Test Kit Type:Anti-IgE Test Kit (CLIA)
Analytical Sensitivity:2.00 IU/ml
Linearity:2.00 IU/ml to 1000 IU/ml

Intended Use

PTH iCLIA Kit is intended for the in vitro quantitative measurement of parathyroid hormone (PTH) in human serum/plasma as an aid in evaluating the function of parathroid. This kit is only operational in conjuction 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
  • Linearity : 5.00 pg/ml to 5000 pg/ml
  • Long shelf life: 12 months at 2-8oC
  • Onboard stability of reagents: 30 days at 2-8oC
  • Convenient pack size: 50 Tests
  • Prompt service back-up

Principle

PTH iClia is a Sandwich immunoassay using microparticle acridinium ester chemiluminescent technology. The magnetic microspheres are coated with AntiPTH antibodies. The samples are added in the assay cup containing Anti- PTH antibodies coated microspheres followed by addition of AE conjugate (Anti- PTH antibodies linked to acridinium ester) to assay cup. A sandwich complex is formed wherein PTH (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 PTH 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 PTH present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the established calibration curve and concentration of PTH in the sample is expressed as pg/ml.

Performance Characteristics

Limit of Blank (LoB) :  <2.0pg/ml

Accuracy: The accuracy of PTH iClia was detected with 60 clinical specimen and compared with Roche CLIA. The co-relation co-efficient is >0.990.

Precision:

  1. The test results are repeatable with PTH samples (Low and High) and kit controls in within run precision testing with CV <10%.
  2. The test results are reproducible with PTH samples (Low and High) and kit controls in between run precision testing with CV <15.0%.
  3. The test results are reproducible with PTH samples (Low and High) and kit controls in between instrument precision testing with CV <15%.

Ordering Information

Product Name Pack Size Catalog No.
PTH iCLIA 50 Tests IR063050

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