Lot-to-lot bias for high-sensitivity cardiac troponin I concentrations ≥1000 ng/L

Kavsak, Peter A.

doi:10.1515/cclm-2023-0017

Cited by 3 publications

(3 citation statements)

References 19 publications

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“…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 ]. 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 ].…”

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 ]. The objective of the present study was to evaluate cTn change alone for ruling-in an MI or a composite acute cardiovascular event across four different cTn assays using the 20% criterion, the ESC absolute cutoffs, and a new Common Change Criteria (3C) in patients presenting to the emergency department (ED) with symptoms suggestive of acute coronary syndrome (ACS).…”

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%