Lab Med Online.  2014 Apr;4(2):65-70.

Verification of Comparability among Quantitative Results Obtained Using Multiple Instruments within a Health Care System

Affiliations
  • 1Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea. chayoung@cau.ac.kr

Abstract

BACKGROUND
The comparability of results obtained for the same analyte using more than 1 instrument should be evaluated periodically. We used a standardized guideline (C54-A) proposed by the Clinical and Laboratory Standards Institute in 2008 to verify comparability of patient results between 2 automated biochemical analyzers used within 1 healthcare system.
METHODS
Comparability between 2 automated biochemical analyzers [OLYMPUS AU5421 (Beckman-Coulter, USA)] were evaluated using patient blood samples. The test parameters were albumin, alkaline phosphatase, alanine transaminase, aspartate aminotransferase, blood urea nitrogen, calcium, cholesterol, creatinine, direct bilirubin, gamma-glutamyl transpeptidase, glucose, ionized phosphorus, lactate dehydrogenase, protein, total bilirubin, and uric acid.
RESULTS
Quality control data for 6 months were used to calculate the desired concentration. Biological variation was used to establish critical differences and determine the number of replicates. The calculated ranges of all test parameters were less than their critical differences, so comparability between the 2 instruments was considered acceptable.
CONCLUSIONS
The Clinical and Laboratory Standards Institute C54-A guideline is useful for the verification of comparability of results obtained with 2 instruments within 1 healthcare system.

Keyword

Bias; Quality control; Comparative study
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