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

NCT05107362 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1347

Last updated 2023-07-12

No results posted yet for this study

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.

Conditions

  • Streptococcus Pyogenes Infection
  • Pharyngitis
  • Respiratory Tract Infections

Interventions

DIAGNOSTIC_TEST

untrained lay user performs investigational diagnostic test

Untrained lay users (parents/guardians of pediatric subjects or friends/family members of adult subjects) collect throat swab specimens and perform the investigational diagnostic test.

Sponsors & Collaborators

  • Curebase Inc.

    collaborator INDUSTRY

  • Checkable Medical Inc

    lead INDUSTRY

Principal Investigators

  • Marla McIntyre · Checkable Medical

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-21
Primary Completion
2023-07-10
Completion
2023-07-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05107362 on ClinicalTrials.gov