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• W2769799002 abstract "Recent studies have demonstrated the ability to rule out myocardial infarction with a single low measurable value of high-sensitivity cardiac troponin I (hs-cTnI) (ie, < 5 ng/L) or by using an accelerated diagnostic pathway (ADP) 0/1 hour algorithm (ie, a change/delta < 2 ng/L).1Boeddinghaus J. Nestelberger T. Twerenbold R. et al.Direct comparison of 4 very early rule-out strategies for acute myocardial infarction using high-sensitivity cardiac troponin I.Circulation. 2017; 135: 1597-1611Crossref PubMed Scopus (118) Google Scholar Others have proposed alternative 0/2 hour ADPs that incorporate higher hs-cTn concentrations and larger changes in hs-cTn for decision-making, thus limiting the impact of analytical variation on patient classification.2McRae A.D. Innes G. Graham M. et al.Comparative evaluation of 2-hour rapid diagnostic algorithms for acute myocardial infarction using high-sensitivity cardiac troponin T.Can J Cardiol. 2017; 33: 1006-1012Abstract Full Text Full Text PDF PubMed Scopus (22) Google Scholar Regardless of the ADP, clinicians need to be aware that a major gap in laboratory testing is that despite standard recommendations to measure quality control (QC) material at medical decision levels (ie, hs-cTnI at 5 ng/L), these materials are often not commercially available. This low-/normal-level QC material is needed to ensure that the hs-cTn assays remain stable and precise over time and over various lots of reagents, which is important to prevent patient misclassification when using algorithms that use small deltas.3Lyon A.W. Kavsak P.A. Lyon O.A. et al.Simulation models of misclassification error for single thresholds of high-sensitivity cardiac troponin I due to assay bias and imprecision.Clin Chem. 2017; 63: 585-592Crossref PubMed Scopus (39) Google Scholar Abbott Diagnostics is the manufacturer of the hs-cTnI assay for which the 5 ng/L cutoff has been established (limit of detection ∼ 1 ng/L for this assay). The company recently resolved problems with reagent calibration failures and in October 2017 issued a notification that expiration for reagent lots have been extended from 4 to 6 months. We obtained daily QC data from February 16, 2016 to September 12, 2017 from 9 different lots of 100-test reagent packs at McMaster University Medical Centre and 10 different lots of 500-test reagent packs at the Juravinski Hospital (Supplemental Appendix S1). Plotting each mean and the standard deviation (SD) achieved for the normal hs-cTnI concentration QC per reagent lot identified larger biases and variation between the 100-test pack lots (lot No. 5: QC mean, 3.8 ng/L [SD, 0.5 ng/L] vs lot No. 8: QC, mean, 5.4 ng/L [SD, 3.3 ng/L]) (Fig. 1A) compared with the 500-test pack lots (lot No. 6: QC, mean, 3.4 ng/L [SD, 0.5 ng/L] vs lot No. 9: QC, mean 4.5 ng/L [SD, 0.6 ng/L]) (Fig. 1B). At the hs-cTnI 99th percentile concentration QC material, the biases and variation between reagent lots were not as evident, with the overall imprecision for the 100- and 500-test packs and the difference between the overall means < 10%, an error estimate that will have a minimal effect on patient misclassification (Fig. 1C).3Lyon A.W. Kavsak P.A. Lyon O.A. et al.Simulation models of misclassification error for single thresholds of high-sensitivity cardiac troponin I due to assay bias and imprecision.Clin Chem. 2017; 63: 585-592Crossref PubMed Scopus (39) Google Scholar The analytical variation (SD reported in whole numbers) observed for the normal QC material for 2 100-test pack reagent lots range from 2-3 ng/L (ie, lot No. 6 and lot No. 8, respectively), with this variation exceeding the < 2 ng/L delta in the 0/1 hour ADP (Fig. 1A). This increased variation did not appear to be related to the reagent expiration but rather to the specific reagent lots' ability to measure hs-cTnI concentrations in the normal range (Supplemental Appendix S1). Before adopting cutoffs < the 99th percentile for decision-making, clinicians will need to be reassured that the observed biases and variation in hs-cTn reagent lots are within acceptable limits.3Lyon A.W. Kavsak P.A. Lyon O.A. et al.Simulation models of misclassification error for single thresholds of high-sensitivity cardiac troponin I due to assay bias and imprecision.Clin Chem. 2017; 63: 585-592Crossref PubMed Scopus (39) Google Scholar, 4Kavsak P.A. Jaffe A.S. Greene D.N. et al.Total analytic error for low cardiac troponin concentrations (≤ 10 ng/L) by use of a high-sensitivity cardiac troponin assay.Clin Chem. 2017; 63: 1043-1045Crossref PubMed Scopus (37) Google Scholar P.A.K. has received grants; reagent, consultant, and advisor fees; and honoria from Abbott Laboratories, Abbott Point of Care, Abbott Diagnostics Division Canada, Beckman Coulter, Ortho Clinical Diagnostics, Randox Laboratories, Roche Diagnostics, and Siemens Healthcare Diagnostics. McMaster University has filed patents with P.A.K. listed as an inventor in the acute cardiovascular biomarker field. A.S.J. has or currently consults for most of the major diagnostic companies, including Abbott Diagnostics whose assay was used in the current article. The other authors have no conflicts of interest to disclose. Download .doc (.04 MB) Help with doc files Supplemental Appendix S1" @default.
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• W2769799002 title "Variability Between Reagent Lots for High-Sensitivity Cardiac Troponin I May Affect Performance of Early Rule Out Strategies" @default.
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