R3002C Troponin I Combo Rapid Test CE

Clinical performance:
Relative Sensitivity: 95.8% (95% CI: 91.5-97.9%) compared to a reference CLIA
Relative Specificity: 99.7% (95% CI: 98.8-99.9%)
Analytical sensitivity: The detection limit of cTnI is 1.0 ng/mL or greater in serum, plasma or whole blood specimen
Cross-reactivity: No cross reactivity with 10 µg/mL skeletal muscle TnI, 2,000 ng/mL cardiac muscle TnT, 20 µg/mL cardiac muscle Myosin
Dose hook effect: No hook effect was observed for cTnI at concentrations up to 3,521 µg/mL
Interference: No interference was seen with 20 mg/dl Acetaminophen, 20 mg/dl Acetylsalicylic acid, 10.5 g/dl Albumin, 20 mg/dl Ascorbic acid, 1,000 mg/dl Bilirubin, 20 mg/dl Caffeine, 800 mg/dl Cholesterol, 200 mg/dl Creatinine, 20 mg/dl Gentistic acid, 1,000 mg/dl Hemoglobin, 600 mg/dl Oxilic acid, 1,600 mg/dl Triglycerides
Shelf life: 24 months