Cancer Antigen 15-3 (CA15-3)
CID 643993. Source: PubChem. For illustration purposes only.
VeriGoldTM 糖抗原15-3
The VeriGoldTM Cancer Antigen 15-3 (CA 15-3) Rapid Test is a chromatographic immunoassay designed for the quantitative measurement of the CA 15-3 tumor-associated antigen in human serum or plasma. CA 15-3 is commonly associated with breast cancer and is used as a biomarker to support clinical assessment in patients with established disease. The assay provides rapid, point-of-care results, enabling timely evaluation of tumor marker levels without requiring centralized laboratory testing.
This test is indicated for serial monitoring of patients with confirmed breast cancer, particularly those with elevated CA 15-3 levels at diagnosis. It is intended to assist in tracking disease progression and evaluating treatment response over time. As CA 15-3 can also be influenced by non-malignant conditions, results must always be interpreted together with clinical findings and other diagnostic data.
| Ref. Code | 808085-1 |
| Analyte | Cancer Antigen 15-3 (CA15-3) |
| Format | POCT rapid test (cassette / cartridge) |
| Diagnostic Readout | Quantitative |
| Reading Time | 20 minutes |
| Measuring Range | 10–400 U/mL |
| Cut-off Value | 30 U/mL |
| Sensitivity / Specificity / r-Value | 85.71% / 96.77% / 0.883 |
| Storage Conditions | 2–8°C |
| Shelf Life | 12 months |
| Certificate | CE |
| Sample Types | Serum or plasma |
| Sample Volume | 100 µL / 2 drops |
| 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 test operates via a sandwich immunochromatographic method, where CA 15-3 antigen in the sample reacts with labeled antibodies and migrates through the membrane. The antigen–antibody complexes are captured by specific immobilized antibodies, producing a signal whose intensity correlates with CA 15-3 concentration. |
| 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- 20 dropper vials of dilution buffer (2 mL each) - Instructions for Use |
| Storage & Shipping Conditions | Standard ambient transport; store according to product label requirements |
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