{"title":"A non-parametric framework for evaluating total analytical error in in vitro diagnostic medical devices in transfusion medicine","authors":"","doi":"10.1016/j.transci.2024.104026","DOIUrl":null,"url":null,"abstract":"<div><div>The performance assessment of quantitative measurements is predominantly based on evaluating Total Analytical Error (TAE). This evaluation encompasses several key objectives critical to ensuring accurate, reliable, and clinically relevant test results. Traditional parametric methods often fall short due to data normality assumptions in the performance assessment of <em>in vitro</em> diagnostic medical devices (IVD-MDs). This study presents a non-parametric approach to estimating and evaluating the TAE in transfusion medicine, aiming to enhance the reliability and patient safety of IVD-MDs. A protocol to estimate TAE over diverse data distributions is suggested, employing a robust statistical definition and comparative measurement procedures. Results from 200 samples indicate that non-parametric methods provided a more accurate reflection of TAE. The findings assert that non-parametric TAE estimation is vital for ensuring the 'fitness for purpose' of clinical tests in transfusion medicine, directly impacting post-transfusion outcomes and patient care. The study concludes that adopting non-parametric methods in transfusion services can significantly improve test accuracy, aligning with the highest laboratory practice standards.</div></div>","PeriodicalId":49422,"journal":{"name":"Transfusion and Apheresis Science","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Transfusion and Apheresis Science","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1473050224002076","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
The performance assessment of quantitative measurements is predominantly based on evaluating Total Analytical Error (TAE). This evaluation encompasses several key objectives critical to ensuring accurate, reliable, and clinically relevant test results. Traditional parametric methods often fall short due to data normality assumptions in the performance assessment of in vitro diagnostic medical devices (IVD-MDs). This study presents a non-parametric approach to estimating and evaluating the TAE in transfusion medicine, aiming to enhance the reliability and patient safety of IVD-MDs. A protocol to estimate TAE over diverse data distributions is suggested, employing a robust statistical definition and comparative measurement procedures. Results from 200 samples indicate that non-parametric methods provided a more accurate reflection of TAE. The findings assert that non-parametric TAE estimation is vital for ensuring the 'fitness for purpose' of clinical tests in transfusion medicine, directly impacting post-transfusion outcomes and patient care. The study concludes that adopting non-parametric methods in transfusion services can significantly improve test accuracy, aligning with the highest laboratory practice standards.
期刊介绍:
Transfusion and Apheresis Science brings comprehensive and up-to-date information to physicians and health care professionals involved in the rapidly changing fields of transfusion medicine, hemostasis and apheresis. The journal presents original articles relating to scientific and clinical studies in the areas of immunohematology, transfusion practice, bleeding and thrombotic disorders and both therapeutic and donor apheresis including hematopoietic stem cells. Topics covered include the collection and processing of blood, compatibility testing and guidelines for the use of blood products, as well as screening for and transmission of blood-borne diseases. All areas of apheresis - therapeutic and collection - are also addressed. We would like to specifically encourage allied health professionals in this area to submit manuscripts that relate to improved patient and donor care, technical aspects and educational issues.
Transfusion and Apheresis Science features a "Theme" section which includes, in each issue, a group of papers designed to review a specific topic of current importance in transfusion and hemostasis for the discussion of topical issues specific to apheresis and focuses on the operators'' viewpoint. Another section is "What''s Happening" which provides informal reporting of activities in the field. In addition, brief case reports and Letters to the Editor, as well as reviews of meetings and events of general interest, and a listing of recent patents make the journal a complete source of information for practitioners of transfusion, hemostasis and apheresis science. Immediate dissemination of important information is ensured by the commitment of Transfusion and Apheresis Science to rapid publication of both symposia and submitted papers.