Posted May 28May 28 comment_94540 Has anyone validated the Ortho Optix reader and would be willing to share their validation plan?
May 28May 28 comment_94542 I always suggest starting with the vendor. They often provide a validation plan that you can then tailor to meet your facilities requirements.
May 28May 28 Author comment_94543 I have the guide from the vendor, but they said it up to us how many and what type of scenarios to test with the reader. I was just curious if someone had done it before and had some insight.
May 28May 28 comment_94544 I think there are a lot of variables that you, and your medical director, need to consider. The biggest is your patient population. Do you have a lot of cancer patients taking monoclonal antibody drugs? Do you have a lot of maternity patients? Do you have a lot of antibody positive patients? The only correct answer is to test 100% of the samples to be 100% sure. That is not practical, and no one would ever suggest that. Scan the FDA guidance documents to see if you find any relevant ones. Here are a couple of unrelated ones: https://www.fda.gov/files/drugs/published/Process-Validation--General-Principles-and-Practices.pdf https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf For a NEW process that we were unfamiliar with, I always went with 385, regardless of the population size. We migrated a patient database with millions of records from our homegrown system to a commercial system, we tested different scenarios 385 times. As time went on, and we grew more confident with that particular software system, and continuously found no errors, we reduced it, slowly, over each validation. The key point is that you and your medical director need to have a sound, and justified plan. Your primary goal is to protect your patients. Your secondary goal is not to get closed down. Should you test every sample, no. Should you test 20 samples for a process you have never performed before, no. I suggest looking at some statistics sites and determining what works best for you. Here's just one, there are MANY: https://www.calculator.net/sample-size-calculator.html?type=1&cl=95&ci=5&pp=50&ps=&x=Calculate
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