FT3 iClia

Intended Use

FT3 iClia is a chemiluminescent microparticle immunoassay for the quantitative detection of free triiodothyronine (FT3) in human serum/plasma. Clinically, it is mainly used to evaluate thyroid function. The assay kit is intended for in vitro diagnostic use.

Salient Features

• Based on Competitive chemiluminescent microparticle immunoassay
• Acridinium Ester (AE) based kit for more accurate results
• Test result within 30 minutes
• Analytical Sensitivity: 2 pmol/L
• Linearity: 2 pmol/L to 50 pmol/L
• 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
• First make in India product

Principle

FT3 iClia is a “competitive” immunoassay using microparticle, acridinium ester-labeled chemiluminescent technology. In the first step, anti-FT3 antibody labeled magnetic microparticle and human serum/plasma are mixed and incubated in an assay tube. Next, FT3 conjugated acridinium ester is added and combined, AE labelled FT3 and FT3 in sample compete for the binding site of FT3 antibody on the binding magnetic microparticle, and the microparticle FT3 antibody/FT3 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 Pre-Trigger Solution and Trigger Solution. The relative light unit (RLU) intensity is inversely proportional to the amount of FT3 antigen. According to the FT3 RLU-concentration standard curve, the RLU tested can be interpreted to FT3 concentration in the sample expressed as pmol/L. For quantitative testing of free triiodothyronine (FT3), the FT3 iCLIA assay utilizes a predefined lot-specific Master Curve which is uploaded into the instrument through the reagent Master Calibration Curve barcode. Based on the Master Curve and results obtained by running two Calibrators, an instrument specific Working Curve is created, which is used to calculate pmol/L from the RLU obtained for each sample.   Performance Characteristics Limit of Blank (LoB) :  <1.5 pmol/L Accuracy: The accuracy of FT3 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.
FT3 iClia	50 Tests	IR036050
FT3 iClia	100 Tests	IR036100