Vitamin B12 iClia

Intended Use

Vitamin B12 iClia is a chemiluminescent microparticle immunoassay designed for in vitro quantitative measurement of vitamin B12 (cyanocobalamin) in human serum. This kit is only operational in conjunction with J. Mitra CLIA Analyzer.

Salient Features

• Based on Competitive chemiluminescent microparticle immunoassay
• Acridinium Ester (AE) based kit for more accurate results
• Test result at 55 minutes
• Analytical Sensitivity: 100 pg/ml
• Linearity: 100 pg/ml to 2000 pg/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 & 100 Tests
• Prompt service back-up

Principle

Vitamin B12 iClia is chemiluminescent immunoassay based on the “competitive” principle.

The Denaturation reagent, stabilizing reagent and samples are mixed, after incubation, neutralization reagent and Vit B12 antibody coated magnetic microparticles are added to reaction and incubate. After incubation, Vitamin B12 of a sample and Vitamin B12 of biotin completes for binding to anti-vitamin B12 antibodies coated magnetic microparticle. After incubation and washing, streptavidin Acridinium ester conjugate is added to reaction mixture. After that Trigger and Pre-Trigger Solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative Light units (RLUs). There is an indirect relationship between the amount of Vitamin B12 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):  ≤50 pg/ml

Accuracy: The accuracy of Vitamin B12 iClia is tested with 60 clinical specimens and compared with Roche CLIA. The accuracy co-efficient is ≥0.970.

Precision:

1. The test results are repeatable in within run precision testing with CV <6%.
2. The test results are reproducible in between run precision testing with CV <10%.

Ordering Information