Assay precision and risk of misclassification at rule-out cut-offs for high-sensitivity cardiac troponin

Peter A Kavsak; Nicholas L Mills; Lorna Clark; Dennis Ko; Sameer Sharif; Annabel Chen-Tournoux; Steven M. Friedman; Emilie P. Belley-Cote; Andrew Worster; Jafna Cox; Venkatesh Thiruganasambandamoorthy; Amy Lou; Jennifer Taher; Frank Scheuermeyer; Chris Mccudden; Beth L Abramson; Shaun Eintracht; Jennifer L. Shea; Paul M. Yip; Yun Huang; Michael Chen; Albert K.y. Tsui; Laurel Thorlacius; Kristin M Aakre; Joshua E. Raizman; Angela W.s. Fung; Karin H Humphries; Saranya Arnoldo; Vipin Bhayana; Rose Djiana; Daniel R. Beriault; Julie St-Cyr; Ronald A. Booth; David W. Blank; Marco L.a. Sivilotti; Allan S Jaffe

doi:10.1016/j.cjca.2024.05.007

Assay precision and risk of misclassification at rule-out cut-offs for high-sensitivity cardiac troponin

Peter A Kavsak^*, Nicholas L Mills, Lorna Clark, Dennis Ko, Sameer Sharif, Annabel Chen-Tournoux, Steven M. Friedman, Emilie P. Belley-Cote, Andrew Worster, Jafna Cox, Venkatesh Thiruganasambandamoorthy, Amy Lou, Jennifer Taher, Frank Scheuermeyer, Chris Mccudden, Beth L Abramson, Shaun Eintracht, Jennifer L. Shea, Paul M. Yip, Yun HuangMichael Chen, Albert K.y. Tsui, Laurel Thorlacius, Kristin M Aakre, Joshua E. Raizman, Angela W.s. Fung, Karin H Humphries, Saranya Arnoldo, Vipin Bhayana, Rose Djiana, Daniel R. Beriault, Julie St-Cyr, Ronald A. Booth, David W. Blank, Marco L.a. Sivilotti, Allan S Jaffe

^*Corresponding author for this work

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

Abstract / Description of output

Clinical trials and guidelines support the use of very low high-sensitivity cardiac troponin (hs-cTn) results to rule-out a myocardial infarction (MI) ( 1) ). The International Federation of Clinical Chemistry and Laboratory Medicine Committee on Clinical Applications of Cardiac Biomarkers committee, through a modeling approach, suggests assays need to have a lower limit near 3 ng/L and an analytical variation of 10% below 7 ng/L if these low values are to perform consistently in practice ( 2) ). Our objectives for the present study were to assess: i) if any type of instrument or individual instrument could achieve a coefficient of variation (CV) of ≤10% at very low hs-cTn cut-offs (i.e., targets) recommended in clinical pathways; ii) the frequency of results at the hs-cTn target, above the target and below the target, with the latter group representing potential misclassification to the low risk group where the target level would in the intermediate risk range.

Original language	English
Journal	Canadian journal of cardiology
Early online date	13 May 2024
DOIs	https://doi.org/10.1016/j.cjca.2024.05.007
Publication status	E-pub ahead of print - 13 May 2024

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Kavsak, P. A., Mills, N. L., Clark, L., Ko, D., Sharif, S., Chen-Tournoux, A., Friedman, S. M., Belley-Cote, E. P., Worster, A., Cox, J., Thiruganasambandamoorthy, V., Lou, A., Taher, J., Scheuermeyer, F., Mccudden, C., Abramson, B. L., Eintracht, S., Shea, J. L., Yip, P. M., ... Jaffe, A. S. (2024). Assay precision and risk of misclassification at rule-out cut-offs for high-sensitivity cardiac troponin. Canadian journal of cardiology. Advance online publication. https://doi.org/10.1016/j.cjca.2024.05.007

@article{16bf459c1c0a4ac5a1f99d877d7aa54d,

title = "Assay precision and risk of misclassification at rule-out cut-offs for high-sensitivity cardiac troponin",

abstract = "Clinical trials and guidelines support the use of very low high-sensitivity cardiac troponin (hs-cTn) results to rule-out a myocardial infarction (MI) ( 1) ). The International Federation of Clinical Chemistry and Laboratory Medicine Committee on Clinical Applications of Cardiac Biomarkers committee, through a modeling approach, suggests assays need to have a lower limit near 3 ng/L and an analytical variation of 10% below 7 ng/L if these low values are to perform consistently in practice ( 2) ). Our objectives for the present study were to assess: i) if any type of instrument or individual instrument could achieve a coefficient of variation (CV) of ≤10% at very low hs-cTn cut-offs (i.e., targets) recommended in clinical pathways; ii) the frequency of results at the hs-cTn target, above the target and below the target, with the latter group representing potential misclassification to the low risk group where the target level would in the intermediate risk range.",

