Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains

Not Applicable

Completed

Conditions: Streptococcus Agalactiae Infection

Interventions: Device: Comparison between GenePOC PCR and Reference Method

Registration Number: NCT02718157

Lead Sponsor: Meridian Bioscience, Inc.

Brief Summary: The primary purpose of this clinical investigation is to verify the performance of the GenePOC GBS Assay on the GenePOC Instrument. This will be achieved by comparing the Assay to the a Culture, a conventional method for detection of Streptococcus agalactiae in vaginal/rectal swab specimens from antepartum women.

Detailed Description: The GenePOC GBS Test performed on the GenePOC System is a qualitative in vitro diagnostic (IVD) 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.

The GenePOC GBS is an IVD system is comprised of the GenePOC Diagnostics System and the GenePOC Group B Step \[GBS\] Test, the components of which are:

1. Instrument

2. GBS disposable microfluidic cartridges (PIE) (described in this document as PIEs because of the shape of the cartridge)

3. GBS Sample Buffer Tube (SBT)

4. Sample Transfer Device (STD).

The GenePOC Instrument is fully automated and integrates sample lysis, dilution, amplification and detection of the target sequence in complex samples using real-time Polymerase chain reaction (rtPCR). User intervention is only required for discharging the patient sample into the SBT (sample Buffer Tube), transferring the sample into the PIE and for loading/unloading the PIEs into the instrument. The GenePOC instrument consists of a rotor to spin the PIEs, temperature control, fluorescence detection, a tactile user-friendly interface, two barcode readers, and integrated firmware and software to deliver results to the user. The PIE is a closed system that prevents the risk of contamination.

Lim Broth is used for the selective enrichment of group B streptococci (Streptococcus agalactiae). An aliquot of the broth is mixed with GenePOC Sample Buffer Tube Reagent (SBT), after which a sample is transferred to the GenePOC GBS PIE. The GenePOC GBS PIE is then automatically processed by the GenePOC Instrument.

On completion of a run, the user removes the processed PIEs from the instrument and discards them according to local biological waste management procedures.

One GenePOC instrument per site will be allocated. The purpose of the clinical investigation is to enroll sufficient specimens from four (4) Clinical Centers to obtain a total of 150 specimens positive for GBS based on the Reference Method final result.

Subject Informed consent is not required for this clinical trial as the testing will be performed on excess de-identified specimens only.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 771

Inclusion Criteria

Antepartum pregnant women
18 years old and more
Being at a gestation period of 35 to 37 weeks.
Vaginal/rectal swab specimen
Transport and storage times, and conditions (e.g. room temperature and/or refrigerated) within the labeled indications.
- Fresh specimens available to be tested with the GenePOC GBS System within 96 hours (4 days) of collection if kept at 2-25°C
- Fresh specimens 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

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
Specimens without all test results required by this Study Protocol. Specimens that are inadvertently entered into the study that do not meet the specimen inclusion criteria will be made non-compliant.
The GenePOC GBS System and the Reference Method not performed according to the GenePOC GBS Investigation Documents.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Accuracy Testing	Comparison between GenePOC PCR and Reference Method	Comparison between GenePOC PCR and Reference Method

Primary Outcome Measures

Name	Time	Method
Performance Characteristics	At the time of the results with Reference Method is confirmed, up to 6 months	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, specimens from antepartum pregnant women. Sensitivity and specificity will be established in comparison to the Reference Method. Sensitivity performance results from the comparison of specimens being reported as positive by both method against the total number of specimen reported as positive on the Reference Method only. Sensitivity is reported as a percentage (i.e. concondant positives / concordant positive + discordant positive (\[False Negative\]). Specificity performance results from the comparison of specimens being reported as negative by both method against the total number of specimen reported as negative on the Reference Method only. Specificity is reported as a percentage (i.e. concondant negatives / concordant negatives + discordant negatives (\[False Positive\]).

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Predictive Values	At the time of the results with Reference Method is confirmed, up to 6 months	To estimate the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC GBS System. PPV results from the comparison of specimens being reported as positive by both method against the total number of specimen reported as positive on the Investigational test only. PPV is reported as a percentage (i.e. concondant positives / concordant positive + discordant positive (\[False Positive\]). NPV results from the comparison of specimens being reported as negative by both method against the total number of specimen reported as negative on the Investigational test only. NPV is reported as a percentage (i.e. concondant negatives / concordant negatives + discordant negatives (\[False Negative\]).
Unresolved Sample Results	At the time of the results with Reference Method is confirmed, up to 6 months	To estimate the rate of unresolved results for the GenePOC GBS System due to Sample Processing control failure (unresolved sample results).
Indeterminate Sample Results	At the time of the results with Reference Method is confirmed, up to 6 months	To estimate the rate of indeterminate results for the GenePOC GBS Test due to an Instrument failure (indeterminate sample results).

Trial Locations

Locations (4): Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex
🇨🇦
Toronto, Ontario, Canada
Tricore Laboratory University of New Mexico
🇺🇸
Albuquerque, New Mexico, United States
Detroit Medical Center University Laboratories
🇺🇸
Detroit, Michigan, United States
CHU de Québec - Université Laval
🇨🇦
Québec, Canada