hs-Tnl verification- precision criteria
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Hello,
We're working on our verification of the hs-Tnl iSTAT cartridges. I am looking for assistance on acceptable criteria for precision for this analyte. After reviewing the IFU and method evaluation from Abbott, I cannot find criteria with supporting evidence. The precision in the IFU is not to be used for precision criteria per the method evaluation. The method evaluation states that precision must include SD and %CV but doesn't provide guidance.
Does anyone who has verified this test have any documentation to support the acceptable criteria used to accept this test?
We're working on our verification of the hs-Tnl iSTAT cartridges. I am looking for assistance on acceptable criteria for precision for this analyte. After reviewing the IFU and method evaluation from Abbott, I cannot find criteria with supporting evidence. The precision in the IFU is not to be used for precision criteria per the method evaluation. The method evaluation states that precision must include SD and %CV but doesn't provide guidance.
Does anyone who has verified this test have any documentation to support the acceptable criteria used to accept this test?
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Best,
Anil Chokkalla, PhD, D(ABCC)
Clinical Chemist, Sanford Health