EQA/PT scheme to improve the equivalence of enzymatic results between mutual recognition laboratories in Beijing

• Main Authors: Tong, Q. (Author), Zhang, S. (Author), Zuo, C. (Author)
• Format: Article
• Language: English
• Published: John Wiley and Sons Inc 2021
• Subjects: alanine aminotransferase; Alanine Transaminase; Article; aspartate aminotransferase; Aspartate Aminotransferases; Beijing; biological variation; blood; calibration; China; Clinical Enzyme Tests; clinical laboratory service; Clinical Laboratory Services; creatine kinase; Creatine Kinase; enzymatic assay; enzyme assay; external quality assessment; gamma glutamyltransferase; gamma-Glutamyltransferase; good laboratory practice; health care quality; human; Humans; Laboratories; laboratory; Laboratory Proficiency Testing; lactate dehydrogenase; L-Lactate Dehydrogenase; measurement accuracy; procedures; proficiency testing; Quality Assurance, Health Care; quality control; standardization
• Online Access: View Fulltext in Publisher

 Background: To utilize the external quality assessment (EQA)/proficiency testing (PT) scheme to evaluate the equivalence of different clinical enzymatic measuring systems in Beijing. Methods: The Beijing Center for Clinical Laboratory (BCCL) distributed three investigation samples to mutual recognition clinical laboratories in Beijing including alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltransferase (GGT), creatine kinase (CK), and lactate dehydrogenase (LDH). These samples were derived from serum pools with values assigned by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) enzymatic reference measurement procedures (RMPs). Each laboratory performed duplicate tests of the samples. Then, the samples at level 1 were used to recalibrate individual measuring systems for repeating the tests. BCCL collected data for evaluation of their analytical quality. Results: Before recalibration, the biases of ALT and AST tests were not traceable to the IFCC RMPs, and the bias pass rates of GGT, CK, and LDH tests were only 51.2%, 55.7%, and 48.6% respectively. After recalibration, the pass rates of ALT, AST, GGT, CK, and LDH increased to 95.1%, 82.9%, 95.1%, 97.1%, and 70.0% respectively. The EQA/PT also showed that after recalibration, more than 95% of laboratories met the optimum level specifications of the biological variation for ALT, AST, GGT, and CK tests and the desirable for LDH tests. Conclusion: The enzymatic tests in Beijing need to be further standardized by category 1 or 2 EQA/PT scheme for mutual recognition between clinical laboratories. The criteria of biological variation are more relevant for determining the equivalence of clinical enzymatic tests. © 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC