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Performance Characteristics

Availability

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  • Entire test performed in-house

Analytical Validity

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100 copies/ml published LOD established by 21 replicates

Citations

Not provided

Proficiency Testing (PT)

Is proficiency testing performed for this test? Help
Yes
Method used for proficiency testingHelp
Formal PT program
PT ProviderHelp
College of American Pathologists, CAP

FDA Regulatory Clearances of the Test

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FDA Category Designation
EUA - Emergency Use Authorization

Clinical resources

Practice guidelines

  • NICE, 2024
    UK NICE Guideline NG191, COVID-19 rapid guideline: managing COVID-19, 2024

Consumer resources

IMPORTANT NOTE: NIH does not independently verify information submitted to the GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in the GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.