Peter A. Kavsak , Lorna Clark , Saranya Arnoldo , Amy Lou , Jennifer L. Shea , Shaun Eintracht , Andrew W. Lyon , Vipin Bhayana , Laurel Thorlacius , Joshua E. Raizman , Albert Tsui , Rose Djiana , Michael Chen , Yun Huang , Ali Haider , Ronald A. Booth , Chris McCudden , Paul M. Yip , Daniel Beriault , David Blank , Allan S. Jaffe
{"title":"女性第 99 百分位数高灵敏度心肌肌钙蛋白测定的不精确性","authors":"Peter A. Kavsak , Lorna Clark , Saranya Arnoldo , Amy Lou , Jennifer L. Shea , Shaun Eintracht , Andrew W. Lyon , Vipin Bhayana , Laurel Thorlacius , Joshua E. Raizman , Albert Tsui , Rose Djiana , Michael Chen , Yun Huang , Ali Haider , Ronald A. Booth , Chris McCudden , Paul M. Yip , Daniel Beriault , David Blank , Allan S. Jaffe","doi":"10.1016/j.clinbiochem.2024.110731","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>An analytical benchmark for high-sensitivity cardiac troponin (hs-cTn) assays is to achieve a coefficient of variation (CV) of ≤ 10.0 % at the 99th percentile upper reference limit (URL) used for the diagnosis of myocardial infarction. Few prospective multicenter studies have evaluated assay imprecision and none have determined precision at the female URL which is lower than the male URL for all cardiac troponin assays.</p></div><div><h3>Methods</h3><p>Human serum and plasma matrix samples were constructed to yield hs-cTn concentrations near the female URLs for the Abbott, Beckman, Roche, and Siemens hs-cTn assays. These materials were sent (on dry ice) to 35 Canadian hospital laboratories (n = 64 instruments evaluated) participating in a larger clinical trial, with instructions for storage, handling, and monthly testing over one year. The mean concentration, standard deviation, and CV for each instrument type and an overall pooled CV for each manufacturer were calculated.</p></div><div><h3>Results</h3><p>The CVs for all individual instruments and overall were ≤ 10.0 % for two manufacturers (Abbott CV<sub>pooled</sub> = 6.3 % and Beckman CV<sub>pooled</sub> = 7.0 %). One of four Siemens Atellica instruments yielded a CV > 10.0 % (CV<sub>pooled</sub> = 7.7 %), whereas 15 of 41 Roche instruments yielded CVs > 10.0 % at the female URL of 9 ng/L used worldwide (6 cobas e411, 1 cobas e601, 4 cobas e602, and 4 cobas e801) (CV<sub>pooled</sub> = 11.7 %). Four Roche instruments also yielded CVs > 10.0 % near the female URL of 14 ng/L used in the United States (CV<sub>pooled</sub> = 8.5 %).</p></div><div><h3>Conclusions</h3><p>The number of instruments achieving a CV ≤ 10.0 % at the female 99th-percentile URL varies by manufacturer and by instrument. Monitoring assay precision at the female URL is necessary for some assays to ensure optimal use of this threshold in clinical practice.</p></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":null,"pages":null},"PeriodicalIF":2.5000,"publicationDate":"2024-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0009912024000250/pdfft?md5=52e249591a3160ac3ecd0fabbb6789b2&pid=1-s2.0-S0009912024000250-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Imprecision of high-sensitivity cardiac troponin assays at the female 99th-percentile\",\"authors\":\"Peter A. Kavsak , Lorna Clark , Saranya Arnoldo , Amy Lou , Jennifer L. Shea , Shaun Eintracht , Andrew W. Lyon , Vipin Bhayana , Laurel Thorlacius , Joshua E. Raizman , Albert Tsui , Rose Djiana , Michael Chen , Yun Huang , Ali Haider , Ronald A. Booth , Chris McCudden , Paul M. Yip , Daniel Beriault , David Blank , Allan S. Jaffe\",\"doi\":\"10.1016/j.clinbiochem.2024.110731\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>An analytical benchmark for high-sensitivity cardiac troponin (hs-cTn) assays is to achieve a coefficient of variation (CV) of ≤ 10.0 % at the 99th percentile upper reference limit (URL) used for the diagnosis of myocardial infarction. Few prospective multicenter studies have evaluated assay imprecision and none have determined precision at the female URL which is lower than the male URL for all cardiac troponin assays.