Clinical evaluation of Ortho Clinical Diagnostics high-sensitivity cardiac Troponin I assay in patients with symptoms suggestive of acute coronary syndrome

Using the clinical chemistry score in the emergency department to detect adverse cardiac events: a diagnostic accuracy study

“…Published mean concentrations on this material were as follows: Beckman Access hs-cTnI, 3.4 ng/L; Abbott Architect i1000 hs-cTnI, 5.1 ng/L; Siemens Advia Centaur hs-cTnI, 5.0 ng/L; and Siemens Dimension EXL hs-cTnI, 8.6 ng/L; 11,13,26,27 measurement of this material by the Ortho Vitros 3600 hs-cTnI assay yielded the lowest concentration (Ortho hs-cTnI mean 1.1 ng/L). 14 The suitability of frozen samples (stored below -70°C for over 15 yr) has also been demonstrated for the Ortho hs-cTnI assay, consistent with other assays. 14,28 To further demonstrate differences between the various hs-cTnI assays, 10 different EDTA plasma samples were measured on the Abbott Architect i1000 (hs-cTnI range 4.7-43 ng/L, with EDTA being the only sample type approved by the United States Food and Drug Administration for the Abbott hs-cTnI assay on the Architect analyzer) 29 and on the Siemens Advia Centaur, the Beckman Access and the Ortho Vitros 3600 analyzers.…”

“…14 The suitability of frozen samples (stored below -70°C for over 15 yr) has also been demonstrated for the Ortho hs-cTnI assay, consistent with other assays. 14,28 To further demonstrate differences between the various hs-cTnI assays, 10 different EDTA plasma samples were measured on the Abbott Architect i1000 (hs-cTnI range 4.7-43 ng/L, with EDTA being the only sample type approved by the United States Food and Drug Administration for the Abbott hs-cTnI assay on the Architect analyzer) 29 and on the Siemens Advia Centaur, the Beckman Access and the Ortho Vitros 3600 analyzers. All 3 hs-cTnI assays yielded lower results than the Abbott assay in EDTA plasma, with Siemens reporting on average 26% lower concentrations, Beckman reporting on average 30% lower concentrations and Ortho reporting on average 65% lower concentrations.…”

“…Compared with other companies' hs-cTnI assays, the Ortho hs-cTnI assay generally yields the lowest cTnI concentrations. [12][13][14] Testing performed on patient pool plasma material in citrate phosphate dextrose (stored for quality control purposes) used to validate hs-cTnI assays supports this finding. Published mean concentrations on this material were as follows: Beckman Access hs-cTnI, 3.4 ng/L; Abbott Architect i1000 hs-cTnI, 5.1 ng/L; Siemens Advia Centaur hs-cTnI, 5.0 ng/L; and Siemens Dimension EXL hs-cTnI, 8.6 ng/L; 11,13,26,27 measurement of this material by the Ortho Vitros 3600 hs-cTnI assay yielded the lowest concentration (Ortho hs-cTnI mean 1.1 ng/L).…”

“…10 Since that publication, 3 additional companies (Beckman Coulter, Siemens Healthcare Diagnostics and Ortho Clinical Diagnostics) have obtained regulatory approval for hs-cTnI assays from Health Canada. [11][12][13][14] There is no standardization between hs-cTnI assays, so different hs-cTnI assays may give very different results for the same sample (cTnT and cTnI are different proteins, so the corresponding assays will produce different results). 15,16 For example, for a given patient, the same lithium heparin plasma material measured on the Abbott Architect i1000 (hs-cTnI), Siemens Dimension EXL (hs-cTnI) and Roche Cobas (hs-cTnT) instruments yielded mean hs-cTn results of 4.4 ng/L, 7.2 ng/L and 26.8 ng/L, respectively.…”

Misclassification of Myocardial Injury by a High-Sensitivity Cardiac Troponin I Assay

“…Retrospective analyses were performed to compare the prevalence of positive results with the Ortho hs-cTnI assay (female: URL < 10 ng/L and male: URL < 14 ng/L) and the Abbott hs-cTnI assay (female: URL < 17 ng/L and male: URL < 35 ng/L) from the Optimum Troponin Cutoffs for ACS in the ED (ROMI-3) study (NCT01994577), which enrolled patients with symptoms suggestive of acute coronary syndrome (ACS) in the emergency department. 2,3 A prospective cohort comparison between Ortho and Abbott hs-cTnI concentrations also occurred for inpatients (n ¼ 59; patients/70 lithium heparin samples) and ED patients (n ¼ 84; patients/134 ethylenediamine tetra-acetic acid [EDTA] samples) at the JHCC in September 2020. The 2 different matrices (lithium heparin and EDTA plasma) were tested, as the sample matrix has been identified as an important variable when investigating discordant results (ie, if the ratio of Ortho hs-cTnI to Abbott hs-cTnI was either < 0.33 or > 2.0).…”