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• W2802059557 abstract "High-Sensitivity (hs) cardiac troponin (cTn) assays are categorized by two criteria: (i) cTn values above the limit of detection (LoD) for >50% of male and female healthy cohorts of ≥300 individuals; (ii) imprecision ≤10% total %CV for sex-specific 99th-percentile clinical decision values (CDVs). No documented hs-Tn assay has yet been FDA-cleared.The PATHFAST cTnI-II assay's LoD was 2.3 ng/L using CLSI EP-17. The AACC Universal Sample Bank of 847 healthy men (50.6%) and women (49.4%) was used to determine 99th-percentile CDVs with Nonparametric, Harrell-Davis and Robust modeling. Health/Medication questionnaires and Amino-terminal proBNP, Hemoglobin A1c and estimated Glomerular Filtration Rate surrogates excluded underlying health conditions.The cTnI-II test's total CV was 6.1% at 29 ng/L and 7.1% at 22 ng/L; the LoD was 2.3 ng/L. Of the full 847-member healthy cohort, 113 (13.3%) were excluded by abnormal surrogate biomarkers. The final 734-member healthy population had the following (% > LoD): overall, 487 (66.3%); women, 186 (52.8%); and men, 301 (78.8%). 99th-percentile CDVs by Nonparametric modeling were: 28 ng/L (90% CI: 20-30), overall final 732-member healthy population; 20 ng/L (90% CI: 13-30), 352 women; and 30 ng/L (90% CI: 21-37), 382 men. Differences between sex-specific CDVs were not significantly different (p > .05) with Nonparametric or Harrell-Davis modeling; however, Robust Modeling did show significance (<0.05), with lower CDVs at 11 ng/L (90% CI: 9-12) and 16 ng/L (90% CI: 15-18) for the female and male cohorts, respectively.cTnI-II is the only FDA-cleared assay that has demonstrated high-sensitivity cTn assay. Use of recommended modeling in >300 healthy subjects for determining sex-specific 99th-percentile CDVs did not show statistically significant differences except with the Robust modeling." @default.
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• W2802059557 date "2018-06-01" @default.
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• W2802059557 title "Validation of high-sensitivity performance for a United States Food and Drug Administration cleared cardiac troponin I assay" @default.
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• W2802059557 doi "https://doi.org/10.1016/j.clinbiochem.2018.05.004" @default.
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