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- W4386945554 abstract "Aim: To investigate the impact of sample replication number (duplicate vs triplicate) on the validation of ELISA methodology. Materials & methods: The methodology was validated with reference sample and test sample as an 11-point triplicate dilution series. The data were reanalyzed post-validation as if conducted as a duplicate dilution series. Results: The triplicate methodology was validated with a precision of 5.3% and mean bias of -1.7%. The duplicate methodology generated a precision of 5.7% and mean bias of -2.2%. Conclusion: Both the triplicate (method capability index = 1.37) and duplicate (method capability index = 1.25) ELISA methodology can support an 80-125% relative potency specification with a 0.004% or 0.018% probability of out-of-specification results, respectively." @default.
- W4386945554 created "2023-09-23" @default.
- W4386945554 creator A5023980645 @default.
- W4386945554 date "2023-09-22" @default.
- W4386945554 modified "2023-09-28" @default.
- W4386945554 title "The application of capability indices in the validation of ELISA methodology" @default.
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- W4386945554 doi "https://doi.org/10.4155/bio-2023-0065" @default.
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