The test is a real-time reverse transcription polymerase chain reac-tion (rRT-PCR) assay designed to qualitatively detect RNA from SARS-CoV-2 in respiratory specimens from individuals with signs and symptoms of infection who are suspected of COVID-19 by their healthcare provider.
Limit of Detection
|7500 Fast Dx Real-Time PCR Instrument||CFX96 Touch Real-Time PCR|
|Per reaction||12.5 GE||10 GE|
|Per ml specimen||1100 GE||860 GE|
The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA) . The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.
An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in the detection of the virus that causes COVID-19.
The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).
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