法国多中心对自动 Lumipulse G sNfL 血液检测法（Fujirebio®）进行分析评估，并将其与其他四种用于临床评估血清神经丝轻链的免疫检测法进行比较。

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2024-10-23 DOI:10.1016/j.cca.2024.120007

Etienne Mondésert , Susanna Schraen-Maschke , Isabelle Quadrio , Olivier Bousiges , Damien Bouvier , Constance Delaby , Aurélie Bedel , Sylvain Lehmann , Anthony Fourier

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引用次数: 0

摘要

目的：血清神经丝轻链（sNfL）蛋白的测定正成为许多神经系统疾病的关键生物标志物。为满足这些临床需求，已开发出多种免疫测定方法，但在变异性和结果方面存在显著差异。方法：6 个独立的法国临床实验室分析了低值（10 pg/mL）、中值（30 pg/mL）和高值（100 pg/mL）sNfL 的 3 个样品池的 6 个重复样本和 sNfL 值不断增长的 12 个样品的 1 个重复样本。首先评估了 Lumipulse G 上的 sNfL 血液分析法（Fujirebio®）的分析性能，然后与其他四种免疫分析法进行了比较：NF-light V2（Quanterix®）在SiMOA HD-X上、人NF-L（Biotechne®）在Ella上、R-Plex人神经丝L（MSD®）在Sector 2400上；手工ELISA检测使用Uman Diagnostic/Quanterix®：结果： Lumipulse 血液检测的中心间比较显示，每个城市的低、中、高池的平均 sNfL 值差异有限但显著（p 结论： Lumipulse 血液检测的中心间比较显示，每个城市的低、中、高池的平均 sNfL 值差异有限但显著（p 结论）：自动卢米帕斯检测法在各实验室得出的 sNfL 值具有可比性；但还需进一步调整，以统一 sNfL 结果。生物学家和医生应注意不同免疫测定供应商之间的结果差异。

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A French multicenter analytical evaluation of the automated Lumipulse G sNfL blood assay (Fujirebio®) and its comparison to four other immunoassays for serum neurofilament light chain assessment in clinical settings

Objectives

Measurement of serum neurofilament light chain (sNfL) protein is becoming a key biomarker for many neurological diseases. Several immunoassays have been developed to meet these clinical needs, revealing significant differences in terms of variability and results. Here, we propose a French multicenter comparison of 5 sNfL assays.

Methods

6 replicates of 3 pools with low (10 pg/mL), medium (30 pg/mL) and high (100 pg/mL) sNfL values and one replicate of 12 samples with growing sNfL values were analyzed by six independent French clinical laboratories. The analytical performances of the sNfL blood assay (Fujirebio®) on Lumipulse G were first evaluated then compared to four other immunoassays: NF-light V2 (Quanterix®) on SiMOA HD-X, Human NF-L (Biotechne®) on Ella, R-Plex Human Neurofilament L (MSD®) on Sector 2400; manual ELISA test using Uman Diagnostic/Quanterix®.

Results

Inter-center comparison of the Lumipulse blood assay revealed limited but significant differences in the mean sNfL values across low, medium, and high pools between each city (p < 0.001) and between the two different batches used. Coefficients of variation of pools ranged from 2.0 to 16.9 %. Z-score of sNfL results of the 12 samples ranged from −1.70 to +1.71. Inter-technique comparison showed a systematic difference of sNfL values, with a overestimation of MSD and Ella over other tests. Nonetheless, results were all significantly correlated (p < 0.001).

Conclusion

The automated Lumipulse assay produced comparable sNfL values across laboratories; but further adjustments are needed to harmonize sNfL results. Biologists and physicians should be aware of the variability in results between different immunoassay suppliers.

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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.