CompletedNot Applicable

Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.

United States497 participantsStarted 2018-02-14

Plain-language summary

The primary purpose of this clinical investigation is to establish the performance of the GenePOC Strep A, C/G assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Group A β-hemolytic Streptococcus (GAS) and pyogenic Group C and G β-hemolytic Streptococcus (GCS/GGS) in throat swab samples.

Who can participate

Age range25 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Samples from patients suspected of having signs and symptoms of a pharyngitis infection * Patient that signed the approved Informed Consent Form (if applicable) * Patient older than 2 years of age * Only one (1) compliant sample per patient is allowed * Use of dual swab with either liquid Stuart or liquid Amies transport Medium Exclusion Criteria: • Patient/sample not meeting inclusion criteria above

What they're measuring

Performance characteristics of the GenePOC Streap A, C/G assay

Timeframe: Up to 14 months

Trial details

NCT IDNCT03422341

SponsorMeridian Bioscience, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-07-11

View on ClinicalTrials.gov More Pharyngitis, Infective trials