Clinical trial NCT02497430: Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay
Official title: A Multi-Site Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay With Vaginal-Rectal Swab Specimens From Antepartum Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
GBS
Lead sponsor: Luminex Molecular Diagnostics
Sponsor class: INDUSTRY
First posted: 2015-07-14
Enrollment: 918
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All comers

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic accuracy expressed in terms of clinical sensitivity and clinical specificity
timeFrame: Within the first year of sample collection
Secondary outcomes:
measure: Comparison of clinical performance per clinical site and per age group
timeFrame: Within the first year of sample collection
Other outcomes:
Locations:
city: Pensacola
country: United States
facility: Sacred Heart Health System
state: Florida
city: Detroit
country: United States
facility: Detroit Medical Center University Laboratories
state: Michigan
city: Albuquerque
country: United States
facility: TriCore Reference Laboratories
state: New Mexico
city: Danville
country: United States
facility: Geisinger Medical Laboratories
state: Pennsylvania
city: Temple
country: United States
facility: Baylor Scott & White
state: Texas
Study officials:
affiliation: Luminex Corporation
name: Ronald D Dunn
role: STUDY_DIRECTOR
References: