VITROS® High Sensitivity
Troponin I Assay
Confidence in Result. Confidence in Decision.
VITROS® hsTnI delivers high clinical sensitivity and specificity for diagnostic accuracy, high analytical sensitivity and precision for detecting small changes at the 99th percentile*, and high negative predictive value for confidence in early rule out of acute myocardial infarction (AMI).
Did you miss our Workshop at IFCC Barcelona 2019 about - The clinical use and performance of high-sensitivity (hs) Cardiac Troponin assays with the ESC 0-1 hour algorithm: Overcoming challenges in implementation.
For laboratorians: Confidence in Result
Ortho understands the challenges in the laboratory. Clinicians rely on their labs to provide accurate and fast results. VITROS hsTnI is the result of our commitment to continuous improvement of our cardiac assay menu: True high sensitivity Fully compliant with the IFCC high sensitivity definition: Imprecision (%CV) less than 10% at the 99th percentile upper reference limit; detects troponin at a concentration at or above the limit of detection (LOD) in >50% of healthy individuals Interference Reduction: Not susceptible to biotin interference; minimizes interference from hemolysis, that can lead to inaccurate results and repeat tests Excellent analytical performance: LOD at 0.39- 0.86 ng/L, LOQ (10% CV) at 1.99 ng/La Less workload, better efficiency Long calibration intervals reduces waste and maintenance time.
For Clinicians: Confidence in Decision
Delivers the sensitivity and precision to detect small changes at very low troponin concentrations, enabling early diagnosis of AMI Demonstrated high clinical sensitivity and specificity at 1, 2 and 3 hours to accelerate decisionmaking with a rapid rule-in/rule-out algorithm, as specified by the European Society of Cardiology Demonstrates excellent performance for AMI/no AMI discrimination across all collection time points overall and across gender.
*Clinical Performance - Data from clinical trials demonstrates VITROS hs Troponin I test performance in early rule in/out algorithms based on Overall 99th percentile.
| Collection Point | Sensitivity (%) | Specificity (%) | NPV (%) | PPV (%) | AUC |
|---|---|---|---|---|---|
| Baseline | 81.65% | 91.99% | 97.15% | 60.00% | 0.949 |
| 1 hour | 93.75% | 90.67% | 99.04% | 58.54% | 0.964 |
| 2 hours | 95.79% | 89.53% | 99.43% | 52.91% | 0.971 |
| 3 hours | 94.44% | 87.63% | 99.13% | 51.52% | 0.952 |
