Vitamin D iClia

Intended Use

Vitamin D iClia is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative measuremetn of 25-hydroxy Vitamin D (25-OH VD) in human serum) in human serum. The assay kit is intended for in vitro diagnostic use. This kit is only operational in conjuction with J. Mitra CLIA Analyzer.

Salient Features

• Based on Competitive chemiluminescent micropartice immunoassay
• Acridinium Ester (AE) based kit for more accurate results
• Test result at 45 minutes
• Analytical Sensitivity: 3 ng/ml
• Linearity: 3 ng/ml to 130 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 & 100 Tests
• Prompt service back-up

Principle

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

The magnetic microparticles are coated with anti-25 OH vitamin D antibodies. The assay diluent, anti-25 OH vitamin D antibodies coated magnetic microparticles and samples are mixed. After incubation, vitamin D AE conjugate is added to reaction mixture. During incubation 25 OH vitamin D of sample compete with 25 OH vitamin D AE conjugate for binding of anti-25 OH vitamin D antibodies coated on magnetic microparticles. After further incubation and washing, Pre-Trigger and 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 D 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):  ≤3 ng/ml

Accuracy: The accuracy of Vitamin D iClia is tested with 60 clinical specimens and compared with Roche CLIA. The accuracy co-efficient is >0.980.

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 <10.0%.

Ordering Information