CA19-9 iClia

Intended Use

CA19-9 iClia is intended for the in vitro quantitative measurement of carbohydrate antigen 19-9 (CA19-9) in human serum/plasma as an aid in clinical monitoring of digestive tract malignancies such as pancreatic carcinoma. 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 30 minutes
• Analytical sensitivity : 1.50 U/mL
• Linearity : 1.50 U/mL – 1000.00 U/ 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

CA19-9 iClia kit is a chemiluminescent based on “Sandwich principle”. The magnetic microparticles are coated with anti-CA19-9 IgG antibodies. The samples are added in the assay cup containing assay buffer and anti- CA19-9 IgG antibodies coated microspheres followed by addition of AE conjugate (anti-CA19-9 IgG labeled acridinium ester conjugate) to assay cup. A sandwich complex is formed wherein CA19-9 (from serum/plasma sample) is “trapped” or “sandwiched” between the microspheres coated antibody and antibody labelled with AE conjugate. Unbound conjugate is then washed off with the wash buffer. The amount of bound AE conjugate is proportional to the concentration of CA19-9 present in the sample. Finally pre-trigger and trigger solution containing hydrogen peroxide and sodium hydroxide solution is added to reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is a direct relationship between the amount of CA19-9 present in the sample and RLUs detected by the optical system. Results are calculated automatically based on the established calibration curve.

Performance Characteristics

Limit of Blank (LoB) : < 1.000 U/mL

Accuracy: The accuracy of CA19-9 iClia was detected with 30 clinical specimens and compared with Roche CLIA. The co-relation co-efficient is >0.990.

Precision:

1. The test results are repeatable with Carbohydrate Antigen 19-9 (CA19-9) samples (Low and High) and kit controls in within run precision testing with CV <8%.
2. The test results are reproducible with Carbohydrate Antigen 19-9 (CA19-9) samples (Low and High) and kit controls in between run precision testing with CV <15%.
3. The test results are reproducible with Carbohydrate Antigen 19-9 (CA19-9) samples (Low and High) and kit controls in between instrument precision testing with CV <15%.

Ordering Information