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

Completed

• Conditions: GBS; Pregnancy

• Registration Number: NCT02497430
• Lead Sponsor: Luminex Corporation

Brief 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.

Study Timeline

• Study First Submitted: 2015-07-09
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-14
• Study Start: 2016-03
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 918

Inclusion Criteria

1. An exemption from the requirement for Informed Consent has been granted by the site IRB to include the left-over patient specimens in the study.
2. Demographic information, including age, geographic location, and number of gestation weeks, is included with the specimen.
3. The specimen is from a female patient who is at 35 - 37 weeks gestation.
4. The specimen was collected in unexpired liquid Transport Media (e.g., Liquid Stuart or Liquid Amies).
5. Enrichment in Lim broth was grown for ≥18 hrs to ≤24 hrs.
6. The specimen is received in good condition (no leakage or drying of the specimen) and was accepted for testing by the site in accordance with established laboratory procedures.
7. The volume of the patient specimen after enrichment is sufficient (≥ 1.75mL) for completion of the study.

Exclusion Criteria

1. The specimen was collected at a site which is not covered under the study IRB.
2. The specimen is from a patient for whom demographic data - age, geographic location and/or gestation weeks cannot be obtained.
3. The specimen was not properly collected, identified, transported, processed or stored according to the instructions provided by the Sponsor.
4. The specimen was enriched in Lim broth for <18 hrs or >24 hrs.
5. A swab specimen that cannot be placed in Lim broth within 4 days of collection.
6. Inconclusive latex agglutination results - weak agglutination, agglutination that occurs in more than one latex reagent or the results are otherwise considered inconclusive based on established laboratory procedures or the instructions included with the latex agglutination test kit.
7. Any specimen that was not tested per the complete testing algorithm provided by the Sponsor.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy expressed in terms of clinical sensitivity and clinical specificity	Within the first year of sample collection

Secondary Outcome Measures

Name	Time	Method
Comparison of clinical performance per clinical site and per age group	Within the first year of sample collection

Trial Locations

Locations (5)

TriCore Reference Laboratories; 🇺🇸 Albuquerque, New Mexico, United States

Sacred Heart Health System; 🇺🇸 Pensacola, Florida, United States

Detroit Medical Center University Laboratories; 🇺🇸 Detroit, Michigan, United States

Geisinger Medical Laboratories; 🇺🇸 Danville, Pennsylvania, United States

Baylor Scott & White; 🇺🇸 Temple, Texas, United States