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Commutability Assessment of Candidate External Quality Assessment Materials for Aminotransferase Activity Measurements Based on Different Approaches in China

Annals of Laboratory Medicine 2021년 41권 1호 p.68 ~ 76
Long Qichen, Qi Tianqi, Zhang Tianjiao, Wang Jing, Zeng Jie, Yan Ying, Wang Meng, Huang Wei, Zhao Haijian, Chen Wenxiang, Zhang Chuanbao,
소속 상세정보
 ( Long Qichen ) - Beijing Engineering Research Center of Laboratory Medicine National Center for Gerontology
 ( Qi Tianqi ) - Beijing Engineering Research Center of Laboratory Medicine National Center for Gerontology
 ( Zhang Tianjiao ) - Beijing Engineering Research Center of Laboratory Medicine National Center for Gerontology
 ( Wang Jing ) - Beijing Engineering Research Center of Laboratory Medicine National Center for Gerontology
 ( Zeng Jie ) - Beijing Engineering Research Center of Laboratory Medicine National Center for Gerontology
 ( Yan Ying ) - Beijing Engineering Research Center of Laboratory Medicine National Center for Gerontology
 ( Wang Meng ) - National Center of Gerontology Beijing Hospital
 ( Huang Wei ) - National Center of Gerontology Beijing Hospital
 ( Zhao Haijian ) - Beijing Engineering Research Center of Laboratory Medicine National Center for Gerontology
 ( Chen Wenxiang ) - Beijing Engineering Research Center of Laboratory Medicine National Center for Gerontology
 ( Zhang Chuanbao ) - Beijing Engineering Research Center of Laboratory Medicine National Center for Gerontology

Abstract


Background: Using commutable external quality assessment (EQA) materials is important for monitoring successful harmonization efforts. We assessed the commutability of four human serum pool (HSP) preparations to identify candidate EQA materials for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activity measurement.

Methods: One set each of 85 clinical samples (CSs) was collected for ALT and AST activity measurement. The 15 candidate EQA materials included four types of HSP preparations (A to D): materials A, C, and D contained human original recombinant (HOR) aminotransferases; materials B was mixed leftover samples. The CSs and 15 candidate EQA materials were analyzed using seven routine assays, and the ln-transformed results were analyzed in 21 assay pairs. Commutability was assessed using Deming regression, with a 95% prediction interval (CLSI approach) and the difference in bias with an error component model (International Federation of Clinical Chemistry and Laboratory Medicine [IFCC] approach).

Results: For ALT, all materials were commutable for 14?21 assay pairs according to the CLSI and IFCC approaches. For AST, B01-03 showed commutability for 14-21 assay pairs, and C01-03 and D01-03 showed commutability for no less than 10 assay pairs according to the two approaches. A01-06 were commutable for 9-16 assay pairs according to the CLSI approach, but for 6-9 assay pairs according to the IFCC approach.

Conclusions: Mixed leftover samples showed desirable commutability characteristics as candidate EQA materials for routine aminotransferase activity measurements. Human serum bases supplemented with HOR were commutable for most routine ALT activity measurements.

키워드

Alanine aminotransferase; Aspartate aminotransferase; Commutability; External quality assessment materials

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