CK-MB iClia

Intended Use

CK-MB iCLIA Diagnostic Kit is intended for the in vitro quantitative measurement of Creatine Kinase MB (CK-MB) in human serum/plasma as an aid in the diagnosis of Myocardial Infarction, myopathy in conjunction with other laboratory and clinical findings. This kit is only operational in conjuction 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 : 0.50 ng/ml to  300ng/ml
• Long shelf life: 12 months at 2-8^oC
• Onboard stability of reagents: 30 days at 2-8^oC
• Convenient pack size: 50 Tests
• Prompt service back-up

Principle

CK-MB iClia is chemiluminescent immunoassay based on the “Sandwich” principle. The magnetic microspheres are coated with anti-CK-MB antibodies . The samples are added in the assay cup containing assay buffer and antiCK-MB antibodies coated microspheres followed by addition of AE conjugate (Anti-CK-MB antibodies linked to acridinium ester) to assay cup . A sandwich complex is formed wherein CK-MB (from serum sample) is “trapped” or “sandwiched” between the microspheres coated antibody and antibody labelled with AE conjugate. Unbound conjugate is then washed off with wash buffer. The amount of bound AE conjugate is proportional to the concentration of CK-MB present in the sample. Finally pre-trigger and trigger solution containing hydrogen peroxide and sodium hydroxide solution is added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative Light units (RLUs). There is a direct relationship between the amount of CK-MB present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the established calibration curve.

Performance Characteristics

Limit of Blank (LoB) :  <0.4ng//ml

Accuracy: The accuracy of CK-MB iClia was detected with 60 clinical specimen and compared with Roche CLIA. The co-relation co-efficient is ≥0.990.

Precision:

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

Ordering Information