{"title":"Establishing reference intervals for soluble urokinase plasminogen activator receptor in Northern European adults","authors":"Stine Bakkensen Bruun , Jeppe Buur Madsen , Claus Lohman Brasen","doi":"10.1016/j.plabm.2024.e00371","DOIUrl":null,"url":null,"abstract":"<div><h3>Objectives</h3><p>Soluble urokinase plasminogen activator receptor (suPAR) may have untapped potential in clinical diagnostics. Previous studies determined reference intervals using an enzyme-linked immunoassay, but there is a need for reference intervals using a faster assay if the analysis is to be used in emergency medicine. The current study aims to determine reference intervals for suPAR using a fully automated particle-enhanced turbidimetric immunoassay (PETIA) according to the Clinical and Laboratory Standards Institute guideline A28-A3c.</p></div><div><h3>Design and methods</h3><p>Blood samples were prospectively collected from Danish blood donors. Plasma suPAR was analyzed on the cobas 8000 module c502 in an open channel using a PETIA. Sex-partitioned reference intervals were determined using a parametric quantile approach.</p></div><div><h3>Results</h3><p>The study included 241 participants—123 females and 118 males. The common reference interval for suPAR was 1.56–4.11 ng/mL (95% confidence intervals (CI) for the lower and upper limits were 1.56–1.63 and 3.81–4.47, respectively). The reference interval for females was 1.59–4.65 ng/mL (95% CIs 1.48–1.70 and 4.09–5.48, respectively) and for males, 1.56–3.59 ng/mL (95% CIs 1.47–1.65 and 3.31–3.93, respectively).</p></div><div><h3>Conclusions</h3><p>Our results support using sex-partitioned reference intervals for suPAR and provide a basis for future studies using the PETIA method.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00371"},"PeriodicalIF":1.7000,"publicationDate":"2024-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000179/pdfft?md5=f335061a211165e564c72fb37dceb885&pid=1-s2.0-S2352551724000179-main.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Practical Laboratory Medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2352551724000179","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Objectives
Soluble urokinase plasminogen activator receptor (suPAR) may have untapped potential in clinical diagnostics. Previous studies determined reference intervals using an enzyme-linked immunoassay, but there is a need for reference intervals using a faster assay if the analysis is to be used in emergency medicine. The current study aims to determine reference intervals for suPAR using a fully automated particle-enhanced turbidimetric immunoassay (PETIA) according to the Clinical and Laboratory Standards Institute guideline A28-A3c.
Design and methods
Blood samples were prospectively collected from Danish blood donors. Plasma suPAR was analyzed on the cobas 8000 module c502 in an open channel using a PETIA. Sex-partitioned reference intervals were determined using a parametric quantile approach.
Results
The study included 241 participants—123 females and 118 males. The common reference interval for suPAR was 1.56–4.11 ng/mL (95% confidence intervals (CI) for the lower and upper limits were 1.56–1.63 and 3.81–4.47, respectively). The reference interval for females was 1.59–4.65 ng/mL (95% CIs 1.48–1.70 and 4.09–5.48, respectively) and for males, 1.56–3.59 ng/mL (95% CIs 1.47–1.65 and 3.31–3.93, respectively).
Conclusions
Our results support using sex-partitioned reference intervals for suPAR and provide a basis for future studies using the PETIA method.
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.