Dengue NS1 Ag iClia

Intended Use

Dengue NS1 Ag iClia is a chemiluminescent microparticle immunoassay designed for in vitro qualitative detection of Dengue NS1 antigen in human serum or plasma and is used as a screening test for testing of collected blood samples suspected for Dengue. The kit detects all four subtypes; DEN1, DEN2, DEN3 & DEN4 of Dengue Virus. This kit is only operational in conjunction with J. Mitra CLIA Analyzer.

Salient Features

• Based on Direct Sandwich chemiluminescent microparticle immunoassay
• Acridinium Ester (AE) based kit for more accurate results
• Detection of all 4 serotypes of Dengue (DEN 1 – DEN 4)
• Test result within 20 minutes
• Sensitivity: 100%
• Specificity: 100%
• Long shelf life: 12 months at 2-8^oC
• Onboard stability of reagents: 30 days at 2-8oC
• Convenient pack size: 100 Tests
• Prompt service back-up

Principle

Dengue NS1 Ag iClia is chemiluminescence immunoassay based on the “Direct Sandwich” principle. The magnetic microparticles are coated with Anti-dengue NS1antibodies with high reactivity for Dengue NS1 Antigen. The samples are added in the assay cup followed by addition of AE conjugate (monoclonal anti-dengue NS1 antibodies linked to acridinium ester). A sandwich complex is formed wherein dengue NS1 Ag (from serum sample) is “trapped” or “sandwiched” between the microparticles coated antibody and antibody labelled with AE conjugate. Unbound conjugate is then washed off with wash buffer. The amount of bound AE conjugate is proportional to the concentration of dengue NS1 Ag present in the sample. Finally pre-trigger and trigger solution containing hydrogen peroxide and sodium hydroxide solution is added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative Light units (RLUs). There is a direct relationship between the amount of Dengue NS1 antigen present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the calibrator.

Performance Characteristics

Sensitivity: 100%

Specificity: 100%

Precision:

1. The test results are repeatable with Dengue NS1 antigen positive samples and controls in within run precision testing with CV <10%.
2. The test results are reproducible with Dengue NS1 antigen positive samples and controls in within run precision testing with CV <10%.

Ordering Information