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

NCT02718157 | Completed Results FDA Device

• 1 other identifier: GenePOC-GBS_clinical-01
• Study Type: interventional
• Target: 771
• Locations: 2 countries
• Sites: 4

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.

Conditions

Streptococcus Agalactiae Infection

Keywords

Polymerase Chain Reaction (PCR); GBS; Streptococcus agalactiae; Antepartum women

Outcome Measures

Primary Outcomes (1)

• Performance Characteristics

  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 (\[False Positive\]).

  At the time of the results with Reference Method is confirmed, up to 6 months

Secondary Outcomes (3)

• Positive and Negative Predictive Values

  At the time of the results with Reference Method is confirmed, up to 6 months

• Unresolved Sample Results

  At the time of the results with Reference Method is confirmed, up to 6 months

• Indeterminate Sample Results

  At the time of the results with Reference Method is confirmed, up to 6 months

Study Arms (1)

Accuracy Testing

EXPERIMENTAL

Comparison between GenePOC PCR and Reference Method

Device: Comparison between GenePOC PCR and Reference Method

Interventions

Comparison between GenePOC PCR and Reference Method DEVICE

Antepartum women swab specimen incubated in Lim Broth will be tested with the GenePOC GBS test on the GenePOC Instrument. The results will be compared to Reference Method defined as incubated Lim broth subcultured onto blood agar plate for observation of a Streptococcus agalactiae strain.

Accuracy Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Antepartum pregnant women
• 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

You may not qualify if:

• 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
• The GenePOC GBS System and the Reference Method not performed according to the GenePOC GBS Investigation Documents.

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead

Study Sites (4)

Detroit Medical Center University Laboratories

Detroit, Michigan, 48201, United States

Location

Tricore Laboratory University of New Mexico

Albuquerque, New Mexico, 87102, United States

Location

Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex

Toronto, Ontario, M5G 1X5, Canada

Location

CHU de Québec - Université Laval

Québec, G1V 4G2, Canada

Location

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Dr Keith Chiasson, PhD
• Organization: GenePOC

keith.chiasson@genepoc.ca

418-650-3535

Study Officials

• Patrice Allibert

  Meridian Bioscience, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 24, 2016
• Study Start: August 10, 2016
• Primary Completion: February 7, 2017
• Study Completion: February 7, 2017
• Last Updated: May 3, 2021
• Results First Posted: December 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (2)