Carbohydrate Antigen 19-9 (CA19-9)
CID 643993. Source: PubChem. For illustration purposes only.
VeriGoldTM 糖抗原19-9
The VeriGoldTM Carbohydrate Antigen 19-9 (CA19-9) Rapid Test is a chromatographic immunoassay developed for the quantitative detection of the CA19-9 tumor-associated antigen in human serum or plasma. Commonly associated pancreatic/biliary cancers, CA19-9 serves as an important biomarker for monitoring disease activity and supporting patient management in clinical settings. The assay delivers fast and convenient results, making it suitable for point-of-care applications where timely evaluation is required.
This test is primarily intended for the serial monitoring of patients with confirmed pancreatic cancer who present elevated CA19-9 levels at diagnosis. It may assist in assessing disease progression, treatment response, and post-therapy follow-up. Due to possible elevations in non-malignant conditions, CA19-9 results should always be interpreted together with clinical findings, imaging studies, and other laboratory data.
| Ref. Code | 808086-1 |
| Analyte | Carbohydrate Antigen 19-9 (CA19-9) |
| Format | POCT rapid test (cassette / cartridge) |
| Diagnostic Readout | Quantitative |
| Reading Time | 15 minutes |
| Measuring Range | 15–400 U/mL |
| Cut-off Value | 37 U/mL |
| Sensitivity / Specificity / r-Value | 93.55% / 93.75% / 0.951 |
| Storage Conditions | 2–8°C |
| Shelf Life | 12 months |
| Certificate | CE |
| Sample Types | Serum or plasma |
| Sample Volume | 100 µL |
| Collection Method | Venous blood |
| Sample Stability | Stable for testing within 1 hour at room temperature (as validated) |
| Acceptable Anticoagulants | EDTA / Heparin / Citrate (as applicable) |
| Notes on Handling | Specimens should be collected and handled using standard laboratory procedures. Use fresh samples when possible and avoid hemolyzed, lipemic, or contaminated specimens. |
| Detection Method | Immunochromatography |
| Antibody Format | Monoclonal / sandwich |
| Signal Generation | Colloidal gold |
| Reading Method | Instrument-based |
| Mechanism | The assay uses a sandwich chromatographic immunoassay principle, in which CA19-9 in the specimen binds to labeled monoclonal antibodies during lateral flow. The resulting immune complexes are captured by immobilized antibodies at the test line, generating a signal proportional to the CA19-9 level in the sample. |
| Tests per Kit | 20 Tests |
| Dimension of Kit Box | 16.5 × 13.5 × 8cm |
| Boxes per Carton | 55 Kits |
| Tests per Carton (Bulk) | 1100 Tests |
| G.W. per Carton (Boxed) | 20 kg |
| G.W. per Carton (Bulk) | 23.6 kg |
| Carton Dimension | 67 × 57.5 × 39 cm |
| Carton Volume | 0.15 CBM |
| Packaging Format | Individual sealed test kits / bulk configuration (as applicable) |
| Items Included | - 20 test cassettes - Instructions for Use |
| Storage & Shipping Conditions | Standard ambient transport; store according to product label requirements |
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