Prospective Study for Clinical Validation of the Molecular-Based GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains in Vaginal/Rectal Swab Specimens, After Lim Broth Enrichment, From Pregnant Women
Phase: NA
Conditions: Streptococcus Agalactiae Infection
Sponsor: Meridian Bioscience, Inc.

 
 
GenePOC GBS Clinical Trial Protocol 
 
 
GenePOC-GBS_clinical-01 
Final version 1.4 dated 2017-Jan-05 
 
 
 
Confidential Proprietary Information 
 
 
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Protocol No.: GenePOC-GBS_clinical-01 
 
 
 
 
 
 
 
 
 
Prospective Multi-Center Study for Clinical Validation of the 
Molecular-Based GenePOC GBS test for the Detection of the 
cfb Gene from Streptococcus agalactiae strains in 
vaginal/rectal swab amples, after Lim Broth enrichment, from 
antepartum pregnant women. 
 
 
 
 
 
 
 
 
 
Protocol version 
Version date 
Final version (1.0) 
2015-Oct-06 
1.1 
2015-Oct-20 
1.2 
2015-Nov-02 
1.3 
2016-Jul-20 
1.4 
2017-Jan-05 
 
 
 
 
 
 
 
 

 
 
GenePOC GBS Clinical Trial Protocol 
 
 
GenePOC-GBS_clinical-01 
Final version 1.4 dated 2017-Jan-05 
 
 
 
Confidential Proprietary Information 
 
 
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FOR INVESTIGATOR USE ONLY 
 
The performance characteristics of the GenePOC™ GBS system have not been 
established. To be used by qualified investigators only. The GenePOC GBS system must 
not be used as a diagnostic procedure without confirmation of the diagnosis by another 
medically established diagnostic product or procedure. 
 
 
 
CONFIDENTIAL AND PROPRIETARY 
 
The information contained herein is the property of GenePOC Inc. and is provided to you 
as an investigator or potential investigator for review by you, your staff, and the applicable 
independent ethics committee (IEC): Institutional Review Board (IRB) for the US or 
Research Ethics Board (REB) in Canada. By accepting this document, you agree to not 
disclose the information in part or in whole to a third party without written authorization 
from GenePOC per the separate Confidential Disclosure Agreement (CDA). Data 
obtained from this clinical investigation may be submitted to regulatory agencies. Terms 
regarding trial confidentiality, data ownership and publication can be found in the separate 
Clinical Trial Agreement (CTA). 
 
 
 
 
 
 

 
 
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REVISION SUMMARY 
 
 
This revision summary is intended as an aid in understanding the changes being 
implemented. Review of the summary alone does not ensure complete understanding. 
The actual text must be reviewed to ensure full understanding of the change(s).  
 
Version 
Date 
Change(s) description 
Section 
Reason for 
change (s) 
CRF 
versions 
to be 
used 
Final 
(1.0) 
2015-Oct-06
Original 
NA 
NA 
1.0 
1.1
(final with 
minor 
changes) 
2015-Oct-20
Page 3:
DELETED: If the change is a 
protocol amendment, IEC 
approval is required 
REVISION 
SUMMARY 
REASON: as detailed 
in section 6.6.2.1, 
approval will be 
required only if 
requested by IEC. 
1.0
Page 18 and page 22: 
Changes in storage 
temperature for specimens 
5.3.1, 6.1 
and 6.2  
REASON: typewriting 
error in final version 
1.0 and to 
standardize, 
throughout protocol, 
storage temperature 
requirements 
Page 27, 28, 32, 33, 35 and 37: 
Changes in wording of IEC 
requirements 
6.6.2.1, 
6.6.3, 8.4, 
9.1, 9.7.1 
and 11.1 
REASON: To request 
approval from IEC 
only if needed. 
1.2 
2015-Nov-02
Page 20
DELETED: The Study Subject 
Log will allow reconciliation with 
the subject's hospital files, if 
needed. 
5.5.1
REASON: Hospital 
files cannot be 
accessed if informed 
consent is not 
obtained from subject. 
1.0 
Page 7
DELETED: but some 
demographic data will be 
gathered. 
Protocol 
Summary 
1.3
2016-Jul-18
FONT CHANGED: cfb put in 
italics 
Whole 
document 
GenePOC
nomenclature 
1.0
CHANGED: 
- GenePOC System changed 
for  GenePOC system 
- GenePOC GBS Assay 
changed for  GenePOC 
GBS test 
- GenePOC changed for 
GenePOC Inc. 
- Training manual changed for 
 Study Site Manual 
- Specimen changed for  
Sample 
DELETED: 1.3 Clinical 
1 Sponsor 
New Information

 
 
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Version 
Date 
Change(s) description 
Section 
Reason for 
change (s) 
CRF 
versions 
to be 
used 
Research Associate Section.
Contact
CHANGED: intended use text 
modified to match the official 
intended use 
Protocol 
Summary 
and 3.2 
Intended 
Use 
New information
ADDED: DTT: Disposable 
Transfer Tool 
2.1 
Acronyms 
GenePOC 
nomenclature 
CHANGED:
- GenePOC System 
Investigation Documents User’s 
Manual changed for 
GenePOC instrument User’s 
manual 
2.2 
Definitions  
To match GenePOC 
documents 
nomenclature  
CHANGED: Disposable 
Transfer Pipette changed for 
 Disposable Transfer Tool 
3.3 Device 
Description 
GenePOC
nomenclature 
CHANGED: 
[…] must repeat the training 
panel in duplicate and will be 
qualified if he/she meets the 
acceptance criteria for each of 
the repeated runs 
independently. changed for (a 
maximum of two times)  
changed for  […] must 
repeat the training panel (a 
maximum of two times) and will 
be qualified if he/she meets the 
acceptance criteria for the 
repeated runs. changed for (a 
maximum of two times) 
5.2.1 
Proficiency 
Testing 
Training method 
updated  
CHANGED: […] true negative 
and high negatives samples. 
Changed for   and negative 
sample 
5.2.4 
second 
paragraph 
Not required 
DELETED GenePOC GBS in 
the following sentence: Once 
per day GenePOC GBS, a 
reference GBS […]. 
5.2.4 Last 
paragraph 
Typo error
CHANGED: 
The operator will save the 
instrument data on two(2) 
properly labeled USB keys on 
each testing day. Once or 
twice per week, one USB key 
must be sent to GenPOC. The 
other USB key must be 
maintained as a backup at the 
5.5.2 
GenePOC 
Data and 
appendix A 
New information

 
 
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Version 
Date 
Change(s) description 
Section 
Reason for 
change (s) 
CRF 
versions 
to be 
used 
Clinical Center.
Changed for  The operator 
will save the instrument data 
on properly labeled USB keys 
on each testing day. On every 
testing day, data will be 
uploaded to study specific 
database 
CHANGED in 2nd bullet:- VWR 
Multi Tube Vortexer (VWR 
catalog no. 58816115) and 
appropriate vial holder; 
changed for  Tube Vortexer 
ADDED to 4th bullet: (including 
PIE, SBT and DTT) 
DELETED from 8th bullet: 
isolates 
DELETED from 10th bullet: 
Required calibrated pipettes 
DELETED from 11th bullet: 
broths and isolates 
DELETED from 12th bullet: 
“and shipping to GenePOC 
once or twice per week” 
CHANGED in 13th bullet: 
microfluidic cartridges changed 
for  PIE 
5.6.1 
Provided 
by 
GenePOC 
Administrative 
changes 
ADDED to 2nd bullet: 
GBS collection (if available) 
5.6.2
Provided 
by 
Investigator 
Due to multiple 
collection sites, 
GBS sampling 
procedures may not 
be available 
DELETED: The vaginal/rectal 
swab should be placed into its 
designed transport media 
(Amies or Stuart). Care should 
be taken not to mix stool, water, 
urine or soap in the sample” 
ADDED: Vaginal/Rectal swab 
should be performed in 
accordance with published 
guidelines for collection of 
clinical specimens for culture of 
Group B Streptococcus (CDC in 
United States and SOGC in 
Canada). 
6.1 Sample
Collection 
To reflect what is 
done in this study 
using left over 
sample 
DELETED: Fresh specimens 
stored at 2-25°C can be 
tested with the GenePOC 
5.3.1 
Inclusion 
Criteria and 
New information

 
 
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Version 
Date 
Change(s) description 
Section 
Reason for 
change (s) 
CRF 
versions 
to be 
used 
GBS System and the 
Reference Method up to 96h 
of collection. 
ADDED: If the sample will be 
processed within 24 hours, 
store at room temperature. If 
the sample will be tested after 
24 hours, refrigerate until 
testing is performed. Sample 
stored at 2-8oC can be tested 
with the GenePOC GBS 
System and the Reference 
Method up to 96h of 
collection. 
6.2 Sample
Storage 
and 
Handling, 
3rd Bullet 
CHANGED: 
External control materials are 
not provided by GenePOC. 
Commercially available control 
material may be used or a 
≥18 hour GBS culture in Lim 
Broth may be utilized as 
positive control material. GBS 
(Streptococcus agalactiae 
ATCC 12973) is a 
recommended strain to use as 
a control. An uninoculated 
GBS Sample Preparation 
Reagent tube or a 15 µL 
aliquot of pure Lim Broth is 
recommended for use as an 
external negative control.  
Preparation of these controls 
will be detailed in the Package 
lnsert and in the Training 
Manual. Changed for  
External control materials are 
provided by GenePOC. A 
reference GBS strain bearing 
the cfb gene (e.g. ATCC 12973) 
will be used as a positive 
external control (EC) while not 
inoculated Lim broth will be 
used as a negative EC. 
6.5.1.1 
External 
Controls 
and 6.5.2 
Reference 
Method 
New Information
CHANGED: 
Broth enrichment culture Plate 
(15 µL) changed for  (100-
150 µL) 
Appendix B
Typo error
1.4
2017-Jan-05
CHANGED: 
Rachelle Nadeau, B.Sc. for 
Whole 
document 
New Study Manager

