This usually involves demonstrating overlap of the confidence interval for the laboratory’s estimate with the manufacturer’s claim, or demonstrating that laboratory estimate falls within the confidence interval of the manufacturer’s claim. Then, the acceptability of performance is assessed by comparing the two estimates. Typically, laboratory verification of a manufacturer’s claim involves the laboratory’s performing a “smaller” experiment than that performed by the manufacturer to establish the claim. Other programs, such as MedCalc, Analyze-it, or Minitab also support probit analysis and may be more familiar and available to clinical laboratory scientists. We expect that the results here are within the uncertainty or confidence ranges of the “claimed” LoDs, but determining those confidence limits requires more complicated calculations with statistical software, such as the Maplesoft program described by Vaks. See even more stories about COVID-19 Laboratory Challenges.
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