Product Features
- 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
Product specifications
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Plastic droppers
- Sample diluent (REF SB-R3002, 5 mL/bottle)
- One package insert (instruction for use)
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