Guinea Bissau, 139 patients were enrolled, 89 with TB (27 of them confirmed) and 50 with unlikely TB up 
to April 2020 (recruitment was stopped 2 months in advance due to Covid-19). In Malakal, 39 patients were 
enrolled in a first phase in 2019-20 and recruitment stopped in January 2020 due to HR constraints and then 
Covid-19 and resumed in April 2020. By July 2021, 84 more patients were enrolled. Till then, POCUS was used 
as part of the diagnostic tools, thus a proper evaluation study required blinding POCUS results to clinicians 
and a new sample size has been calculated. 
A new sensitivity of 70% has been assumed for the recalculation of the sample size. The sample size has been 
estimated with a variety of assumptions: we assume that TB confirmed and unconfirmed will represent 60% 
of suspected cases, sensitivity of 70% and precision of 10%. The sample size of TB as a composite will be 81 
patients, therefore a total of 131 suspected TB patients will need to be included.  
 
e. Definitions 
a) SAM (severe acute malnutrition) in children (Appendix 14): 
• 
Children < 5 years old: Z-score weight / height <-3 and / or MUAC <11.5 cm, and / or bilateral 
oedema. 
• 
Children 5-15 years old: weight for height < 70% or bilateral oedema 
 
b) HIV infection: 
All patients with suspected TB will be tested for HIV, after consent of the legal responsible and pre-test 
counselling. The algorithm test will be adjusted to the age of the child (see Appendix 10). All children < 18 
months will need PCR DNA for HIV diagnosis. All children ≥ 18 months and > 6 weeks of breastfeeding 
cessation will follow same diagnostic algorithm as for adults, which requires 3 positive rapid tests.  
 
c) Suspected case of tuberculosis: 
Any child with at least one of the following signs, symptoms or features is considered a suspected case of 
tuberculosis (Appendix 3): 
 
• 
Persistent cough for more than 2 weeks 
• 
Unexplained fever for more than a week 
• 
Suspected extra-pulmonary tuberculosis (TBEP), e.g.:  
o 
Angular deformation of the spine (gibbous)  
 
 
o 
Lymphadenopathy 
 
 
 
 
 
o 
Subacute meningitis 
 
 
 
 
 
o 
Abdomen distended with ascites 
 
 
 
o 
> 2 weeks of diarrhoea  
o 
Painless enlarged joints 
o 
Pleural effusion 
 
 

   
14 
 
o 
Other 
 
All HIV positive and SAM children, as well as all TB contacts, will systematically and actively be screened for 
TB. 
 
Tuberculosis screening in children is done on admission and during hospitalization. If children are not 
identified as suspected TB cases at admission, a new assessment will be done after 1 week of admission. In 
addition to the above criteria, tuberculosis is suspected based on the following signs, symptoms and 
characteristics during hospitalization: 
 
• 
Low weight gain despite correct nutritional treatment 
• 
Persistent pneumonia or cough after adequate and well-followed antibiotic therapy 
• 
Persistent fever (>38ºC) beyond one week after exclusion from classical causes such as malaria or 
pneumonia 
• 
Persistence or aggravation of fatigue 
• 
Chest radiographs imaging suggestive of tuberculosis 
 
d) Case with diagnosis of tuberculosis (52,53): 
 
• 
Confirmed TB: patients with Xpert MTB/RIF positive (or TB culture positive when available) in a 
respiratory sample (pulmonary TB) or in other sample, such as CSF, lymph node or other tissue/liquid 
(extra pulmonary TB); TB LAM positive in HIV-infected patients. 
 
• 
Unconfirmed TB: no microbiological confirmation but clinical diagnosis of TB and started on anti TB 
treatment (as established in Appendix 4). 
 
• 
Unlikely TB: good response to other treatments (antibiotic, nutritional support, etc.) and no 
suggestive symptoms after 1 week of admission. 
 
e) POCUS assessment: 
 
Please, find below the definition of the main Chest and FASH sonographic signs: 
 
FASH signs: 
 
• 
Hepatic focal lesions: multiple small hypo-echoic lesions which represent TB micro-abscesses. 
• 
Splenic focal lesions: multiple small hypo-echoic lesions which represent TB micro-abscesses. 
• 
Ascites: free fluid in the abdominal cavity may be a sign of abdominal TB; sonographically free 
abdominal fluid is best investigated for in the Morison pouch, spleno-renal area and pelvis. In the TB-
focused POCUS protocol FASH, presence of ascites only (without other abdominal pathology such as 
abdominal lymphadenopathy or hepatic or splenic focal lesions) is traditionally not considered 
sufficient to establish the diagnosis of abdominal TB (and POCUS would be reported as "negative"). 
• 
Abdominal lymph nodes: tuberculous abdominal lymphadenopathy is a common presentation of 
EPTB and can occur at different intraabdominal locations. Common locations that are easily 
accessible to POCUS are the epigastric region, splenic hilum region and mesenteric/paraaortal 
region. Abdominal lymph nodes larger than 1 cm diameter short axis are considered pathologic and 

   
15 
 
reported as abdominal lymphadenopathy. 
 
CHEST signs: 
 
• 
Sub-pleural nodules: sonographic multiple small (<1cm) hypoechoic nodules have recently been 
suggested as a possibly TB-specific finding; these may be present at various areas of the lung even in 
areas that appear normal on CXR. 
• 
Consolidation: consolidated lung (sonographically presenting as hypoechoic tissue with or without air 
bronchograms) exceeding an area of 1 cm can represent local lung infection by TB or common 
bacterial pathogens causing pneumonia. 
• 
Pericardial fluid: tuberculous pericarditis sonographically presents with free fluid between the 
visceral and parietal pericardium, which presents with an anechoic rim around the heart. 
• 
Pleural effusion: tuberculous pleuritis sonographically presents with free fluid in the pleural cavity, 
which sonographically presents with anechoic areas commonly adjacent to the parietal pleura. 
 
According to these findings, we can establish POCUS positive vs. negative results: 
 
A) POCUS positive and highly suggestive of TB: presence of at least one of the following findings:  
1) Subpleural nodules 
2) Pericardial effusion 
3) Abdominal lymphadenopathy 
4) Focal splenic lesions 
 
B) POCUS positive and compatible with TB: presence of any finding not including the findings above (pleural 
effusion, consolidation, focal hepatic lesions, ascites) 
 
C) POCUS negative: if no suggestive sonographic signs present 
8. Study procedures  
a. Identification of participants 
Eligible children will be identified upon admission to paediatric ward, ITFC, PICU/NICU (only in Bissau) or as 
suggestive cases in OPD. The identification of suspected TB cases will be mainly based on clinical criteria. A 
diagnostic algorithm (Appendix 4) will be applied to all suspected cases. The populations of interest for this 
study are hospitalized children, severely malnourished (SAM) and HIV positive or exposed children. 
b. Laboratory  
1. Sample collection 
The medical team will follow a specific SOP for respiratory sample collection (naso-pharyngeal aspirate, 
gastric lavage or spontaneous sputum), lymph nodes (or other validated extra pulmonary samples) as 
described in the appendixes. In hospitalized children, all samples will be collected during hospitalisation. For 
ambulatory patients, samples will be collected within 2 hours in Observation. 
2. Laboratory procedures 

   
16 
 
Xpert MTB/RIF will we performed to respiratory or extra pulmonary validates samples at baseline, and for 
those with negative results and persistent symptoms, will be repeated after 1 to 2 weeks. TB LAM will be 
done to all HIV-infected patients. 
c. POCUS assessment 
At least two medical national staff is trained on POCUS performance using FASH and chest methodologies. 
Training was executed in two different rounds and staffs capable of performing the POCUS independently 
have been identified. The detailed procedures for performing the point of care ultrasound examination are 
documented in the POCUS MSF protocol. Results of the point of care ultrasound examination will be 
documented in the POCUS  study report form (Appendix 15) for study purposes and on a POCUS form which 
will be kept with the patient file for clinical management; the POCUS form will be provided to the attending 
medical staff immediately after the POCUS examination. All patients will have a POCUS done at baseline and 
after 2 months. 
As per routine, all patients are discussed with Expat Medical Doctor who supports and supervises the 
national team in patient management. On top of that, all patients’ summaries and POCUS images and clips 
will systematically be posted on the Telemedicine platform and discussed with both the POCUS expert, 
Sabine Bélard, and the TB expert, Laura Moretó.  
In order to achieve the objectives, the following information will be collected: 
• 
POCUS positive or negative (as described in section “Definitions”) 
• 
Time to final diagnosis (confirmed TB, unconfirmed TB, unlikely TB) 
• 
POCUS interpretation (suspicion of TB or not) and impact on decision making 
• 
Sonographic signs after 2 months of follow-up: improvement / resolution vs. no change in 
sonographic signs 
In the first part of the study, POCUS has been used to support TB diagnosis in a total of 262 patients 
(139 in Bissau and 123 in Malakal). Starting from July 2021, POCUS results have been blinded to the 
Clinician, to ensure proper evaluation of the diagnostic tool. 
The concordance between the operator and the POCUS expert will be recorded, and all cases of 
discordance will further be evaluated by a third reader.  
d. Linkage to care for HIV/TB patients 
All patients HIV positive will be enrolled into HIV care either in MSF program (Malakal) or MoH programs 
(Bissau). MSF will guarantee that all children will be started on ART after 2 weeks of TB treatment (or as soon 
as possible if TB has been excluded) or differed to 4-6 weeks in case of TB meningitis. 
 
All TB cases (confirmed or unconfirmed) will be enrolled in TB care in MSF program (Malakal) or MoH 
program (Bissau). MSF will ensure that all patients to be started on adequate weight-based dose fix 
combinations and followed up during the length of treatment. All children diagnosed of DRTB will be initiated 
on DRTB treatment regimen according to national recommendation. 
e. Follow-up patients and tracing of defaulters 
All TB patients will be followed up for the duration of the treatment. The clinical appointments will take place 
according to TB program requirements. After the initial assessment, all study participants will have a follow-
up appointment at month 2 to perform a follow-up POCUS (regardless of TB treatment). 
 

   
17 
 
All patients included in the study (including those with unlikely TB) will provide telephone number (if 
available) and address. Whenever possible and if accepted by parent or guardian, a community health 
worker (CHW) will accompany the patient home after discharge. This CHW will be responsible for tracing the 
patients not attending the follow-up appointment. The CHWs are part of the Health Promotion / Community 
Engagement team and routinely involved in tracing of defaulters, including HIV/TB patients. 
 
