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

NCT02497430 | Completed

• 1 other identifier: LMA-GBS-01-CS-001
• Study Type: observational
• Target: 918
• Locations: 1 country
• Sites: 5

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.

Conditions

Pregnancy; GBS

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy expressed in terms of clinical sensitivity and clinical specificity

  Within the first year of sample collection

Secondary Outcomes (1)

• Comparison of clinical performance per clinical site and per age group

  Within the first year of sample collection

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All comers

You may qualify if:

• 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.
• Demographic information, including age, geographic location, and number of gestation weeks, is included with the specimen.
• The specimen is from a female patient who is at 35 - 37 weeks gestation.
• The specimen was collected in unexpired liquid Transport Media (e.g., Liquid Stuart or Liquid Amies).
• Enrichment in Lim broth was grown for ≥18 hrs to ≤24 hrs.
• 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.
• The volume of the patient specimen after enrichment is sufficient (≥ 1.75mL) for completion of the study.

You may not qualify if:

• The specimen was collected at a site which is not covered under the study IRB.
• The specimen is from a patient for whom demographic data - age, geographic location and/or gestation weeks cannot be obtained.
• The specimen was not properly collected, identified, transported, processed or stored according to the instructions provided by the Sponsor.
• The specimen was enriched in Lim broth for \<18 hrs or \>24 hrs.
• A swab specimen that cannot be placed in Lim broth within 4 days of collection.
• 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.
• Any specimen that was not tested per the complete testing algorithm provided by the Sponsor.

Sponsors & Collaborators

• Luminex Corporation: lead

Study Sites (5)

Sacred Heart Health System

Pensacola, Florida, 32504, United States

Location

Detroit Medical Center University Laboratories

Detroit, Michigan, 48201, United States

Location

TriCore Reference Laboratories

Albuquerque, New Mexico, 87102, United States

Location

Geisinger Medical Laboratories

Danville, Pennsylvania, 17822-0131, United States

Location

Baylor Scott & White

Temple, Texas, 76508, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

vaginal-rectal swab

Study Officials

• Ronald D Dunn

  Luminex Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 14, 2015
• Study Start: March 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 15, 2016

Record last verified: 2016-09

Locations

US (5)