Cristiano Ialongo, Maria Sapio, Leda Elisabetta Antetomaso, Antonio Angeloni
{"title":"The importance of regulation (EU) 2017/746 for quality control in medical laboratories.","authors":"Cristiano Ialongo, Maria Sapio, Leda Elisabetta Antetomaso, Antonio Angeloni","doi":"10.11613/BM.2022.010301","DOIUrl":null,"url":null,"abstract":"The guideline C24 (now in its 4th edition) issued by the Clinical and Laboratory Standards Institute (CLSI) recommends that for purchased quality control (QC), the laboratory should never use the manufacturer’s declared target (T) value but that identified by testing the product at least ten times with each new batch (1). Of course, verifying T is quite different from estimating the variability of the analytical process, albeit both are used for the statistical process control (SPC) since T should be the production target of the QC material on which the manufacturer has complete control.","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":"32 1","pages":"010301"},"PeriodicalIF":3.8000,"publicationDate":"2022-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8672393/pdf/","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Biochemia Medica","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.11613/BM.2022.010301","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2021/12/15 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
引用次数: 1
Abstract
The guideline C24 (now in its 4th edition) issued by the Clinical and Laboratory Standards Institute (CLSI) recommends that for purchased quality control (QC), the laboratory should never use the manufacturer’s declared target (T) value but that identified by testing the product at least ten times with each new batch (1). Of course, verifying T is quite different from estimating the variability of the analytical process, albeit both are used for the statistical process control (SPC) since T should be the production target of the QC material on which the manufacturer has complete control.
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).
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