Transportation fees will be covered for patients requested to attend consultation outside of the 
appointments stipulated for conventional follow-up of TB (ie. patients with unlikely TB who need to attend 
after 2 months of discharge).  
f. Data collection 
The following information will be noted in an individual case study report form (CRF) for each participant: 
 
 
1. DEMOGRAPHIC INFORMATION AND INFORMED CONSENT OF PATIENTS: 
• 
Study code 
• 
Date of birth / age 
• 
Sex 
• 
Parent or guardian's informed consent: Yes / No 
• 
Consent to be traced in case of defaulting 
 
2. CLINICAL AND DIAGNOSTIC INFORMATION OF STUDY PARTICIPANTS AT BASELINE AND DURING FOLLOW-
UP: 
• 
Entry point  (OPD, TB or HIV or Nutrition program, IPD) 
• 
History of TB contact, HIV or malnutrition 
• 
Temperature (axillary) (◦C) 
• 
Weight and size 
• 
Nutritional status 
• 
Co-morbidities: malaria, respiratory infection, HIV status 
• 
Signs and clinical symptoms suggestive of tuberculosis 
• 
Final diagnosis 
• 
TB treatment started: Yes / No 
• 
Date of TB treatment started 
• 
Follow-up information at month 2 and 6 
• 
TB treatment outcomes 
 
3. LAB EXAMS INFORMATION: 
Lab information will be recorded using the Lab form in the study “Evaluating Xpert MTB/RIF in stools 
and urine to improve TB diagnosis in children”. 
 
4. POCUS INFORMATION (BASELINE AND AT MONTH 2):  
• 
Date of POCUS chest and FASH exam 
• 
POCUS positive: presence of 1 or more suggestive sonographic signs described below 
• 
FASH signs: 
o Hepatic focal lesions 
o Splenic focal lesions 

   
18 
 
o Ascites 
o Abdominal lymph nodes 
• 
CHEST signs: 
o Pleural line 
o Consolidation 
o Pericardial fluid 
o Pleural effusion 
• 
Patient’s compliance with POCUS: 
o Good: patient was cooperative and remained calm 
o Moderate: patient was crying but remained calm 
o Bad: patient was crying and moving 
• 
Every sonographic sign/assessment will be rated with one of the following options:  
o Yes: target pathology present 
o No: target pathology not present 
o Not evaluated/not evaluable (NE) 
• 
Duration of the examination:  
o < 10 minutes 
o 10-20 minutes 
o 20-30 minutes 
o > 30 minutes 
• 
Date and time point of POCUS: day (D0, D1…) on which the POCUS was performed 
• 
Interpretation of POCUS: 
o Positive with high suspicion of TB 
o Positive with low suspicion of TB 
o Negative (no suspicion of TB) 
• 
Impact on decision making:  
o No change in diagnosis or therapeutic management 
o Changed diagnosis or therapeutic management 
o Repeat POCUS scan after 2 weeks 
• 
Follow-up POCUS after 2 months: 
o Resolution of sonographic signs 
o Improvement of sonographic signs: decrease in size of lesions 
o No change in sonographic signs 
 
g. Flow of patients 
OPD patients who don’t need hospitalization will be requested to stay in observation for 2 hours to 
perform all initial exams (including POCUS) after obtaining the informed consent, but all diagnostic 
process and follow-up will take place at the external consultation.  
 
 
 
 
 
 
 
All children from 6 m to 15 y: 
- At IPD (day 1) or OPD 
- SAM / at ITFC (day 1) 
- HIV 
- TB contact 
At least 1 present 

   
19 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9. Safety Considerations  
There are safety considerations related to infection control of TB, even if children are only considered 
contagious after they acquire the capacity of expectorating (> 8 years old). For older children, isolation 
procedures for coughing patients, as well as protection measures for medical staff, need to be implemented. 
Lab staff needs to wear respirator and gloves when manipulating samples for Xpert MTB/RIF. Safety 
procedures related to Xpert MTB/RIF need to be in place. 
SCREENING of TB: 
- Cough > 2 weeks 
- Fever > 1 week 
- Suspected EPTB  
- Information sheet 
- Consent (x2) to parent 
or guardian 
- Assent for children > 10 
Obvious TB: Start ATT 
Not obvious TB but 
still suspected 
Reassess at 1 week: 
- Clinical 
- Xpert sputum 
Re-assess at day 10-12: 
- Clinical 
Unlikely TB 
HIV positive 
Enrolled in HIV care 
Child unstable: 
- Hospitalization 
Child stable: 
- Refer to TB clinic  
- Observation 2 hours 
- Xpert sputum or EP 
sample (LN, CSF, pleural / 
ascetic liquid, pus) 
- POCUS 
- HIV counselling and test 
Unconfirmed TB (clinical)  
- Start ATT 
FU at 2 months: POCUS 

   
20 
 
 
Diagnostic procedures are routinely done in all children with suspected TB (on not specifically for the study). 
Gastric lavage and naso-pharyngeal aspirate can be uncomfortable. For gastric lavage, there’s a small risk of 
spasms of vocal cords, tube entering in the airway instead of the oesophagus, minor bleeding or aspiration 
pneumonia. Regarding naso-pharyngeal aspirate, the actual risks for participants are still smaller; it can cause 
nausea or local annoyance. Lymph node puncture is a routine procedure as well and is only performed in 
palpable lymph nodes (≥ 2 cm). The risks are small and can comprise blood vessel punction or accidental 
exposure to blood for the staff. All three are common procedures which will only be performed by trained 
staff. Any possible complication will be treated by MSF. 
 
No specific additional safety considerations related to POCUS. 
10. 
 Data Management and Analysis  
The number of children tested by the program for suspected tuberculosis, the number of eligible children 
and the number of cases included in the study during the recruitment period will be noted. The number of 
parent or guardian of eligible children who refuse their participation will also be registered. Demographic, 
clinical and diagnostic characteristics at baseline and during patient follow-up under the program will also be 
recorded.  
 
Data will be collected in the files by the study team members. Data will be coded and entered into a RedCap 
database and analysed with SPSS software. Continuous variables (e.g. age, distance) will be summarized 
using mean and standard deviation or median and interquartile range as appropriate and may also be 
expressed as ordinal categories with frequencies; frequencies will be reported with corresponding 95% 
confidence intervals. The main outcome of interest for POCUS study is to describe the findings obtained by 
POCUS methodology for pulmonary and extra pulmonary tuberculosis in children.  
 
Bivariate analysis is planned for TB (confirmed and unconfirmed) vs unlikely TB, HIV positive vs. HIV negative, 
and for SAM vs. not SAM. Children with HIV and SAM will be considered as a confounder. Comparisons of 
these categorical variables across groups will use Chi-squared or Fisher’s exact test. All estimates will be 
presented with respective 95% confidence intervals. Cohen’s kappa coefficient will be used to determine the 
inter reader agreement of TB-focused POCUS positive, negative and per sign between the operator and 
second reader, and third reader in case of disagreement.  
 
The number of children screened for suspected tuberculosis, the number of eligible children and the number 
of cases included in the study during the recruitment period will be noted. The number of parents or 
guardians of eligible children who refuse their participation will also be registered. Demographic, clinical and 
diagnostic characteristics at baseline and during patient follow-up under the program will also be recorded. 
 
Data analysis of the study will be conducted by the Epidemiologist/Statistician involved in the study, in 
collaboration with the PI. 
11. 
Ethical Considerations 
The study will be conducted in accordance with the Declaration of Helsinki on Ethical Principles of Medical 
Research on Human Subjects, and in accordance with the rules of the National Ethics Committee of South 

   
21 
 
Sudan and Guinea Bissau. The protocol will be submitted for approval to the National Committee for Ethics 
of South Sudan and Guinea Bissau, and the MSF Ethics Committee. 
a. Informed consent 
Participation in the study is on a voluntary basis and requires prior informed consent. Trained staff will 
provide eligible parents or guardians with detailed information on the study's objectives and procedures, as 
well as a clear explanation of the risks and benefits of participation. A written information sheet will be given 
to the parents or guardians, in English or in local language (appendix 1). The study staff will assist the parents 
or guardians on all the points indicated in the form and answer all the questions. If the parent or guardian is 
not able to read the information sheet, staff should read it aloud.  
 
All children will be briefed on the study and the information will be adjusted to the age range and an assent 
process will take place for children older than 10 years old, but following national legislature, the consent 
must be signed by an adult. All questions will be answered by medical staff responsible for the study. 
 
Parents or guardians agreeing to have their child participating in the study will need to sign an informed 
consent, which will also be signed by the study staff. For illiterate parents or guardians, a witness who can 
read and write, designated by the parent or guardian himself and who will not be a staff member of the 
study, will be present throughout the information process and will co-sign the form to confirm that the 
parents or guardians has understood and willingly accepts participation in the study.  
 
The process of informed consent will be done in an area of the clinic that offers enough privacy to make a 
voluntary decision without constraint. Parents or guardians will be explicitly informed that they have the 
right to refuse participation or withdraw from the study at any time during the research. Copies of both 
forms (ie. the study information sheet and informed consent, in English or in the local language) will be given 
to the parents or guardians. 
b. Confidentiality  
All information collected during the study will be recorded and identified by a specifically assigned number 
for the study and the number assigned routinely for the program. Patient or parents or guardians names will 
not be recorded in the study form or electronic databases. Access to the study information (in paper or 
electronic format) is restricted to authorized staff. 
Home visits are part of the regular work of CHWs, who have specifically been trained for this task. To 
guarantee confidentiality, they are not informed about the reason of the visit and just deliver a request to 
attend the clinic as soon as possible. This information has been shared with the local authorities and is 
routinely explained to all patients prior to asking for consent for home visits. 
Informed consent forms will be kept in a secure and confidential place in a locked cabinet by the study 
coordinator throughout the study. The consent forms will be archived for a minimum of 5 years after the end 
of the research, in a secure and locked archive by the investigator at MSF OCBA, in Barcelona. After this 
period, all documents will be destroyed.  If the Ministry of Health requests to archive copies of the informed 
consents, they will be given at the end of the research study. 

