Pregnancy Clinical Trial
Official title:
A Multi-Site Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay With Vaginal-Rectal Swab Specimens From Antepartum Pregnant Women
The ARIES GBS Assay is a real-time PCR based qualitative test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women between 35 - 37 weeks gestation.
The ARIES GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in
vitro diagnostic test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim
Broth enriched vaginal-rectal specimen swabs obtained from pregnant women.
The objective of this study is to establish the diagnostic accuracy of ARIES GBS Assay
through a multi-site, method comparison on prospectively collected, left-over enriched Lim
broth specimens.
Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity.
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Observational Model: Case-Only, Time Perspective: Prospective
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