Test Kit Type:Thyroid Test Kit (CLIA)
Analytical Sensitivity:0.005 μIU/ml
Linearity0.005 μIU/ml to 100 μIU/ml

Intended Use

TSH iClia is a chemiluminescent microparticle immunoassay designed for in vitro quantitative measurement of TSH in human serum or plasma. This kit is only operational in conjunction 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 30 minutes
  • Analytical Sensitivity: 005 μIU/ml
  • Linearity: 005 μIU/ml to 100 μIU/ml
  • Long shelf life: 12 months at 2-8oC
  • Onboard stability of reagents: 30 days at 2-8oC
  • Convenient pack size: 50 Tests & 100 Tests
  • Prompt service back-up

Principle

TSH iClia is chemiluminescent immunoassay based on the “Sandwich” principle. The magnetic microspheres are coated with Anti-TSH antibodies.

The samples are added in the assay cup containing anti-TSH antibodies coated microspheres followed by addition of AE conjugate (Anti-TSH antibodies linked to acridinium ester) to assay cup . A sandwich complex is formed wherein TSH (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 TSH present in the sample. Finally pretrigger 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 TSH 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) :  <0.005 μIU/ml

Accuracy: The accuracy of TSH 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 <6%.
  2. The test results are reproducible in between run precision testing with CV <10%.

Ordering Information

Product Name Pack Size Catalog No.
TSH iClia 50 Tests IR019025
TSH iClia 100 Tests IR019100

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