   
22 
 
c. Benefits  
We expect that the study will contribute to a better definition of an appropriate pediatric POCUS protocol for 
childhood TB in different settings. Improved tools for paediatric TB diagnostic will ultimately have an impact 
in improving TB diagnosis in children and reducing mortality in paediatric TB.  
We expect that the results of the study will build the base of an improved diagnostic strategy in which 
diagnostic tools are more adapted to a particular operational/epidemiological context. 
At an individual level, a potential benefit would be a most efficient diagnosis of TB in the child, which will 
lead to an earlier treatment and improved prognosis. All patients will be included in the TB (and HIV when 
required) program. The community will benefit of the improved TB detection in children. 
d. Risks 
The potential risk for the implementation related to the study is eventual challenges in manipulation of TB 
samples. The risks linked to the field might be instability of the context and lower recruitment rate than 
expected which would lead to a longer duration of the study. 
Regarding the potential individual risks for the subjects in the study could be a longer stay at the hospital. 
The POCUS and the sample collection are not invasive, therefor no expected harms due to this procedure. No 
harms have been identified at community level. The risks related to sample collection are described in 
section 9 and can be related to gastric lavage, naso-pharyngeal aspirate or lymph node punction; these 
procedures are used routinely for the diagnosis and not specifically for this study. 
Being diagnosed of TB can be associated to stigma. MSF has been supporting the TB program in Malakal for 
the last 3 years and a health promotion and community engagement strategy to increase knowledge and 
reduce stigma is already in place; an assessment on TB related stigma showed that stigma on TB is relatively 
low in the area. In Bissau, the National TB Program is responsible for TB treatment initiation and follow-up. 
TB stigma in the capital was evaluated as low. Moreover, all children in both settings will be treated with 
strict confidentiality.   
12. 
Timeline 
The estimated overall duration will be 36 months, starting from January 2019, 28 of them in the field: 
- 
Ethical review: 2 months 
- 
Training to staff: 1 month 
- 
Inclusion and data collection: 24 months 
- 
Data analysis and report: 3 months 
- 
Dissemination: 6 months 
13. 
Dissemination of Results and Publication Policy  
Programme results will be presented to MoH authorities, as well as to WHO, to advocate for the use of 
POCUS in the TB diagnosis in children if the study show promising results and added value in the TB 
diagnosis.  
 
The results of the study will be presented in conferences and published in a peer reviewed journal in order to 
share results with the TB public health professionals and other medical-humanitarian actors. 

   
23 
 
14. 
Budget needs  
Costs related to the study are guaranteed by MSF operational budget, including necessary human resources 
and all consumables and diagnostic tests, which will be available through standard MSF procurement and 
supply mechanisms. 
 

   
24 
 
15. 
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Infect Dis J. 2018 Jul;37(7):637-642. 
37. Heller, T., S. Goblirsch, C. Wallrauch, R. Lessells, and E. Brunetti. Abdominal tuberculosis: sonographic 
diagnosis and treatment response in HIV-positive adults in rural South Africa. Int J Infect Dis 2010. 14 
Suppl 3: p. e108-12. 
38. Pereda MA et al. Lung ultrasound for the diagnosis of pneumonia in children: a meta-analysis. 
Pediatrics. 2015 Apr;135(4):714-22. 
39. Agostinis P, Copetti R, Lapini L, Badona Monteiro G, N'Deque A, Baritussio A. Chest ultrasound 
findings in pulmonary tuberculosis. Trop Doct. 2017 Oct;47(4):320-328.  
40. Hunter L et al, Miliary tuberculosis: sonographic pattern in chest ultrasound. Infection. 2016 
Apr;44(2):243-6.  
41. Pool KL et al. Technical aspects of mediastinal ultrasound for pediatric pulmonary tuberculosis. 
Pediatr Radiol. 2017 Dec;47(13):1839-1848.  
42. Pedrazzoli D, Lalli M, Boccia D, Houben R, Kranzer K. Eur Respir J. Can tuberculosis patients in 
resource-constrained settings afford chest radiography? 2017 Mar 22;49(3).  
43. Du Toit G, Swingler G, Iloni K. Observer variation in detecting lymphadenopathy on chest 
radiography. Int J Tuberc Lung, 2002. Dis 6:814–817. 
44. Swingler GH, du Toit G, Andronikou S et al. Diagnostic accuracy of chest radiography in detecting 
mediastinal lymphadenopathy in suspected pulmonary tuberculosis. Arch Dis Child 2015. 90: 1153–
115. 
45. Richter-Joubert L, Andronikou S, Workman L, Zar H. Assessment of airway compression on chest 
radiographs in children with pulmonary tuberculosis. Pediatr Radiol. 2017 Sep;47(10):1283-1291. 
46. World Health Organization fact sheet https://www.afro.who.int/health-topics/tuberculosis-tb. 
47. Corbett EL, Tuberculosis in sub-Saharan Africa: opportunities, challenges, and change in the era of 
antiretroviral treatment. Lancet. 2006 Mar 18;367(9514):926-37. 
48. TB country profile 2017 South Sudan, World Health Organization 2018. 
49. Kimbrough W et al. The burden of tuberculosis in crisis-affected populations: a systematic review, 
Lancet Infect Dis. 2012 Dec;12(12):950-65. 
50. TB country profile 2017 Guinea Bissau, World Health Organization 2018 
51. Fact sheet HIV Guinea Bissau 2017, UNAIDS (http://www.unaids.org/en/regionscountries/countries/ 
guinea-bissau)  
52. Graham SM, Cuevas LE, Jean-Philippe P, Browning R, Casenghi M, Detjen AK, Gnanashanmugam D, 
Hesseling AC, Kampmann B, Mandalakas A, Marais BJ, Schito M, Spiegel HM, Starke JR, Worrell C, 
Zar. Clinical Case Definitions for Classification of Intrathoracic Tuberculosis in Children: An Update. 
HJ. Clin Infect Dis. 2015 Oct 15;61Suppl 3:S179-87.  
53. Zar HJ, Workman LJ, Little F, Nicol MP. Diagnosis of Pulmonary Tuberculosis in Children: Assessment 
of the 2012 National Institutes of Health Expert Consensus Criteria. Clin Infect Dis. 2015 Oct 15; 61 
Suppl 3:S173-8.  
54. Shah et al, Prospective Evaluation of Point-of-Care Ultrasonography for the Diagnosis of Pneumonia 
in Children and Young Adults, JAMA Pediatr. 2013;167(2):119-125. doi:10.1001/2013. 

   
27 
 
16. 
Appendixes 
 
Please, note that many of the following appendixes will be used for the study “Evaluating Xpert MTB/RIF in 
stools and urine to improve diagnosis in children”. Only the appendixes marked with an asterisk are specific 
for this study: 
 
Appendix 1: Study Information Sheet: POCUS*  
 
Appendix 2: Informed Consent Form POCUS* 
 
Appendix 3: Clinical form (CRF) 
 
Appendix 4: TB diagnostic algorithm (SOP of TB diagnosis in children)  
 
Appendix 5: SOP for naso-pharyngeal aspirate 
 
Appendix 6: SOP for gastric lavage 
 
Appendix 7: SOP for pulmonary sample collection, storage and shipment  
 
Appendix 8: SOP for lymph node punction and Xpert MTB/RIF assay 
 
Appendix 9: SOP for Xpert MTB/RIF assay performance 
 
Appendix 10: SOP for the diagnosis of HIV in children 
 
Appendix 11: Checklist for adherence counselling (HIV and TB) 
 
Appendix 12: Anti-TB dosages for children 
 
Appendix 13a: Weight for height from 5 to 10 year old 
     
Appendix 13b: Wight for height in adolescents (10 to 18 year old) 
 
Appendix 14: POCUS report form* 
 
 
 
 

   
28 
 
Appendix 1:  Study Information Sheet POCUS 
Title of the study: EVALUATING POINT OF CARE ULTRASOUND (POCUS) TO IMPROVE TB DIAGNOSIS IN 
CHILDREN 
Principal investigators: Laura Moretó (MSF OCBA) and Sabine Bélard (Charité hospital Berlin) 
Co-authors South Sudan: Endashaw Mengistu (MSF OCBA), Maria José Sagrado (MSF OCBA), Erin Stratta 
(MSF), Adi Nadimpalli (MSF, Godwin Ohisa (MoH), Mohamed Eltom (MSF OCBA) 
Co-authors Guinea Bissau: Jonathan Gallo (MSF OCBA), Pablo Nuozzi (MSF OCBA), Maria José Sagrado (MSF 
OCBA), Jamila Vieira Fonseca (MoH), Cándida Redina Rodrigues (MoH), Armando Sifna (MoH), Miguel Camará 
(MoH), Mercè Rocaspana (MSF OCBA) 
Partnership: Ministry of Health of South Sudan and Ministry of Health of Guinea Bissau 
ERB South Sudan:  Dr. Richard Lako Lino Loro, Director Generral for Policy Planning, Budgeting and Research, 
MoH SS, HQ Ministerial Complex, Juba, SS – PO Box 88, Juba, Tel: +2110177800281.  
ERB Guinea Bissau: Cunhate Na Bangna MD, HMP, MSc - Epidemiologist M&A TB/Malária CG-PNDS / MINSAP 
Av. Unidade Africana, CP 50 - Códex Bissau, Guiné-Bissau E-mail: nabangna.julho2009@gmail.com Tel: +245 
96 693 85 11 / 95 533 52 17. 
Version: version 1.11, March 2019 
 
 
Dear Sir or Madam, 
Médecins sans Frontières (Operational Centre Barcelona-Athens - OCBA) and the Ministry of Health, invite 
you to participate with your child in a study to evaluate Xpert MTB/RIF in stools and urine to improve the 
diagnostic of TB in children. Before making your decision and accepting or refusing to participate, it is 
important that you understand this information sheet which explains several aspects of the study. You can 
read it, or we can read it and explain it to you, and we will answer any questions you wish to ask. 
Please, note that we will also offer your child to participate to the research “Evaluating Xpert MTB/RIF in 
stools and urine to improve diagnosis in children” and a separate information sheet and consent form will be 
shared with you as well. Please note that it is your decision whether to participate only in one of the studies, 
both studies or not at all, without any consequences. 
All the relevant information will be shared also with your child adjusted to age range and all questions will be 
answered, but for ethical reasons we ask you to sign the consent form. 
Background and purpose of the study: Tuberculosis (TB) is a very common disease but its diagnosis is 
difficult, especially in children. Point of care ultrasound (POCUS) has been studied for TB diagnosis in children 
but there is still a need to collect more data on the utility of the test. POCUS is done by a trained medical 
professional, it’s a non-invasive and bedside procedure, and it usually takes less than 30 minutes. We hope 
that this research will help improve the diagnosis of tuberculosis in children Malakal, South Sudan, as well as 
in other places where resources are limited. 
Why are you asked to participate? We want your child to participate because he/she meets all the criteria of 
the study: he/she is between 6 months and 15 year old, he/she presents the symptoms of tuberculosis and 
he/she has not been treated for TB in the last 3 months. 
What happens if you participate in the study? If you agree to participate in the study, your child will be 
examined as normally done in that hospital, and will be given all the usual tests for the diagnosis of 
tuberculosis. In addition, a POCUS study will be performed on him/her. The result of the POCUS will only be 
used for the study, because it is not yet known whether this test works well in children. The usual treatment 

