T4 iClia

Intended Use

T4 iClia is a chemiluminescent microparticle immunoassay designed for in vitro quantitative measurement of Total Thyroxine (T4) in human serum or plasma. 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 got more accurate results
• Test result wihtin 40 minutes
• Analytical Sensitivity: 393 μg/dl
• Linearity: 42 μg/dl to 24.86 μg/dl
• 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

T4 iClia is chemiluminescent immunoassay based on the “competitive” principle.

The Assay Buffer and samples are mixed and added in the assay cup containing anti-T4 antibodies coated microspheres. After incubation, T4-biotin conjugate is added to reaction mixture. During incubation, T4 present in sample compete with T4-biotin conjugate for binding of anti-T4 antibodies coated on magnetic microparticles. After incubation and washing streptavidin acridinium ester conjugate is added to the reaction mixture. 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 T4 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) :  ≤0.42 μg/dl

Accuracy: The accuracy of T4 iClia is tested with 60 clinical specimens and compared with Roche CLIA. The accuracy co-efficient is ≥0.990.

Precision:

1. The test results are repeatable in within run precision testing with CV <7.0%.
2. The test results are reproducible in between run precision testing with CV <7.0%.

Ordering Information