 
 
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Version 
Date 
Change(s) description 
Section 
Reason for 
change (s) 
CRF 
versions 
to be 
used 
Catherine Lippé, M.Sc.
and contact information was 
modified 
DELETED:
The GenePOC GBS System 
and the Reference Method not 
performed according to the 
GenePOC GBS Investigation 
Documents 
Exclusion 
criteria 
This sentence was 
written twice 
ADDED:
When it is confirmed that no 
repeat on fresh Lim broth culture 
is 
necessary, 
it 
will 
be 
transferred 
to 
a 
single 
appropriately labelled tube and 
frozen at -70±5°C or colder for 
further testing of all negative 
frozen samples and /or possible 
future discrepant testing. 
6.3 Testing 
algorithm 
New Information
ADDED:
6.3.2.3. Repeat of negative 
samples for the Reference 
Method 
 
In case of suspected irregularity 
in the testing of the reference 
method, the entirety of the 
specimens that gave a negative 
result with the reference method 
could be re-tested at a single 
testing site according to section 
6.3.2. In this case, the tested 
material will be the frozen LIM 
broth culture stored at -70⁰C. 
6.3.2 
Reference 
Method 
New Information
 
 

 
 
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PROTOCOL ACCEPTABILITY 
 
Protocol Proposed by: 
 
 
__________________________________ 
 
 
_____________________ 
Catherine Lippé M.Sc 
 
 
 
 
 
Date (yyyy-mmm-dd) 
Study Manager 
GenePOC inc. 
 
 
 
 
Acceptability 
 
I have reviewed and understood this protocol and agree to its provisions. Any 
modifications must be made by written mutual agreement. 
 
 
Clinical Center 
 
 
Address:   
________________________________ 
 
 
________________________________ 
 
 
________________________________ 
 
 
________________________________ 
 
__________________________________ 
Principal Investigator Name 
 
 
__________________________________ 
 
 
_____________________ 
Principal Investigator Signature  
 
 
 
Date (yyyy-mmm-dd) 
 
 
 
 
 
Sponsor 
 
 
_________________________________ 
 
 
_____________________ 
Dany Leblanc, Eng  
 
 
 
 
 
Date (yyyy-mmm-dd) 
Director QA/RA 
GenePOC Inc. 
 

 
 
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PROTOCOL SUMMARY 
 
Study 
Protocol 
Number 
GenePOC-GBS_clinical-01 
Protocol Title
Prospective Multi-Center Study for Clinical Validation of the Molecular-
Based GenePOC™ GBS test for the Detection of the cfb gene from 
Streptococcus agalactiae strains in vaginal/rectal swab sample, after Lim 
Broth enrichment, from antepartum pregnant women. 
System 
Summary 
The primary purpose of this clinical investigation is to verify the performance 
of the GenePOC GBS test on the GenePOC system. This will be achieved 
by comparing the GBS test to the Culture, a conventional method for 
detection of Streptococcus agalactiae in vaginal/rectal swab samples. 
Study 
Locations 
Up to four (4) geographically diverse Canadian (2) and US (2) Clinical 
Centers are targeted, with each site testing high volumes of samples for 
GBS combined with high prevalence rates and ability to perform the 
reference method. 
Intended Use
The GenePOC GBS test performed on the GenePOC system is a qualitative in 
vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 
vaginal/rectal swabs from antepartum women following enrichment in Lim broth 
for 18-24 hours. The GenePOC GBS test utilizes automated sample preparation 
and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence 
specific to the Streptococcus agalactiae genome.  The GenePOC GBS test is 
indicated for the identification of antepartum GBS colonization and does not 
provide susceptibility results. Culture isolates are needed for performing 
susceptibility testing as recommended for penicillin-allergic women. 
Investigational 
Product 
(IUO) 
The GenePOC GBS test will be performed according to the Study Protocol 
using the GenePOC™ instrument. The GenePOC system, used in 
conjunction with appropriate reagents, is capable of automated cell lysis, 
dilution of nucleic acids from multiple sample types as well as automated 
amplification and detection of target nucleic acid sequences. 

 
 
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Reference 
Method 
Culture is defined as Lim broth culture, subcultured onto blood agar plate 
(BAP) for observation of a Streptococcus agalactiae strain. More 
specifically, the Streptococcus agalactiae bacteria, when present, will be 
isolated using an Enriched Culture and then identified by usual 
microbiological method.  
The exact same media type, reagents and procedure will be used for 
performing the Reference Method throughout the clinical investigation by 
all sites. 
 
 

 
 
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Phase 
Development Phase - Qualification of investigational device (IUO). 
Planned 
Study Period
Clinical investigation to begin in January 2016 at the earliest and to be 
completed within approximately 8 weeks. 
Planned 
Sample Size
The purpose of the clinical investigation is to enroll sufficient samples 
from four (4) Clinical Centers to obtain a total of 150 samples positive 
for GBS based on the Reference Method final result. With an estimated 
prevalence of approximately 25%, up to 600 samples will be tested 
across all Clinical Centers. The performance obtained and the 
confidence interval will be monitored during the study in order to stop 
the enrollment when appropriate. A minimum of 30 positive results per 
site is expected but sites with a higher prevalence of GBS could 
contribute with more positive results to reach the required number. 
Objectives 
The primary objectives of this multi-center prospective investigational trial 
are: 
• To establish the performance characteristics of the GenePOC GBS 
Assay for its use to detect Group B Streptococcus (GBS) DNA from 
Lim broth cultures. Sensitivity and specificity will be established in 
comparison to the Reference Method. 
• To estimate the Positive and Negative Predictive Values (PPV and 
NPV) of the GenePOC GBS Assay. 
• To estimate the rate of unresolved results for the GenePOC GBS 
Assay due to Sample Processing Control failure (Unresolved sample 
results). 
• To estimate the rate of indeterminate results for the GenePOC GBS 
Assay due to an Instrument failure (Indeterminate sample results). 
• To determine the reproducibility between sites of the GenePOC GBS 
System. 
 
 

 
 
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Study Design
Four (4) geographically diverse Clinical Centers will be selected based on 
a number of criteria, such as investigator and site personnel availability, 
number of samples of interest tested for Streptococcus agalactiae, GBS 
prevalence, familiarity with the Study Reference Method, experience with 
Streptococcus agalactiae culture isolation and clinical studies.  
Site(s) that will perform the Reference Method will have laboratory facilities 
where Streptococcus agalactiae characterization methods are performed 
for routine, investigation or research purposes.  
This clinical investigation will be composed of the following segments: 
Proficiency testing, Clinical Accuracy, Discrepant testing (optional) and 
Assay Reproducibility (selected sites). 
There are no risks to the patient inherent to the execution of this 
investigation since it will: 
1) Be performed on excess de-identified samples only; and 
2) Include parallel clinical routine testing by an approved and established 
method for reporting patient results. 
Results obtained from testing using the GenePOC GBS System will be 
compared to those obtained by the Reference Method. Investigators will 
ensure that, for a given sample, the participating technicians performing 
the Assay are masked from the results of the Reference Method and vice-
versa. 
Electronic and/or paper Case Report Form(s) will be used to record 
pertinent sample and laboratory information. No personal subject 
information will be collected by GenePOC.  
In cases of discrepant results between the Reference Method and the 
GenePOC GBS Assay, GenePOC staff will perform further characterization 
testing to elucidate the discrepancies. 
 
 
 

 
 
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Clinical Study
Main 
Eligibility 
Criteria 
• 
Antepartum pregnant women 
• 
18 years old and more 
• 
Gestation period at 35 to 37 weeks 
• 
Only one (1) sample per patient will be included in the study. 
• 
If the sample will be processed within 24 hours, store at room 
temperature. If the samples will be tested after 24 hours, 
refrigerate until testing is performed. Samples stored at 2-8oC can 
be tested with the GenePOC GBS System and the Reference 
Method up to 96h of collection. 
Clinical Study
Statistical 
Methods 
Results obtained with the GenePOC GBS System will be compared to those 
obtained with the Reference Method. The statistical analyses will include all 
compliant samples and will determine at least the following: 
• 
The sensitivity and specificity, PPV and NPV as well as exact 95% 
confidence interval. 
• 
The unresolved and indeterminate rates along with 95% exact 
confidence interval. 
• 
Poolability of the data. 
• 
Reproducibility percent agreements for qualitative and quantitative 
data. 
 
