Test Kit Type:AMH Test Kit (CLIA)
Analytical Sensitivity:0.02 ng/ml
Linearity:0.02 ng/ml to 24 ng/ml

Intended Use

AMH iClia is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of Anti-Mullerian Hormone (AMH) in human serum/ plasma as an aid in the diagnosis of reproductive hormone diseases. The assay kit is intended for in vitro diagnostic use. 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: 0.02 ng/ml
  • Linearity: 0.02 ng/ml to 24 ng/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

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

The samples are added in the assay cup containing coated microparticles followed by addition of AMH assay buffer and AE conjugate (Anti- AMH antibodies linked to acridinium ester) to assay cup. A sandwich complex is formed wherein AMH (from serum sample) is “trapped” or “sandwiched” between the microparticles 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 AMH 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 AMH 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):  0.02 ng/ml

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

Ordering Information

Product Name Pack Size Catalog No.
AMH iClia 50 Tests IR035050
AMH iClia 100 Tests IR035100

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