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 Details — Status: Completed

Administrative data

• NCT number: NCT02497430
• Other study ID #: LMA-GBS-01-CS-001
• Status: Completed
• Phase: N/A
• First received: July 9, 2015
• Last updated: September 14, 2016
• Start date: March 2016
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Luminex Molecular Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 918
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• GBS
• Pregnancy

Locations

Country	Name	City	State
United States	TriCore Reference Laboratories	Albuquerque	New Mexico
United States	Geisinger Medical Laboratories	Danville	Pennsylvania
United States	Detroit Medical Center University Laboratories	Detroit	Michigan
United States	Sacred Heart Health System	Pensacola	Florida
United States	Baylor Scott & White	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Luminex Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy expressed in terms of clinical sensitivity and clinical specificity		Within the first year of sample collection	No
Secondary	Comparison of clinical performance per clinical site and per age group		Within the first year of sample collection	No