[Histonet] Precision in IHC validations

[Martha Ward-Pathology via Histonet]

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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[Histonet] How are you documenting precision in IHC validations

[Martha Ward-Pathology via Histonet]

We are working on IHC antibody validations and I want to know if there is a 
minimum number of slides you must run to demonstrate precision? I have not 
been able to find a definitive number or procedure.   What is everyone doing 
for this?

Thanks in advance for everyone's help.

Martha Ward
Atrium Health Wake Forest Baptist



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