   
29 
 
for tuberculosis, like any other necessary treatment, will normally be given to your child, according to the 
MSF and national recommendations. Your child will be followed during the whole duration of the treatment 
as part of the TB program and regardless of the participation in the study. You will be requested to come 
back to the facility after 2 months to repeat POCUS.  
Do you have the right not to participate? Participation in the study is left to your decision alone. You are 
free to decide whether your child will participate in the study or not. You are also free to withdraw your child 
from the study at any time. Your decision will not affect the care your child will receive at this hospital. 
Are there disadvantages and risks if you participate in the study? Participation in the study entails no risk. 
The rest of procedures are routinely done (not specifically for the study). 
What are the advantages if you participate? There are no direct benefits for you or your child if he/she 
participates in the study. But your child's participation in the study will improve the diagnosis of TB in the 
future, and we hope to be able to better manage TB in children. You will not receive any direct monetary 
benefit such as food or payment as a reward for participating in the study. Only children without TB 
requested to come back after 2 months to repeat POCUS will have transportation reimbursed. 
Is confidentiality assured? All information we collect about your child during the course of the study will 
remain strictly confidential. Your child's name will not appear on the study documents or on the reports. All 
documents will be kept in a locked cupboard and only staff working for the study will have access to the 
information that will be collected. 
How will the results of the study be used? The results of this research will be shared within MSF and with 
experts at the national and international levels in both national and international meetings, and will be 
published in specialized medical journals. All available results will be shared with you as well.  
Who did verify and approve the study? This study was verified by the National Ethics Committee of South 
Sudan and by the MSF Ethics Committee. 
If you agree to your child's participation in the study, please sign with your name below indicating that you 
have read and understood the nature of the study, your responsibilities as a participant, the risks and 
benefits associated with your free and voluntary participation, and that all your questions about the study 
have been answered satisfactorily. 
You will receive a copy of this consent form once it is signed, which you can keep at home. 
 
 
 
 
 
 
 
 

   
30 
 
Assent process for children older than 10 years old:  
There’s a disease called Tuberculosis which is quite common in the area where you live but unfortunately 
diagnostic is difficult and many children remain without diagnosis. This is the reason why we are proposing a 
study to evaluate your abdomen and test by an ultrasound. 
Your parent or guardian said it would be all right for you to take part of this study but this is your decision. If 
you don’t want to participate, you don’t have to and if you want to stop it at any time, just let us know and 
we will proceed accordingly. We will ask you to participate to a second study that wants to evaluate Xpert in 
stools and urine, and you can accept to participate in both, in only one or in none of them. 
If you agree to help us, we will ask you to do an ultrasound today and in 2 months. Normally, it doesn’t take 
more than 30 minutes to perform and it is not painful.  
If you sign or mark this document it means that you understand the information I just explained and that you 
agree to be part of the study. If you don’t want, don’t sign the document. 
The above statement has been read to the child and he agrees to participate in the study. 
The child accepts participating in the study:          Yes                    No 
  
 
 
 

   
31 
 
Appendix 2: Informed consent form POCUS 
 
 
Declaration of the parent or guardian of the participating child 
 
I confirm that I received orally and in writing all the information concerning this study, and that I understood what is 
asked if I participate. I know who to contact if I need more information about this study. I understood that the 
personal information will remain confidential throughout the study and that I have the freedom to stop the 
participation of my child at any time without this modifying the care s/he receives / will normally receive in the clinic. 
 
I accept that my child under my care is participating in this study. I will receive a copy of this informed consent to 
keep. 
 
Name of child participating in study: _____________________________________________ 
 
 
 
 
 
-----------------        ----------------------------------               ----------------------- 
Date  
     Nameparent/guardian       Signature                                         or thumbprint   
                                                                                                                                             If caretaker can’t read or write 
 
 
-----------------        ----------------------------------               -------------------------------------- 
Date  
     Name of staff   
 
 Signature  
 
 
 
 
 
 
 
-----------------        ----------------------------------                -------------------------------------- 
Date  
     Name of the witness                                   Signature 
                              If parent/guardian can’t read or write 
 
Contact persons for further information 
If you have a problem or have questions about this study, you can contact the staff collaborating in the study directly, 
and also contact: 
 
Laura Moretó, Principal Investigator in the Study 
MSF OCBA, Medical Department 
Tel: +34 93 304 6168 
Email: laura.moreto@barcelona.msf.org 
 
 
 
 
 
 
 

   
32 
 
Appendix 3: CRF clinical form 
Background information of study participant  
Date:       /        /    
 
Study code patient: 
Date of birth:  
 
 
 
Age: 
Sex:  
Female □ 
Male □  
 
Parent or guardian's informed consent:  
Yes □  
No □ 
  
Consent to be traced in case of defaulting: Yes / No 
 
Baseline clinical information at entry of study  
Date:       /        /    
 
Entry point to study: 
OPD 
 
 
□ 
 
TB program (ie. TB contact) 
□ 
IPD 
 
 
□ 
 
HIV program 
 
 
□ 
Nutrition program 
□ 
 
other  
 
 
□ 
Specify:  
 
 
Screening in all children, HIV, SAM or TB contacts: 
Fever > 1 week   
 
 
 
□ 
Cough > 2 weeks 
 
 
 
□ 
Suspected extra pulmonary TB  
 
□ 
Site: 
 
Screening in all hospitalized children after 1 week hospitalisation if suggestive symptoms:  
Loss weight despite correct nutritional treatment 
 
□ 
Persistent cough or pneumonia despite antibiotic 
 
□ 
Persistent fever once classical causes excluded  
 
□ 
Persistent or aggravated fatigue 
 
 
 
□ 
Chest radiography suggestive of TB 
 
 
 
□ 
 
History of: 
TB or chronic coughing contact:  
Yes □ No □ 
Unexplained weight loss in the last 3 months 
□ 
MAM □ 
SAM □ 
Known HIV status: Negative □   
Positive □ 
Unknown □ 
 
Clinical condition:  
Temperature (axillary) (◦C): 
 
Weight (kg):  
 
 
Size (cm): 
Nutritional status:  
Not significantly malnourished □  
MAM □ 
SAM □ 
Co-morbidities:  
Malaria  
 
 
 
Respiratory infection: 
HIV:  
Negative □ 
Positive □ 
Unknown □ 
First PCR DNA pending  □ 
Confirmation PCR DNA pending (first positive) □ 
ART regimen:  
 
 
 
 
Date ART started:       /        /    
Signs of pulmonary TB: 
Cough  
 
 
 
 
□ 
Tachypnea 
 
 
 
 
□ 
Hypoxemia (sat O2 < 92%) 
 
 
□ 
Fever (axillary temperature > 38ºC) 
 
□ 
Signs of extra pulmonary TB: 
Angular deformation of the spine (gibbous)  
□ 
Lymphadenopathy 
 
 
 
□ 
Subacute meningitis 
 
 
 
□ 
Abdomen distended with ascites 
 
□ 
Note that this form will be shared between the 2 studies 
(Xpert MTB/RIF stools/urine & POCUS) and only filled once 

   
33 
 
> 2 weeks of diarrhoea  
 
 
□ 
Painless enlarged joints  
 
 
□ 
Pleural effusion 
 
 
 
□ 
Other  
 
 
 
 
□   
Specify: 
POCUS done:  Yes □ No □ 
 
 
Date:       /        /    
 
Information at discharge: final diagnosis 
 
Date:       /        /    
 
Confirmed pulmonary TB 
 
 
□ 
Suspected pulmonary TB 
 
 
□ 
Confirmed extra pulmonary TB  
 
□ 
Suspected extra pulmonary TB  
 
□ 
Unlikely TB 
 
 
 
 
□ 
Other  
 
 
 
 
□ 
 Specify: 
 
TB treatment  
Started: Yes □ No □ 
 
 
 
 
Date ATT started:       /        /    
Regimen:  
 
Follow-up after 2 months of discharge  (POCUS participants) Date:       /        /    
 
Nutritional status: 
Not significantly malnourished □  
MAM □ 
SAM □ 
TB treatment prescribed: 
Yes □  
No □ 
Under TB treatment: 
 
Yes □  
No □ 
 
 
If interruption, specify reason: 
Smear at month 2:  
Done □  
Positive □ 
Negative □   
 
 
 
 
Not done □ 
POCUS done: 
Yes □ No □ 
 
 
Date:       /        /    
 
TB patients: follow-up after 6 months of discharge (POCUS participants) 
 
Date:       /        /    
 
Nutritional status: 
Not significantly malnourished □  
MAM □ 
SAM □ 
TB treatment finalised: Yes □  
No □ 
 
 
Smear at month 6:  
Done □  
Positive □ 
Negative □   
 
 
 
 
Not done □ 
POCUS done: 
Yes □ No □ 
 
 
Date:       /        /    
 
TB treatment outcomes: 
Cured:  
 
□ 
 
 
Defaulted: 
 
□ 
Date:      /        / 
Completed: 
 
□ 
 
 
Death:  
 
□ 
Failure:  
 
□ 
 
 
Not evaluated:   
□ 
 
 

