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
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引用次数: 0
Abstract
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.
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.