Troponin I Combo Rapid Test CE

The OnSite Troponin I Combo Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (cTnI) in human serum, plasma or whole blood. The test has a detection sensitivity of 0.3 ng/mL in human serum/plasma and 0.5 ng/mL in whole blood. It can be performed within 15 minutes by minimally skilled personnel, and without the use of laboratory equipment.

The OnSite Troponin I Combo Rapid Test It is intended to be used as a screening test by professionals and provides a preliminary test result to aid in the early diagnosis of Acute Myocardial Infarction (AMI). Any use or interpretation of this preliminary test result must also rely on patient’s symptoms and the professional judgment of a physician. A more precise test method such as an instrument method must be used to confirm the test result obtained by this device.

AMI susceptible levels of cTnI in the blood are very low (≥0.3 ng/mL) as cTnI is released into the blood stream in forms of free cTnI and cTnI-C-T complex at 4-6 hours after myocardial cell damage. The elevated level of cTnI could be elevated as high as 50 ng/mL during 60-80 hours after AMI and remains detectable for up to 10 -14 days post AMI. Therefore, circulating cTnI is a specific and sensitive marker for AMI.

  • Clinical performance:
    • Relative Sensitivity: 95.6% (95% CI: 91.5-97.7%) compared to a reference CLIA
    • Relative Specificity: 100% (95% CI: 98.7-100%)
  • Analytical sensitivity: The detection limit of cTnI is 0.3 ng/mL in serum or plasma specimen and 0.5 ng/mL in whole blood specimen
  • Cross-reactivity: no cross reactivity with 10 µg/mL skeletal muscle TnI, 10 µg/mL cardiac muscle TnT, 10 µg/mL cardiac nuscle TnC, HAMA, RH (up to 8400 IU/mL)
  • Dose hook effect: no hook effect was observed for cTnI at concentrations up to 5.0 µg/mL
  • Interference: No interference was seen with 60 g/L Albumin, 20 mg/dL Bilirubin, 442 µmol/L Creatinine, 3.4 µmol/L EDTA, 55 mmol/L Glucose, 3,000 U/L Heparin, 1000 mg/dL Human IgG, 2 g/L Hemoglobin, 34 mmol/L Salicylic acid, 3.8% solium citrate
  • Shelf life: 24 months
  • 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)

Catalog #

Product

Quantity

Specimen

R3002C

Troponin I Combo Rapid Test CE

30/kit

S, P & WB

Other Products You Might Be Interested In…

Catalog #

Product

Quantity

Specimen

R2002C

PSA Semi-quantitative Rapid Test

30/kit

S, P & WB

R2010C

FOB Rapid Test CE

25/kit

Fecal

To learn about distribution opportunities or for additional product information, please contact info@ctkbiotech.com

FOR EXPORT ONLY