EQA: There's not a glitch in the matrix. Investigation of CRP bias on the Roche Cobas c701.

IF 2.1 4区医学 Q3 MEDICAL LABORATORY TECHNOLOGY

Annals of Clinical Biochemistry Pub Date : 2023-09-01 Epub Date: 2023-05-17 DOI:10.1177/00045632231169151

Emma Stevenson, Chelsey Walsh, Sadie Thomas

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引用次数: 0

Abstract

Background: The Roche Cobas c Tina-quant C-Reactive Protein (CRP) IV method has shown persistent, significant negative bias compared to other methodologies in the UK NEQAS external quality assurance (EQA) scheme. The aim of this study was to compare CRP concentrations determined by this restandardized 4th generation assay with another commercially available method to assess the extent of any bias and impact on clinical cut-offs.

Methods: CRP concentrations in 38 anonymized patient serum samples were determined by a particle-enhanced immunoturbidimetric assay on the Roche Cobas c701 module and a latex assay on the Beckman Coulter AU5800 analyser over a concentration range of 1-308 mg/L.

Results: 97.4% samples analysed by the Roche Tina-quant CRP IV method demonstrated a negative bias compared to the Beckman AU latex method. The mean absolute bias was -4.12 mg/L (range: -19.13-10.93 mg/L; 95% CI: -17.25-9.01 mg/L). The mean relative difference was -15.5% (range: -40-4%; 95% CI: -33.03-1.94%). This bias was seen across the range of samples assayed, including at clinically significant cut-offs of 5 mg/L (-24% bias), 20 mg/L (-5%) and 100 mg/L (-13%).

Conclusion: The negative bias of the Roche method demonstrated in the EQA scheme appears to reflect genuine differences in patient results, rather than an EQA matrix effect, despite re-standardization of the CRP assay. This report indicates that clinical cut-offs and reference ranges may be method-dependent, which should be reflected in published guidance and interpretation provided by laboratories.

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EQA：矩阵中没有任何故障。罗氏Cobas c701的CRP偏倚研究。

背景：与英国NEQAS外部质量保证（EQA）计划中的其他方法相比，罗氏Cobas c Tina定量c反应蛋白（CRP）IV方法显示出持续的、显著的负偏差。本研究的目的是将这种重新标准化的第四代测定法测定的CRP浓度与另一种市售方法进行比较，以评估任何偏差的程度和对临床效果的影响在Beckman Coulter AU5800分析仪上，浓度范围为1-308 mg/L。结果：与Beckman AU乳胶法相比，Roche Tina定量CRP IV法分析的97.4%的样品显示出负偏差。平均绝对偏倚为-4.12 mg/L（范围：-19.13-10.93 mg/L；95%可信区间：-17.25-9.01 mg/L）。平均相对差异为-15.5%（范围：-40-4%；95%置信区间：-33.03-1.94%），20 mg/L（-5%）和100 mg/L（-13%）。结论：尽管CRP测定重新标准化，但EQA方案中证明的罗氏方法的负偏差似乎反映了患者结果的真正差异，而不是EQA基质效应。本报告指出，临床截止值和参考范围可能取决于方法，这应反映在实验室提供的已出版指南和解释中。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of Clinical Biochemistry Biochemistry, Genetics and Molecular Biology-Clinical Biochemistry

CiteScore

5.20

自引率

4.50%

发文量

期刊介绍： Annals of Clinical Biochemistry is the fully peer reviewed international journal of the Association for Clinical Biochemistry and Laboratory Medicine. Annals of Clinical Biochemistry accepts papers that contribute to knowledge in all fields of laboratory medicine, especially those pertaining to the understanding, diagnosis and treatment of human disease. It publishes papers on clinical biochemistry, clinical audit, metabolic medicine, immunology, genetics, biotechnology, haematology, microbiology, computing and management where they have both biochemical and clinical relevance. Papers describing evaluation or implementation of commercial reagent kits or the performance of new analysers require substantial original information. Unless of exceptional interest and novelty, studies dealing with the redox status in various diseases are not generally considered within the journal''s scope. Studies documenting the association of single nucleotide polymorphisms (SNPs) with particular phenotypes will not normally be considered, given the greater strength of genome wide association studies (GWAS). Research undertaken in non-human animals will not be considered for publication in the Annals. Annals of Clinical Biochemistry is also the official journal of NVKC (de Nederlandse Vereniging voor Klinische Chemie) and JSCC (Japan Society of Clinical Chemistry).