771
Participants
Start Date
August 10, 2016
Primary Completion Date
February 7, 2017
Study Completion Date
February 7, 2017
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.
Detroit Medical Center University Laboratories, Detroit
Tricore Laboratory University of New Mexico, Albuquerque
Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex, Toronto
CHU de Québec - Université Laval, Québec
Lead Sponsor
Meridian Bioscience, Inc.
INDUSTRY