</p></div><div><h3>Methods</h3><p>Human serum and plasma matrix samples were constructed to yield hs-cTn concentrations near the female URLs for the Abbott, Beckman, Roche, and Siemens hs-cTn assays. These materials were sent (on dry ice) to 35 Canadian hospital laboratories (n = 64 instruments evaluated) participating in a larger clinical trial, with instructions for storage, handling, and monthly testing over one year. The mean concentration, standard deviation, and CV for each instrument type and an overall pooled CV for each manufacturer were calculated.</p></div><div><h3>Results</h3><p>The CVs for all individual instruments and overall were ≤ 10.0 % for two manufacturers (Abbott CV<sub>pooled</sub> = 6.3 % and Beckman CV<sub>pooled</sub> = 7.0 %). One of four Siemens Atellica instruments yielded a CV > 10.0 % (CV<sub>pooled</sub> = 7.7 %), whereas 15 of 41 Roche instruments yielded CVs > 10.0 % at the female URL of 9 ng/L used worldwide (6 cobas e411, 1 cobas e601, 4 cobas e602, and 4 cobas e801) (CV<sub>pooled</sub> = 11.7 %). Four Roche instruments also yielded CVs > 10.0 % near the female URL of 14 ng/L used in the United States (CV<sub>pooled</sub> = 8.5 %).</p></div><div><h3>Conclusions</h3><p>The number of instruments achieving a CV ≤ 10.0 % at the female 99th-percentile URL varies by manufacturer and by instrument. Monitoring assay precision at the female URL is necessary for some assays to ensure optimal use of this threshold in clinical practice.</p></div>\",\"PeriodicalId\":10172,\"journal\":{\"name\":\"Clinical biochemistry\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2024-02-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S0009912024000250/pdfft?md5=52e249591a3160ac3ecd0fabbb6789b2&pid=1-s2.0-S0009912024000250-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical biochemistry\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0009912024000250\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical biochemistry","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0009912024000250","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
Imprecision of high-sensitivity cardiac troponin assays at the female 99th-percentile
Background
An analytical benchmark for high-sensitivity cardiac troponin (hs-cTn) assays is to achieve a coefficient of variation (CV) of ≤ 10.0 % at the 99th percentile upper reference limit (URL) used for the diagnosis of myocardial infarction. Few prospective multicenter studies have evaluated assay imprecision and none have determined precision at the female URL which is lower than the male URL for all cardiac troponin assays.
Methods
Human serum and plasma matrix samples were constructed to yield hs-cTn concentrations near the female URLs for the Abbott, Beckman, Roche, and Siemens hs-cTn assays. These materials were sent (on dry ice) to 35 Canadian hospital laboratories (n = 64 instruments evaluated) participating in a larger clinical trial, with instructions for storage, handling, and monthly testing over one year. The mean concentration, standard deviation, and CV for each instrument type and an overall pooled CV for each manufacturer were calculated.
Results
The CVs for all individual instruments and overall were ≤ 10.0 % for two manufacturers (Abbott CVpooled = 6.3 % and Beckman CVpooled = 7.0 %). One of four Siemens Atellica instruments yielded a CV > 10.0 % (CVpooled = 7.7 %), whereas 15 of 41 Roche instruments yielded CVs > 10.0 % at the female URL of 9 ng/L used worldwide (6 cobas e411, 1 cobas e601, 4 cobas e602, and 4 cobas e801) (CVpooled = 11.7 %). Four Roche instruments also yielded CVs > 10.0 % near the female URL of 14 ng/L used in the United States (CVpooled = 8.5 %).
Conclusions
The number of instruments achieving a CV ≤ 10.0 % at the female 99th-percentile URL varies by manufacturer and by instrument. Monitoring assay precision at the female URL is necessary for some assays to ensure optimal use of this threshold in clinical practice.
期刊介绍：
Clinical Biochemistry publishes articles relating to clinical chemistry, molecular biology and genetics, therapeutic drug monitoring and toxicology, laboratory immunology and laboratory medicine in general, with the focus on analytical and clinical investigation of laboratory tests in humans used for diagnosis, prognosis, treatment and therapy, and monitoring of disease.
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