[Histonet] Precision in IHC validations

[Martha Ward-Pathology]

Thanks to everyone that has responded to my question.

We specifically interested in the procedure for this CAP question:

COM.40350 Validation of Test Performance Specifications - Modified FDA-cleared/
approved Tests and LDTs

Prior to clinical use of each modified FDA-cleared or approved test and laboratory developed
tests (LDTs), the laboratory has performed a validation study and prepared a
written assessment of each of the following test method performance specifications, as
applicable, using a sufficient number of characterized samples:

● Analytical accuracy
● Analytical precision
● Reportable range
● Analytical sensitivity (lower detection limit)
● Analytical specificity
● Any other performance characteristic required to ensure analytical test performance




Do you comment at all regarding precision…..do you run the same slide each day over 3 days, or something like that?
NOTE 3: Precision is validated by repeat measurement of samples at varying concentrations or
activities within-run and between-run over a period of time.

We are just not sure what number of repeats is best…..


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