Performance evaluation of the LumiraDx quantitative microfluidic point-of-care CRP test

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine Pub Date : 2023-12-12 DOI:10.1016/j.plabm.2023.e00349

Jayne Ellis , James Harnett , Gregor Cameron , Phil Moss , Alasdair Gray

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引用次数: 0

Abstract

C-reactive protein (CRP) is an established acute-phase marker for infection, inflammation and tissue injury, used to guide clinical decision-making in primary and secondary care. This study compared the analytical performance of the quantitative microfluidic point-of-care LumiraDx CRP Test to a laboratory-based reference method (Siemens RCRP Flex assay on the Dimension® Xpand®) and evaluated equivalence of sample matrices (blood versus plasma) in point-of-care settings using samples from patients presenting with symptoms of infection or inflammation. The LumiraDx CRP Test demonstrated close agreement with the lab reference test (range, 5.1 to 245.2 mg/L, r = 0.992, slope = 0.998, intercept = –0.476; n = 205) and notable agreement between fingerstick and venous blood and plasma (r = 0.974–0.983; n = 44). Paired replicate precision had mean coefficients of variation of 6.4 % (plasma), 6.6 % (capillary direct) and 8.1 % (venous blood); overall error rates were 2.9 %. The quantitative LumiraDx CRP Test showed robust analytical performance across sample matrices and close agreement compared to the laboratory reference method when used at the point of care.

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LumiraDx 床旁 CRP 定量微流控检测仪的性能评估

c反应蛋白(CRP)是公认的感染、炎症和组织损伤的急性期标志物，用于指导初级和二级保健的临床决策。本研究比较了定量微流控护理点LumiraDx CRP检测与基于实验室的参考方法(Dimension®Xpand®上的西门子RCRP Flex检测)的分析性能，并使用出现感染或炎症症状的患者的样本评估了护理点环境中样品基质(血液与血浆)的等效性。LumiraDx CRP测试结果与实验室参考测试结果一致(范围:5.1 ~ 245.2 mg/L, r = 0.992，斜率= 0.998，截距= -0.476;N = 205)，指检与静脉血、血浆吻合显著(r = 0.974 ~ 0.983;n = 44)。配对重复精密度的平均变异系数分别为6.4%(血浆)、6.6%(毛细管直血)和8.1%(静脉血);总体错误率为2.9%。定量的LumiraDx CRP测试显示了跨样品矩阵的强大分析性能，与在护理点使用的实验室参考方法相比，具有密切的一致性。

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

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

期刊介绍： Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.