Atellica VTLi 护理点高灵敏度肌钙蛋白 I 检测的分析验证。

IF 3.8 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Christopher M Florkowski, Vanessa Buchan, Bobby V Li, Felicity Taylor, Minh Phan, Martin Than, John W Pickering
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引用次数: 0

摘要

目的:西门子护理点检测 (POC) Atellica® VTLi 高敏肌钙蛋白 I (hsTnI) 仪器已通过验证。验证可独立证明分析程序符合实验室检测的一致性、不精确性和溶血干扰要求:方法:连续分析 20 次测量间隔内的 5 份全血样本。通过向血浆中添加五种浓度的溶血物,使游离血红蛋白浓度达到 35-1,000 mg/dL,从而评估三种浓度肌钙蛋白的溶血干扰。实验室分析仪(贝克曼、罗氏、西门子)上的全血(VTLi)和血浆之间的一致性是通过皮尔逊相关性和卡帕统计在(LOQ)和参考上限(URL)进行评估的。对冷冻血浆样本进行了重复评估:结果:全血的变异系数为结论:VTLi 与实验室检测之间的一致性至少不低于实验室检测之间的一致性。不精确度符合制造商的要求,并与高灵敏度测定相一致。存在溶血干扰的可能性,因此需要高质量的样本。结果支持之前在验证研究中报告的性能特征,该设备在预定的医疗环境中使用具有可接受的性能。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analytical verification of the Atellica VTLi point of care high sensitivity troponin I assay.

Objectives: The Siemens Point-of-Care Testing (POC) Atellica® VTLi high-sensitivity troponin I (hsTnI) device has been previously validated. Verification independently provides evidence that an analytical procedure fulfils concordance with laboratory assays, imprecision, and hemolysis interference requirements.

Methods: Five whole blood samples spanning the measuring interval were analysed 20 times in succession. Hemolysis interference was assessed at three troponin concentrations by spiking five hemolysate concentrations to plasma to achieve free hemoglobin concentrations 35-1,000 mg/dL. Concordance between whole blood (VTLi) and plasma on laboratory analysers (Beckman, Roche, Siemens) was assessed by Pearson correlation and kappa statistics at the (LOQ) and upper reference limit (URL). This was repeated for frozen plasma samples.

Results: Coefficients of variation for whole blood were <10 % for whole blood troponin concentrations of 9.2 and 15.9 ng/L, thus below the URL. Hemolysis positively interfered; at 250 mg/dL affecting the low troponin sample (+3 ng/L; +60 %) and high troponin sample (+37 ng/L; +24 %). Correlation coefficients were 0.98, 0.90 and 0.97 between VTLi and Beckman, Roche and Siemens assays respectively. Corresponding kappa statistics were 0.80, 0.73 and 0.84 at the LOQ and 0.70, 0.44 and 0.67 at the URL.

Conclusions: Concordances between VTLi and laboratory assays were at least non-inferior to those between laboratory assays. Imprecision met manufacturer claims and was consistent with a high sensitivity assay. There is potential for hemolysis interference, highlighting the need for quality samples. The results support performance characteristics previously reported in validation studies, and the device offers acceptable performance for use within intended medical settings.

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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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