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GTR Home > > Inform Diagnostics V3.0 SARS-CoV-2 RT-PCR assay

Performance Characteristics

Availability

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  • Entire test performed in-house

Analytical Validity

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Sensitivity 100%, Specificity 100%, Limit of detection 0.125 copies/uL for NP and OP, 0.5 copies/uL for saliva

Citations

Not provided

Proficiency Testing (PT)

Is proficiency testing performed for this test? Help
No

FDA Regulatory Clearances of the Test

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Not provided

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.