定义一种新的高灵敏度护理点肌钙蛋白I测定在其预期的临床环境的分析特点。

IF 3.7 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
James Hatherley, Sarah Davies, Suzannah Phillips, Ahmed Dakshi, Guy Miller, Lisa Bailey, Paul Collinson, Aleem Khand
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引用次数: 0

摘要

目的:评估急诊科即时肌钙蛋白I检测的不精确性和稳定性,以及其与两种中心实验室肌钙蛋白I检测(西门子Atellica和雅培Alinity)的相关性和偏倚性。方法:由未经实验室培训的人员在急诊科随机抽取全血样本进行不精确性和稳定性检测。对默西急性冠状动脉综合征排除研究参与者的样本进行了分析比较。结果:变异系数(95 %置信区间),在第99个百分位数的护理点检测,为8.1 %(6.1-12.1 %),但具有较宽的置信区间,反映了相当大的分散值刚好低于第99个百分位数。10 %的定量限为7.5 ng/L(1.7 ~ 61.8 ng/L)。所有样品均满足≤2 ng/L的稳定性标准,持续时间为4 h及以下。即时护理检测与西门子Atellica和雅培Alinity检测具有很强的相关性和负偏倚,皮尔逊R=0.99和0.95,平均差值分别为-29.7 ng/L和-13.3 ng/L。结论:西门子VTLi即时检测法在非实验室培训人员使用全血操作时满足高灵敏度标准。锂肝素样品可能稳定到4 h。护理点和两个中心实验室检测之间的显著偏差否定了这些检测的互换使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Defining the analytical characteristics of a novel high-sensitivity point-of-care troponin I assay in its intended clinical environment.

Objectives: To assess the imprecision and stability of the point-of-care troponin I assay in the Emergency Department and its correlation and bias to two central laboratory troponin I assays (Siemens Atellica and Abbott Alinity).

Methods: Imprecision and stability testing was performed on opportunistically selected samples using whole blood in the emergency department by non-laboratory trained personnel. Assay comparisons were undertaken on samples taken from participants of the Mersey Acute Coronary syndrome Rule Out Study.

Results: The coefficient of variation (95 % confidence interval), at the 99th percentile for the point-of-care assay, was 8.1 % (6.1-12.1 %) but with a wide confidence interval reflective of considerable scatter at values just below the 99th percentile. The 10 % limit of quantification was 7.5 ng/L (1.7-61.8 ng/L). All samples met the ≤2 ng/L stability criteria for a duration of 4 h and under. The point-of-care assay very strongly correlated and had a negative bias with the Siemens Atellica and Abbott Alinity assays, Pearson's R=0.99 and 0.95, mean difference -29.7 ng/L and -13.3 ng/L respectively.

Conclusions: The Siemens VTLi point-of-care assay fulfils high-sensitivity criteria when operated by non-laboratory trained staff using whole blood in its intended environment. Lithium heparin samples are likely stable up to 4 h. Significant bias between the point-of-care and two central laboratory assays negates the use of these assays interchangeably.

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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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