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

year = "2024",

month = may,

day = "13",

doi = "10.1016/j.cjca.2024.05.007",

language = "English",

journal = "Canadian journal of cardiology",

issn = "0828-282X",

publisher = "Pulsus Group Inc.",

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Kavsak, PA, Mills, NL, Clark, L, Ko, D, Sharif, S, Chen-Tournoux, A, Friedman, SM, Belley-Cote, EP, Worster, A, Cox, J, Thiruganasambandamoorthy, V, Lou, A, Taher, J, Scheuermeyer, F, Mccudden, C, Abramson, BL, Eintracht, S, Shea, JL, Yip, PM, Huang, Y, Chen, M, Tsui, AKY, Thorlacius, L, Aakre, KM, Raizman, JE, Fung, AWS, Humphries, KH, Arnoldo, S, Bhayana, V, Djiana, R, Beriault, DR, St-Cyr, J, Booth, RA, Blank, DW, Sivilotti, MLA & Jaffe, AS 2024, 'Assay precision and risk of misclassification at rule-out cut-offs for high-sensitivity cardiac troponin', Canadian journal of cardiology. https://doi.org/10.1016/j.cjca.2024.05.007

TY - JOUR

T1 - Assay precision and risk of misclassification at rule-out cut-offs for high-sensitivity cardiac troponin

AU - Kavsak, Peter A

AU - Mills, Nicholas L

AU - Clark, Lorna

AU - Ko, Dennis

AU - Sharif, Sameer

AU - Chen-Tournoux, Annabel

AU - Friedman, Steven M.

AU - Belley-Cote, Emilie P.

AU - Worster, Andrew

AU - Cox, Jafna

AU - Thiruganasambandamoorthy, Venkatesh

AU - Lou, Amy

AU - Taher, Jennifer

AU - Scheuermeyer, Frank

AU - Mccudden, Chris

AU - Abramson, Beth L

AU - Eintracht, Shaun

AU - Shea, Jennifer L.

AU - Yip, Paul M.

AU - Huang, Yun

AU - Chen, Michael

AU - Tsui, Albert K.y.

AU - Thorlacius, Laurel

AU - Aakre, Kristin M

AU - Raizman, Joshua E.

AU - Fung, Angela W.s.

AU - Humphries, Karin H

AU - Arnoldo, Saranya

AU - Bhayana, Vipin

AU - Djiana, Rose

AU - Beriault, Daniel R.

AU - St-Cyr, Julie

AU - Booth, Ronald A.

AU - Blank, David W.

AU - Sivilotti, Marco L.a.

AU - Jaffe, Allan S

PY - 2024/5/13

Y1 - 2024/5/13

N2 - Clinical trials and guidelines support the use of very low high-sensitivity cardiac troponin (hs-cTn) results to rule-out a myocardial infarction (MI) ( 1) ). The International Federation of Clinical Chemistry and Laboratory Medicine Committee on Clinical Applications of Cardiac Biomarkers committee, through a modeling approach, suggests assays need to have a lower limit near 3 ng/L and an analytical variation of 10% below 7 ng/L if these low values are to perform consistently in practice ( 2) ). Our objectives for the present study were to assess: i) if any type of instrument or individual instrument could achieve a coefficient of variation (CV) of ≤10% at very low hs-cTn cut-offs (i.e., targets) recommended in clinical pathways; ii) the frequency of results at the hs-cTn target, above the target and below the target, with the latter group representing potential misclassification to the low risk group where the target level would in the intermediate risk range.

AB - Clinical trials and guidelines support the use of very low high-sensitivity cardiac troponin (hs-cTn) results to rule-out a myocardial infarction (MI) ( 1) ). The International Federation of Clinical Chemistry and Laboratory Medicine Committee on Clinical Applications of Cardiac Biomarkers committee, through a modeling approach, suggests assays need to have a lower limit near 3 ng/L and an analytical variation of 10% below 7 ng/L if these low values are to perform consistently in practice ( 2) ). Our objectives for the present study were to assess: i) if any type of instrument or individual instrument could achieve a coefficient of variation (CV) of ≤10% at very low hs-cTn cut-offs (i.e., targets) recommended in clinical pathways; ii) the frequency of results at the hs-cTn target, above the target and below the target, with the latter group representing potential misclassification to the low risk group where the target level would in the intermediate risk range.

U2 - 10.1016/j.cjca.2024.05.007

DO - 10.1016/j.cjca.2024.05.007

M3 - Letter

SN - 0828-282X

JO - Canadian journal of cardiology

JF - Canadian journal of cardiology

ER -

Assay precision and risk of misclassification at rule-out cut-offs for high-sensitivity cardiac troponin

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