A method for measuring the experimental resolution of laboratory assays (clinical biochemical, blood count, immunological, and qPCR) to evaluate analytical performance. Issue 12 (1st November 2021)

• Record Type: Journal Article
• Authors: Sun, Chenxi; Wang, Dongxia; Xu, Henggui; Yang, Guang; Yan, Xiaomei; Liu, Hui
• Is Part Of: Journal of clinical laboratory analysis. Volume 35:Issue 12(2021)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2021-11-01
• Subjects: analytical performance -- biochemical test -- experimental resolution -- immunoassay -- qPCR; Diagnosis, Laboratory -- Periodicals; Medical laboratory technology -- Periodicals; 616
• DOI: 10.1002/jcla.24087
• Languages: English
• ISSNs: 0887-8013

Abstract

Abstract: Background: The measurement method for experimental resolution and related data to evaluate analytical performance is poorly explored in clinical research. We established a method to measure the experimental resolution of clinical tests, including biochemical tests, automatic hematology analyzer methods, immunoassays, chemical experiments, and qPCR, to evaluate their analytical performance. Methods: Serially diluted samples in equal proportions were measured, and correlation analysis was performed between the relative concentration and the measured value. Results were accepted for p ≤ 0.01 of the correlation coefficient. The minimum concentration gradient (eg, 10%) was defined as the experimental resolution. For this method, the smaller the value, the higher the experimental resolution and the better the analytical performance. Results: The experimental resolution of the most common biochemical indices reached 10%, with some even reaching 1%. The results of most counting experiments showed experimental resolution up to 10%, whereas the experimental resolution of the classical chemical assays reached 1%. Unexpectedly, the experimental resolution of more sensitive assays, such as immunoassays was only 25% when using the manual method and 10% for qPCR. Conclusion: This study established a method for measuring the experimental resolution of laboratory assays and provides a new index for evaluating the reliability of methods in clinical laboratories. Abstract : The experimental resolution of most common biochemical indexes reached 10%, and the experimental resolution of some indexes reached 1%. The results of counting experiments showed that, in most cases, the experimental resolution was up to 10%. The experimental resolution of classical chemical assays reached 1%. Unexpectedly, the experimental resolution of assays generally considered to be more sensitive, such as immunoassays and qPCR, was only 25% using the manual method and 10% by qPCR.