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| Product Name | Carbohydrate Antigen 19-9 (CA19-9) ELISA Test System |
| Catalog No. | TMTR-HMM-0051 |
| Description | An enzyme immunoassay kit for the quantitative measurement of CA19-9 antigen levels in human serum, providing a laboratory tool for monitoring pancreatic and biliary tract malignancies. |
| Intended Use | Quantitative determination of CA19-9 in serum as an adjunct marker for monitoring patients with pancreatic cancer, biliary tract cancer, and gastric cancer. |
| Principle / Technology | Solid-phase sandwich ELISA employing monoclonal antibodies that specifically recognize the sialyl-Lewis A carbohydrate moiety present on the CA19-9 mucin glycoprotein. |
| Detection Method | Absorbance measurement at 450 nm wavelength using a microplate spectrophotometer |
| Sample Type | Human serum; grossly hemolyzed, icteric, or lipemic specimens should be evaluated for potential interference |
| Performance Range / Specifications | 3.0–240 U/mL standard curve range; samples reading above the highest standard should be diluted with the zero standard and re-assayed |
| Sensitivity / LOD | Analytical sensitivity: ≤1.5 U/mL, defined as the concentration at 2 standard deviations above the mean zero calibrator signal |
| Specificity | High specificity for the sialyl-Lewis A epitope (the CA19-9 determinant); cross-reactivity with CA125, CA15-3, and CEA is below the lower limit of detection at physiologically relevant concentrations |
| Reaction Conditions / Protocol | Transfer 50 μL of standard or pre-diluted sample to each well, add 50 μL of assay buffer, incubate at 37°C for 60 minutes, wash thoroughly, add 100 μL of enzyme conjugate, incubate 60 minutes, wash, develop color with TMB substrate for 20 minutes at room temperature in the dark, stop, and read absorbance promptly |
| Components / Formulation | Anti-CA19-9 monoclonal antibody-coated 96-well break-apart microplate, CA19-9 standard set (0, 3, 10, 30, 100, 240 U/mL), HRP-conjugated detection antibody, TMB substrate solution, stop solution, 10× wash buffer, assay diluent, plate sealers |
| Storage Conditions | Store kit at 2–8°C; once opened, standards are stable for 7 days at 2–8°C; for longer storage, aliquot standards and keep at -20°C |
| Shelf Life | 12 months from date of manufacture |
| Package Specifications | 96 tests per kit |
| Product Form | Pre-coated microplate with liquid and lyophilized reagent components |
| Quality Control | Validation according to CLSI EP guidelines: intra-assay precision below 7%, inter-assay precision below 9%; dilutional linearity within 90–110% of expected recovery; spike recovery between 85% and 115% |
| Key Features | Comprehensive validation documentation supports regulatory submission packages; the break-apart well format enables flexible batch sizes; standard curve can be stored and reused for up to 4 weeks when standards are aliquoted and kept frozen |
For research use only, not for clinical use.
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