Imprecision of high-sensitivity cardiac troponin assays at the female 99th-percentile

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; Angela W.S. Fung; Jennifer Taher; Julie St-Cyr; Sameer Sharif; Emilie Belley-Cote; Beth L. Abramson; Steven M. Friedman; Jafna L. Cox; Marco L.A. Sivilotti; Annabel Chen-Tournoux; Jesse McLaren; Susanna Mak; Venkatesh Thiruganasambandamoorthy; Frank Scheuermeyer; Karin H. Humphries; Andrew Worster; Dennis Ko; Kristin M. Aakre; Nicholas L. Mills; Allan S. Jaffe

doi:10.1016/j.clinbiochem.2024.110731

Imprecision of high-sensitivity cardiac troponin assays at the female 99th-percentile

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 BlankAngela W.S. Fung, Jennifer Taher, Julie St-Cyr, Sameer Sharif, Emilie Belley-Cote, Beth L. Abramson, Steven M. Friedman, Jafna L. Cox, Marco L.A. Sivilotti, Annabel Chen-Tournoux, Jesse McLaren, Susanna Mak, Venkatesh Thiruganasambandamoorthy, Frank Scheuermeyer, Karin H. Humphries, Andrew Worster, Dennis Ko, Kristin M. Aakre, Nicholas L. Mills, Allan S. Jaffe

Cardiovascular Medicine

Research output: Contribution to journal › Article › peer-review

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 CV_pooled = 6.3 % and Beckman CV_pooled = 7.0 %). One of four Siemens Atellica instruments yielded a CV > 10.0 % (CV_pooled = 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_pooled = 11.7 %). Four Roche instruments also yielded CVs > 10.0 % near the female URL of 14 ng/L used in the United States (CV_pooled = 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.

Original language	English (US)
Article number	110731
Journal	Clinical Biochemistry
Volume	125
DOIs	https://doi.org/10.1016/j.clinbiochem.2024.110731
State	Published - Mar 2024

Keywords

Female 99th percentile
High-sensitivity cardiac troponin
Imprecision
Upper reference limit

ASJC Scopus subject areas

Clinical Biochemistry

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10.1016/j.clinbiochem.2024.110731

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Kavsak, P. A., Clark, L., Arnoldo, S., Lou, A., Shea, J. L., Eintracht, S., Lyon, A. W., Bhayana, V., Thorlacius, L., Raizman, J. E., Tsui, A., Djiana, R., Chen, M., Huang, Y., Haider, A., Booth, R. A., McCudden, C., Yip, P. M., Beriault, D., ... Jaffe, A. S. (2024). Imprecision of high-sensitivity cardiac troponin assays at the female 99th-percentile. Clinical Biochemistry, 125, Article 110731. https://doi.org/10.1016/j.clinbiochem.2024.110731

Kavsak, PA, Clark, L, Arnoldo, S, Lou, A, Shea, JL, Eintracht, S, Lyon, AW, Bhayana, V, Thorlacius, L, Raizman, JE, Tsui, A, Djiana, R, Chen, M, Huang, Y, Haider, A, Booth, RA, McCudden, C, Yip, PM, Beriault, D, Blank, D, Fung, AWS, Taher, J, St-Cyr, J, Sharif, S, Belley-Cote, E, Abramson, BL, Friedman, SM, Cox, JL, Sivilotti, MLA, Chen-Tournoux, A, McLaren, J, Mak, S, Thiruganasambandamoorthy, V, Scheuermeyer, F, Humphries, KH, Worster, A, Ko, D, Aakre, KM, Mills, NL & Jaffe, AS 2024, 'Imprecision of high-sensitivity cardiac troponin assays at the female 99th-percentile', Clinical Biochemistry, vol. 125, 110731. https://doi.org/10.1016/j.clinbiochem.2024.110731

@article{923d0f960fea43dfbfb6788533307338,

title = "Imprecision of high-sensitivity cardiac troponin assays at the female 99th-percentile",

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.",

keywords = "Female 99th percentile, High-sensitivity cardiac troponin, Imprecision, Upper reference limit",

author = "Kavsak, {Peter A.} and Lorna Clark and Saranya Arnoldo and Amy Lou and Shea, {Jennifer L.} and Shaun Eintracht and Lyon, {Andrew W.} and Vipin Bhayana and Laurel Thorlacius and Raizman, {Joshua E.} and Albert Tsui and Rose Djiana and Michael Chen and Yun Huang and Ali Haider and Booth, {Ronald A.} and Chris McCudden and Yip, {Paul M.} and Daniel Beriault and David Blank and Fung, {Angela W.S.} and Jennifer Taher and Julie St-Cyr and Sameer Sharif and Emilie Belley-Cote and Abramson, {Beth L.} and Friedman, {Steven M.} and Cox, {Jafna L.} and Sivilotti, {Marco L.A.} and Annabel Chen-Tournoux and Jesse McLaren and Susanna Mak and Venkatesh Thiruganasambandamoorthy and Frank Scheuermeyer and Humphries, {Karin H.} and Andrew Worster and Dennis Ko and Aakre, {Kristin M.} and Mills, {Nicholas L.} and Jaffe, {Allan S.}",

note = "Publisher Copyright: {\textcopyright} 2024 The Author(s)",

year = "2024",

month = mar,

doi = "10.1016/j.clinbiochem.2024.110731",

language = "English (US)",

volume = "125",

journal = "Clinical Biochemistry",

issn = "0009-9120",

publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Imprecision of high-sensitivity cardiac troponin assays at the female 99th-percentile

AU - Kavsak, Peter A.

AU - Clark, Lorna

AU - Arnoldo, Saranya

AU - Lou, Amy

AU - Shea, Jennifer L.

AU - Eintracht, Shaun

AU - Lyon, Andrew W.

AU - Bhayana, Vipin

AU - Thorlacius, Laurel

AU - Raizman, Joshua E.

AU - Tsui, Albert

AU - Djiana, Rose

AU - Chen, Michael

AU - Huang, Yun

AU - Haider, Ali

AU - Booth, Ronald A.

AU - McCudden, Chris

AU - Yip, Paul M.

AU - Beriault, Daniel

AU - Blank, David

AU - Fung, Angela W.S.

AU - Taher, Jennifer

AU - St-Cyr, Julie

AU - Sharif, Sameer

AU - Belley-Cote, Emilie

AU - Abramson, Beth L.

AU - Friedman, Steven M.

AU - Cox, Jafna L.

AU - Sivilotti, Marco L.A.

AU - Chen-Tournoux, Annabel

AU - McLaren, Jesse

AU - Mak, Susanna

AU - Thiruganasambandamoorthy, Venkatesh

AU - Scheuermeyer, Frank

AU - Humphries, Karin H.

AU - Worster, Andrew

AU - Ko, Dennis

AU - Aakre, Kristin M.

AU - Mills, Nicholas L.

AU - Jaffe, Allan S.

PY - 2024/3

Y1 - 2024/3

N2 - 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.

AB - 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.

KW - Female 99th percentile

KW - High-sensitivity cardiac troponin

KW - Imprecision

KW - Upper reference limit

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DO - 10.1016/j.clinbiochem.2024.110731

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SN - 0009-9120

VL - 125

JO - Clinical Biochemistry

JF - Clinical Biochemistry

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ER -

Imprecision of high-sensitivity cardiac troponin assays at the female 99th-percentile

Abstract

Keywords

ASJC Scopus subject areas

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