{"title":"同一制造商生产的两种不同 TSH 试剂之间的分析差异。","authors":"Sudhesna Mohapatra, Sutirtha Chakraborty","doi":"10.1007/s12291-021-00957-2","DOIUrl":null,"url":null,"abstract":"<p><p>Thyroid stimulating hormone (TSH) immunoassays are known for giving varying results based on the platform of testing and the generation of kit used. It is generally expected that the results should not vary to affect clinical diagnosis and management. We aimed to perform method comparison study between two TSH assays by the same manufacturer Siemens Healthineers. Results show that there is a large proportional error between the assays with a bias of -3.71mIu/L indicating that TSH assay gives higher values for TSH for the same patient as measured against the TSH3-Ultra kit. This can affect interpretation of results leading to false increase in patients categorized under hypothyroidism and subclinical hypothyroidism. We strongly suggest, to prevent errors in clinical evaluation of a patient with thyroid dysfunction, validation of the performance of the assay and method comparison should be performed in-house.</p>","PeriodicalId":13280,"journal":{"name":"Indian Journal of Clinical Biochemistry","volume":"38 1","pages":"132-135"},"PeriodicalIF":1.5000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1007/s12291-021-00957-2","citationCount":"0","resultStr":"{\"title\":\"Analytical Variation Between Two Different TSH Reagents from the Same Manufacturer.\",\"authors\":\"Sudhesna Mohapatra, Sutirtha Chakraborty\",\"doi\":\"10.1007/s12291-021-00957-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Thyroid stimulating hormone (TSH) immunoassays are known for giving varying results based on the platform of testing and the generation of kit used. It is generally expected that the results should not vary to affect clinical diagnosis and management. We aimed to perform method comparison study between two TSH assays by the same manufacturer Siemens Healthineers. Results show that there is a large proportional error between the assays with a bias of -3.71mIu/L indicating that TSH assay gives higher values for TSH for the same patient as measured against the TSH3-Ultra kit. This can affect interpretation of results leading to false increase in patients categorized under hypothyroidism and subclinical hypothyroidism. We strongly suggest, to prevent errors in clinical evaluation of a patient with thyroid dysfunction, validation of the performance of the assay and method comparison should be performed in-house.</p>\",\"PeriodicalId\":13280,\"journal\":{\"name\":\"Indian Journal of Clinical Biochemistry\",\"volume\":\"38 1\",\"pages\":\"132-135\"},\"PeriodicalIF\":1.5000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1007/s12291-021-00957-2\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Indian Journal of Clinical Biochemistry\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s12291-021-00957-2\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2021/2/11 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q4\",\"JCRName\":\"BIOCHEMISTRY & MOLECULAR BIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Indian Journal of Clinical Biochemistry","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s12291-021-00957-2","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2021/2/11 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"BIOCHEMISTRY & MOLECULAR BIOLOGY","Score":null,"Total":0}
Analytical Variation Between Two Different TSH Reagents from the Same Manufacturer.
Thyroid stimulating hormone (TSH) immunoassays are known for giving varying results based on the platform of testing and the generation of kit used. It is generally expected that the results should not vary to affect clinical diagnosis and management. We aimed to perform method comparison study between two TSH assays by the same manufacturer Siemens Healthineers. Results show that there is a large proportional error between the assays with a bias of -3.71mIu/L indicating that TSH assay gives higher values for TSH for the same patient as measured against the TSH3-Ultra kit. This can affect interpretation of results leading to false increase in patients categorized under hypothyroidism and subclinical hypothyroidism. We strongly suggest, to prevent errors in clinical evaluation of a patient with thyroid dysfunction, validation of the performance of the assay and method comparison should be performed in-house.
期刊介绍：
The primary mission of the journal is to promote improvement in the health and well-being of community through the development and practice of clinical biochemistry and dissemination of knowledge and recent advances in this discipline among professionals, diagnostics industry, government and non-government organizations. Indian Journal of Clinical Biochemistry (IJCB) publishes peer reviewed articles that contribute to the existing knowledge in all fields of Clinical biochemistry, either experimental or theoretical, particularly deal with the applications of biochemistry, molecular biology, genetics, biotechnology, and immunology to the diagnosis, treatment, monitoring and prevention of human diseases. The articles published also include those covering the analytical and molecular diagnostic techniques, instrumentation, data processing, quality assurance and accreditation aspects of the clinical investigations in which chemistry has played a major role, or laboratory animal studies with biochemical and clinical relevance.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
