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Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02497430
Study type Observational
Source Luminex Molecular Diagnostics
Contact
Status Completed
Phase N/A
Start date March 2016
Completion date August 2016
View Details
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