CompletedNot Applicable

Clinical Performance of the Checkable Medical At-Home Strep A Test

United States1,347 participantsStarted 2021-12-21

Plain-language summary

The Checkable Medical At-Home Strep A Test is a rapid chromatographic immunoassay for the qualitative detection of Group A Strep (GAS) antigens from throat swabs. The purpose of the study is to evaluate the clinical performance of the investigational device (i.e., sensitivity, specificity, NPV and PPV) when used by untrained lay persons to detect the presence of Group A Streptococcal antigens in throat swab specimens from individuals five years of age and older with signs and symptoms of pharyngitis, such as fever and sore throat.

Who can participate

Age range5 Years

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

✓. Subjects seeking medical care for two or more of the following signs/symptoms of pharyngeal streptococcal infections:
✓. Subjects who have not received antibiotic treatment within the past 14 days.
✓. Subjects (or their parents/guardians) provide written informed consent/assent to participate in the study

What they're measuring

Clinical Sensitivity and Clinical Specificity

Timeframe: 1 day

Trial details

NCT IDNCT05107362

SponsorCheckable Medical Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-07-10

View on ClinicalTrials.gov More Streptococcus Pyogenes Infection trials