PCT iClia

Intended Use

PCT iClia kit is intended for the in vitro quantitative measurement of Procalcitonin (PCT) in human serum/plasma as an aid in the diagnosis of bacterial infectious disease in conjunction with other laboratory and clinical findings. 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 20 minutes
• Analytical sensitivity : 0.02 ng/mL
• Linearity: 0.02 ng/mL to 100 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

PCT iClia Diagnostic Kit is a sandwich immunoassay using microparticle acridinium ester-labeled chemiluminescent technology. In the first step, anti-PCT labeled magnetic microparticle , human serum, diluent and an anti-PCT labeled acridinium ester (AE Conjugate) are mixed and incubated in an assay tube, which allows patient specific PCT to bind to microparticle. After sample matrix is removed by washing, the Microparticle anti- PCT 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 PCT. According to the PCT RLU-concentration standard curve, the RLU tested can be interpreted to PCT concentration in the sample expressed as ng/mL.

Performance Characteristics

Limit of Blank (LoB) : <0.02ng/mL

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

Precision:

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

Ordering Information