   
34 
 
Appendix 4: TB diagnostic algorithm  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
………………………………………………………………………………………………………………………………………………….
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Cough > 2 weeks or fevera > 1 week or suspicion of  
Extra pulmonary TBb 
Comprehensive assessmentc 
Antibioticse, nutritional treatment or other treatment 
according to clinical findings  
Start TB treatment 
Repeat comprehensive assessmentc and other 
investigations after 1 week 
Is the child HIV exposed / infected or 
is a contact of a TB case? 
Repeat comprehensive assessmentc: 
- Poor weight gain / poor appetite test 
- Persistent cough 
- Persistent fever
None presentf 
One present  
≥2 present  
TB Unlikely  
Start TB treatment  
Start TB treatment in 
particular if child is:  
- HIV positive or  
- < 3 years or  
- SAM or  
- TST + 
Day 1 
Day 7 
YES 
NO 
Start TB treatment 
Day 10-12 
Not obvious TB 
Continue antibioticse, nutritional treatment or 
other treatment according to clinical findings  
If obvious TBd 
If obvious TBd 
If not obvious TB 
SAM 
NO 
YES 
Xpert respiratory 
sample 
POCUS 
Repeat if likely TB: 
Xpert respiratory 
sample 

   
35 
 
a) Axillar temperature > 38ºC 
b) Enlarged lymph nodes, gibbous, > 2 weeks diarrhoea, meningitis  
c) Comprehensive assessment includes: 
a. Clinical assessment  
b. Growth assessment 
c. Bacteriological test (sputum collection, naso-pharyngeal aspirate, gastric lavage, 
lymph node aspiration):  
➢ Xpert MTB/RIF testing (sputum, nasopharyngeal aspirate, gastric lavage, 
lymph node aspirate, CSF);  
➢ Xpert MTB/RIF in stools and urine;  
➢ TB culture and DST (only at baseline): 
For children: 
• 
< 5 years old: do nasopharyngeal aspirate (Appendix 5) 
• 
From 5 years old until child can expectorate: gastric lavage (Appendix 6) 
• 
For children who can expectorate: sputum 
d. POCUS (only at baseline) 
e. HIV testing if not yet performed (Appendix 16) 
f. When relevant and available: X-ray (CXR, spine)  
d) Xpert MTB/RIF positive, CXR showing suggestive lesions (e.g. hilar lymphadenopathy, 
upper lobe infiltrates, and miliary picture), gibbous. 
e) Broad spectrum antibiotics:  
• 
If no signs of severity: 
o First line: amoxicillin PO for 7 days (NO fluoroquinolones) 
o If a second course of antibiotics is needed: azithromycin PO for 5 days 
• 
If signs of severity:  
o Parenteral antibiotics (ceftriaxone ± cloxacillin if S.aureus is suspected) 
o If a second course of antibiotic is needed: azithromycin PO for 5 days 
o In addition: PCP treatment should be given presumptively to all HIV-exposed 
or infected children < 1 year of age and any older child with sever immune 
suppression and not on CTX prophylaxis. For all other HIV-exposed or infected 
children, it should be considered if there is poor response to broad spectrum 
antibiotics after 48 h 
f) Clinical response to broad-spectrum antibiotic does not rule out TB. Continue follow up to 
see if symptoms re-occur 
 
 

   
36 
 
Appendix 5: SOP for naso-pharyngeal aspirate2 
Equipment required: 
• 
Disposable gloves and respirator masks (N95) 
• 
Suction apparatus 
• 
Sterile 6/7/8 G mucus extractor or nasogastric catheter 
• 
Normal saline (0.9%) 5 ml 
• 
Sterile syringe 50 ml (single use) 
 
Performing nasopharyngeal aspiration: 
1. Infection control measures: All personnel responsible for collecting respiratory specimens 
must wear personal protective equipment. The procedure will take place in a dedicated cough 
room or should be fitted with a door that can lock and windows that open to the outside. 
Alternatively, samples may be collected outside in the open air or in sputum collection 
booth/other appropriate structure housed outdoors. 
2. The child’s nose is cleaned with saline drops. If old enough, the child can be asked to blow 
the nose into a tissue. If the nasal mucus is too thick to be removed with the measures above, 
it can be suctioned prior to nasopharyngeal aspiration. A soft catheter size F6/7 is used for 
suctioning and is discarded immediately afterwards. 
4. Two drops of sterile saline are instilled into each nostril. 
5. The length of the cannula used for aspirating the NPA sample is measured as the distance 
from nostril to tragus of the ear; then the posterior nasopharynx is suctioned using a soft 
plastic cannula connected to a mucus trap. 
6. Suctioning is activated only when the tip of the cannula is in the posterior nasopharynx. 
When the cannula is passed through the nostrils (during introduction and extraction), the 
suction is de-activated. 
7. Transfer full volume of sample into a sterile container (Falcon tube). 
8. Clean Falcon tube with alcohol swabs. 
9. Label sample: sample type and number, date, time, total sample volume. 
10. Place specimen in sample bag, seal and put into a cold box for transport to lab. 
 
 
 
 
2 Based on SOP collection of respiratory specimens in children, Desmond Tutu TB Centre Paediatric Studies 
 

   
37 
 
Appendix 6: SOP for gastric lavage3 
Equipment required: 
• 
Gloves and respirator 
• 
Suction catheter (6, 7, 8F) 
• 
Sputum container 
• 
50 ml syringe 
• 
Sterile water 
Performing gastric lavage: 
1. Infection control measures: All personnel responsible for collecting respiratory specimens 
must wear personal protective equipment. The procedure will take place in a dedicated cough 
room or should be fitted with a door that can lock and windows that open to the outside. 
Alternatively, samples may be collected outside in the open air or in sputum collection 
booth/other appropriate structure housed outdoors. 
2. Child needs to be fasting for at least 4 hours and the procedure will take place early in the 
morning.  
3. Place the child in a half-sitting or sitting position in the adult’s arms. 
4. Insert a nasogastric tube and check that it is correctly placed. 
5. First suction to collect the gastric fluid and place it in the sputum container, then rinse the 
stomach with 30 ml of sterile water and suction again. Add the suctioned fluid to the first 
sample. 
6.  
 
 
 
 
 
 
 
 
 
3 Based on SOP of sputum collection in MSF TB guidelines 2014 

   
38 
 
Appendix 7: SOP for pulmonary sample collection, storage and 
shipment  
Sputum collection techniques: 
Regardless the collection technique used, staff member present during sputum collection 
should wear a respirator to prevent bacilli inhalation. 
Sputum obtained spontaneously: 
Two specimens are to be collected. When possible, specimens should be collected outside in 
the open air and far away from other people. 
The first sample is collected on the spot, at the consultation, when the patient is identified as 
suspected TB case. If the patient has recently eaten, ask him/her to rinse his/her mouth with 
water in order to avoid the presence of food in the sample. 
The second sample is collected the day after, in the early morning, right after the patient 
wakes up and before eating. The second sample may be collected at home then the patient 
brings it to the health facility. 
Alternatively, two sputum specimens can be collected one hour apart (frontloaded 
microscopy). Collection technique: 
• 
The patient must be given a labelled sputum container (or a Falcon® tube, if the 
sample is to be shipped by air). 
• 
Have the patient take a deep breath, hold for a few seconds, exhale, repeat two or 
three times, then cough: sputum is material brought up from the lungs after a 
productive cough. One or two minutes of chest clapping are of benefit. 
• 
Collect at least 3 ml and close the container hermetically. 
The quality of sample determines the reliability of the result. Always check that the sample 
contains solid or purulent material and not only saliva. Take a new sample if unsatisfactory. 
If the sample is collected at home, make sure that the patient has understood the technique, 
including closing the container hermetically after collecting the sputum. 
Sputum specimen storage 
When examinations are not performed on the site of collection: 
• 
Specimen for smear microscopy 
Smears should be performed within three-four days of collection and in the meanwhile stored 
refrigerated (2 to 8°C) and protected from light. 
Contamination does not affect microscopy but heat make specimen liquefy, with selection of 
mucopurulent part of the sample more difficult. 

   
39 
 
• 
Specimen for culture in liquid medium 
Keep the specimen refrigerated (2 to 8°C), protected from light. Do not use cethylpyrodinium 
chloride (CPC) as it is not compatible with MGIT. 
The specimen should be processed as soon as possible. 
• 
Specimen for culture on Lowenstein-Jensen medium (LJ) 
- Specimens that can be cultured in less than 3 days after collection: 
Keep refrigerated (2 to 8°C) and protected from light until transport OR immediately transport 
to the laboratory for processing. 
- Specimens that will be cultured more than 3 days after collection: 
Use Falcon tubes and add 1% CPC to preserve the specimen for up to 2 weeks. Specimens with 
CPC should not be refrigerated, as the CPC will crystallize and be ineffective. Samples with CPC 
can be inoculated on LJ. For inoculation on agar, they require prior neutralization by 
neutralizing buffer (Difco ). 
CPC can be used for specimens tested by Xpert MTB/RIF. 
Sputum specimen shipment 
To a local laboratory 
• 
Without CPC transport medium: between 2 and 8°C and protected from light; 
• 
With CPC transport medium: should not be refrigerated because at low temperatures 
the CPC will crystallize and ruin the sample. Specimens should be kept at room 
temperature, protected from heat and light. 
By air to a reference laboratory for culture 
Samples are collected and shipped in 50 ml Falcon® conical tubes with screw caps. The tubes 
are labelled UN 3373, corresponding to Category B infectious substances. If transport times are 
less than 12 hours, even specimens without CPC can be transported at room temperature. 
Samples are triple-packaged, in accordance with IATA packing instruction 650: 
1. 
Primary container holding the sputum sample: tube tightly closed and placed into a 
latex glove; 
2. 
Secondary container intended to protect the primary container: leak-proof box with 
enough absorbent material to absorb the entire sample, should the primary container break; 
3. 
Outer packaging intended to protect the secondary container, with UN 3373 labelling. 
Information to be provided: 

   
40 
 
• 
Primary container: label with the patient’s name or identification number and the 
sample collection date and location; 
• 
Outer package: indicate the name of the receiving laboratory, the complete address 
(name, street, postal code, locality, country), and telephone number. 
All samples must be accompanied by the corresponding laboratory test request form (including 
clinical information). 
Notes: 
• 
Procedures for shipping bacterial strains obtained after culture are different, more 
complicated, and rarely feasible in practice. Cultures are classified as Category A 
infectious substances (UN 2814). 
• 
For a detailed description of the shipment procedures, see MSF Medical catalogue, 
volume 4. 
 
