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

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 recognit...

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Autores principales: Tong, Qing, Zhang, Shunli, Zuo, Chang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8183905/
https://www.ncbi.nlm.nih.gov/pubmed/33948986
http://dx.doi.org/10.1002/jcla.23814
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author Tong, Qing
Zhang, Shunli
Zuo, Chang
author_facet Tong, Qing
Zhang, Shunli
Zuo, Chang
author_sort Tong, Qing
collection PubMed
description 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.
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spelling pubmed-81839052021-06-16 EQA/PT scheme to improve the equivalence of enzymatic results between mutual recognition laboratories in Beijing Tong, Qing Zhang, Shunli Zuo, Chang J Clin Lab Anal Research Articles 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. John Wiley and Sons Inc. 2021-05-05 /pmc/articles/PMC8183905/ /pubmed/33948986 http://dx.doi.org/10.1002/jcla.23814 Text en © 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Research Articles
Tong, Qing
Zhang, Shunli
Zuo, Chang
EQA/PT scheme to improve the equivalence of enzymatic results between mutual recognition laboratories in Beijing
title EQA/PT scheme to improve the equivalence of enzymatic results between mutual recognition laboratories in Beijing
title_full EQA/PT scheme to improve the equivalence of enzymatic results between mutual recognition laboratories in Beijing
title_fullStr EQA/PT scheme to improve the equivalence of enzymatic results between mutual recognition laboratories in Beijing
title_full_unstemmed EQA/PT scheme to improve the equivalence of enzymatic results between mutual recognition laboratories in Beijing
title_short EQA/PT scheme to improve the equivalence of enzymatic results between mutual recognition laboratories in Beijing
title_sort eqa/pt scheme to improve the equivalence of enzymatic results between mutual recognition laboratories in beijing
topic Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8183905/
https://www.ncbi.nlm.nih.gov/pubmed/33948986
http://dx.doi.org/10.1002/jcla.23814
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