 
 

 
 
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TABLE OF CONTENTS 
1. 
INVESTIGATION CONTACTS ....................................................................................................... 15 
2. 
TERMINOLOGY ............................................................................................................................. 16 
3. 
INTRODUCTION ............................................................................................................................ 18 
 
Protocol Scope ......................................................................................................................... 18 
 
lntended Use ............................................................................................................................. 18 
 
Device Description .................................................................................................................... 18 
 
Test Principle .......................................................................................................................... 19 
 
Clinical Benefits and Justification for the Use of a New Technology ......................................... 19 
4. 
TRIAL OBJECTIVES ...................................................................................................................... 20 
5. 
STUDY DESIGN ............................................................................................................................. 20 
 
Clinical Investigation Requirements .................................................................................... 20 
 
Overview of the Evaluation ....................................................................................................... 21 
 
Study Criteria ......................................................................................................................... 23 
 
Sample Size Justification ........................................................................................................ 24 
 
Data Collection ........................................................................................................................ 24 
5.5.1 
Case Report Form………………………….……………………………………………………………...20 
 
Study Materials ........................................................................................................................ 25 
6. 
LABORATORY TESTING PROCEDURES .................................................................................... 27 
 
Sample Collection ..................................................................................................................... 27 
 
Sample Storage and Handling .................................................................................................. 27 
 
Testing Algorithm ...................................................................................................................... 27 
 
Storage & Shipping ................................................................................................................... 30 
 
Quality Control Testing ............................................................................................................. 30 
 
Clinical Trial Quality Assurance ................................................................................................ 31 
7. 
DATA COLLECTION, MANAGEMENT AND REPORTING ........................................................... 33 
 
Clinical Center Responsibility ............................................................................................... 33 
 
GenePOC Responsibility .......................................................................................................... 34 
 
Data Confidentiality ................................................................................................................. 34 
 
Data Verification and Validation Rules ................................................................................... 35 
8. 
CLINICAL TRIAL INCIDENTS, RISK MANAGEMENT AND ADVERSE EVENTS ........................ 35 
9. 
REGULATORY AND ADMINISTRATIVE INFORMATION ............................................................. 37 
10. REFERENCES ............................................................................................................................... 41 
11. APPENDIX ...................................................................................................................................... 42 
 
APPENDIX A: Clinical Investigation Requirements Relating to Each Clinical Center ............... 42 
 
APPENDIX B: Testing Algorithm .............................................................................................. 44 
 
APPENDIX C: Discrepant Testing Algorithm  ........................................................................... 45 
 
 

 
 
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1. SPONSOR CONTACTS 
 
 
 
 Sponsor 
GenePOC inc. 
360 Franquet Street, door 3 
High Tech Park 
Québec, Qc 
Canada, G1P 4N3 
e-mail: info@genepoc.ca 
www.genepoc-diagnostic.com 
 
 Study Manager 
Catherine Lippé, M.Sc. 
Study Manager 
GenePOC Inc. 
e-mail: catherine.lippe@genepoc.ca 
Phone: +1 418 650-3535 #269 
 
 
 
 

 
 
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2. TERMINOLOGY 
 
 
 
 Acronyms 
BAP 
Blood Agar Plate 
bp 
Base pairs 
CDA 
Confidentiality Disclosure Agreement 
CDC 
Centers for Disease Control and Prevention 
CLIA 
Clinical Laboratory Improvement Amendments 
CRA 
Clinical research associate 
CTA 
Clinical Trial Agreement 
DNA 
Deoxyribonucleic Acid 
DTT 
Disposable Transfer Tool 
EC 
External control 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
GBS 
Group B Streptococcus 
IEC 
Independent Ethics Committee 
INC 
Inconclusive 
IND 
Indeterminate 
IRB 
Investigational Review Board 
IUO 
Investigational use only 
NPV 
Negative predicative value 
PC 
Process Control 
PCR 
Polymerase Chain Reaction 
PI 
Principal investigator 
PPV 
Positive predictive value 
SB 
Sample Buffer 
SBT 
Sample Buffer Tube 
UNR 
Unresolved 
 
 
 

 
 
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 Definitions 
 
 
 
Clinical Center(s) 
The site(s) that will perform the GENEPOC GBS test and, the 
culture method for the clinical study. 
GENEPOC GBS 
Documents provided to investigators by GenePOC including the 
GenePOC instrument User's Manual, the GenePOC GBS Study 
Protocol, the GenePOC GBS Package lnsert and the GenePOC 
GBS Study Site Manual. 
GENEPOC GBS 
System 
The system is composed of the GenePOC GBS test which is 
used in conjunction with the GenePOC™ instrument. 
PCR Operator 
Participating laboratory technician who has successfully 
completed the proficiency testing  
PIE 
GBS disposable microfluidic cartridges (describe in this 
document as PIE because of the shape of the cartridge). 
Principal 
Investigator 
Principal Investigator (Pl): A person who actually conducts the 
clinical investigation, under whose immediate direction the test 
article (device) is used involving a sample derived from a human 
subject; or, in the event of an investigation conducted by a team 
of individuals, is the responsible leader of that team. 
Reference Method 
The Reference Method for this study will be the Culture, a culture 
method to detect Streptococcus agalactiae strain from a sample. 
Sample 
Left over Lim broth enrichment intended for regular culture. 
Sponsor 
GenePOC Inc.  
(Patient) sample 
Vaginal/rectal swab samples collected for routine laboratory 
testing from a pregnant woman suspected to be colonized with 
Streptococcus agalactiae (GBS). 
 
 
 

 
 
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3. INTRODUCTION 
 
 
 
 Protocol Scope 
 
The purpose of this clinical investigation is to establish the performance characteristics 
of the GenePOC GBS system for its use in determining the presence of GBS in 
vaginal/rectal swab samples, after Lim Broth enrichment, from pregnant women. 
Sensitivity and Specificity will be established in comparison to the Reference Method. 
For this investigation the Reference Method will be Lim broth culture, subcultured onto 
blood agar plate (BAP), routine method for detection of GBS coming from vaginal/rectal 
swab samples. Up to four (4) selected sites will perform this clinical investigation. 
 
 lntended Use 
The GenePOC GBS test performed on the GenePOC System is a qualitative in vitro 
diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 
vaginal/rectal swabs from antepartum women following enrichment in Lim broth for 18-
24 hours. The GenePOC GBS test utilizes automated sample preparation and real-time 
polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the 
Streptococcus agalactiae genome. The GenePOC GBS test is indicated for the 
identification of antepartum GBS colonization and does not provide susceptibility results. 
Culture isolates are needed for performing susceptibility testing as recommended for 
penicillin-allergic women. 
 
 Device Description 
The GenePOC GBS test will be performed using the GenePOC instrument. The 
GenePOC instrument, used in conjunction with appropriate reagents, is capable of 
automated lysis cells, dilution of nucleic acids from multiple sample types as well as 
automated amplification and detection of target nucleic acid sequences. 
 
 
The GenePOC GBS Assay reagents kits consist of: 
 
 
Components 
Packaging 
Sample Buffer Tube (SBT) 
A 4.5ml tube containing 1ml of sample buffer 
Disposable Transfer Tool 
Plastic disposable transfer pipette for transferring 
inoculated sample buffer (SB) into the PIE. 
GBS disposable microfluidic cartridges 
(PIE) 
Fully integrated disposable microfluidic cartridge for 
detection of GBS. 
 
 
 
 

 
 
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 Test Principle 
 
The study population consists of vaginal/rectal swab samples from pregnant women at 
35-37 weeks of gestation for whom GBS diagnostic procedures are indicated and 
ordered. After the sample is collected and transferred into the transport media (Amies 
or Stuart), it is transported to the laboratory and stored at the appropriate temperature 
for no more than 96 hours.  
When ready for testing, the swab is placed into a culture tube with Lim Broth for 18-24 
hours. After incubation, a 15 µL aliquot of the broth is used for detection of the presence 
of GBS. The aliquot of the broth is mixed with GenePOC Sample Buffer Tube Reagent 
(SBT) and then vortex for 5 seconds, 100 to 200 µL of the Sample-SBT mix is transferred 
to the GBS PIE using the disposable transfer pipette. GBS PIE is then transferred into 
the GenePOC System for fully integrated real time analysis.  
The GenePOC GBS test includes reagents for the simultaneous detection of the target 
GBS DNA, a process control (PC) to monitor processing, amplification, and the absence 
of reaction inhibitors. The GBS primers and probe detect a target region of 190 base 
pairs (bp) of the cfb gene of Streptococcus agalactiae. The results are interpolated by 
the system from measured fluorescent signals and embedded calculation algorithms. 
Results may be viewed, be printed, transferred and/or stored by the user. 
 
 Clinical Benefits and Justification for the Use of a New Technology 
The group B streptococcus (Streptococcus agalactiae, GBS) is a cocci gram-positive 
bacterium that is one of the main causes of neonatal mortality in developed countries. 
Neonatal infections caused by GBS are found in two forms1,2, early or late onset. The 
early-onset infections occur during the 7 days following birth; they are the cause of 
approximately 80% of GBS infections in newborns with mortality rate of 5-20%3. The late 
onset infections occur between the first week and the seventh month of life. They are 
rarer and the mortality rate is lower. In the case of early-onset infections, GBS is 
transmitted during childbirth via the genital tract of the mother while for late onset 
infections, contamination is not necessarily via the mother4. Prolonged hospitalization 
and the use of expensive equipment is generally required for GBS infected newborn 
care. Survivors may also suffer permanent damage such as mental developmental delay 
or loss of vision. 
Currently, the clinical guidelines of the Centers for Disease Control and Prevention5 and 
the Canadian Society of Obstetricians and Gynaecologists6 recommend the use of a 
GBS screening during pregnancy (antepartum) combined with a treatment of antibiotics 
for prophylaxis during delivery (intrapartum) to all women detected GBS positive. This 
approach has reduced the incidence of perinatal GBS infections in North America7. 
Unfortunately, the presence of a vaginal colonization in pregnancy does not necessarily 
indicate the presence of a settlement at the time of delivery. Some women are treated 
when they are no longer carriers of GBS, while others are not, consequently they will be 
carrying GBS at the time of delivery. 

 
 
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A first version of a screening test by polymerase chain reaction (PCR) in the early 2000s 
has demonstrated the usefulness of a rapid detection of GBS8. This method however, 
was not fully integrated (independent lysis method of PCR system), unlike the GenePOC 
system, limiting its use to hospital laboratories. 
The GenePOC GBS test is a step further in rapid detection of GBS by increasing the 
automation of the detection and simultaneously increasing the ease-of-use.  
 
