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| Product Name | AFP Rapid Lateral Flow Test Cassette |
| Catalog No. | TMTR-HMM-0047 |
| Description | A colloidal gold immunochromatographic test device for the rapid qualitative assessment of elevated alpha-fetoprotein levels in human whole blood, serum, or plasma samples, intended for point-of-care use in preliminary screening applications. |
| Intended Use | Rapid qualitative screening of AFP elevation in whole blood and serum specimens to support liver cancer risk triage at the point of care. |
| Principle / Technology | Lateral flow immunochromatography utilizing colloidal gold-conjugated monoclonal anti-AFP antibodies in a sandwich format on a nitrocellulose membrane strip. |
| Detection Method | Visual interpretation of test line and control line color development against a white background within the result window |
| Sample Type | Human whole blood collected by fingerstick or venipuncture, serum, or plasma |
| Performance Range / Specifications | Cut-off threshold set at 20 ng/mL AFP; test line intensity correlates semi-quantitatively with antigen concentration above this level |
| Sensitivity / LOD | Reported relative sensitivity of ≥95% and relative specificity of ≥97% when compared with a reference quantitative ELISA method at the cut-off concentration |
| Specificity | No significant interference observed in samples containing up to 20 mg/dL bilirubin, 10 g/L hemoglobin, and 10 g/L triglycerides |
| Reaction Conditions / Protocol | Dispense 2–3 drops of specimen into the sample well, add 1–2 drops of chase buffer if specified, and interpret results at 10–15 minutes at ambient temperature (15–30°C); results read beyond 20 minutes should be disregarded |
| Components / Formulation | Individually foil-pouched test cassettes containing desiccant, disposable transfer pipettes, sample dilution buffer vials, and a package insert with illustrated interpretation guide |
| Storage Conditions | Sealed foil pouch at 2–30°C; avoid freezing, excessive heat, and prolonged exposure to high humidity |
| Shelf Life | 24 months from the manufacturing date when stored in the unopened foil pouch |
| Package Specifications | 25 individually sealed test cassettes per kit box |
| Product Form | Test cassette in sealed foil pouch with desiccant packet |
| Quality Control | Each manufacturing batch undergoes quality release testing against a characterized AFP panel; the internal procedural control line must appear on every device to validate proper test function; sensitivity and specificity verified with each lot |
| Key Features | Results available within 15 minutes without laboratory instrumentation; room temperature storage eliminates cold chain logistics requirements; built-in procedural control confirms adequate sample volume and correct reagent migration on every test |
For research use only, not for clinical use.
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