FROM RESEARCH TO POLICY TO IMPLEMENTATION:THE TB-LAMP EXPERIENCEIN THE PHILIPPINESRosarie Villabito Gabuya, MHSS, RNDEPARTMENT OF HEALTHRESEARCH INSTITUTE FOR TROPICAL MEDICINENATIONAL TUBERCULOSIS REFERENCE LABORATORY1PRESENTATION OUTLINE❶❷❸❹❺❻❼❶❷❸❹❺❻❼

HIGH PREVALENCE-TO-NOTIFICATION RATIO=HIGH NUMBER OF MISSED CASES=IMPROVEMENT IN CASEFINDING NEEDEDSOURCE: National TB Prevalence Survey 2016, Philippines

2,872 TB Microscopy Laboratories (TMLs)• 12 Regions with TML using LED-FM403 Rapid TB Diagnostic Laboratories (RTDLs)• 107 sites to be added this year
29 TB Culture Laboratories• 6 labs with Non functional MGIT (liquid culture)
9 Drug Susceptibility Testing Laboratories

2 Line Probe Assay Sites

Xpert coverage and usage statistics, 2018
Indicator

Data

Total no. of Xpert machines in the country

323

Xpert machines linked with diagnostic connectivity network

41

Total no. of Xpert tests done in 2018
Proportion of Xpert tests with Invalid/ Error/ No results
Use ULTRA cartridges (Yes/No, %)No. Xpert machines linked480,666
3.5% (17,094)
No, 0%N/A

EVALUATION PROCESS AS DONE FOR TB LAMP

Two-Phased Evaluation:
1. Central Level Evaluation
2. Peripheral Level Evaluation

Policy Formulation Basedfrom Evaluation Studies
Done

Pilot Implementation
and OperationalAssessment

TIMELINE OF ACTIVITIES INVOLVING THE TB-LAMP EVALUATIONPHASE IINDIVIDUAL EVALUATIONOF TB LAMP AND
GENOSCHOLAR LPA AT
CENTRAL LEVEL

EXTENSION/PHASE III
TB LAMPDEPLOYMENT AT
SELECT SITES AND
OPERATIONAL
ASSESSMENT2017201920162018

RESEARCH
COLLABORATIONAGREEMENTSIGNING AND
LAUNCH

PHASE IISIMULTANEOUSEVALUATION OF TB LAMPAND GENOSCHOLAR LPA
UNDER A HYPOTHETICALDIAGNOSTIC ALGORITHM

PHASE 1

PHASE 2

• TB-LAMP performed at central levellaboratory• TB-LAMP performed at peripherallevel laboratories (n=5)• Diagnostic performance evaluationand end-user appraisal• Diagnostic performance evaluationand end-user appraisal• Total participants = 279• Total participants = 507

PHASE 186.1(78.7-93.4, 95% CI)

SPECIFICITY• Diagnostic performance evaluationand end-user appraisal

SENSITIVITY• TB-LAMP performed at central level
laboratory

FINDINGS

95.7(92.9-98.6, 95%CI)• Total participants = 279• More sensitive than smear microscopy(66.3, p=0.001)• Similar sensitivity to Xpert (93.0,p=0.109)• Similar specificity to both smear
microscopy and Xpert (97.9 and 95.8)• Received positive feedback from endusers (n=2), citing ease of use andshorter time to obtain results

PHASE 2

73.5(66.1-80.0, 95% CI)

SPECIFICITYSENSITIVITY

FINDINGS

97.1(94.7-98.6, 95%CI)• TB-LAMP performed at peripherallevel laboratories (n=5)• Diagnostic performance evaluationand end-user appraisal• Total participants = 507• More sensitive than smear microscopy(66.1, p=0.0013)• Similar sensitivity to Xpert (68.9,p=0.4545)• Similar specificity to both smear
microscopy and Xpert (97.47 and 94.8)• Received positive feedback from endusers (n=10), citing ease of use andshorter time to obtain results

CONCLUSIONS AND RECOMMENDATIONS• TB-LAMP has good diagnostic performance both in acentral laboratory setting and local field conditions• Intended users gave positive feedback on the test andfound it easy to use• The technology could be integrated into the country
diagnostic algorithm following further assessment
covering cost effectiveness and once logistics are inplace

TB-LAMP proposed to be
included in the revised TB
diagnostic algorithm as analternative primary diagnostic
test in settings where access
to Xpert is limited**Subject to change depending on the policies tobe adopted by the Philippine NTP

