At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Comparison between GenePOC PCR and Reference Method for Streptococcus Agalactiae Infection. Completed, enrolled 771 participants across 4 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.