Alpha Fetoprotein (AFP)
PDB ID: 8X1N. Source: RCSB Protein Data Bank. For illustration purposes only.
VeriGoldTM 甲胎蛋白
The VeriGoldTM Alpha-Fetoprotein (AFP) Rapid Test is a chromatographic immunoassay developed for the quantitative detection of alpha-fetoprotein (AFP) in human serum or plasma. AFP is a tumor-associated biomarker commonly linked to hepatocellular carcinoma and certain germ cell tumors. The assay provides rapid and convenient measurement of AFP levels, supporting timely evaluation in point-of-care and clinical laboratory settings.
This test is primarily used as an aid in monitoring disease status, evaluating treatment response, and supporting the clinical management of patients with AFP-associated malignancies. Elevated AFP levels may also occur in some non-malignant conditions; therefore, results should always be interpreted together with clinical findings and other laboratory or imaging data.
| Ref. Code | 808110-1 |
| Analyte | Alpha Fetoprotein (AFP) |
| Format | POCT rapid test (cassette / cartridge) |
| Diagnostic Readout | Quantitative |
| Reading Time | 20 minutes |
| Measuring Range | 2.5–200 U/mL |
| Cut-off Value | 7 U/mL |
| Sensitivity / Specificity / r-Value | 98.94% / 100% / 0.983 |
| 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 utilizes a sandwich chromatographic immunoassay method, in which AFP present in the specimen binds to labeled anti-AFP antibodies during membrane migration by capillary action. The formed antigen–antibody complexes are captured by immobilized antibodies at the test region, generating a signal proportional to the AFP concentration 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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深圳市康生保
生物技术有限公司
深圳市宝安区
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新和 社区 安达
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518103
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info@ksbbiotech.com