Progesterone iClia

Intended Use

Progesterone iClia kit is intended for the in vitro quantitative measurement of progesterone in human serum/plasma, as an aid in the diagnosis of threatened abortion in conjunction with other laboratory and clinical findings. 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 for more accurate results
• Test result within 30 minutes
• Analytical Sensitivity: 1 ng/ml
• Linearity: 1 ng/ml to 40 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
• Prompt service back-up

Principle

Progesterone iClia is a Competitive immunoassay using microparticle acridinium ester chemiluminescent technology.

In the first step, anti-Progesterone antibody labeled magnetic microparticle, Assay buffer and human serum/ plasma are mixed and incubated in an assay tube. In the Next step, AE Conjugate (Progesterone conjugated acridinium ester) is added and combined, AE labels Progesterone and Progesterone in sample compete for the binding site of Progesterone antibody on the binding magnetic particle, and the Microparticle- Progesterone antibody/ Progesterone immune complex is kept with the help of a magnetic separator. Unbound acridinium ester and other substance are removed by washing and finally the bound enzyme is detected by addition of chemiluminescent substrate; pre-trigger and trigger solution containing hydrogen peroxide and sodium hydroxide to the reaction mixture. The resulting chemiluminescent reaction is measured as relative Light units (RLUs). The relative light unit (RLU) intensity is inversely proportional to the amount of Progesterone in the sample. . Results are calculated automatically based on the established calibration curve and concentration of Progesterone in the sample is expressed as ng/ml.

Performance Characteristics

Limit of Blank (LoB): <0.05 ng/ml

Accuracy: The accuracy of Progesterone iClia is tested with 60 clinical specimens and 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