 
 
 
 

   
41 
 
Appendix 8: SOP for lymph node puncture and Xpert MTB/RIF 
assay4 
FNAC is used to obtain material from lymph nodes. The material is expressed onto slides and 
prepared for examination. 
Two smears will be prepared with Giemsa staina2 to look for caseum, granuloma, giants cells, 
and epithelioid cells or histocytes and 1 or 2 will be prepared with Ziehl-Neelsen (ZN) stain to 
look for acid-fast bacilli (AFB). 
Equipment 
▪ 
Needle 23G (in very few cases, it would be possible to use 19G) 
▪ 
10 ml syringe 
▪ 
2 slides for Giemsa + one or 2 slides for ZN stain 
▪ 
10% polyvidone iodine, sterile gauze, gloves 
Technique 
▪ 
Disinfect the area. 
▪ 
With the needle attached to the syringe, insert the needle deep into the lymph node. 
▪ 
After the needle has entered the mass, pull back on the syringe plunger to create a 
vacuum. 
▪ 
Rapidly move the needle in a to-and-fro fashion to allow material entering the needle. 
▪ 
When blood or material appears in the needle hub the aspiration should be stopped. 
Try to aspirate as much as possible of materials, the amount of materials that has 
been aspirated would have effect on the specificity and sensitivity of diagnosis. 
▪ 
Release the negative pressure before to take out the needle from the lymph node. Do 
not continue sucking while taking out the needle, this will avoid aspiration of materiel 
into the barrel of the syringe and avoid mixing the sample with the possible peripheral 
blood in the skin. 
 
 
 
 

   
42 
 
Appendix 9: SOP for Xpert MTB/RIF assay performance 
 
Xpert MTB/RIF assay is based on hemi-nested real time PCR for simultaneous detection of M. 
tuberculosis (MTB) and rifampicin (RIF) resistance. The target is the rpoB gene, critical for 
detection of mutations associated to rifampicin resistance. Xpert MTB/RIF automates all aspects 
of real time PCR analysis, with results available in 2 hours. 
 
Sample processing 
 
The test can be performed using fresh sputum samples or decontaminated samples prior 
culture inoculation. 
 
Procedure with fresh sputum samples: 
• 
Ask the patient to rinse the mouth twice before collecting the sample. 
• 
Collect a minimum of 1.5 ml good quality sputum. 
• 
Follow the procedures outlined below: 
 
Procedure for Xpert MTB/RIF* 
 
Step 1 
 
Add the reagent 2:1 (v/v) 
to the sample and shake 
10-20 times. 
Incubate 
at 
room 
temperature for 15 min.; 
during incubation repeat 
once shaking for 10- 20 
times. 
Step 2 
 
With a pipette transfer 
the diluted sample into a 
cartridge. 
Step 3 
 
Insert the cartridge in the 
machine and start the 
test. 
 
* Source: National Health Laboratory Services, South Africa. 
 
Procedure for sediment samples: 
 
• 
Sediments can be prepared according to standard decontamination procedure (NALC- 
NaOH method) and re-suspend with phosphate buffer. 
• 
Ensure 0.5 ml is available for the test; add 1.5 ml of reagent for 0.5 ml of re-suspended 
sediment. 
• 
Follow the procedure described in the above figure. 

   
43 
 
 
Interpretation of the results: 
 
Proper test performance is ensured by 2 internal controls: 
 
• 
Sample processing control (SPC) ensures adequate processing and monitors presence of 
inhibition. 
• 
Probe check control (PCC) verifies that the steps of the tests (rehydration, filling of the 
cartridge, etc.) take place correctly. 
 
When the test is completed the display can show: 
 
• 
“MTB detected” expressed by levels (the higher the level, the higher the amount of 
MTB detected in the sample) or “MTB not detected”; 
• 
RIF results expressed as “detected”, “not detected” or “indeterminate” are available 
only if MTB is detected. 
 
Other possible results: 
 
• 
Invalid: MTB invalid and SPC failed due to one of several reasons, such as inhibition; 
• 
Error: MTB no result, SPC no result, PCC failed; fail of system components; 
• 
No result: e.g. tests stopped during processing. 
 
Storage of samples and cartridges: 
 
Samples: 
 
• 
For a period ≤ 3 days: store at 35°C maximum. A cold chain is not required for up to 3 
days after collection. During this period of time, overgrowth of normal flora does not 
have negative influence on the test. However, if a cold chain is available, samples 
should be stored at 2 to 8°C in order to help their preservation. 
• 
For a period of 4 to 10 days: store refrigerated at 2 to 8°C. 
 
If samples require other testing (i.e. smear microscopy and/or culture), sample storing 
conditions adequate for microscopy and culture have to be followed. CPC does not interfere 
with Xpert MTB/RIF testing. 
 
Cartridges: 
 
• 
To be stored at 2 to 28°C. 
• 
The cartridge should be used within 30 minutes of opening the cartridge lid. 
• 
Cartridges are stable for 7 days after opening the packaging. 
 
Logistic requirements 
 

   
44 
 
Power supply 
• 
The device requires stable and uninterrupted power supply. 
• 
Each GeneXpert instrument will need a uninterruptible power supply (UPS). 
• 
The minimum requirement for the functioning of the GeneXpert instrument is to have 
a 800VA UPS. 
 
Operating temperature 
• 
The operating temperature for GeneXpert instrument device is 15 to 30°C. According 
to climate conditions, the installation of air conditioning can be recommended to keep 
the area within the temperature ranges indicated by the manufacturer. 
  
Calibration 
• 
The GeneXpert modules require annual calibration, which must be performed by an 
authorised service provider or carried out by swapping out the modules. A detailed 
commercial sales contract and customer support plan should be negotiated with the 
supplier, guaranteeing regular maintenance, calibration, repair and replacement 
(when needed). 
• 
Cartridges and reagents shelf-life 
• 
12 months from date of production. 
 
Storage space 
• 
Each kit contains 10 cartridges and all reagents necessary to run 10 tests. The 
dimensions of the kit are 27 x 20 x 17 cm and the weight is 800 g. 
 
Lab space 
• 
The GeneXpert IV instrument (4 modules allowing the processing of 4 specimens at the 
same time) has the following dimensions: 
• 
29.8 cm wide, 35.6 cm high, 31.1 cm deep; weight: 12 kg. It is designed for indoor use 
only. 
• 
Provide at least 5 cm of clearance on each side of the instrument to ensure adequate 
ventilation. 
• 
Do not place the instrument close to the vents of other instruments or air-handling 
units. 
 
Safety 
• 
The personal protection requirements for microscopy should be adopted, including 
use of gloves and respirators. 
 
Waste disposal 
• 
Same procedure as for sputum containers. To be noted is the large volume of 
additional waste generated by Xpert MTB/RIF compared to smear microscopy. 
 
 

   
45 
 
Appendix 10: SOP for the diagnosis of HIV in children 
1.1. Indication:  
HIV infection should be systematically assessed in all children admitted to the ITFC ward and in 
children admitted to the Paediatric ward who present with clinical suspicion of HIV infection. 
1.2.  General principles: 
• 
HIV testing should be performed by trained staff. 
• 
HIV testing can only be performed after counselling and informed consent from the 
parents. 
• 
In children under 5 years old, the mother will be tested first and the children will be 
tested only when: 
o Mother is HIV positive 
o Mother is negative but strong suspicion of HIV infection (ie. unsafe blood 
transfusion, traditional scarification or circumcision) or  
o In the absence of the mother 
• 
HIV testing will be performed by using standard MSF (algorithm 1) or National testing 
algorithm.  
• 
Children and/or mother with positive HIV diagnosis will be immediately linked to the 
HIV program, MSF supported or not.  
1.3.  Algorithm 1: MSF testing algorithm for mothers and children 18 months or more1 
 
 
1 New HIV testing algorithm for MSF setting, October 2017 
A1: Determine HIV 1 / 2 
A2: Stat Pak HIV 1 / 2 
A3: SD Bioline HIV 1 / 2 

   
46 
 
1.4.  MSF testing for children under 18 months: 
• 
If child < 9 months and mother HIV positive or unknown: perform PCR DNA. 
• 
If child is 9 or more months but not yet 18 months, and mother positive or unknown: 
perform rapid test and confirm with PCR DNA if positive. 
• 
If child is 18 months and not breastfed in the last 6 weeks: follow algorithm 1. 
 
Source WHO guidelines 2016 ‘Consolidated guidelines on the use of Antiretroviral drugs for treating and preventing HIV infection’ 
 
 

   
47 
 
Appendix 11: Checklist for adherence counselling (HIV and TB) 
Pre HIV test counselling check list: individual or in group 
Reasons and benefits of having an HIV test 
 
What the patient knows about HIV? 
 
What is HIV and its modes of transmission 
 
A brief description of prevention options 
 
Reinforce that results will remain confidential 
 
Reinforce the fact that the patient can deny the test, but explain the importance of doing it 
 
The HIV testing process (finger-prick, testing procedure, timing of results) 
 
The meaning of an HIV-positive and an HIV-negative result 
 
The potential for incorrect results if a person already on ART is given an HIV test 
 
Information regarding the follow-up services that are available in the case of an HIV-positive test 
result 
 
Assess personal risky behaviour an discuss risk reduction plan 
 
Information about support mechanisms, who will the patient tell about the results? Where can he 
get support? 
 
