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Imprecision of high-sensitivity cardiac troponin assays at the female 99th-percentile.
Kavsak, Peter A; Clark, Lorna; Arnoldo, Saranya; Lou, Amy; Shea, Jennifer L; Eintracht, Shaun; Lyon, Andrew W; Bhayana, Vipin; Thorlacius, Laurel; Raizman, Joshua E; Tsui, Albert; Djiana, Rose; Chen, Michael; Huang, Yun; Haider, Ali; Booth, Ronald A; McCudden, Chris; Yip, Paul M; Beriault, Daniel; Blank, David; Fung, Angela W S; Taher, Jennifer; St-Cyr, Julie; Sharif, Sameer; Belley-Cote, Emilie; Abramson, Beth L; Friedman, Steven M; Cox, Jafna L; Sivilotti, Marco L A; Chen-Tournoux, Annabel; McLaren, Jesse; Mak, Susanna; Thiruganasambandamoorthy, Venkatesh; Scheuermeyer, Frank; Humphries, Karin H; Worster, Andrew; Ko, Dennis; Aakre, Kristin M; Mills, Nicholas L; Jaffe, Allan S.
Afiliación
  • Kavsak PA; McMaster University, Hamilton, ON, Canada. Electronic address: kavsakp@mcmaster.ca.
  • Clark L; McMaster University, Hamilton, ON, Canada.
  • Arnoldo S; University of Toronto, Toronto, ON, Canada.
  • Lou A; Dalhousie University, Halifax, NS, Canada.
  • Shea JL; Saint John Regional Hospital, Saint John, NB, Canada.
  • Eintracht S; McGill University, Montréal, QC, Canada.
  • Lyon AW; University of Saskatchewan, Saskatoon, SK, Canada.
  • Bhayana V; Western University, London, ON, Canada.
  • Thorlacius L; University of Manitoba, Winnipeg, MB, Canada.
  • Raizman JE; University of Alberta, Edmonton, AB, Canada.
  • Tsui A; University of Alberta, Edmonton, AB, Canada.
  • Djiana R; McGill University, Montréal, QC, Canada.
  • Chen M; University of British Columbia, Vancouver, BC, Canada.
  • Huang Y; Queen's University, Kingston, ON, Canada.
  • Haider A; Queen's University, Kingston, ON, Canada.
  • Booth RA; University of Ottawa, Ottawa, ON, Canada.
  • McCudden C; University of Ottawa, Ottawa, ON, Canada.
  • Yip PM; University of Toronto, Toronto, ON, Canada.
  • Beriault D; University of Toronto, Toronto, ON, Canada.
  • Blank D; McGill University, Montréal, QC, Canada.
  • Fung AWS; University of British Columbia, Vancouver, BC, Canada.
  • Taher J; University of Toronto, Toronto, ON, Canada.
  • St-Cyr J; McGill University, Montréal, QC, Canada.
  • Sharif S; McMaster University, Hamilton, ON, Canada.
  • Belley-Cote E; McMaster University, Hamilton, ON, Canada.
  • Abramson BL; University of Toronto, Toronto, ON, Canada.
  • Friedman SM; University of Toronto, Toronto, ON, Canada.
  • Cox JL; Dalhousie University, Halifax, NS, Canada.
  • Sivilotti MLA; Queen's University, Kingston, ON, Canada.
  • Chen-Tournoux A; McGill University, Montréal, QC, Canada.
  • McLaren J; University of Toronto, Toronto, ON, Canada.
  • Mak S; University of Toronto, Toronto, ON, Canada.
  • Thiruganasambandamoorthy V; University of Ottawa, Ottawa, ON, Canada.
  • Scheuermeyer F; University of British Columbia, Vancouver, BC, Canada.
  • Humphries KH; University of British Columbia, Vancouver, BC, Canada.
  • Worster A; McMaster University, Hamilton, ON, Canada.
  • Ko D; University of Toronto, Toronto, ON, Canada.
  • Aakre KM; Institute of Clinical Science, University of Bergen, Bergen, Norway; Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway.
  • Mills NL; BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.
  • Jaffe AS; Mayo Clinic and Medical Center, Rochester, MN, United States.
Clin Biochem ; 125: 110731, 2024 Mar.
Article en En | MEDLINE | ID: mdl-38360198
ABSTRACT

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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Infarto del Miocardio Tipo de estudio: Clinical_trials / Diagnostic_studies Límite: Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: Clin Biochem Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Infarto del Miocardio Tipo de estudio: Clinical_trials / Diagnostic_studies Límite: Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: Clin Biochem Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos