证明现有认证标准物质与原始可交换性评估中未包括的最终用户测量程序的可交换性

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-08-10 DOI:10.1016/j.cca.2025.120548

W. Greg Miller , Liesbet Deprez , Sverre Sandberg , Jesper V. Johansen , Neil Greenberg , Cas Weykamp , Thomas Keller , Jeffrey Budd , Vincent Delatour , Elizabeth Barczak , Robert Rej , Pernille Kjeilen Fauskanger , Finlay MacKenzie , Johanna E. Camara , Alicia N. Lyle , Mauro Panteghini

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引用次数: 0

摘要

作为二级校准器使用的认证标准物质（CRM）的可交换性评估应由CRM生产商在材料最初制备时进行。评估通常包括医学实验室常用的几种体外诊断（IVD）测量程序（MPs）。由于后勤方面的限制，通常不可能将所有现有的IVD-MPs纳入可交换性评估。此外，一种新的IVD-MP （IVD-MPn）可能会在对给定的CRM进行可交换性评估后引入市场。在这里，我们提供了如何评估现有CRM与原始可交换性评估中未包括的IVD-MPn使用的可交换性的建议。研究设计遵循与完全可交换性评估相同的原则，但它仅包括IVD-MPn和较少的额外比较物MP(s)，其中CRM与临床样品的可交换性先前已被证明。当没有参考测量程序（RMP）可用时，或者当物流使RMP难以使用时，应使用作为CRM原始可交换性评估一部分的其他IVD-MP作为比较MP。在选择比较器IVD-MP时，必须仔细考虑其性能，其对测量的选择性应与IVD-MPn相当。在最初的可交换性评估中，CRM应该与比较物IVD-MP具有可忽略不计的不可交换性偏差。当现有的CRM满足IVD-MPn的可交换准则时，该CRM可用于IVD-MPn的校准层次。

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Demonstrating commutability of an existing certified reference material for use with an end-user measurement procedure that was not included in the original commutability assessment

Commutability assessment of a certified reference material (CRM) intended for use as a secondary calibrator should be performed by the CRM producer at the time the material is originally prepared. Assessment typically includes several in-vitro diagnostic (IVD) measurement procedures (MPs) in common use in medical laboratories. Due to logistical constraints, it is usually not possible to include all existing IVD-MPs in a commutability assessment. In addition, a new IVD-MP (IVD-MP_n) may be introduced into the market after a commutability assessment was performed for a given CRM. Here we provide a recommendation how to assess commutability of an existing CRM for use with an IVD-MP_n that was not included in the original commutability assessment.

The study design follows the same principles as a full commutability assessment, but it includes only the IVD-MP_n and fewer additional comparator MP(s) for which the CRM’s commutability with clinical samples was previously demonstrated. When no reference measurement procedure (RMP) is available, or when the logistics make an RMP difficult to use, other IVD-MP(s) that were part of the original commutability assessment for the CRM should be used as comparator MP(s).

When selecting a comparator IVD-MP, its performance must be carefully considered and its selectivity for the measurand should be equivalent to that of the IVD-MP_n. The CRM should have had negligible noncommutability bias with the comparator IVD-MP in the original commutability assessment. When the existing CRM meets the commutability criterion for IVD-MP_n, the CRM can be used in the calibration hierarchy of the IVD-MP_n.

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来源期刊

Clinica Chimica Acta 医学-医学实验技术

CiteScore

10.10

自引率

2.00%

发文量

1268

审稿时长

23 days

期刊介绍： The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells. The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.