NCT02497430

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

A Multi-Site Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay With Vaginal-Rectal Swab Specimens From Antepartum Pregnant Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 918 (actual)
• Sponsor: Luminex Corporation · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pregnancy
• GBS

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-07-14
• Last updated: 2016-09-15

Locations

5 sites across 1 country: United States