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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; GBS

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 Type: Observational
• Enrollment (Actual): 918

Contacts and Locations

Study Locations

• United States
  • Florida
    • Pensacola, Florida, United States, 32504
      • Sacred Heart Health System
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Detroit Medical Center University Laboratories
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • TriCore Reference Laboratories
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-0131
      • Geisinger Medical Laboratories
  • Texas
    • Temple, Texas, United States, 76508
      • Baylor Scott & White

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All comers

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic accuracy expressed in terms of clinical sensitivity and clinical specificity	Within the first year of sample collection

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of clinical performance per clinical site and per age group	Within the first year of sample collection

Collaborators and Investigators

• Sponsor: Luminex Corporation
• Investigators: Study Director: Ronald D Dunn, Luminex Corporation

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: July 9, 2015
• First Submitted That Met QC Criteria: July 10, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Estimate): September 15, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: LMA-GBS-01-CS-001