 
4. TRIAL OBJECTIVES 
 
 
 
The objectives of this multi-center prospective clinical study are: 
 
• To establish the performance characteristics of the GenePOC GBS System 
for its use in determining the presence of GBS in vaginal/rectal swab, after Lim 
Broth enrichment, samples from antepartum pregnant women. Sensitivity and 
specificity will be established in comparison to the Reference Method. 
• To estimate the Positive and Negative Predictive Values (PPV and NPV) of the 
GenePOC GBS System. 
• To estimate the rate of unresolved results for the GenePOC GBS System due 
to Sample Processing Control failure (Unresolved sample results). 
• To estimate the rate of indeterminate results for the GenePOC GBS test due to 
an Instrument failure (Indeterminate sample results). 
• To determine the reproducibility between sites of the GenePOC GBS System. 
 
 
5. STUDY DESIGN 
 
 
 
 Clinical Investigation Requirements 
Up to four (4) GenePOC GBS clinical centers will participate in the clinical study. Clinical 
centers will be selected for the clinical study based on a number of criteria, such as 
investigator and site personnel availability, number of samples of interest tested for GBS, 
GBS prevalence, familiarity with the study Reference Method, and experience with GBS 
culture isolation and clinical investigations. 
Site(s) will have a laboratory where GBS characterization methods are performed for 
routine, investigation or research purposes. The exact same media type, reagents and 
procedure will be used for performing the Reference Method throughout the clinical 
investigation by all sites. 
 
The Clinical investigation requirements relating to each Clinical Centers are detailed in 
Appendix A. 

 
 
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 Overview of the Evaluation 
The Clinical investigation will consist of four (4) distinct segments: Proficiency testing, 
Clinical Accuracy testing, Discrepant testing (optional) and Assay Reproducibility 
(selected sites). 
 
5.2.1. Proficiency Testing 
Each PCR operator who will participate in the GenePOC GBS clinical study will be 
trained by a GenePOC Study Manager (or CRA) on handling and performing the 
GenePOC GBS testaccording to the Investigational Use Only (IUO) Package insert, the 
Study Site Manual and the GenePOC System User's Manual. 
A test panel containing negative samples and GBS positive samples will be used to 
assess each new participating technician proficiency with the protocol test methods. This 
panel will be provided in a sufficient number and will contain negative samples and GBS 
positive samples. A participating technician failing to achieve the qualification criteria on 
initial testing of the GenePOC GBS System must repeat the training panel (a maximum 
of two times), and will be qualified if he/she meets the acceptance criteria for the 
repeated runs. If the participating technician fails to meet the retest criteria, he/she 
cannot be qualified for participation in the GenePOC GBS clinical study as a PCR 
operator for the GenePOC GBS System unless re-training occurs and the participating 
technician is able to pass the proficiency test. 
To be qualified for participation in the GenePOC GBS clinical study as a PCR operator, 
each participating technician must achieve a correct answer for all positive samples and 
true negative (no target) samples in the molecular method using the provided proficiency 
panel. 
For the Reference Method no proficiency testing will be done. 
If a new participating technician is included in the study after the initial training and 
proficiency testing occurs, the training of this person can be performed by a GenePOC 
representative or by a proficient PCR operator on-site. The new participating technician 
must also pass the proficiency test to participate in the study. 
 
5.2.2. Clinical Accuracy Testing 
This clinical study is designed in such a way that all sites may perform the Reference 
Method, which requires that each Clinical Center has laboratory facilities where GBS 
characterization methods are performed for routine, investigation or research purposes. 
Reference method is defined as Lim broth culture, subcultured onto blood agar plate 
(BAP) for detection of Streptococcus agalactiae strains. More specifically, the 
Streptococcus agalactiae bacteria, when present, will be isolated using an Enriched 
Culture method. The exact same media type, reagents and procedure will be used 
for performing the Reference Method throughout the clinical investigation by all 
sites. 
To be considered for enrollment in the study, a sample must satisfy all eligibility criteria 

 
 
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described in Section 5.3 of this Protocol. Samples will be collected using a swab.  
Sample testing will be performed according to Section 6 of this protocol. Results 
obtained from testing of samples using the GenePOC GBS System will be compared to 
those obtained by the Reference Method. These results will serve to verify the GenePOC 
GBS System performance. 
GenePOC GBS System and Reference Method testing will be performed as described 
in the GenePOC GBS Investigation Documents and the testing algorithm shown in 
Appendix B. Investigators will ensure that, for a given sample, the PCR operator 
performing the test are masked from the results of the Reference Method and vice-versa. 
The purpose of the clinical investigation is to enroll sufficient samples to obtain 
approximately 150 positives samples for GBS based on the Reference Method final 
result. With an estimated prevalence of approximately 25%, it is projected that up to 600 
samples will be needed across all participating Clinical Centers. 
The Study Manager will monitor sample enrollment and prevalence of GBS across all 
participating Clinical Centers. It may be necessary to increase the enrollment rate of 
samples or to prematurely stop enrollment at one or more participating centers, 
depending upon the total number of samples and the positive samples obtained across 
all Clinical Centers. 
At least three (3) lots of the GenePOC GBS Assay kits will be used for this Clinical trial. 
Each Clinical Center with test a minimum of two (2) lots. 
Once per day, a reference GBS strain bearing the cfb gene (e.g. American Type Culture 
Collection, ATCC 12973) will be used as a positive external control (EC) while not 
inoculated sample buffer will be used as a negative EC. If either or both of the ECs fail 
to give the expected result, all samples tested in that run will be repeated from the 
remaining SBT containing the sample stored at 2-8°C along with new positive and 
negative ECs. 
 
5.2.3. Discrepant Testing (optional) 
 
In cases of discrepant results between the Reference Method and the GenePOC GBS 
Assay, further characterization testing may be requested by GenePOC to be performed 
by the Clinical Center and possibly at GenePOC to attempt to resolve the discrepancy. 
See Section 6.3.3 and Appendix C for description of the minimal discrepant testing. An 
electronic or paper Discrepant Results Form will be used for recording discrepant testing 
information. 
 
5.2.4. Assay Reproducibility Testing (for selected sites) 
 
Reproducibility study will be performed with a panel of samples spiked at 4 different 
concentrations of GBS: Negative, High negative (1/50x LOD), Low positive (1.5x LOD), 
Moderate positive (3x LOD). Each panel will consist of 8 samples with 2 replicates of 
each concentration. 

 
 
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The site-to-site reproducibility will test the same reproducibility panel at three (3) 
designated sites (2 external sites and GenePOC laboratories) for the within-run (3 
replicates), between-run (2 runs per day) and between-day (5 days, consecutive or not) 
variance with multiple operators and instruments. A single lot of the GenePOC GBS test 
will be tested by each sites according to the Study Site Manual instructions and the IUO 
GBS test Package Insert. 
The reproducibility panel will contain randomized moderate positive, low positive and 
negative samples. 
Once per day, a reference GBS strain bearing the cfb gene (e.g. ATCC 12973) will be 
used as a positive external control (EC) while not inoculated sample buffer will be used 
as a negative EC. If either or both of the ECs fail to give the expected result, all samples 
tested in that run will be repeated from the remaining SBT containing the sample stored 
at 2-8°C along with new positive and negative ECs. 
 
 Study Criteria 
Note: For this study, samples will not be collected for the express purposes 
of this evaluation. Only excess de-identified samples will be used. 
 
5.3.1. Inclusion Criteria 
• Antepartum pregnant women  
• 18 years old and more 
• Being at a gestation period of 35 to 37 weeks. 
• Vaginal/rectal swab sample  
• Transport and storage times, and conditions (e.g. room 
temperature and/or refrigerated) within the labeled indications. 
o : If the sample will be processed within 24 hours, store at room 
temperature. If the sample will be tested after 24 hours, 
refrigerate until testing is performed. Sample stored at 2-8oC can 
be tested with the GenePOC GBS System  
o Fresh sample must be tested with the Reference Method 
within 96 hours (4 days) of collection if kept at 2-25°C 
• The GenePOC GBS System and the Reference Method will be 
performed according to the GenePOC GBS Investigation 
Documents. 
• Materials use within their expiration date 
 
 
 

 
 
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5.3.2. Exclusion Criteria 
• Non pregnant women 
• Less than 18 years old 
• Gestation not between 35-37 weeks  
• Transport and storage times and conditions that exceed these Study 
Protocol requirements 
• The GenePOC GBS System and the Reference Method not performed 
according to the GenePOC GBS Investigation Documents 
• Materials used beyond their expiration date 
• Samples without all test results required by this Study Protocol. 
Samples that are inadvertently entered into the study that do not 
meet the sample inclusion criteria will be made non-compliant. 
 
 Sample Size Justification 
The purpose of the clinical investigation is to enroll sufficient samples from up to four (4) 
Clinical Centers to obtain a minimum of 150 and a maximum of 160 samples positive for 
GBS based on the Reference Method final result. With an estimated prevalence of 
approximately 25%, up to 600 samples could be tested across all Clinical Centers.  
 
A minimum of 30 positive results per site is expected but sites with a higher prevalence 
of GBS could contribute more positive results to reach the required number. A potential 
minimum of 200 samples and a potential maximum of 300 total samples will be obtained 
at each clinical center. 
 
The performance obtained and the statistical confidence intervals will be monitored 
during the study in order to stop the enrollment when deemed appropriate. 
 
