Journal
CLINICA CHIMICA ACTA
Volume 461, Issue -, Pages 98-102Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.cca.2016.07.008
Keywords
Standardization; Bias; Trueness verification program; Commutable material; Traceability
Categories
Funding
- Special Program for Science and Technology Basic Work [2013FY113800]
- National Natural Science Foundation of China [81301488]
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Background: Since 2003, the National Center for Clinical Laboratories (NCCL) has organized a network of reference laboratories and several survey programs to improve standardization in China. Methods: We analyzed the 2015 trueness verification program to assess the status of enzyme measurement standardization. Commutable serum-based materials were prepared and sent to 10 reference laboratories to assign target values for 2 enzymes (alanine aminotransferase-pyridoxal phosphate [ALT-pp] and gamma-glutamyltransferase [GGT]) using IFCC reference measurement procedures. Results: Analytical performance was assessed for compliance to 3 indexes: trueness (bias), imprecision (CV), and accuracy (total error). Of the 250 participating laboratories, about half (>= 124) used heterogeneous systems. More laboratories met the tolerance limit of imprecision than of trueness or accuracy. Except at the lowest concentration, the CV pass rates were >90% for the 2 enzymes. The optimal performance criterion derived from biological variation yielded pass rates for total error (ALT 77%, GGT 80%) that were higher than for bias (ALT 63%, GGT 73%). Conclusions: PT/EQA results for commutable samples can be used to assess trueness against reference measurement procedures. Despite global and national standardization programs, bias remains a critical limitation of current enzyme measurement procedures in China. (C) 2016 Elsevier B.V. All rights reserved.
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