Biochip Langdao (Tianjin)Medical Technology Limited

1.Product Overview

 [product name] : High-sensitivity troponin I (hs-cTnI)

 [Package Specification] : 30 tests/kit;60 tests/kit

 [Applicable Device] : CLite-160i

 [Specimen Type] : plasma

 [Storage] : 2-8℃

 [Product validity] : 12 months

 [Detection method] : magnetic particle chemiluminescence method

2.technique principle

  Double antibody sandwich method was used in the kit. The detection principle is: the sample to be tested, R1 reagent, R2 reagent and M reagent are mixed for incubation, and the fluorescein (FITC) labeled cTnI antibody 1 in R1 reagent and the alkaline phosphatase (ALP) labeled cTnI antibody 2 in R2 reagent are combined with the cTnI antigen molecules in the sample to form an immune complex. The immune complex is further captured by anti-FITC antibodies coupled to the surface of the magnetic particle and adsorbed to the surface of the magnetic particle. After washing, the unbound material was removed and the luminescent substrate was added, ALP catalyzed the luminescence of the substrate, and the relative luminescence intensity (RLU) was determined.

3.The clinical significance

  High-sensitivity cardiac troponin, as a highly sensitive index, is helpful to detect small missed myocardial injury. High-sensitivity cardiac troponin can detect clinically significant increase as early as 1 to 3 hours after myocardial injury. High-sensitivity troponin detection has a high predictive value for myocardial infarction, which can reduce the time of troponin blind zone and detect acute myocardial infarction (AMI) earlier.

  High-sensitivity troponin can obviously improve the early diagnosis of AMI, improve acute coronary syndrome (ACS) early risk stratification and prognosis evaluation. Compared with the traditional cTnI detection method, the hs-cTnI detection method can detect more abnormal cTnI elevation (about 20%) in patients with NSTEMI.

4.Product features and indicators

High sensitivity: the detection limit is not higher than 5pg/mL;

Wide linear range: samples in the range of [10,50000](pg/mL) do not need to be diluted;

Good correlation: correlation with Beckman reagent R > 0.95;

Good stability: the calibration cycle can be up to 14 days, and the reagent can be stored at 4℃ for 1 year;

Fast results: only 16-18 minutes to get results.