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….. ________________________________ This electronic message is intended only for the use of the individual(s) and entity named as recipients in the message. If you are not an intended recipient of this message, please notify the sender immediately and delete the material from any computer. Do not deliver, distribute or copy this message, and do not disclose its contents or take any action in reliance on the information it contains. Thank you. _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
