Trial Outcomes & Findings for Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains (NCT NCT02718157)
NCT ID: NCT02718157
Last Updated: 2021-05-03
Results Overview
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 (\[False Positive\]).
COMPLETED
NA
771 participants
At the time of the results with Reference Method is confirmed, up to 6 months
2021-05-03
Participant Flow
Participant milestones
| Measure |
Accuracy Testing
Comparison between GenePOC PCR and Reference Method
Comparison between GenePOC PCR and Reference Method: 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.
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Overall Study
STARTED
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771
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Overall Study
COMPLETED
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609
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Overall Study
NOT COMPLETED
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162
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Accuracy Testing
n=771 Participants
Comparison between GenePOC PCR and Reference Method
Comparison between GenePOC PCR and Reference Method: 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.
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Age, Categorical
<=18 years
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0 Participants
n=771 Participants
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Age, Categorical
Between 18 and 65 years
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771 Participants
n=771 Participants
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Age, Categorical
>=65 years
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0 Participants
n=771 Participants
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Sex: Female, Male
Female
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771 Participants
n=771 Participants
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Sex: Female, Male
Male
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0 Participants
n=771 Participants
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Region of Enrollment
Canada
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238 participants
n=771 Participants
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Region of Enrollment
United States
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533 participants
n=771 Participants
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PRIMARY outcome
Timeframe: At the time of the results with Reference Method is confirmed, up to 6 monthsTo 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 (\[False Positive\]).
Outcome measures
| Measure |
Accuracy Testing
n=771 Participants
Comparison between GenePOC PCR and Reference Method
Comparison between GenePOC PCR and Reference Method: 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.
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|---|---|
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Performance Characteristics
Sensitivity
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95.9 percentage of specimens
Interval 91.7 to 98.0
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Performance Characteristics
Specificity
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95.5 percentage of specimens
Interval 93.5 to 96.9
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SECONDARY outcome
Timeframe: At the time of the results with Reference Method is confirmed, up to 6 monthsTo 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 (\[False Negative\]).
Outcome measures
| Measure |
Accuracy Testing
n=771 Participants
Comparison between GenePOC PCR and Reference Method
Comparison between GenePOC PCR and Reference Method: 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.
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|---|---|
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Positive and Negative Predictive Values
PPV
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85.8 percentage of specimens
Interval 80.1 to 90.0
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Positive and Negative Predictive Values
NPV
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98.8 percentage of specimens
Interval 97.5 to 99.4
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SECONDARY outcome
Timeframe: At the time of the results with Reference Method is confirmed, up to 6 monthsTo estimate the rate of unresolved results for the GenePOC GBS System due to Sample Processing control failure (unresolved sample results).
Outcome measures
| Measure |
Accuracy Testing
n=771 Participants
Comparison between GenePOC PCR and Reference Method
Comparison between GenePOC PCR and Reference Method: 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.
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Unresolved Sample Results
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0.74 percentage of Unresolved
Interval 0.34 to 1.6
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SECONDARY outcome
Timeframe: At the time of the results with Reference Method is confirmed, up to 6 monthsTo estimate the rate of indeterminate results for the GenePOC GBS Test due to an Instrument failure (indeterminate sample results).
Outcome measures
| Measure |
Accuracy Testing
n=771 Participants
Comparison between GenePOC PCR and Reference Method
Comparison between GenePOC PCR and Reference Method: 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.
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Indeterminate Sample Results
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1.48 percentage of Indeterminates
Interval 0.85 to 2.57
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Adverse Events
Accuracy Testing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place