C–Peptide iClia

Intended Use

C-Peptide iClia is intended for the in vitro quantitative measurement of C-Peptide in human serum/plasma as an aid in evaluating the function of pancreatic islets. The assay kit is intended for in-vitro diagnostic use. This kit is only operational with J.Mitra CLIA 181 Analyzer.

Salient Features

• Based on Sandwich chemiluminescent microparticle immunoassay
• Acridinium Ester (AE) based kit for more accurate results
• Test result at 30 minutes
• Analytical Sensitivity : 0.025 ng/ml
• Linearity: 0.025 ng/ml to 50.000 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

C-Peptide iClia Diagnostic Kit is a sandwich immunoassay for determination of C-Peptide in human serum and plasma using chemiluminescent technology. In the first step, anti-C-Peptide labeled magnetic microparticle , human serum, assay buffer and an anti- C-Peptide labeled acridinium ester (AE Conjugate) are mixed and incubated in an assay tube, which allows patient specific C-Peptide to bind to microparticle. After sample matrix is removed by washing, the Microparticle-anti- C-Peptide antibody/antigen/antibody immune complex is kept with the help of a magnetic separator. Excess acridinium ester conjugate is removed by washing and finally the bound enzyme is detected by addition of chemiluminescent substrate. The relative light unit (RLU) intensity is proportional to the amount of C-Peptide. According to the C-Peptide RLU-concentration standard curve, the RLU tested can be interpreted to C-Peptide concentration in the sample expressed as ng/ml.

Performance Characteristics

Limit of Blank (LoB): ≤ 0.50 ng/ml.

Accuracy: The accuracy of C-Peptide iClia was detected 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 C-Peptide positive samples (Weak and strong) and kit controls in within run precision testing with CV <10%.
2. The test results are reproducible with C-Peptide positive samples (Weak and strong) and kit controls in between run precision testing with CV <10%.
3. The test results are reproducible with C-Peptide positive samples (Weak and strong) and kit controls in between instrument precision testing with CV <10%.

Ordering Information