 Data Collection 
The principal investigator (PI) will ensure that each designee and the scope of the 
designee's delegated authority are recorded on the Site Signature and Delegation of 
Authority Log. The designee's signature, initials, start and end dates, list of study related 
tasks, and document review and approval must be recorded on the form. 
 
5.5.1. Case Report Forms 
All Clinical Centers will use electronic data capture (EDC) through an electronic Case 
Report Forms (eCRF). 
An eCRF will be completed for each sample enrolled in the study in order to record 
relevant demographic, clinical and laboratory information. These forms must be 

 
 
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completed and approved as described in the Study site Manual and as instructed during 
the training.  
 
Patients whose sample will be included in the study will not be identified by name or by 
hospital medical record number on the eCRF. A field is available for a study-specific 
patient identifier code which will uniquely identify each subject. This code will be 
assigned by a designated individual at the Clinical Center., who is not directly involved 
in any other aspects of the study. This code will be a series of: 
• 5 digit XX-00Y (X being the site number and Y the samples number attributed 
sequentially 
• And three letters FML: (F being the first letter of the First Name; M being the first 
letter of the Middle Name or a dash (-) if the persons does not have a middle name; 
L being the first letter of Last name). As per local regulations, initials can also be a 
series of three letters determined by clinical center. 
This code will have no relation with protected health information, and will be used only 
to track subject enrollment. A Study Subject Log associating each patient with its patient 
identifier code will be maintained in a secure location on-site by the designated individual 
assigning the codes to the patients. Neither the investigator, nor any member of the 
study team will have access to this log.  
 
Each enrolled sample will be assigned a unique Study Number, which will be identified 
by bar code labels to be provided by GenePOC. Study Numbers will conform to seven 
(7) characters in a "GXnnnnA" format: where "G" is a letter identifying the assay (GBS), 
"X" is a letter identifying the site, "nnnn" is an incrementing number identifying each 
sample within a study segment, and "A" is a letter denoting the study segment, ("A" for 
Accuracy or "D" for Discrepant testing). For panel members provided by GenePOC for 
testing, the same study number pattern will be used and the study segment will be 
identified as follows:  "P" for Proficiency, “R” for Reproducibility and "W" for Workflow 
Practice. 
 
5.5.2. GenePOC Data 
The operator will save the instrument data on properly labeled USB keys on each 
testing day.On every testing day, data will be uploaded to study specific database. 
 
 Study Materials 
5.6.1. Provided by GenePOC 
• GenePOC starter kit will minimally contain the following components:  
o GenePOC Instrument 
o GenePOC Sample Racks; 
o GenePOC System User's Manual. 
• 
Tube Vortexer  
• 
Instructions and Training Materials for the Study (Study Site Manual); 
• 
GenePOC GBS test IUO kits (including PIE, SBT and DTT); 

 
 
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• 
CRFs and other required electronic and printed forms; 
• 
Barcode labels with study numbers for all samples and study segments; 
• 
Masked and randomized proficiency panel of characterized samples; 
• 
Shipping materials ice packs, shipping boxes, labels and GenePOC FedEx 
account number for returning samples, forms, material and equipment, and 
any other study-required shipping; 
• 
GenePOC Import permit (into Canada) for pathogens (US sites only); 
• 
Freezer boxes, plastic microtubes and screw-caps; 
• 
Sufficient numbers of USB keys for instrument data daily backup; 
• Plastic bags to hold/store and ship PIE; 
• Swabs for environmental testing; 
• Listing for Study binder(s) indicating essential information for archiving purposes 
at the closing of the study; 
• Technical and engineering support as needed; 
• Miscellaneous supplies as agreed upon. 
 
5.6.2. Provided by Investigator 
• Sample meeting the eligibility criteria outlined in Section 5.3 above; 
• Copies of the laboratory’s procedures for the GBS collection (if available), 
routine diagnostic method and quality control; 
• Material for routine testing of GBS: 
o Transport media (Amies or Stuart) 
o Lim broth; 
o Blood agar plate (BAP); 
o Tests for identification; 
• Facilities, time and personnel necessary to perform the evaluation according 
to this Study Protocol, and manage the study records according to the 
Training Manual, the GenePOC instructions and Regulatory Requirements; 
• Import permit provided by the CDC (into US only) for pathogens including at 
least Streptococcus genera. 
• Trained personnel in the preparation and shipment of biological substances per 
CDC (USA sites only), Transportation of Dangerous Goods Regulations 14 
(TDGR) (Canadian sites only), and IATA guidelines (all sites); 
• lncubator at 35-37°C; 
• Vaginal/rectal swab; 
• All equipment and supplies necessary to perform Reference Method testing, 
except as noted in previous section; 
• Secure room temperature storage space for the GenePOC GBS Assay kits 
and culture media (as required by package inserts and study Training 
Manual); 
• Adequate refrigerator (between 2oC and 8oC) for the storage of culture 
media, reference kits (as required by Package lnserts) and fresh samples; 

 
 
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• Adequate storage space in a -70±5oC freezer or colder to hold frozen SBT, 
broths, isolates and panels; 
• Control organisms for Reference Method and external control, i.e. 
Streptococcus agalactiae strain (e.g. ATCC  12973); 
• Dry ice to send frozen SBT and isolates to GenePOC; 
• Site policies or procedures to prevent the release of personal information about 
patients to the investigator; 
• Miscellaneous supplies as agreed upon. 
 
6. LABORATORY TESTING PROCEDURES 
 
 
 
 Sample Collection 
 
 Vaginal/Rectal swab should be performed in accordance with published guidelines for 
collection of clinical samples for culture of Group B Streptococcus (CDC in United States 
and SOGC in Canada). 
Samples should be transported to the laboratory according to the hospital's policies 
but viability of GBS is preserved in transport medium for up to 4 days between 2oC 
to 25oC.  
 
 Sample Storage and Handling 
 
• Samples that meet the study criteria should be labelled with a bar coded study 
number provided by GenePOC; 
• All relevant information regarding the sample will be recorded on the eCRF; 
If the sample will be processed within 24 hours, store at room temperature. If the 
sample will be tested after 24 hours, refrigerate until testing is performed. Sample 
stored at 2-8oC can be tested with the GenePOC GBS System and the Reference 
Method up to 96h of collection. 
 
 Testing Algorithm 
 
 
Results obtained with the GenePOC GBS System will be compared to those 
obtained with the Reference Method. All Clinical Centers will be using the same 
protocol, media and the same Reference Method to ensure uniformity of the test 
methods across sites. The Reference Method is described in detail in Section 6.3.2 
of this protocol. 
 
The vaginal/rectal swab sample will follow the normal hospital path up to the Lim Broth 
culture, of which an aliquot will be transferred to the GenePOC sample buffer tube 
(SBT) to be processed with the GenePOC instrument as described in the GenePOC 
GBS test Package insert. Lim Broth culture remaining in the container will then be 
used to start the Reference Method. 
 
Lim broth culture must be kept at 2-8°C after testing for a maximum of five (5) days. 

 
 
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When it is confirmed that no repeat on fresh Lim broth culture is necessary, it will be 
transferred to a single appropriately labelled tube and frozen at -70±5°C or colder for 
further testing of all negative frozen samples and /or possible future discrepant testing.  
 
The SBTs will be placed at 2-8°C in the event repeat testing is required. If the sample 
does not require repeat testing, the SBT will be frozen at -70±5°C. 
 
6.3.1. GenePOC GBS Assay 
 
The GenePOC GBS Assay will be performed according to the assay Package insert. 
 
 Non-Reportable Results 
 
 
Samples that initially produce a non-reportable result (Unresolved, indeterminate or 
External Control failure) will be repeated as described below. Samples that have a 
reportable (Positive, Negative) result upon repeat testing will be included in the data 
analyses. Repeated samples that do not give a reportable result will not be included in 
data analyses. They will be reported separately as non-reportable samples. 
 
6.3.1.1.1. 
Unresolved Samples (UNR) 
 
 
An Unresolved Sample is when the internal control fail (no amplification) and the target 
reaction (GBS) also show no amplification.  
An Unresolved sample will be repeated from the refrigerated SBT. These samples may 
be repeated alone, with other samples to be repeated, or included in a new run with 
fresh sample. In cases where the sample is Unresolved again, no additional repeat 
testing will be performed. 
 
6.3.1.1.2. 
Indeterminate Result (IND) 
 
 
For an Indeterminate (IND) result due to an instrument failure, testing of the sample(s) 
will be repeated from the refrigerated SBT and may be tested with other samples that 
require repeat testing, or included in a new run with fresh samples. For any IND result, 
the Study Manager should be contacted and the incident must be documented on the 
eCRF. 
 
6.3.1.1.3. 
External control failure 
 
 
ln case of a failure of either or both external control, the testing of all clinical samples 
and any repeated samples included in the run will be repeated from the refrigerated 
SBTs along with new external control (see Section 6.5 for details). In cases where 
external control fails again, the Study Manager should be contacted. 
 
 
 

 
 
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6.3.2. Reference Method 
 
 
The Group B streptococcus bacteria, when present, will be isolated from vaginal/rectal 
swab samples from pregnant women using a Lim Broth culture and subcultured on Blood 
agar plate (Important note, only Lim Broth could be used for the study). The swab will 
be inoculated into a Lim broth (Todd-Hewitt broth supplemented with colistin (10 µg/ml) 
and nalidixic acid (15 µg/ml)). Incubate inoculated selective broth for 18–24 hours at 
35°–37°C in ambient air or 5% CO2. Subculture the incubated broth on a non-selective 
blood agar plate (e.g., tryptic soy agar (TSA) with 5% defibrinated sheep blood). After 
incubation for 18–24 hours at 35°–37°C in ambient air or 5% CO2, inspect agar plates 
and identify organisms suggestive of GBS (e.g., large, gray colonies with narrow zone 
of beta hemolysis). If GBS is not identified after incubation for 18–24 hours, then plates 
should be reincubated overnight and examine for suspected GBS colonies.  
 
