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| Product Name | Lens Culinaris Agglutinin-Reactive AFP (AFP-L3) Analytical Reagent |
| Catalog No. | TMTR-HMM-0054 |
| Description | A specialized reagent system for the separation and quantitation of the fucosylated AFP-L3 glycoform fraction in serum. The AFP-L3 isoform serves as a highly specific biomarker for hepatocellular carcinoma, enabling more precise differentiation from benign hepatic conditions. |
| Intended Use | Detection of the AFP-L3 isoform in serum as an aid in the differential diagnosis of hepatocellular carcinoma versus benign liver diseases in patients presenting with elevated total AFP levels. |
| Principle / Technology | Lectin-affinity chromatography using immobilized Lens culinaris agglutinin to selectively capture fucosylated AFP glycoforms, followed by quantitative immunoassay detection of the bound AFP-L3 fraction. |
| Detection Method | Lectin affinity separation coupled with subsequent chemiluminescence immunoassay detection |
| Sample Type | Human serum specimens with total AFP concentration ≥10 ng/mL; specimens with lower total AFP may yield unreliable AFP-L3 ratio results |
| Performance Range / Specifications | AFP-L3 ratio expressed as a percentage of total AFP: reportable range 0.5–95%; clinical cut-off of 10% is commonly applied for HCC risk assessment |
| Sensitivity / LOD | AFP-L3 fraction detectable at ≥0.5% of total AFP when total AFP concentration exceeds 10 ng/mL |
| Specificity | The Lens culinaris agglutinin lectin exhibits specific binding affinity for core α-1,6-fucosylated N-glycans on the AFP protein; LCA-nonreactive AFP forms and other serum glycoproteins are not retained on the affinity column |
| Reaction Conditions / Protocol | Apply diluted serum sample to the LCA affinity column, incubate for 15 minutes to allow fucosylated AFP binding, wash to remove non-reactive AFP forms, elute the bound AFP-L3 fraction with haptenic sugar solution, neutralize the eluate, then quantify both the AFP-L3 fraction and total AFP using the immunoassay detection reagents |
| Components / Formulation | Pre-packed LCA affinity micro-columns, binding/wash buffer, haptenic sugar elution buffer, neutralization buffer, total AFP immunoassay detection reagents, AFP-L3 calibrator solutions, negative and positive quality control materials |
| Storage Conditions | 2–8°C; affinity columns must not be frozen as freezing compromises the lectin binding activity; immunoassay reagents are stable for 30 days after opening when stored at 2–8°C |
| Shelf Life | 12 months from the date of manufacture |
| Package Specifications | 50 determinations per kit |
| Product Form | Disposable affinity micro-columns with liquid immunoassay reagents |
| Quality Control | Each lot of affinity columns is tested for AFP-L3 binding capacity using characterized clinical serum pools; column-to-column consistency verified; positive and negative controls included for daily quality monitoring |
| Key Features | Lectins provide a gentle, non-denaturing separation suitable for subsequent immunoassay detection; automated or semi-automated protocols reduce operator-dependent variability; the well-established 10% AFP-L3 cut-off provides clinical interpretability |
For research use only, not for clinical use.
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