EP15A3 Based Precision and Trueness Verification of VITROS HbA1C Immunoassay.

Verification of analytical performance of measurands becomes an essential requirement for the laboratories before proceeding to patients' samples testing. In our study we have verified the performance of HbA1C Immunoturbidimetric assay (VITROS 5600) against manufacturers' claims using CLSI EP15A3 Guidelines. We performed our study using two concentrations of Quality Control from Bio-Rad (Level 1 and Level 2). A precision verification study was carried out using five replicates of QC per day for five days following which imprecision estimates in form of Within Run (Repeatability) %CV and Within Lab %CV were calculated and compared against manufacturer's claims. Second part of our study included derivation of grand mean from the results of 25 replicates of QC used for precision verification. This was compared against the Target Value of the assigned QC obtained from the peer group mean of laboratories participating in interlaboratory QC program (unityTM Interlab-Bio-Rad) for %bias estimation. The findings of our precision study showed an acceptable Within Lab imprecision (%CV

Déclaration de conflit d'intérêts

None of the authors of this study have any conflict of interest.This article contains study only with quality control materials commercially obtained. No patient samples were involved.