 GBS Identification 
 
 
Colonies morphologically resembling GBS from blood agar plate (large, gray, and 
translucent with a small zone of beta-hemolysis or no zone of hemolysis) will be 
confirmed as follows: 
• Catalase negative; 
• Gram-positive cocci in pairs and chains; 
• And one of the following positive reactions: 
• Group B streptococcal grouping antisera; 
• Camp test; 
• Rapid hippurate and: 
• PYR test negative if strain is hemolytic (Enterococci can be haemolytic, 
hippurate positive but PYR positive) or a second previous test if strain is 
nonhemolytic. 
 
Note: no chromogenic agars could be used as FDA has not cleared any. 
 lnconclusive Result 
 
For an lnconclusive (lNC) result in the Reference Method due to a non-interpretable 
blood agar plate, sample will be retested from the existing inoculated and incubated Lim 
broth. The Lim broth kept at 2-8°C should be used to inoculate a new blood agar plates 
as directed in Section 6.3.2. 
 
 Repeat of negative samples for the Reference Method 
In case of suspected irregularity in the testing of the reference method, the entirety of 
the specimens that gave a negative result with the reference method could be re-tested 
at a single testing site according to section 6.3.2. In this case, the tested material will be 
the frozen LIM broth culture stored at -70⁰C. 
 
 

 
 
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)
6.3.3. Discrepant Testing 
Frozen Lim Broth and frozen SBT coming from discrepant result samples will be send 
to GenePOC for further testing. 
 
During the course of the trial, the GenePOC Study Manager will inform the sites which 
samples require to be ship to GenePOC.  
 
 Storage & Shipping 
 
• SBT samples must be kept at 2-8oC after testing for a maximum of five (5) days. 
When it is confirmed that no repeat is necessary, they will be frozen at -70±5oC 
or colder for possible future discrepant testing; 
• All Lim broths (Streptococcus agalactiae isolates) must be stored at -70±5oC or 
colder, but only samples requested by the Study Manager must be shipped on 
dry ice to GenePOC; 
• All microfluidic cartridges (containing amplified product) must be stored between 
2oC to 8oC in a plastic bag and shipped on icepacks to GenePOC as directed by 
Study Manager. 
• Detailed shipping instructions will be provided in the Training Manual. 
• At the end of the trial, clinical center will be instructed by Study Manager to 
destroy, as per their institution policy, samples that did not require shipment to 
GenePOC. 
 
 Quality Control Testing 
 
In addition to the quality assurance and quality control programs of each laboratory 
under their respective certification (e.g. CLIA), the minimum quality control 
described below must be performed during the course of this study. 
 
6.5.1. GENEPOC GBS Assay 
 
 External Controls 
 
 
For each day in which samples are processed, appropriate positive and negative 
external control (ECs) will be tested. These external controls results will need to be 
kept in the Site File and forwarded to GenePOC. 
 
External control materials are provided by GenePOC. A reference GBS strain bearing 
the cfb gene (e.g. ATCC 12973) will be used as a positive external control (EC) while 
not inoculated Lim broth will be used as a negative EC. 
 
 Sample Processing Control 
The Processing Control (PC) is incorporated into each microfluidic cartridges and is 
intended to monitor for the effectiveness of liquid displacement, sample treatment (Lysis) 
and heating during the sample processing steps. The PC also monitors the integrity of 

 
 
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the PCR reagents, the thermal cycling, and for the presence of inhibitory substances 
during the amplification and detection steps. A failed PC renders the sample Unresolved. 
 
 Monitoring for the Presence of DNA Contamination 
 
 
At the request of the GenePOC Study Manager, the work area and equipment will 
be monitored for the presence of Streptococcus agalactiae cfb gene contamination 
using the GenePOC GBS test. Should contamination arise, the Study Manager will 
instruct the site on the measures to take prior to testing additional samples. 
 
 
6.5.2 Reference Method 
As determined by the Laboratory procedure, appropriate positive and negative external 
control (ECs) will be tested on regular basis for the reference method. These external 
controls results will need to be kept in the Site File and forwarded to GenePOC. 
 
External control materials are provided by GenePOC. A reference GBS strain bearing 
the cfb gene (e.g. ATCC 12973) will be used as a positive external control (EC) while 
not inoculated Lim broth will be used as a negative EC. 
 
 Clinical Trial Quality Assurance 
The following measures will be taken to assure the quality of the trial conduct and data. 
 
6.6.1. Accountability of investigational Materials 
 
The Clinical Center will account for all GenePOC GBS System investigational materials 
received from GenePOC. GenePOC clinical trial team will monitor site records for 
investigational materials accountability. All materials will be handled and disposed of 
according to Package Insert instructions, Study Site Manual or as directed by the 
GenePOC Study Manager. Upon completion of the study, all remaining supplies 
provided by GenePOC will be returned to GenePOC unless otherwise directed by the 
GenePOC Study Manager in writing. 
 
6.6.2. Process for Protocol Changes and Deviations 
 
 Protocol Amendment 
 
 
A Protocol Amendment is a change to, or clarification of, the Study Protocol which may 
impact the conduct and potential benefit of the study, or participant safety. For each 
protocol amendment, the GenePOC Study Manager will complete a Protocol Change 
Form. Protocol changes must be reviewed, approved and signed by the GenePOC 
Study Manager, a representative of GenePOC and the Principal Investigator. All 
changes to the Protocol must be submitted to the Clinical Center IEC for examination 
and approval (if required). The Principal Investigator will ensure that protocol changes 
are implemented after written approval by all parties (including the IEC if needed), that 

 
 
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all personnel using the protocol at the Clinical Center receive training for the change, 
and that the new protocol is maintained in the study records at the Clinical Center. 
Examples of such changes include, but are not limited to: the study objectives, study 
design, sample sizes, study procedures, or administrative aspects. 
 
 Protocol Deviations 
 
 
Each protocol deviation reported to the GenePOC Study Manager by the Clinical Center, 
observed by the GenePOC Study Manager or CRA during monitoring contacts or visits, 
or observed through review of CRFs will be documented by the GenePOC Study 
Manager, CRA or Clinical Center personnel on a Protocol Deviation Form. The Protocol 
Deviation Form will contain the description of the deviation, the impact on the trial or 
subject enrollment, the impact to the affected data and any corrective action taken to 
conform to the protocol. All Protocol Deviation Forms will be reviewed and signed by the 
GenePOC Study Manager or CRA and either the Principal Investigator (if the Clinical 
Center was involved or concerned) or the GenePOC Clinical Operations Manager. A 
copy of each Protocol Deviation Form will be kept at the Clinical Center and the original 
at GenePOC. 
Examples of such deviations include, but are not limited to: 
• 
not completing the testing required by the protocol; 
• 
enrolling inappropriate samples; 
• 
failure to follow Package lnsert instructions for use and storage of the 
investigational device; 
• 
failure to follow the Reference Method (e.g. use of expired materials); 
• 
failure to perform EC as directed; 
• 
not respecting the time to perform testing or retesting. 
Protocol deviations might render a data not eligible to be include in the final data 
analysis. 
 
6.6.3. Methods to Assure Trial Consistency and Integrity: Monitoring and Auditing 
Monitoring will be accomplished by telephone conversations and recorded on the Site 
contact log, written correspondence (including email and letters), and site visits recorded 
on the site visit log and Clinical Trial Monitoring Reports. 
 
Periodic checks may be made with the Principal Investigator and/or his/her staff that will 
include availability of materials, subject and sample enrollment, product accountability, 
and clarification of any questions. These checks may be accomplished via telephone 
conversations and/or written communication (emails or letters/memos). 
 
Telephone conversations will be documented by the GenePOC Study Manager and 
CRA (recorded on the site Contact log). Critical study communications imparted by 
telephone to Clinical Center personnel (including but not limited to new instructions or 
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will be followed up with a written communication to the Clinical Center. Copies of relevant 
written communication (including e-mails) will be kept by the GenePOC Study Manager 
and the Clinical Center. 
 
Monitoring visits may include review of IEC review status, laboratory accreditation, 
subject enrollment status, regulatory requirements, study compliance, eCRF and source 
data, adverse event and incident reporting, and study materials storage and disposition. 
Protocol Change Forms and Protocol Deviation documentation should be reviewed as 
well as CRFs and applicable source data. Follow-up actions will be documented in 
writing to the Clinical Center. 
The GenePOC CRA will arrange for correction of discrepancies, missing data, or 
omissions on CRFs by the Principal investigator or designee as appropriate.  
 
The GenePOC Study Manager will maintain close liaison to clarify any problems that 
may arise, and to ensure that the study is being carried out according to this protocol. 
The Clinical Center shall permit the GenePOC CRA, and other GenePOC personnel as 
indicated, to visit the Clinical Center and audit or inspect the study records and materials, 
to determine Principal Investigator’s compliance with the protocol, relevant guidelines 
and regulations for clinical trials. 
 
 
7. DATA COLLECTION, MANAGEMENT AND REPORTING 
 
 
 
 Clinical Center Responsibility 
 
 
7.1.1. General Instructions on Recording and Sending Data to GenePOC 
 
An Electronic Data Capture (EDC) system will be used by all Clinical Centers. 
 
Individual instructions for completing paper source documents, CRFs and other 
forms will be provided by GenePOC in the Training Manual. 
 
