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I am new to this role and was wondering if anyone had insight on validating POC urine drug screens. What was your validation plan? I work at a peds hospital so it's easy to find negative samples, but were you able to validate all positive analytes? Also, did you validate the adulteration color strip on the cup? Any help would be much appreciated! iScreen Dx Tox Cup 14 FTY CLIA waived sell sheet - Distributors.pdf
We only validated the 12 test that are performed currently on our lab Chemistry analyzer. We used Quality Control material, 15 frozen CAP surveys from 2024, and 30 patient samples previously ran in our lab. I was able to get at least 5 positives for each drug.