Clinical risk assessment of biotin interference with a high-sensitivity cardiac troponin T assay
| Autor: | Nam K. Tran, Andre Valcour, Deborah B. Diercks, Raphael Twerenbold, Dusanka Kasapic, André Ziegler, André Schützenmeister, Bryn E. Mumma |
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| Rok vydání: | 2020 |
| Předmět: |
Male
030213 general clinical medicine Clinical Biochemistry Myocardial Infarction 030204 cardiovascular system & hematology Cardiovascular Gastroenterology Cohort Studies chemistry.chemical_compound 0302 clinical medicine Biotin high-sensitivity cardiac troponin T Medicine False Negative Reactions General Clinical Medicine Immunoassay Troponin T immunoassay interference false negative General Medicine Middle Aged Heart Disease Female Cognitive Sciences Clinical risk factor medicine.medical_specialty Acute coronary syndrome Cardiac troponin Pharmacokinetic modeling Clinical Sciences acute myocardial infarction Immunologic Tests Risk Assessment 03 medical and health sciences Diagnostic Tests 99th percentile Internal medicine Humans In patient Routine Acute Coronary Syndrome Heart Disease - Coronary Heart Disease Diagnostic Tests Routine business.industry Biochemistry (medical) medicine.disease chemistry business risk of misclassification Biomarkers |
| Zdroj: | Clinical chemistry and laboratory medicine, vol 58, iss 11 |
| Popis: | Objectives Biotin >20.0 ng/mL (81.8 nmol/L) can reduce Elecsys® Troponin T Gen 5 (TnT Gen 5; Roche Diagnostics) assay recovery, potentially leading to false-negative results in patients with suspected acute myocardial infarction (AMI). We aimed to determine the prevalence of elevated biotin and AMI misclassification risk from biotin interference with the TnT Gen 5 assay. Methods Biotin was measured using an Elecsys assay in two cohorts: (i) 797 0-h and 646 3-h samples from 850 US emergency department patients with suspected acute coronary syndrome (ACS); (ii) 2023 random samples from a US laboratory network, in which biotin distributions were extrapolated for higher values using pharmacokinetic modeling. Biotin >20.0 ng/mL (81.8 nmol/L) prevalence and biotin 99th percentile values were calculated. AMI misclassification risk due to biotin interference with the TnT Gen 5 assay was modeled using different assay cutoffs and test timepoints. Results ACS cohort: 1/797 (0.13%) 0-h and 1/646 (0.15%) 3-h samples had biotin >20.0 ng/mL (81.8 nmol/L); 99th percentile biotin was 2.62 ng/mL (10.7 nmol/L; 0-h) and 2.38 ng/mL (9.74 nmol/L; 3-h). Using conservative assumptions, the likelihood of false-negative AMI prediction due to biotin interference was 0.026% (0-h result; 19 ng/L TnT Gen 5 assay cutoff). US laboratory cohort: 15/2023 (0.74%) samples had biotin >20.0 ng/mL (81.8 nmol/L); 99th percentile biotin was 16.6 ng/mL (68.0 nmol/L). Misclassification risk due to biotin interference (19 ng/L TnT Gen 5 assay cutoff) was 0.025% (0-h), 0.0064% (1-h), 0.00048% (3-h), and Conclusions Biotin interference has minimal impact on the TnT Gen 5 assay’s clinical utility, and the likelihood of false-negative AMI prediction is extremely low. |
| Databáze: | OpenAIRE |
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