FDA Authorizes Four-...
6th October 2020 Product update: rapidmicrobiology staff writer
New Saliva-Test for COVID-19 Diagnosis is Now FDA-Authorized
Quadrant Biosciences has received Emergency Use Authorization (EUA) from the US FDA for its Clarifi COVID-19 Test kit; a rapid RT-PCR test that detects SARS-CoV-2 in saliva.
The test was co-developed with SUNY Upstate Medical University and raised over one million dollars through its offering on Wefunder.
Saliva swab collection is performed by a healthcare provider using the ORAcollect•RNA (OR-100) saliva collection device, and RNA is extracted using a viral RNA extraction kit.
Using just a single well, any RNA present is converted to cDNA, amplified and detected by the test.
One of the key features of the Clarifi COVID-19 test is that it is engineered to limit false-negative results by integrating an RNA stabilizing solution into the saliva collection kit.
Prior to laboratory analysis, this stabilizing solution prevents RNA degradation caused by enzymes, present in mucus and saliva.
The test is designed to detect two specific sequences in the RdRp gene of SARS-CoV-2 within the hour.
Date Published: 6th October 2020
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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.
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