Ann Lab Med.  2021 Jan;41(1):68-76. 10.3343/alm.2021.41.1.68.

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

• Long Q
• Qi T
• Zhang T
• Wang J
• Zeng J
• Yan Y
• Wang M
• Huang W
• Zhao H
• Chen W
• Zhang C

• KMID: 2512735
• DOI: http://doi.org/10.3343/alm.2021.41.1.68

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.

Keyword

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

Figure

• 

  Fig. 1 Five representative commutability assessment plots based on the ALT and AST activity measurements of 15 materials according to the CLSI and IFCC approaches. Panels A–B: CLSI approach; panels C–E: IFCC approach; error bars: expanded uncertainty U(DRM); solid black line: 0 line in panels A–B, mean bias line in panels C–E. Abbreviations: CLSI, Clinical and Laboratory Standards Institute; CS, clinical sample; IFCC, International Federation of Clinical Chemistry and Laboratory Medicine; Ln(conc), ln-transformed concentrations; Ln(conc)pred, predicted ln-transformed concentrations in Deming analysis.

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