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Assessing Performance of the Testing Done Simple Covid 19 Antigen Test

NCT05610449 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 171

Last updated 2023-05-15

No results posted yet for this study

Summary

This study will measure the sensitivity and specificity of the Testing Done Simple severe acute respiratory syndrome (SARS) CoV-2 antigen test in subjects with suspected Covid-19 that present throughout several urgent care clinics. The antigen test performance will be compared to a real-time polymerase chain reaction (RT-PCR) test.

Conditions

Interventions

DIAGNOSTIC_TEST

Testing Done Simple SARS CoV-2 Antigen Test

Collections of specimens from subjects presenting with Covid-19 like symptoms or known/suspected exposure to SARS CoV-2 via nasal swabs administered by trained medical personnel.

Sponsors & Collaborators

  • Nao Medical Urgent Care

    collaborator UNKNOWN

  • Testing Done Simple

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-04
Primary Completion
2023-02-17
Completion
2023-03-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05610449 on ClinicalTrials.gov