hs-Troponin-I iClia

Intended Use

hs-Troponin-I iClia is a chemiluminescent microparticle immunoassay (CMIA) designed the quantitative measurement of High Sensitive Cardiac Troponin I (hs-cTnl) in human serum/plasma as an aid in the diagnosis of Myocardial Infarction in conjunction with other laboratory and clinical findings. The assay kit is intended for in-vitro diagnostic use. This kit is only operational with J.Mitra CLIA Analyzer.

Salient Features

• Based on Sandwich chemiluminescent microparticle immunoassay
• Acridinium Ester (AE) based kit for more accurate results.
• Test result within 20 minutes
• Linearity: 0.025 ng/ml to 50.000 ng/ml
• Long shelf life: 12 months at 2-8^oC
• On-board stability of reagents: 30 days at 2-8^oC
• Convenient pack size: 50 Tests
• Prompt service back-up

Principle

hs-Troponin-I iClia Diagnostic Kit is a sandwich immunoassay for determination of cTnl in human serum and plasma using chemiluminescent technology. In the first step, anti-cTnI labelled magnetic microparticle, human serum, assay buffer and an anti- cTnI labelled acridinium ester (AE Conjugate) are mixed and incubated in an assay tube, which allows patient specific cTnI to bind to microparticle. After sample matrix is removed by washing, the Microparticle anti-cTnI antibody/antigen/antibody immune complex is kept with the help of amagnetic separator. Excess acridinium ester conjugate is removed by washing And finally the bound enzyme is detected by addition of chemiluminescent Substrate. The relative light unit (RLU) intensity is proportional to the amount of cTnI. According to the Troponin-I RLU-concentration standard curve, the RLU tested can be interpreted to Troponin-I concentration in the sample expressed as ng/ mL.

Performance Characteristics

Limit of Blank (LoB) : ≤0.020 ng/ml

Accuracy:

The accuracy of Troponin iClia was detected with 60 clinical specimens

And compared with Roche CLIA. The co-relation co-efficient is >0.95.

Precision:

1. The test results are repeatable with hs -Troponin samples (Low and High) and kit controls in within run precision testing with CV <10%.
2. The test results are reproducible with hs -Troponin samples (Low and High) and kit controls in between run precision testing with CV <10%.
3. The test results are reproducible with hs -Troponin (Low and High) and kit controls in between instrument precision testing with CV <10%.

Ordering Information