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Membership & Community

Recent Artery Conversations

Reactive Versus Positive
MAY.25.2020

Many serology assays use reactive for positive, and non-reactive for negative. I think what the package inserts are trying to say is that when a test result shows reactivity, we could imply a positive result, which would ultimately be a clinical interpretation. I am assuming that most clinicians don't really care if we call something reactive versus positive, as long as they get a result; however, does it matter to the FDA on an EUA test whether we use "reactive" on our reports or "positive", or are the words interchangeable, and it doesn't matter? If I use the word positive, does it now become an LDT?
Please share.

CBC/EDTA Lavendar Top Retention Time Survey
MAY.20.2020

CBC/EDTA Lavendar top retention time survey. Mine is 72 hours, what is yours? Beyond a pathologist smear review or HbA1c; what other test could be "added on"?
Please share.

Share of SARS-CoV-2 Positive Samples
MAY.19.2020

Our lab needs 30 positive SARS-CoV-2 swabs to complete the clinical validation of our SARS-CoV-2RT-PCR assay for FDA EUA submission. Would anyone be able to share some positive samples with us?
Please share.

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