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| Product Name | Total Prostate-Specific Antigen (tPSA) ELISA Kit |
| Catalog No. | TMTR-HMM-0053 |
| Description | A quantitative sandwich enzyme immunoassay for measuring total PSA in human serum, detecting both free and complexed forms of the antigen. This reagent supports prostate cancer screening programs and post-treatment patient surveillance. |
| Intended Use | Quantitative measurement of total PSA concentration in human serum as a screening and monitoring tool for prostate cancer. |
| Principle / Technology | Sandwich ELISA using monoclonal antibodies that recognize free PSA and PSA-alpha-1-antichymotrypsin (ACT) complex with equal affinity, providing a true total PSA measurement. |
| Detection Method | Dual-wavelength colorimetric measurement at 450/620 nm |
| Sample Type | Human serum; specimens should be separated from the clot within 3 hours of collection; PSA is stable in serum for 7 days at 2–8°C and for 6 months at -20°C |
| Performance Range / Specifications | 0.2–100 ng/mL; the standard curve is calibrated against the WHO International Standard for PSA (96/670) |
| Sensitivity / LOD | ≤0.1 ng/mL minimum detectable concentration |
| Specificity | Equimolar detection of both free PSA and PSA-ACT complex; cross-reactivity with human glandular kallikrein 2 (hK2) is below 0.01% at concentrations up to 100 ng/mL |
| Reaction Conditions / Protocol | Incubate 50 μL of standard or sample with 50 μL of assay buffer in the pre-coated well for 60 minutes at 37°C, aspirate and wash, add 100 μL of detection antibody for 60 minutes, wash, add 100 μL of streptavidin-HRP for 30 minutes, wash, develop with TMB for 20 minutes at room temperature in darkness, stop and read |
| Components / Formulation | Anti-PSA monoclonal antibody pre-coated 96-well break-apart microplate, total PSA standard set (0, 0.5, 2, 10, 25, 100 ng/mL), biotinylated anti-PSA detection antibody concentrate, streptavidin-HRP concentrate, TMB chromogen, stop solution, 20× wash buffer, standard/sample diluent |
| Storage Conditions | 2–8°C for unopened kit; reconstituted standards may be kept at -20°C for up to 6 weeks when properly aliquoted |
| Shelf Life | 12 months |
| Package Specifications | 96 wells per kit |
| Product Form | Pre-coated microplate with concentrated liquid reagents |
| Quality Control | Intra-assay precision below 5% CV at low, medium, and high PSA concentrations; inter-assay precision below 7%; dilution recovery between 90% and 110% across the assay range; calibrators traceable to WHO IS 96/670 |
| Key Features | Calibrated against the WHO International Standard ensures global harmonization of PSA results across laboratories and assay platforms; the equimolar detection design accurately measures total PSA regardless of the free-to-total ratio in the specimen |
For research use only, not for clinical use.
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