Background: The validity of calibration settings is confirmed by testing materials of known concentration in the same manner as patient specimens to assure the test system is accurate throughout the reportable range. CLIA’88 states calibration verification procedures are required to confirm the continued accuracy of the test system throughout the laboratory’s reportable range of test results.
Methods: In accordance with the instruments used, the albumin data were divided into either the Olympus or the Hitachi groups. The performance of calibration verification was based on the approach of calibration verification currently used by the College of American Pathologists (CAP), i.e., the slope and intercept of the calibration line were tested by a one-sample t test, the percent difference was calculated and was compared with allowable error.
Results: In the Olympus group, verified 1, different 1, verified 2, and different 2 were 5.6%, 0%, 60.6%, and 33.8%, respectively. In the Hitachi group, verified 1, different 1, verified 2, and different 2 were 4.5%, 1.5%, 58.2%, and 35.8%, respectively.
Conclusions: The method of calibration verification used by the CAP was reasonable and feasible. In this study, 64.5% of participating laboratories passed the evaluation of calibration verification for the Olympus and Hitachi analyzers using albumin.
DOI: Clin. Lab. 2012;58:153-159