Assessment of novel POCT to evaluate liver function

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine Pub Date : 2024-01-30 DOI:10.1016/j.plabm.2024.e00367

Carmen Minea , Damien Gruson

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引用次数: 0

Abstract

Objectives

Point of care testing (POCT) offers the possibility of near bedside patient testing with a reduction of the turn-around time of analysis. The aim of our study was to determine the analytical performances and usability of a recently developed POCT device for the measurement of tests related to liver function. We evaluated the performance of a liver tests panel performed on the LINX EVO® POCT device.

Design and methods

The imprecision was determined with the Bio-Rad Liquichek Unassayed Chemistry Control. Method comparison was performed with a Cobas® 8000 analyzer. Samples from twenty healthy volunteers were used to verify the reference intervals. Furthermore, practicality was assessed by the healthcare staff handling the POCT device through a dedicated questionnaire.

Results

The imprecision observed was matching the criteria for the in-lab assay with only one exception, globulin, with an observed imprecision of 6.3 % and a criteria of 5.7 %. With the exception of total and direct bilirubin, the POCT method showed good agreement with the in-lab methods. The verification of reference intervals showed that more than 90 % of the healthy volunteer values were included into the reference interval claimed by the manufacturer except for glucose and globulin. The POCT practicality questionnaire was satisfying overall for users.

Conclusions

Our study showed very good analytical performances overall for the liver test panel performed on the LINX EVO® POCT instrument.

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评估肝功能的新型 POCT

目标护理检测（POCT）为病人提供了近距离床旁检测的可能性，并缩短了分析周转时间。我们的研究旨在确定最近开发的用于测量肝功能相关测试的 POCT 设备的分析性能和可用性。我们评估了在 LINX EVO® POCT 设备上进行的肝脏检测的性能。设计与方法用 Bio-Rad Liquichek Unassayed Chemistry Control 测定不精确度。使用 Cobas® 8000 分析仪进行方法比较。用 20 名健康志愿者的样本来验证参考区间。此外，处理 POCT 设备的医护人员还通过一份专门的调查问卷对实用性进行了评估。除总胆红素和直接胆红素外，POCT 方法与实验室方法显示出良好的一致性。对参考区间的验证表明，除葡萄糖和球蛋白外，90% 以上的健康志愿者数值都被纳入了制造商声称的参考区间。我们的研究表明，LINX EVO® POCT 仪器上进行的肝脏检测项目总体上具有很好的分析性能。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.