Amnisure Performance Verification
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Does anyone have advice on best practice when performing performance verification (aka validation) for qualitative assays for which no method comparison is available?
I am trying to design a performance verification plan for Amnisure ROM testing and am finding it oddly difficult; its a moderate complexity, qualitative, expensive kit test. I have asked our medical director and she as pretty much left it up to my discretion, but at the same time not been able to provide clear direction. Any recommendations?
-Dean Derhaag MS, MLS
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What are you using currently to test for PROM? Fern? You could run a series of Amnisure tests vs. ferning as well as several QC runs.