N/A
Completed N=771
Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains
Source: ClinicalTrials.gov NCT02718157 ↗Enrolled (actual)
771
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Performance Characteristics — 95.9; 95.5 percentage of specimens
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance Characteristics |
95.9; 95.5 | — |
| SECONDARY Positive and Negative Predictive Values |
85.8; 98.8 | — |
| SECONDARY Unresolved Sample Results |
0.74 | — |
| SECONDARY Indeterminate Sample Results |
1.48 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02718157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.