Verification of automatic analysers Roller 20PN and iSED for measuring erythrocyte sedimentation rate.

IF 3.8 3区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Biochemia Medica Pub Date : 2022-02-15 DOI:10.11613/BM.2022.010708

Helena Čičak, Pavica Šonjić, Ana-Maria Šimundić

{"title":"Verification of automatic analysers Roller 20PN and iSED for measuring erythrocyte sedimentation rate.","authors":"Helena Čičak, Pavica Šonjić, Ana-Maria Šimundić","doi":"10.11613/BM.2022.010708","DOIUrl":null,"url":null,"abstract":"Introduction: Automated erythrocyte sedimentation rate (ESR) analysers are based on different methodology than Westergren method. It is questionable whether ESR values obtained from those analysers are comparable with determined values with Westergren method. The aim was verification of the precision, method comparison and accuracy of automated ESR analysers: Roller 20PN (Alifax S.p.A., Polverara, Italy) and iSED (Alcor Scientific, Smithfield, USA).Materials and methods: Blood samples (N = 752 for Roller 20PN and N = 213 for iSED) were sampled into K2EDTA (Kima, Italy) tubes for automated and 3.8% Na-citrate tubes (Kima, Italy) for Westergren method. The data was divided into three groups according to the ESR values obtained with the Westergren method: Group Low (L) (ESR ≤ 20 mm), Group Medium (M) (ESR 21-60 mm), and Group High (H) (ESR ≥ 61 mm). Method agreement was assessed by Bland-Altman analysis and Passing-Bablok regression.Results: Analyser iSED has shown better comparability with Westergren method (bias 0.0 (95%Cl -1.4 to 1.5) range than Roller 20 PN (bias = - 6.4 (95%Cl - 7.1 to -5.7) in the whole measuring. For Roller 20 PN, Passing-Bablok regression has shown constant and proportional difference for Groups L and M, and for iSED only for Group H. Roller 20 PN had lower sensitivity (0.51 (95%Cl: 0.45-0.57) than iSED (0.72 (95%Cl: 0.59-0.80) while they had comparable specificity (> 0.90) and accuracy (≥ 0.80) in comparison with the Westergren method.Conclusion: Both analysers are not comparable with the Westergren method and should not be used interchangeably.","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":null,"pages":null},"PeriodicalIF":3.8000,"publicationDate":"2022-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8833250/pdf/","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biochemia Medica","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.11613/BM.2022.010708","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}

引用次数: 1

Abstract

Introduction: Automated erythrocyte sedimentation rate (ESR) analysers are based on different methodology than Westergren method. It is questionable whether ESR values obtained from those analysers are comparable with determined values with Westergren method. The aim was verification of the precision, method comparison and accuracy of automated ESR analysers: Roller 20PN (Alifax S.p.A., Polverara, Italy) and iSED (Alcor Scientific, Smithfield, USA).

Materials and methods: Blood samples (N = 752 for Roller 20PN and N = 213 for iSED) were sampled into K₂EDTA (Kima, Italy) tubes for automated and 3.8% Na-citrate tubes (Kima, Italy) for Westergren method. The data was divided into three groups according to the ESR values obtained with the Westergren method: Group Low (L) (ESR ≤ 20 mm), Group Medium (M) (ESR 21-60 mm), and Group High (H) (ESR ≥ 61 mm). Method agreement was assessed by Bland-Altman analysis and Passing-Bablok regression.

Results: Analyser iSED has shown better comparability with Westergren method (bias 0.0 (95%Cl -1.4 to 1.5) range than Roller 20 PN (bias = - 6.4 (95%Cl - 7.1 to -5.7) in the whole measuring. For Roller 20 PN, Passing-Bablok regression has shown constant and proportional difference for Groups L and M, and for iSED only for Group H. Roller 20 PN had lower sensitivity (0.51 (95%Cl: 0.45-0.57) than iSED (0.72 (95%Cl: 0.59-0.80) while they had comparable specificity (> 0.90) and accuracy (≥ 0.80) in comparison with the Westergren method.

Conclusion: Both analysers are not comparable with the Westergren method and should not be used interchangeably.

Abstract Image

查看原文本刊更多论文

用于测量红细胞沉降率的自动分析仪Roller 20PN和ise的验证。

简介:自动红细胞沉降率(ESR)分析仪是基于不同的方法比Westergren方法。从这些分析仪获得的ESR值是否与Westergren方法确定的值具有可比性是值得怀疑的。目的是验证自动ESR分析仪的精度、方法比较和准确性:Roller 20PN (Alifax S.p.A, Polverara，意大利)和iSED (Alcor Scientific, Smithfield，美国)。材料和方法:将血液样本(Roller 20PN取N = 752, iSED取N = 213)送入K2EDTA (Kima, Italy)管中进行自动化检测，将3.8%柠檬酸钠(Na-citrate, Kima, Italy)管中进行Westergren检测。根据Westergren法获得的ESR值将数据分为三组:低组(L) (ESR≤20 mm)、中组(M) (ESR 21 ~ 60 mm)和高组(H) (ESR≥61 mm)。采用Bland-Altman分析和Passing-Bablok回归评价方法一致性。结果:在整个测量中，分析仪ed与Westergren方法(偏差0.0 (95%Cl -1.4至1.5)范围比Roller 20 PN(偏差= - 6.4 (95%Cl - 7.1至-5.7))具有更好的可比性。对于Roller 20 PN, Passing-Bablok回归在L组和M组中显示出不变的比例差异，而对于iSED仅在h组中显示出不变的比例差异。Roller 20 PN的敏感性(0.51 (95%Cl: 0.45-0.57)低于iSED (0.72 (95%Cl: 0.59-0.80))，而与Westergren方法相比，它们具有相当的特异性(> 0.90)和准确性(≥0.80)。结论:两种分析仪与Westergren法不具有可比性，不应互换使用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Biochemia Medica 医学-医学实验技术

CiteScore

5.50

自引率

3.00%

发文量

审稿时长

>12 weeks

期刊介绍： Biochemia Medica is the official peer-reviewed journal of the Croatian Society of Medical Biochemistry and Laboratory Medicine. Journal provides a wide coverage of research in all aspects of clinical chemistry and laboratory medicine. Following categories fit into the scope of the Journal: general clinical chemistry, haematology and haemostasis, molecular diagnostics and endocrinology. Development, validation and verification of analytical techniques and methods applicable to clinical chemistry and laboratory medicine are welcome as well as studies dealing with laboratory organization, automation and quality control. Journal publishes on a regular basis educative preanalytical case reports (Preanalytical mysteries), articles dealing with applied biostatistics (Lessons in biostatistics) and research integrity (Research integrity corner).