Individual testing procedure 
Ask for consent for testing  
 
Address any fears related to testing 
 
Post-test individual HIV counselling check list 
For NEGATIVE results 
Ask the patient if he is ready to receive the results 
 
Give the results simply and clear 
 
Explain the meaning of negative HIV test and the window period and assess if there has been at risk 
behaviour in the preceding 3 months; recommend re-testing in case of recent exposure 
 
Discuss the importance of remaining negative by educating on methods of prevention (provision of 
male and female condoms and explain how to use them) 
 
Emphasize on the importance of knowing the HIV status of sexual partner(s) and give information 
about the availability of partner and couples testing services 
 
For POSITVE results 

   
48 
 
Patient education and counselling at screening of TB 
Ask the patient if he is ready to receive the results 
 
Give the results simply and clear 
 
Check with open-ended questions that the person understand the meaning of the result 
 
Allow and encourage the patient to ask questions 
 
Let the patient talk about his feelings about the results 
 
Acknowledge the shock of the diagnosis ; offer support 
 
Determine how the patient will get through the next few hours 
 
Discuss eventual disclosure of the results and to whom 
 
Discuss how to protect partner(s) from infection and explain use of condoms 
 
Encourage and offer HIV testing for sexual partners, children and other family members of the client 
 
Provide clear information on ART and its benefits for maintaining health and reducing the risk of HIV 
transmission, as well as where and how to obtain ART 
 
Encourage and provide time for the client to ask additional questions 
 
Topics 
Give emotional support regarding the diagnosis 
 
Assess previous knowledge and explain facts on TB disease 
▪ 
What is TB (Card 1) 
▪ 
What are the signs and symptoms  of active TB (Card 2) 
▪ 
What are the ways of transmission  and prevention of TB (Card 3) 
▪ 
What is the relationship between HIV and TB (Card 14) 
▪ 
What is the difference between drug-sensitive and drug-resistant TB  
 
Assess previous knowledge and explain the facts on TB treatment: 
▪ 
What does the treatment consist of (Card 5) 
▪ 
How  to adhere (Card 15) 
▪ 
Side effects of treatment (Card 6) 
▪ 
Clinic follow-up for DSTB patients 
▪ 
Clinic follow-up for DSTB patients 
 
Explain risk for family members and ask the patient to bring any family member with TB symptoms 
and all children < 5 years old 
 
Make a plan on how to adhere to TB treatment (getting ready to start treatment, support system, 
getting to the clinic, medication schedule, managing missed doses, reminder strategies, storing 
medication) 
 

   
49 
 
When 
Patients suspected to have active TB disease, including DR-TB, referred for sputum collection 
Mode  
In group or individually 
Duration 
15 minutes 
 
Patient education and counselling at the start of DSTB treatment 
When 
Before or at the day of TB treatment initiation 
Mode  
Individual 
Duration 
30-45 min 
 
Patient education and counselling after starting DSTB treatment 
When 
One week after treatment initiation or at the first visit after commencing treatment 
Mode  
Individual 
Duration 
30 min 
 
Topics 
Give emotional support 
 
Evaluate adherence to TB medication (annex 8) and work around any difficulties taking medication 
since starting 
 
Review knowledge on TB disease and its treatment 
 
Explain monitoring tests for TB treatment 
 
Explain on use of traditional medication, alcohol and drugs in combination with TB treatment 
 
Remind patient to bring any family member with TB symptoms and all children < 5 years old (if the 
patient didn’t yet) 
 
 
Topics 
Explain basic facts on TB (what is TB, signs & symptoms, transmission, prevention, relationship with 
HIV) (Card 1-2-3) 
 
Explain the procedure of TB diagnosis 
 
Explain how to produce sputum (Card 4) 
 

   
50 
 
Patient education and counselling at the end of DSTB intensive phase 
When 
At the end of DSTB intensive phase 
Mode  
Individual or in group 
Duration 
15 min 
 
Topics 
Evaluate adherence 
 
Solve any adherence issues 
 
Explain the change in drug regimen for the continuation phase 
 
Explain the need to continue to take treatment throughout the maintenance phase, even if the 
patient might feel better. Assess and reinforce the patient’s motivation to continue treatment 
 
Remind patient to bring any family member with TB symptoms and all children < 5 years old (if the 
patient didn’t yet) 
 
 
Additional PEC sessions throughout DSTB treatment 
When 
At any moment of TB treatment if adherence problems are detected 
Mode  
Individual 
Duration 
20 min 
 
Topics 
Evaluate adherence 
 
Solve any adherence issues 
 
Explain the need to continue to take treatment throughout the treatment, even if the patient might 
feel better. Assess and reinforce the patient’s motivation to continue treatment 
 
Remind patient to bring any family member with TB symptoms and all children < 5 years old (if the 
patient didn’t yet) 
 
 
Support group TB sessions 
When 
At any moment of TB treatment if adherence problems are detected 

   
51 
 
Mode  
Group  
Duration 
45 minutes 
Methodology 
Discuss challenges and share personal experience without being blamed, judged or stigmatised 
Can be facilitated by staff member or not 
Attention to infection control concerns 
 
 
 

   
52 
 
Appendix 12: Anti-TB dosages for children6  
Intensive phase 
Weight (kg) 
Paediatric formulations 
Adult formulations 
HZR 
50/150/75 
E 
100 
E 
400 
H 
100 
EHZR 
275/75/400/150 
4 
1 tab 
1 tab 
5 
1 tab 
1 tab 
6 
1 tab 
1 tab 
7 
1 tab 
1 tab 
8 
2 tab 
2 tab 
9 
2 tab 
2 tab 
10 
2 tab 
2 tab 
11 
2 tab 
2 tab 
12 
3 tab 
3 tab 
13 
3 tab 
3 tab 
14 
3 tab 
3 tab 
15 
3 tab 
3 tab 
16 
4 tab 
− 
1 tab 
17 
4 tab 
− 
1 tab 
18 
4 tab 
− 
1 tab 
19 
4 tab 
− 
1 tab 
20 
4 tab 
− 
1 tab 
21 
4 tab 
− 
1 tab 
22 
4 tab 
− 
1 tab 
23 
− 
− 
− 
1 tab 
2 tab 
24 
− 
− 
− 
1 tab 
2 tab 
25 
− 
− 
− 
1 tab 
2 tab 
26 
− 
− 
− 
1 tab 
2 tab 
27 
− 
− 
− 
1 tab 
2 tab 
28 
− 
− 
− 
1 tab 
2 tab 
29 
− 
− 
− 
1 tab 
2 tab 
30-34 
− 
− 
− 
− 
2 tab 
35-39 
− 
− 
− 
− 
2 ½ tab 
40-54 
− 
− 
− 
− 
3 tab 
55-70 
− 
− 
− 
− 
4 tab 
> 70 
− 
− 
− 
− 
5 tab 
 
 
6 Based on the Appendix 8a of MSF TB Guideline 2014 

   
53 
 
Continuation phase 
 
Weight (kg) 
Paediatric formulation 
Adult formulation 
HR 
50/75 
HR 
75/150 
4 
1 tab 
5 
1 tab 
6 
1 tab 
7 
1 tab 
8 
2 tab 
9 
2 tab 
10 
2 tab 
11 
2 tab 
12 
3 tab 
13 
3 tab 
14 
3 tab 
15 
− 
2 tab 
16 
− 
2 tab 
17 
− 
2 tab 
18 
− 
2 tab 
19 
− 
2 tab 
20 
− 
2 tab 
21 
− 
2 tab 
22 
− 
3 tab 
23 
− 
3 tab 
24 
− 
3 tab 
25 
− 
3 tab 
26 
− 
3 tab 
27 
− 
3 tab 
28 
− 
3 tab 
29 
− 
3 tab 
30-34 
− 
2 tab 
35-39 
− 
2 ½ tab 
40-54 
− 
3 tab 
55-70 
− 
4 tab 
> 70 
− 
5 tab 
Daily dosing in patients < 30 kg 
Daily dosing in patients ≥ 30 kg 
E 
15 to 25 mg/kg once daily 
15 to 25 mg/kg once daily 
H 
7 to 15 mg/kg once daily 
4 to 6 mg/kg once daily 
Z 
30 to 40 mg/kg once daily 
20 to 30 mg/kg once daily 
R 
10 to 20 mg/kg once daily 
8 to 12 mg/kg once daily 
 
 

