Analytic Result Variation for High-Sensitivity Cardiac Troponin: Interpretation and Consequences

Kavsak, Peter A.; Clark, Lorna; Arnoldo, Saranya; Lou, Amy; Shea, Jennifer; Eintracht, Shaun; Lyon, Andrew W.; Bhayana, Vipin; Thorlacius, Laurel; Raizman, Joshua E.; Tsui, Albert K.Y.; Djiana, Rose; Chen, Michael; Huang, Yun; Booth, Ronald A.; McCudden, Christopher R.; Lavoie, Joël; Beriault, Daniel; Blank, David; Fung, Angela W.S.; Hoffman, Barry; Taher, Jennifer; St-Cyr, Julie; Yip, Paul; Belley‐Côté, Emilie P.; Abramson, Beth L.; Borgundvaag, Bjug; Friedman, Steven; Mak, Susanna; McLaren, Jesse T.T.; Steinhart, Brian; Udell, Jacob A.; Wijeysundera, Harindra C.; Atkinson, Paul; Campbell, Samuel; Chandra, Kavish; Cox, Jafna L.; Mulvagh, Sharon L.; Quraishi, Ata-ur-Rehman; Chen‐Tournoux, Annabel; Clark, Gregory A.; Segal, Eli; Suskin, Neville; Johri, Amer M.; Sivilotti, Marco L.A.; Garuba, Habibat A.; Thiruganasambandamoorthy, Venkatesh; Robinson, Simon D.; Scheuermeyer, Frank; Humphries, Karin H.; Than, Martin; Pickering, John W.; Worster, Andrew; Mills, Nicholas L.; Devereaux, P.J.; Jaffe, Allan S.

doi:10.1016/j.cjca.2023.04.013

Cited by 11 publications

(4 citation statements)

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“…The new common change criteria or 3C utilized combined absolute and relative change criteria of >3 ng/L, >30%, or >15% based on the initial cTn concentration of <10 ng/L, 10 to 100 ng/L, or >100 ng/L, respectively. Briefly, if the 1st sample had a cTn concentration <10 ng/L, then a change would be detected if the difference between the 2nd from the 1st was >3 ng/L (absolute level) [ 13 ]. If the 1st sample had a cTn concentration between 10 ng/L and 100 ng/L, then a difference >30% (absolute percent) was needed to detect a change [ 13 ].…”

Section: Methodsmentioning

confidence: 99%

“…Briefly, if the 1st sample had a cTn concentration <10 ng/L, then a change would be detected if the difference between the 2nd from the 1st was >3 ng/L (absolute level) [ 13 ]. If the 1st sample had a cTn concentration between 10 ng/L and 100 ng/L, then a difference >30% (absolute percent) was needed to detect a change [ 13 ]. If either the first or second sample had a concentration >100 ng/L, then a difference >15% (absolute percent) was needed to detect change [ 14 ].…”

Section: Methodsmentioning

confidence: 99%

“…The 100 ng/L is equivalent to 0.1 µg/L with the non-hs-cTn assays where a change of 20% was commonly used to detect change [ 23 ]. The 3C method was derived from analytical imprecision and accuracy estimates from laboratories that were and are involved in the CODE-MI (NCT03819894) and VISION Cardiac Surgery (NCT01842568) studies [ 13 , 14 ]. Descriptive analyses were performed with diagnostic estimates (specificity, positive predictive value (PPV), positive likelihood ratio (PLR), sensitivity, negative predictive value, and negative likelihood ratio) and kappa for agreement with 95% confidence intervals (CI) provided.…”

Section: Methodsmentioning

confidence: 99%

“…Recently, common analytical criteria have been published for hs-cTn assays; specifically, allowable variation would be ± 3 ng/L for concentrations <10 ng/L and ±30% for concentrations slightly above and around the 99th percentiles [ 13 ]. At higher concentrations, there has been less emphasis on what is the acceptable analytical variation, with a recent long-term publication (data over 7 years) indicating a 15% cutoff would be suitable [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

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The Clinical Validation of a Common Analytical Change Criteria for Cardiac Troponin for Ruling in an Acute Cardiovascular Outcome in Patients Presenting with Ischemic Chest Pain Symptoms

Kavsak,

Sharif,

Globe

et al. 2023

JCDD

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Serial cardiac troponin (cTn) testing on patients with symptoms suggestive of acute coronary syndrome (ACS) is primarily to identify those patients with evolving myocardial injury. With the improved analytical performance of the high-sensitivity cTn (hs-cTn) assays, different change criteria have been proposed that are mostly assay dependent. Here, we developed and compared a new Common Change Criteria (3C for the combined criteria of >3 ng/L, >30%, or >15% based on the initial cTn concentration of <10 ng/L, 10 to 100 ng/L, or >100 ng/L, respectively) method, versus the 2 h assay-dependent absolute change criteria endorsed by the European Society of Cardiology (ESC), versus the common relative >20% change criterion. These different analytical change criteria were evaluated in 855 emergency department (ED) patients with symptoms of ACS and who had two samples collected 3 h apart. The cTn concentrations were measured with four different assays (Abbott hs-cTnI, Roche hs-cTnT, Ortho cTnI-ES, and Ortho hs-cTnI). The outcomes evaluated were myocardial infarction (MI) and a composite outcome (MI, unstable angina, ventricular arrhythmia, heart failure, or cardiovascular death) within 7 days of ED presentation. The combined change criteria (3C) method yielded higher specificities (range: 93.9 to 97.2%) as compared to the >20% criterion (range: 42.3 to 88.1%) for all four assays for MI. The 3C method only yielded a higher specificity estimate for MI for the cTnI-ES assay (95.9%) versus the absolute change criteria (71.7%). Similar estimates were obtained for the composite outcome. There was also substantial agreement between hs-cTnT and the different cTnI assays for MI with the 3C method, with the percent agreement being ≥95%. The Common Change Criteria (3C) method combining both absolute and different percent changes may be used with cTnI, hs-cTnT, and different hs-cTnI assays to yield similar high-specificity (rule-in) estimates for adverse cardiovascular events for patients presenting to the ED with ACS symptoms.

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Section: Methodsmentioning

confidence: 99%