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APPLICATION OF CLSI'S EP15A3 GUIDELINES IN CONFIRMING THE PRECISION AND ACCURACY OF THE 17-OHP TEST ON THE VICTOR 2D PERKIN ELMER SYSTEM
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Abstract
Verification of precision and accuracy is a necessary requirement recommended when performing method verification in medical laboratory. This study aims to demonstrate and provides evidence that the method is reliable and consistent with the technical requirements published by the manufacturer at the user's facility. The study was conducted with the goal of verifying the precision and accuracy of 17-OHP testing in dried blood spot samples on the VICTOR 2D system by Perkin Elmer, using Neonatal 17-OHP internal quality control (QC) for three levels and Neonatal 17-OHP test kit to assess the precision and accuracy following EP15A3-CLSI guideline. The precision of the test results, corresponding to the three QC concentrations, are 7,80%, 7,19% and 7,82%, respectively, which are lower than the manufacturer's claim of 13,90%, 11,90% and 11,00%. The accuracy of the method was also verified to meet the manufacturer's claim. The precision and accuracy of 17-OHP testing have been verified, and the test service can be provided to patients of the laboratory
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Keywords
17-OHP, newborn screening, method verification, EP15A3, Perkin Elmer.
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