   
54 
 
 
Appendix 13a: Weight for height in children from 5 to 10 year old 
 
RECONSTRUCTED FROM BMI charts: height between 120,5 and 140,0 cm
MALE
FEMALE
-3
-2
-1
Median
cm
Median
-1
-2
-3
14.4
15.6
17.0
18.5
110
18.6
17.0
15.5
14.2
14.5
15.8
17.1
18.7
110.5
18.8
17.1
15.7
14.4
14.6
15.9
17.3
18.9
111
19.0
17.3
15.8
14.5
14.8
16.0
17.5
19.1
111.5
19.2
17.5
16.0
14.7
14.9
16.2
17.6
19.2
112
19.4
17.7
16.2
14.8
15.0
16.3
17.8
19.4
112.5
19.6
17.9
16.3
15.0
15.2
16.5
18.0
19.6
113
19.8
18.0
16.5
15.1
15.3
16.6
18.1
19.8
113.5
20.0
18.2
16.7
15.3
15.4
16.8
18.3
20.0
114
20.2
18.4
16.8
15.4
15.6
16.9
18.5
20.2
114.5
20.5
18.6
17.0
15.6
15.7
17.1
18.6
20.4
115
20.7
18.8
17.2
15.7
15.8
17.2
18.8
20.6
115.5
20.9
19.0
17.3
15.9
16.0
17.4
19.0
20.8
116
21.1
19.2
17.5
16.0
16.1
17.5
19.2
21.0
116.5
21.3
19.4
17.7
16.2
16.2
17.7
19.3
21.2
117
21.5
19.6
17.8
16.3
16.4
17.9
19.5
21.4
117.5
21.7
19.8
18.0
16.5
16.5
18.0
19.7
21.6
118
22.0
19.9
18.2
16.6
16.7
18.2
19.9
21.8
118.5
22.2
20.1
18.4
16.8
AGE
16.8
18.3
20.0
22.0
119
22.4
20.3
18.5
16.9
AGE
year:month
16.9
18.5
20.2
22.2
119.5
22.6
20.5
18.7
17.1
year:month
06:08
17.1
18.6
20.4
22.4
120
22.8
20.7
18.7
17.2
06:10
06:09
17.5
19.0
20.6
22.4
120.5
22.8
20.8
18.8
17.3
06:11
06:10
17.9
19.2
20.8
22.5
121
22.9
20.9
18.9
17.3
07:00
6:11 / 7:00
18.0
19.3
21.0
22.9
121.5
23.0
20.9
19.0
17.4
07:01
07:01
18.3
19.6
21.1
23.1
122
23.1
21.0
19.1
17.6
7:02 / 7:03
07:02
18.5
19.8
21.3
23.3
122.5
23.3
21.1
19.2
17.7
07:04
07:03
18.6
20.0
21.6
23.4
123
23.4
21.2
19.4
17.9
07:05
07:04
18.8
20.1
21.8
23.8
123.5
23.6
21.4
19.5
18.0
07:06
07:05
18.9
20.3
22.0
24.0
124
23.8
21.5
19.7
18.1
07:07
07:06
19.1
20.5
22.2
24.2
124.5
24.2
21.7
19.8
18.3
07:08
07:07
19.2
20.6
22.3
24.4
125
24.4
22.0
20.0
18.4
07:09
07:08
19.4
20.8
22.5
24.6
125.5
24.6
22.2
20.3
18.7
07:10
07:09
19.7
21.1
22.7
24.9
126
24.9
22.4
20.5
18.9
07:11
07:10
19.8
21.3
23.0
25.1
126.5
25.1
22.6
20.6
19.0
08:00
7:11 / 8:00
20.0
21.5
23.2
25.3
127
25.3
22.7
20.8
19.2
08:01
08:01
20.2
21.6
23.4
25.7
127.5
25.5
23.1
21.0
19.3
08:02
08:02
20.3
21.8
23.6
25.9
128
25.9
23.3
21.1
19.5
08:03
08:03
20.5
22.0
23.8
26.1
128.5
26.1
23.4
21.5
19.6
08:04
08:04
20.6
22.3
24.1
26.3
129
26.3
23.6
21.6
20.0
08:05
08:05
21.0
22.5
24.3
26.7
129.5
26.7
24.0
21.8
20.1
08:06
08:06
21.1
22.6
24.5
26.9
130
26.9
24.2
22.0
20.3
08:07
08:07
21.3
22.8
24.7
27.1
130.5
27.1
24.4
22.1
20.4
08:08
08:08
21.5
23.0
24.9
27.3
131
27.5
24.5
22.5
20.6
08:09
08:09
21.6
23.2
25.2
27.7
131.5
27.7
24.9
22.7
20.9
08:10
8:10 / 8:11
21.8
23.5
25.4
27.9
132
28.1
25.1
22.8
21.1
08:11
09:00
22.1
23.7
25.6
28.1
132.5
28.3
25.3
23.0
21.2
09:00
09:01
22.3
23.9
25.8
28.5
133
28.5
25.6
23.3
21.4
09:01
09:02
22.5
24.1
26.2
28.7
133.5
28.9
25.8
23.5
21.6
09:02
09:03
22.6
24.2
26.4
28.9
134
29.1
26.0
23.7
21.9
09:03
9:04 / 9:05
22.8
24.6
26.6
29.3
134.5
29.5
26.4
23.9
22.1
09:04
09:06
23.1
24.8
27.0
29.5
135
29.7
26.6
24.2
22.2
09:05
09:07
23.3
25.0
27.2
29.9
135.5
29.9
26.8
24.4
22.4
09:06
09:08
23.5
25.2
27.4
30.1
136
30.3
27.2
24.6
22.8
09:07
09:09
23.7
25.5
27.6
30.4
136.5
30.6
27.4
25.0
22.9
09:08
09:10
23.8
25.7
28.0
30.8
137
31.0
27.6
25.2
23.1
09:09
9:11 / 10:00
24.2
25.9
28.2
31.0
137.5
31.2
28.0
25.3
23.3
09:10
10:01
24.4
26.3
28.6
31.4
138
31.6
28.2
25.5
23.6
09:11
10:02
24.6
26.5
28.8
31.7
138.5
31.8
28.4
25.9
23.8
10:00
10:03
24.7
26.7
29.0
32.1
139
32.3
28.8
26.1
24.0
10:01
10:04
25.1
26.9
29.2
32.3
139.5
32.5
29.0
26.3
24.1
10:02
10:05
25.3
27.2
29.6
32.5
140
32.9
29.4
26.7
24.5
10:03
Reconstruction based on WHO 2007 references 
Older children from 60 months to 10 years (110,0 - 140,0 cm)
Weight-for-Height (Standing up)

   
55 
 
Appendix 13b: Weight for height in adolescents  
 
 
 
Weight adaptations between 140,0 (BMI charts WHO 2007) to 145,0 cm (NCHS 198
MALE
FEMALE
70%
80%
85%
Median
cm
Median
85%
80%
70%
25.1
27.2
29.6
32.5
140
32.9
29.4
26.7
24.5
25.2
27.4
29.7
33.0
140.5
33.2
29.6
26.8
24.7
25.2
27.6
29.9
33.4
141
33.6
29.8
27.0
24.9
25.3
28.0
30.0
33.8
141.5
33.8
30.2
27.4
25.0
25.4
28.2
30.2
34.1
142
34.1
30.4
27.6
25.2
25.4
28.4
30.3
34.7
142.5
34.8
30.7
27.8
25.6
25.5
28.8
30.5
35.0
143
35.6
31.1
28.0
25.7
25.6
29.0
30.6
35.3
143.5
36.0
31.3
28.4
25.8
25.6
29.1
30.8
35.7
144
36.4
31.4
28.6
25.9
25.7
29.2
30.9
36.1
144.5
36.9
31.5
29.1
26.0
25.8
29.2
31.0
36.5
145
37.1
31.5
29.7
26.0
25.8
29.5
31.3
36.8
145.5
37.4
31.8
29.9
26.2
26.0
29.7
31.6
37.2
146
37.8
32.1
30.2
26.5
26.3
30.0
31.9
37.6
146.5
38.1
32.4
30.5
26.7
26.5
30.3
32.2
37.9
147
38.4
32.6
30.7
26.9
26.8
30.6
32.5
38.3
147.5
38.8
33.0
31.0
27.2
27.0
30.9
32.8
38.6
148
39.1
33.2
31.3
27.4
27.3
31.2
33.1
39.0
148.5
39.5
33.6
31.6
27.7
27.5
31.5
33.4
39.3
149
39.8
33.8
31.8
27.9
27.8
31.7
33.7
39.7
149.5
40.1
34.1
32.1
28.1
28.0
32.0
34.0
40.0
150
40.5
34.4
32.4
28.4
28.3
32.3
34.3
40.4
150.5
40.8
34.7
32.6
28.6
28.5
32.6
34.7
40.8
151
41.2
35.0
33.0
28.8
28.8
32.9
34.9
41.1
151.5
41.5
35.3
33.2
29.1
29.1
33.2
35.3
41.5
152
41.9
35.6
33.5
29.3
29.3
33.5
35.6
41.9
152.5
42.3
36.0
33.8
29.6
29.6
33.8
35.9
42.3
153
42.6
36.2
34.1
29.8
29.8
34.1
36.2
42.6
153.5
43.0
36.6
34.4
30.1
30.1
34.4
36.6
43.0
154
43.4
36.9
34.7
30.4
30.4
34.7
36.9
43.4
154.5
43.8
37.2
35.0
30.7
30.7
35.0
37.2
43.8
155
44.2
37.6
35.4
30.9
30.9
35.4
37.6
44.2
155.5
44.6
37.9
35.7
31.2
31.2
35.7
37.9
44.6
156
45.1
38.3
36.1
31.6
31.5
36.0
38.3
45.0
156.5
45.5
38.7
36.4
31.9
31.8
36.3
38.6
45.4
157
46.0
39.1
36.8
32.2
32.1
36.7
38.9
45.8
157.5
46.5
39.5
37.2
32.6
32.4
37.0
39.3
46.2
158
47.0
40.0
37.6
32.9
32.7
37.3
39.6
46.6
158.5
47.6
40.5
38.1
33.3
33.0
37.7
40.0
47.1
159
48.2
41.0
38.6
33.7
33.3
38.0
40.4
47.5
159.5
48.9
41.6
39.1
34.2
33.6
38.4
40.8
48.0
160
49.7
42.2
39.8
34.8
33.9
38.7
41.1
48.4
160.5
50.5
42.9
40.4
35.4
34.2
39.1
41.5
48.8
161
51.6
43.9
41.3
36.1
34.5
39.4
41.9
49.3
161.5
52.8
44.9
42.2
37.0
34.8
39.8
42.3
49.8
162
54.5
46.3
43.6
37.8
35.1
40.2
42.7
50.2
162.5
56.1
47.7
44.9
38.3
35.5
40.5
43.1
50.7
163
56.4
47.9
45.1
38.8
35.8
40.9
43.5
51.1
163.5
56.7
48.2
45.4
39.0
36.1
41.3
43.9
51.6
164
57.0
48.4
45.6
39.5
36.5
41.7
44.3
52.1
164.5
57.3
48.7
45.8
39.8
36.8
42.1
44.7
52.6
165
57.6
48.9
46.0
40.0
Reconstruction based on NCHS-CDC-WHO 1982 references 
Adolescents from 10 to approx 18 years (140,0 - 165,0 cm)
Weight-for-Height (Standing up)

   
56 
 
 Appendix 14: POCUS form 
Interpretation: POCUS positive [  ] high suspicion / [  ] low suspicion; POCUS negative [  ] no suspicion 
FU at 2 months: [  ] Resolution of signs 
[  ] Improvement of signs  [  ] No change in signs 
Compliance of patient:   [  ] good,     [  ] moderate,    [  ] bad 
Duration of POCUS:         [  ] < 10 min,   [  ] 10-20 min,    [  ] 20-30 min,  [  ] > 30 min 
Impact in decision:  
[  ] no change 
[ ] change 
[ ] repeat POCUS 
CHEST 
Subpleural nodules 
[  ] normal 
[  ] not evaluable, reason: 
 
[  ] pathologic,    [  ] bilateral    or   [  ] unilateral 
Consolidation 
[  ] no 
[  ] not evaluable, reason: 
 
[  ] yes 
     size: _____ cm 
 
Location:         
 
Pleural Effusion 
[  ] no 
[  ] not evaluable, reason: 
 
[  ] yes 
     size: _____ cm 
 
Location:         
 
Pericardial effusion 
[  ] no 
[  ] not evaluable, reason: 
 
[  ] yes 
 
Other findings chest: 
 
 
ABDOMEN 
Ascites 
[  ] no 
[  ] not evaluable, reason: 
 
[  ] yes 
Location:                                
 
Focal liver lesions 
(hypoechoic) 
[  ] no 
[  ] not evaluable, reason: 
 
[  ] yes 
 
Focal splenic lesions 
(hypoechoic) 
[  ] no 
[  ] not evaluable, reason: 
 
[  ] yes 
 
Abdominal lymph 
nodes 
(> 1cm short axis) 
epigastric 
[  ] no 
[  ] not evaluable, reason: 
 
[  ] yes 
splenic hilar 
[  ] no 
[  ] not evaluable, reason: 
 
[  ] yes 
Mesenteric/paraaortal 
[  ] no 
[  ] not evaluable, reason: 
 
 
[  ] yes 
 
Other findings 
abdomen: 
 
Patient code:                       
Date of Scan:         /          /         
Baseline [  ], FU [  ]  
 
 Time point:         day    

   
57