Accula Covid test from Mesa Labs
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Hi, our lab is moving forward with this test. Any of you know how to validate? Do you validate the docks, the cassettes, both? How many samples, 40? This is a PCR waived test under the emergency authorization from FDA. Any help is appreciated.
Thanks,
Vivian
Thanks,
Vivian
3 Replies
We were told by our state CLIA surveyors to validate with 5 negative and 5 positive samples. Since it is waived and under emergency authorization, the usual validation studies are not necessary. We run external controls for each new lot and/or monthly.
Thanks!
We're looking for molecular testing for our per-registered patients but are worried about supply shortages. Has Mesa mentioned anything about supply shortages for the Accula?
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