MYOGLOBIN iClia

Intended Use

Myoglobin iClia Kit is intended for the in vitro quantitative measurement of Myoglobin in human serum/plasma as an aid in the diagnosis of Myocardial Infarction in conjunction with other laboratory and clinical findings. This kit is only operational in conjuction with J.Mitra CLIA 181 Analyzer.

Salient Features

• Based on Sandwich chemiluminescent microparticle immunoassay
• Acridinium Ester (AE) based kit for more accurate results
• Test result within 15 minutes
• Linearity : 5.00 ng/ml to 100 ng/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

Myoglobin iClia Kit is chemiluminescent immunoassay based on the “Sandwich” principle. The magnetic microspheres are coated with Anti-Myoglobin antibodies. The samples are added in the assay cup containing Assay buffer , coated microspheres followed by addition of AE conjugate (Anti- Myoglobin antibodies linked to acridinium ester). A sandwich complex is formed wherein Myoglobin (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 Myoglobin 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 Myoglobin present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the established calibration curve and Myoglobin concentration in the sample expressed as ng/ mL. Performance Characteristics Limit of Blank (LoB) : ≤2.000ng/ml Accuracy: The accuracy of Myoglobin was detected with 60 clinical specimen and compared with Roche CLIA. The co-relation co-efficient is >0.95. Precision:

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

Ordering Information

Product Name	Pack Size	Catalog No.
MYOGLOBIN iClia	50 Tests	IR078050