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与Elecsys BRAHMS降钙素原免疫分析相比,对脓毒症人群中即时检测Finecare™降钙素原快速定量检测的分析评估。

Analytical Evaluation of Point-of-Care Finecare™ Procalcitonin Rapid Quantitative Test in Sepsis Population as Compared with Elecsys BRAHMS Procalcitonin Immunoassay.

作者信息

Mazlan Mohd Zulfakar, Wan Azman Wan Norlina, Yaacob Najib Majdi, Koon Tan Say, Yahya Nurul Khaiza

机构信息

Department of Anaesthesiology and Intensive Care, School of Medical Sciences, Universiti Sains Malaysia, Kubang Kerian 16150, Kelantan, Malaysia.

Department of Chemical Pathology, School of Medical Sciences, Universiti Sains Malaysia, Kubang Kerian 16150, Kelantan, Malaysia.

出版信息

Diagnostics (Basel). 2024 May 22;14(11):1080. doi: 10.3390/diagnostics14111080.

Abstract

The study compared two plasma procalcitonin (PCT) assays, the point of care (POC) Finecare™ Procalcitonin Rapid Quantitative Test and the Elecsys BRAHMS PCT immunoassay, in sepsis ICU patients. Forty-one plasma samples were analyzed, showing a strong correlation (r = 0.98) and no significant difference in PCT values. The mean POC PCT value was 4.46 ng/mL (SD 8.68), and for laboratory BRAHMS PCT, it was 4.67 ng/mL (SD 10.03). The study found a strong linear relationship between plasma POC PCT and laboratory BRAHMS PCT (r = 0.98). Different regression methods showed varying intercepts and slopes: Ordinary Least Squares had an intercept of 0.49 and a slope of 0.85; Deming regression showed an intercept of 0.43 and a slope of 0.86; Passing-Bablok regression showed an intercept of 0.02 and a slope of 1.08. Precision results for cut-offs of 0.5 ng/mL were a coefficient of variation (CV) of 5%, and for 2.5 ng/mL, the CV was 2.5%. The Pearson correlation coefficient (r) for linearity was ≥0.99. The study revealed no significant difference between the POC Finecare™ PCT and Elecsys BRAHMS PCT immunoassay in sepsis samples from ICU patients, supported by strong correlation, minimal bias, a consistent CV, and linearity.

摘要

该研究比较了两种血浆降钙素原(PCT)检测方法,即即时检验(POC)Finecare™降钙素原快速定量检测法和Elecsys BRAHMS PCT免疫分析法,用于脓毒症重症监护病房(ICU)患者。分析了41份血浆样本,结果显示两者具有很强的相关性(r = 0.98),且PCT值无显著差异。POC检测的PCT平均浓度为4.46 ng/mL(标准差8.68),实验室检测的BRAHMS PCT平均浓度为4.67 ng/mL(标准差10.03)。研究发现血浆POC检测的PCT与实验室检测的BRAHMS PCT之间存在很强的线性关系(r = 0.98)。不同的回归方法显示出不同的截距和斜率:普通最小二乘法截距为0.49,斜率为0.85;Deming回归截距为0.43,斜率为0.86;Passing-Bablok回归截距为0.02,斜率为1.08。截断值为0.5 ng/mL时的精密度结果变异系数(CV)为5%,截断值为2.5 ng/mL时CV为2.5%。线性的Pearson相关系数(r)≥0.99。该研究表明,在ICU患者的脓毒症样本中,POC Finecare™ PCT检测法与Elecsys BRAHMS PCT免疫分析法之间无显著差异,两者相关性强、偏差极小、CV一致且具有线性关系。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0363/11172286/e4faa9c2d5ee/diagnostics-14-01080-g001.jpg

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