Electronic media containing instrument data should be sent to GenePOC at least 
once per week. The Clinical Center must keep one of the instrument back-up media 
on site. 
 
Test results should be entered in the eCRF promptly i.e. within 2 days of the test 
results are confirmed. 
 
The following paper forms (but not limited to) will be completed as needed and 
kept on site during the study with a copy at GenePOC. The original will be kept 
at GenePOC at the end of the study with copies kept at the Clinical Center: 
• 
Site Signature and Delegation of Responsibility Log (All persons authorized to 
complete, review and/or sign study documentation, including CRFs, will sign 
this Log. 

 
 
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• 
Study Visit Log; 
• 
Reference method external control forms for culture media will be completed 
and copies will be sent to GenePOC with originals kept at the Clinical Center 
at the end of the study. 
• 
Site Contact Log forms will be completed and maintained at the Clinical 
Center. 
 
Paper source documents will be completed first then the data will be transferred to 
the eCRF. 
 
 Electronic Data Capture (EDC) 
 
 
Electronic CRFs will have to be completed immediately (usually within 2 days of 
collection) following completion of the testing procedure. 
 
The Principal Investigator must designate, in writing, any individuals authorized to 
complete and review the eCRFs. Only the Principal Investigator will have the right 
to sign the eCRFs. 
 
7.1.2. Final Report 
 
The Principal Investigator, with input from the laboratory personnel, will be asked to 
provide GenePOC with a final report of special study issues, findings, assessment 
of ease-of-use and workflow, and any problems or recommendations, within 30 days 
of completion or termination of the study. This final report may include the 
convenience (ergonomies, performance, utility, rapidity, etc.) of the GenePOC GBS 
System for integration into routine laboratory use and potential use near the patient. 
 
 GenePOC Responsibility 
 
A termination letter or notice will be sent by GenePOC to the Principal Investigator 
notifying the Clinical Center of the successful completion of the study terms by the 
Clinical Center. Terms and notifications for other causes of study termination will be 
addressed in the Clinical Trial Agreement. 
 
 Data Confidentiality 
 
GenePOC will maintain the security and confidentiality of all trial data sent to 
GenePOC. GenePOC and the Clinical Center may be required to provide regulatory 
agencies access to trial data and records. GenePOC trial databases will not be 
shared with any third party. GenePOC provides an assurance that the de-identified 
data obtained in this study will be safeguarded and not used for unauthorized 
purposes. All other agreements by GenePOC, the Principal Investigator, and the 
Clinical Center in regards to confidentiality may be found in the Confidential Disclosure 
Agreement and the Clinical Trial Agreement. 
 

 
 
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 Data Verification and Validation Rules 
 
Data captured will be entered into the database through the EDC system. Data related 
to CRF and accountability logs will be transferred from the paper CRFs (forms 
considered as source documents) to the eCRFs. Data related to the Reference Method, 
the discrepancy testing and EC will be transferred directly from the laboratory 
worksheets (considered as source documents) to the eCRFs. 
 
Data will be managed and controlled following GenePOC Quality Procedures and 
stored in a secure database with limited access and with electronic audit trails. 
 
Data validation (confirming the correctness, completeness, and compliance of the 
data) will be performed both during and after data entry. Validation during data entry 
will be performed using both visual inspection and programming incorporated into 
the forms. Post data entry validation procedures will be documented in the Forms 
Specifications and/or Post-Data Entry Processing documents, and will be performed 
at minimum prior to the final Data Analysis. 
 
 
8. CLINICAL TRIAL INCIDENTS, RISK MANAGEMENT AND ADVERSE 
EVENTS 
 
 
 Clinical Trial Incidents 
 
 
A Clinical Trial Incident is defined as any problem involving the investigational device, 
Reference Method, procedures, human subjects, or operators as a result of execution 
of this Study Protocol. Clinical Trial Incidents may adversely (or potentially adversely) 
affect human safety, the integrity of the evaluation data, or the operation of devices. 
All serious occurrences which affect the health or safety of human subjects or operators 
involved in this evaluation are considered a Clinical Trial Incident, and may also be 
determined to be an Adverse Event. Adverse Events are addressed specifically in 
Section 8.4 below. Since patients are not directly affected by the diagnostic device under 
evaluation and results are not used for clinical decisions, virtually all Clinical Trial 
Incidents are not considered Adverse Events. 
The Clinical Trials Incident Report Form is used to capture problems or observations 
arising during the use of the investigational product or in the execution of this Study 
Protocol and should be reported to the GenePOC Study Manager. The form should be 
filled out with a full description of the incident, and sent by fax to the GenePOC Study 
Manager. Incidents might include but are not limited to such occurrences as: instrument 
failure (IND or other), run incomplete (NA or other), damage or deterioration of the 
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•
handling, or other incidents deemed to be failures or problems with the product or the 
execution of this Study Protocol. 
 
 Reporting of Incidents 
 
Any incidents which occur during the use of the GenePOC-GBS System or execution of 
this Study Protocol must be reported immediately to GenePOC. 
The primary contact will be the Study Manager. 
 
Rachelle Nadeau
Phone 
(418) 650-3535 #254 
Study Manager 
e-mail 
rachelle.nadeau@genepoc.ca 
 
 
 
 
In case of a problem with the GENEPOC™ instrument, the second line of support will 
be GenePOC: 
 
 
The Clinical Center must identify itself as a GenePOC GBS clinical trial site and 
by providing it site number 
 
ln case of a problem with the EDC System, contact the first line of support listed 
above who will either address the problem or dispatch the problem, as needed, to 
the Data Manager or the EDC System support line. 
All incidents must be documented on a Clinical Trial Incident report form. 
 
 Risk Management 
 
8.3.1. Potential Risks to the Patient 
 
There are no risks to the patient inherent to the execution of this evaluation; the 
investigational testing will: 
 
1) Be performed on excess de-identified samples only; and, 
2) Include parallel clinical routine testing by an approved and established method for 
reporting patient results. 
 
8.3.2. Potential Risks to the Personnel operating the Product 
 
To reduce the risk of exposed personnel, all processing, testing, and culturing of 
potentially infectious samples must always be performed according to Standard 
Precautions, CDC Guidelines, Standard Guidelines, and the Clinical Center's own 
Sébastien Chapdelaine
Phone 
(418) 650-3535 #221 
Vice President Research & 
Development 
Cell Phone 
(418) 803-0650 
e-mail
sebastien.chapdelaine@genepoc.ca 
 
 
 

 
 
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Laboratory Safety procedures and policies. 
 
 Adverse Events 
 
• An Adverse Event (AE) is defined as any untoward medical occurrence, 
unintended disease or injury or any untoward clinical signs (including an abnormal 
laboratory finding) in subjects, users or other persons (investigational devices 
only) which is associated with the use of an investigational product or participation 
in an investigation, whether or not related to the investigational medical device. 
This includes event not seen at baseline and event that if present at baseline have 
worsened in intensity. 
• Anticipated adverse events are defined as adverse events that are already known 
to occur from past experience. However, as cited in Section 8.1 above, there are 
no anticipated adverse events associated with this Study Protocol. 
• An Adverse Device Effect is defined as an adverse event related to the use of an 
investigational medical device. 
• A Serious Adverse Device Effect is defined as any serious adverse effect on health 
or safety or any life-threatening problem or death caused by, or associated with, a 
device. 
• An Unanticipated Serious Adverse Device Effect is a Serious Adverse Device 
Effect for which the effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan, or any other 
unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects. 
• If an Unanticipated Serious Adverse Device Effect occurs, it must be reported 
immediately by the Principal investigator to GenePOC and to the IEC (when 
required). GenePOC may additionally be required to report the occurrence to 
regulatory authorities. 
• Medical Device Reporting (MDR) - Any commercially marketed device used in the 
trial which causes or contributes to a death or serious injury must be additionally 
reported to the commercial manufacturer as an MDR reportable event, under US 
federal regulations and Health Canada. An occurrence of serious injury during the 
trial that resulted from the use of a marketed device may require reporting as both 
an Adverse Event (to the IEC and Sponsor of the trial) and as an MDR (to the 
commercial manufacturer of the device). 
 
 
9. REGULATORY AND ADMINISTRATIVE INFORMATION 
 
 
 
 Institutional Requirements 
 
The Study Protocol must be submitted for review to the Clinical Center's IEC prior 
to the start of the study. In addition, this committee will inform the Principal 

 
 
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investigator and the sponsor as to whether a waiver of informed consent has been 
granted. 
 
This must be done in accordance with Part 56 (Institutional Review Boards) of 
the Code of Federal Regulations Title 21 (USA) and Section 81(k) of the 
Canadian Medical Device Regulations. 
 
A copy of the IEC acknowledgment of review or approval from each institution must 
be forwarded to the study sponsor, GenePOC. 
 
 Ethical Conduct and Good Clinical Practice 
 
The procedures set forth in this Study Protocol are designed to ensure that 
GenePOC and the clinical investigators abide by the principles of Parts 50 and 56 
of the Code of Federal Regulations Title 21 (USA), the Tri-Council's Code of Ethical 
Conduct for Research involving Humans (1998) and Part 3 of the Medical Devices 
Regulations (Canada), the Declaration of Helsinki (USA and Canada), and the Good 
Clinical Practices (ICH: USA, Canada and Europe), in the conduct, evaluation and 
documentation of this study. 
 
 Investigator Responsibilities 
 
The investigator responsibilities are defined in the present Study Protocol. The 
Financial Disclosure certification must be filled out in accordance with Part 54 of the 
Code of Federal Regulations, Title 21. 
 