SOURCE: National Tuberculosis Control Program – Manual of Procedures 6th Edition,Pre-Final Text (September 27, 2019)

SYSTEMATIC SCREENING FOR PTB IN ADULTS>15 YEARS OLD WITH UNKNOWN HIV INFECTION STATUS

FINDINGSSUGGESTIVE
OF PTBRISK FACTORS Age >60 years old
 Diabetes
 Smokers/Alcoholics
 4Ps beneficiary Contacts of TB
 Previously treated for TB
 With other immuno-suppressive
medical conditions

If CXR is not accessible, in thepresence of cough of any
duration with or without other
TB S/S in high risk group, collectsputum sample on the spot andrequest for Xpert or DSSM/TB
LAMP if Xpert is not available.

CONSULTATION FOROTHER DISEASESTake consent before taking CXRin pregnant women.

SYSTEMATIC SCREENING FOR ACTIVE PULMONARY TB FOR PLHIVAT TIME OF DIAGNOSIS OF HIV AND
ANNUALLY+YES IF >1 CRITERIAPRESENTFINDINGSSUGGESTIVE OFPTBEVERY VISIT(IF NOT ON TB TREATMENT)ABOUT THE PILOT IMPLEMENTATION• TB-LAMP deployed as primary diagnostic
tool in selected health facilities forpresumptive TB patients with low risk for
drug resistant TB• TB-LAMP positives tested with Xpert toscreen for RIF resistance
Sites:
1. San Lazaro Hospital
2. Commonwealth Health Center
3. Las Piñas City Health Office
4. Santa Rosa City Health Office I
5. Antipolo City Health Office
6. San Jose Rural Health Unit, Romblon• Conducted from April to September 2019

FINDINGS– Average Positivity Rate for TB-LAMP in Pilot Implementation– Country Average Positivity Rate for Smear Microscopy

93.43%AVERAGECONCORDANCEWITH XPERT2X
POSITIVITY
RATE VSSMEAR
MICROSCOPYEXPERIENCES OF PILOT SITES• Smearing, staining, and microscopy entail a lot of time and effort.
While, in using TB LAMP, the procedure is simple and user-friendly.
• TB LAMP alleviates heavy workload from Xpert MTB/Rif assay.

• The number of tests done using TB LAMP is greater than Xpert inthe same span of time.
• Specimen collection for TB LAMP eliminates the burden forcollecting 2 specimens.
• Turnaround time and releasing of result can be released on thesame day the specimen is processed.

CHALLENGES ENCOUNTERED• Unable to maximize the use of detection reagents when few
specimens are processed.

• Challenging to perform in the beginning due to the number ofsteps

IMPROVING CASEFINDING IN URBAN HOSPITALS• Part of the TB Innovations andHealth Systems Strengthening
Project of the FHI360• Selected large private and public
hospitals (n=3) in urban areas
were installed with equipment
and their staff capacitated for
conduct of TB-LAMP insettings where workload for
Xpert is high• Started last August 2019 up toJune 2020

MASS SCREENING IN PRISONS• Part of the ACCESS TB(Advancing Client-centered
Care and Expanding
Sustainable Services forTB) Project under the Global
Fund grant in the Philippines

PHOTO COURTESY OF ICRC

• TB-LAMP to be deployed inselected prisons for use inmass screening amongdetainees• To be conducted in 2020

SUMMARY• Philippines is a high TB burden country and based onestimates, we are not finding enough bacteriologicallyconfirmed cases to curb the TB epidemic• We need more testing and TB-LAMP is a viable option
to the country based from evidence gathered through ourresearch and pilot implementation• TB-LAMP has been proposed in national policies to beused by the program but is currently being further
evaluated by the Department of Health – HealthTechnology Assessment Unit prior to adoption for routineuse26

ACKNOWLEDGMENTS• Eiken Chemical Co., Ltd.,• Japan International Cooperating Agency• Department of Health, Philippines• Research Institute for Tropical MedicineNational Tuberculosis Reference Laboratory

27

THANK YOU FOR YOUR ATTENTION.

28

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FROM RESEARCH TO POLICY TO IMPLEMENTATION:THE TB-LAMP EXPERIENCE
IN THE PHILIPPINES
Rosarie Villabito Gabuya, MHSS, RN
DEPARTMENT OF HEALTHRESEARCH INSTITUTE FOR TROPICAL MEDICINENATIONAL TUBERCULOSIS REFERENCE LABORATORY30