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...Continue Reading
Citations
Oct 23, 2018·JAMA Cardiology·John W PickeringMartin P Than
Nov 30, 2018·Minerva medica·Yader SandovalAllan S Jaffe
Aug 10, 2019·Sensors·Brian ReganDavid Collins
Oct 18, 2019·Clinical Chemistry and Laboratory Medicine : CCLM·Federica BragaMauro Panteghini
Jan 28, 2020·Prehospital Emergency Care : Official Journal of the National Association of EMS Physicians and the National Association of State EMS Directors·Jason P StopyraSimon A Mahler
Feb 14, 2020·Vox Sanguinis·Brian D AdkinsPampee P Young
Aug 5, 2020·Current Cardiology Reports·Kristin E Mullins, Robert H Christenson
Aug 14, 2020·Clinical Chemistry·Alan H B WuAllan S Jaffe
May 12, 2019·Der Internist·M VafaieE Giannitsis
Sep 25, 2019·The Analyst·Satheesh NatarajanYouju Huang
Dec 7, 2020·Clinical Chemistry·Fred S AppleUNKNOWN IFCC Committee on Clinical Application of Cardiac Bio-Markers
Feb 27, 2021·Clinical Research in Cardiology : Official Journal of the German Cardiac Society·Evangelos GiannitsisKurt Huber
Jun 5, 2021·Clinical Chemistry and Laboratory Medicine : CCLM·Vinajak GopiEvangelos Giannitsis
Jun 15, 2021·Annals of Clinical Biochemistry·Rui ZhangQingtao Wang
Mar 14, 2020·Journal of the American College of Cardiology·Jasper BoeddinghausUNKNOWN APACE Investigators