Evaluation of serum alkaline phosphatase measurement through the 4-year trueness verification program in China
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Jing Wang
Abstract
Background
Alkaline phosphatase (ALP) is critical for various diseases. The International Federation of Clinical Chemistry and Laboratory Medicine had recommended the new reference procedure in 2011, but many manufacturers did not trace results to the higher procedure. Since 2012, the National Center for Clinical Laboratories (NCCL) in China has organized the trueness verification program (TV) with commutable materials. The present study summarizes the 4-year TV program to give an overview of the measurement standardization for ALP results.
Methods
Commutable serum-based materials with different concentrations were prepared and sent to participating laboratories. The target values were assigned by the reference lab network.
Results
The analytical performance was evaluated according to three indexes: trueness (bias), imprecision (CV) and accuracy (total error [TE]). The number of participating laboratories increased from 115 in 2012 to 287 in 2016. The pass rates of precision for homogeneous and heterogeneous systems were all above 85% over the 4 years; however, the pass rates of bias were much lower (<50%). Among the homogeneous systems, Roche Cobas/Modular had an obvious negative bias, whereas the mean positive bias for Beckman AU was prominent. As to the heterogeneous systems, the pass rates of bias for Sichuan Maccura (57.1%–78.6%) were higher than Roche Cobas/Modular (4.4%–33.9%) and Beckman AU (35.7%–64.8%).
Conclusions
The PT/EQA program with commutable materials can be used to assess the trueness against target values assigned by reference procedures. For ALP, homogeneous systems did not perform better than heterogeneous systems. The bias for ALP performance was notable and was the main obstacle to its standardization in China.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: The Leaping Development Project of Beijing Biomedical Industry (Z161100001816043). The National High Technology Research and Development Program of China (2011AA02A102).
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
References
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©2018 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- Editorial
- Observing an analyzer’s operational life cycle: a useful management tool for clinical laboratories
- Reviews
- Personalized laboratory medicine: a patient-centered future approach
- Circular RNAs: a new class of biomarkers as a rising interest in laboratory medicine
- Mini Review
- Impact of interactions between drugs and laboratory test results on diagnostic test interpretation – a systematic review
- Opinion Paper
- Uncertainty in measurement and total error: different roads to the same quality destination?
- Guidelines and Recommendations
- Joint EFLM-COLABIOCLI Recommendation for venous blood sampling
- General Clinical Chemistry and Laboratory Medicine
- Evidence for the positive impact of ISO 9001 and ISO 15189 quality systems on laboratory performance – evaluation of immunohaematology external quality assessment results during 19 years in Austria
- Effects of high-dose, intravenous lipid emulsion on laboratory tests in humans: a randomized, placebo-controlled, double-blind, clinical crossover trial
- Commutability of the certified reference materials for the standardization of β-amyloid 1-42 assay in human cerebrospinal fluid: lessons for tau and β-amyloid 1-40 measurements
- Failure rate prediction of equipment: can Weibull distribution be applied to automated hematology analyzers?
- Evaluation of serum alkaline phosphatase measurement through the 4-year trueness verification program in China
- Increased serum concentrations of soluble ST2 predict mortality after burn injury
- The clinical significance of borderline results of the Elia CTD Screen assay
- Reference Values and Biological Variations
- Reference intervals for 33 biochemical analytes in healthy Indian population: C-RIDL IFCC initiative
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- Analytical validation of two second generation thyroglobulin immunoassays (Roche and Thermo Fisher)
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