Ferritin iClia

Intended Use

Ferritin iClia is a chemiluminescent microparticle immunoassay (CMIA) designed for the quantitative measurement of Ferritin in human serum/plasma as an aid in monitoring the recurrence and metastasis of malignant tumors. The assay kit is intended for in-vitro diagnostic use. This kit is only operational with J.Mitra CLIA Analyzer.

Salient Features

• Based on Sandwich chemiluminescent microparticle immunoassay
• Acridinium Ester (AE) based kit for more accurate results
• Test result at 17 minutes
• Linearity – 0.50 ng/mL to 2000.0 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 Test Pack
• Prompt service back-up

Principle

Ferritin iClia Kit is a sandwich immunoassay using microparticle acridinium ester-labeled chemiluminescent technology. In the first step, assay buffer, human serum/plasma and anti-Ferritin labeled magnetic microparticle are mixed and incubated in an assay cup, which allows Ferritin in sample to bind to microparticle and forms microparticle-anti-Ferritin antibody/antigen complex. Next, after washing, anti-Ferritin antibodies labeled acridinium ester conjugate (AE Conjugate) is added and incubated. The above complex is combined with AE Conjugate and formed microparticle-anti-Ferritin antibody/antigen/antibody immune complex. Excess AE conjugate is removed by washing and finally the bound enzyme is detected by addition of chemiluminescent substrate. Pre-trigger & Trigger solution containing hydrogen-peroxide and sodium hydroxide to the reaction mixture. The relative light unit (RLU) intensity is proportional to the amount of Ferritin in the sample. According to the Ferritin RLU-concentration standard curve, the RLU observed can be interpreted to Ferritin concentration in the sample expressed as ng/ml.

Performance Characteristics

Limit of Blank (LoB) :  <0.45 ng/mL

Accuracy: The accuracy of Ferritin iClia was checked with 60 clinical specimens and compared with Roche CLIA. The co-relation co-efficient is >0.95.

Precision:

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

Ordering Information