OnSite™ Troponin I (cTnI) Combo Rapid Test CE

The OnSite® Troponin I Combo Rapid Test CE is a lateral flow chromatographic immunoassay designed for the qualitative detection of cardiac Troponin I (cTnI) in human serum, plasma, or whole blood at concentrations ≥1 ng/mL. As a highly specific and sensitive biomarker of acute myocardial infarction (AMI), Troponin I becomes detectable in blood within 4–6 hours after myocardial damage and remains elevated for up to 10–14 days.

This rapid test offers results in just 15 minutes without requiring laboratory equipment, making it ideal for point-of-care testing in emergency, clinical, or field settings. It is intended for professional use as an aid in diagnosing AMI, with confirmatory testing required for final diagnosis.

Key Features

• Rapid Results: Provides clear results within 15 minutes.
• Specimen Flexibility: Compatible with serum, plasma, or whole blood.
• Analytical Sensitivity: Detects cTnI at ≥1.0 ng/mL.
• Clinical Sensitivity & Specificity:
  • Sensitivity: 95.8% (95% CI: 91.5–97.9%)
  • Specificity: 99.7% (95% CI: 98.8–99.9%)
• Reliable Performance:
  • No cross-reactivity with skeletal muscle TnI, TnT, or cardiac myosin.
  • No hook effect observed up to 3,521 µg/mL cTnI.
  • No interference from common substances (acetaminophen, aspirin, hemoglobin, bilirubin, cholesterol, triglycerides, etc.).
• Convenient Format: Individually sealed pouches with cassettes, desiccants, plastic droppers, sample diluent, and instructions.
• Shelf Life: 24 months at 2–30 °C.

Kit Contents (30 Tests)

• Individually sealed foil pouches (cassette + desiccant)
• Plastic droppers
• Sample diluent (REF SB-R3002, 5 mL/bottle)
• Instructions for use

Applications

• Emergency Care: Rapid screening for AMI in ER and ambulance settings.
• Clinical Diagnostics: Supportive testing for suspected myocardial infarction in hospitals and clinics.
• Point-of-Care Testing: Ideal for bedside use where fast decision-making is critical.
• Public Health Programs: AMI detection in high-risk populations or remote areas.

The OnSite® Troponin I Combo Rapid Test CE (R3002C) provides healthcare professionals with a fast, reliable, and easy-to-use diagnostic tool for detecting elevated cardiac Troponin I associated with acute myocardial infarction. With excellent sensitivity (95.8%) and specificity (99.7%), no cross-reactivity or interference issues, and results available in 15 minutes, it is a practical choice for point-of-care, emergency, and clinical settings.