 Patient Information Confidentiality 
 
 
All information will be treated with the utmost confidentiality by the hospital and the 
study sponsor, GenePOC. Only de-identified data will be obtained. Patient names 
or medical record numbers will not be transferred to the study sponsor.  
 
The samples will be used strictly for isolation of Streptococcus agalactiae in culture, and 
for no other purposes. Results from this study may be used by GenePOC to fulfill 
regulatory requirements of Health Canada, the US Food and Drug Administration (FDA), 
the European Parliament (providing the CE marking) and rest of the world. 
 
 Data Maintenance and Disclosure 
 
 
Study binder(s) will be provided to each Clinical Center to organize the required study 
documentation. Each Clinical Center is directly responsible for the maintenance and 
organization of the study documentation. 
 
Any corrections and/or changes made to entries on paper forms or logs, by the 
Principal Investigator or designees, must be crossed out with a single line leaving 
the initial entry legible. The correction must be dated and initialed. Incorrect entries 

 
 
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must not be covered with correction fluid, obliterated, or made illegible in any way. 
If the reason for the change is not obvious, an explanation for the change must be 
written next to the modification. 
 
Any change performed on an electronic form will be audited by the system and, when 
required, justified before electronic signature. 
 
The investigator is obligated to provide the study sponsor with complete test results and 
all data derived from the study. Any information that is unclear will be brought to the 
attention of the Principal Investigator and/or laboratory contact for prompt resolution. 
 
 Clinical Center Compliance 
 
 
9.6.1. Investigator Responsibility 
 
 
Data generated from this evaluation will be used to support regulatory submissions. The 
Principal Investigator is expected to ensure that the Clinical Center and its personnel 
comply with Good Clinical Practices and pertinent regulations governing clinical 
research. 
 
9.6.2. Accountability of Materials 
 
 
All materials will be handled and disposed of according to manufacturer's instructions. 
All investigational devices and their use and disposal will be accounted for in writing. 
Upon completion of the study, all remaining devices provided by GenePOC will be 
returned to GenePOC unless otherwise directed by the GenePOC Study Manager in 
writing. 
 
9.6.3. Retention of Records 
 
 
The Principal Investigator will retain trial related documents as required by the 
applicable regulatory requirements or by an agreement with GenePOC. The 
Principal Investigator should take measures to prevent accidental or premature 
destruction of these documents. Essential documents should be retained for: 
• A period of five years after the last approval or a marketing application to 
regulatory agencies. 
• A period of five years has elapsed since the formal discontinuation of 
development of the investigational product. 
 
 Trial management 
 
 
9.7.1. Study Initiation 
 
The Clinical study is anticipated to start in January 2016 at the earliest. Sample 
enrollment will begin upon signed approval of all contract trial agreements, receipt of 
written IEC acknowledgment of review of this Study Protocol and demonstration of 
proficiency. The study is expected to be conducted over a period of eight (8) weeks 

 
 
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depending upon the enrollment rate of diagnostic samples and the prevalence of 
Streptococcus agalactiae. 
 
9.7.2. Study Extension 
The evaluation may be extended beyond the estimated duration under terms agreed 
upon by the Clinical Center and GenePOC if more data are required for product 
development, or if the study is redirected or re-initiated. Any redirection of the study or 
re-initiation after a period of suspension would be subject to the re-negotiation of terms 
between GenePOC and the Clinical Center. 
 
9.7.3. Rules for Discontinuation 
 
GenePOC retains the right to terminate or curtail the study if this study protocol is not 
followed, or if the device under evaluation requires further development to meet the 
intended clinical objectives. 
 
The Clinical Center shall terminate the study upon any of the following conditions: 
- 
Completion of the agreed maximum number of positive results or the agreed 
maximum number of total samples;  
- 
Reaching the date of maximum study duration;  
- 
Withdrawal of approval from the Clinical Center Administration or IEC. 
 
Other reasons and conditions for study termination could be addressed in the Clinical 
Trial Agreement. 
 

 
 
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10. 
REFERENCES 
 
 
 
1. 
Edwards, M.S. et al. Streptococcus agalactiae (Group B Streptococcus). In: Mandell GL, Bennet JE, eds. 
Principle and Practice of Infectious Diseases. New York: Churchill Livingstone, 1990:1554-1563. 
2. 
Sweet, R.L. et al, eds. Infectious Diseases of the Female Genital Tract. Baltimore: Williams & Wilkins, 
1990:23-37. 
3. 
Franciosi, R.A et al. Group B streptococcal neonatal and infant infections. J Pediatr, 1973. 82: p. 707-18. 
4. 
Schuchat, A., Epidemiology of group B streptococcal disease in the United States: shifting paradigms. Clin 
Microbiol Rev, 1998. 11(3): p. 497-513. 
5. 
CDC and C.f.D.C.a. Prevention of perinatal group B streptococcal disease: a public health perspective. 
Revised Guidelines. Morbid Mortal Weekly Rep2010. 595: p. 1-32. 
6. 
SOGC Guideline. The Prevention of Early-Onset Neonatal Group B Streptococcal Disease. J Obstet 
Gynaecol Can 2013;35(10):e1-e10. 
7. 
Schrag, S.J., et al. A population-based comparison of strategies to prevent early-onset group B streptococcal 
disease in neonates. N Engl J Med, 2002. 347(4): p. 233-9. 
8. 
Bergeron MG et al. Rapid detection of group B streptococci in pregnant women at delivery. N Engl J Med. 
2000 Jul 20;343(3):175-9. 
 
 
 
 

 
 
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11. 
APPENDIX 
 
 APPENDIX A:  
Clinical Investigation Requirements Relating to Each Clinical Center 
Trial Requirements 
Investigator 
Sponsor 
Confidential Disclosure Agreement: 
CDA 
Sign agreement and keep one of 
the originals in the investigator Site 
Files
Keep one of the originals 
in the Trial Master Files 
Curriculum vitae of principal 
investigator, co-investigators and 
other key site personnel
Keep a copy in the investigator Site 
Files 
Keep a copy in the Trial 
Master Files 
Study training records 
Keep a copy in the investigator Site 
Files 
Keep the original in the 
Trial Master Files 
Laboratory Certification 
Keep a copy in the investigator Site 
Files 
Keep a copy in the Trial 
Master Files 
Protocol, including any revisions 
and changes 
Sign, date and keep one of the 
originals in the investigator Site Files 
Sign, date and keep one of 
the originals in the Trial 
Master Files 
CTA and Financial Agreement 
Sign, date and keep one of the 
originals in the investigator Site 
Files or in the investigator's files 
Sign, date and keep one of 
the originals in the Trial 
Master Files 
IEC composition, approval
notification(s), annual reports, 
correspondence, including notices of 
amendments deviations and 
incidents. 
Or IEC acknowledgment of review
Submit file to applicable 
committee. Keep the originals ln 
the investigator Site Files and send 
a copy to the sponsor 
Keep a copy in the Trial 
Master Files 
Financial Disclosure Agreement and 
Updates 
Sign agreement and keep one of 
the originals in the investigator Site 
Files
Keep one of the originals 
in the Trial Master Files 
Site Contact Log  
No Copy
Fill out and keep the original in 
the investigator Site Files 
Site Signature and Delegation of 
Authority Log and Study Visit Log 
Fill out when necessary, keep 
original in the investigator Site Files 
during the study and send original 
to the sponsor at the end of the 
study.
Keep a copy during the 
study and the original at 
the end of the study in the 
Trial Master Files. 
Clinical Trial Incident Report form 
Fill out, sign and keep original in 
the investigator Site Files and send 
copy to the sponsor 
Keep a copy in the Trial 
Master Files 
Laboratory Worksheets 
Fill out, keep a copy in the 
investigator Site Files and send 
original to the sponsor once or 
twice per week
Keep the original in the 
Trial Master Files 
Paper CRFs and paper EC Form 
Fill out, sign, keep a copy in the
investigator Site Files and send 
originals to the sponsor once or 
twice per week 
Keep originals in the Trial 
Master Files or other data 
binder 
Reference method external control 
forms 
Keep the originals in the
Investigator Site Files or Laboratory 
Files 
Keep a copy of each in the 
Trial Master Files 

 
 
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Trial Requirements 
Investigator 
Sponsor 
Investigational Material 
Accountability Log 
Keep a copy in the investigator Site 
Files and send originals to the 
sponsor every two weeks or when 
completed.
Keep the originals in the 
Trial Master Files 
Data Clarification Forms 
Fill out, keep a copy in the 
investigator Site Files and send 
originals to the sponsor 
Keep originals in the Trial 
Master Files or other data 
binder 
Relevant Communications 
Keep a copy in the investigator Site 
Files printed and/or on a CD. 
Keep a copy in the Trial 
Master Files or other data 
binder printed and/or on a 
CD.
USB Keys for runs 
Export daily runs from the 
GenePOC instrument. keep on site 
for all Instrument backups.
Transfer electronically onto 
server and keep on a CD 
after.
 
 
 

 
 
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 APPENDIX B:  
Testing Algorithm 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PCR GenePOC
(150 µL)
LIM broth 
(18/24 h, 35°C) 
Broth enrichment 
culture Plate (100-
150 µL)
Resuspended 
(15 µL)        
in 1 mL SBT
POS
NEG
IND
UNR
POS
NEG
Residual volume put at 
4°C 
For repeat testing 
Store for 5 days max 
Reference 
PCR on 

 
 
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 APPENDIX C:  
Discrepant Testing Algorithm 
 
 
 
 
 
 
 
 
 
 
 
 
 
Discrepent result
GenePOC
Culture
+
-
 -
+
Frozen SBT   
Frozen LIM Broth 
Ship to GenePOC
Retest on GenePOC GBS
Retest on another test