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| Product Name | Alpha-Fetoprotein (AFP) Quantitative ELISA Assay Kit |
| Catalog No. | TMTR-HMM-0046 |
| Description | An enzyme immunoassay kit designed for the quantitative measurement of alpha-fetoprotein concentration in human serum and plasma specimens. This reagent supports clinical screening and monitoring of hepatocellular carcinoma and germ cell tumors in laboratory settings. |
| Intended Use | Quantitative detection of AFP in human serum and plasma as an aid in the screening, diagnosis, and management of hepatocellular carcinoma and testicular germ cell tumors. |
| Principle / Technology | Sandwich enzyme-linked immunosorbent assay with monoclonal anti-AFP capture antibodies and enzyme-labeled detection antibodies for specific signal amplification. |
| Detection Method | Colorimetric detection at 450 nm with reference correction at 620 nm using a standard microplate reader |
| Sample Type | Human serum, EDTA plasma, or heparinized plasma |
| Performance Range / Specifications | Standard curve range: 2.5–800 ng/mL; samples exceeding the upper limit may be diluted with provided assay diluent |
| Sensitivity / LOD | Analytical sensitivity: ≤1.0 ng/mL, determined as the concentration corresponding to 2 standard deviations above the zero calibrator signal |
| Specificity | Monoclonal antibody pair demonstrates high specificity for human AFP with negligible cross-reactivity toward albumin, transferrin, and other abundant serum proteins |
| Reaction Conditions / Protocol | Apply 100 μL of standard or pre-diluted sample to the pre-coated microplate, incubate for 60 minutes at 37°C, wash, add detection antibody, incubate for 30 minutes, wash, add enzyme conjugate, incubate another 30 minutes, develop with TMB for 15 minutes, stop and read |
| Components / Formulation | Pre-coated anti-AFP 96-well microplate strips, lyophilized AFP standard set (six concentrations plus zero standard), biotinylated detection antibody concentrate, streptavidin-HRP concentrate, TMB chromogen solution, stop solution (0.5 M sulfuric acid), 20× wash buffer concentrate, assay diluent, adhesive plate sealers |
| Storage Conditions | Store unopened kit at 2–8°C; after reconstitution, standards should be aliquoted and stored at -20°C for no more than 4 weeks; avoid repeated freeze-thaw cycles |
| Shelf Life | 12 months from the date of manufacture printed on the kit label |
| Package Specifications | 96 determinations per kit, configured as 12 break-apart 8-well strips |
| Product Form | Solid-phase microplate with lyophilized and liquid reagent components |
| Quality Control | Each production lot is validated with certified reference materials; intra-assay coefficient of variation below 8%; inter-assay CV below 10%; spike recovery falls within 85–115% of expected values |
| Key Features | Break-apart well format allows partial plate usage and reduces waste in lower-throughput laboratories; the biotin-streptavidin signal amplification system delivers consistent sensitivity across the full assay range; all calibrators are formulated in a serum-based matrix to ensure commutability with clinical specimens |
For research use only, not for clinical use.
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