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| Product Name | Free PSA CLIA Reagent |
| Catalog No. | TMTR-HMM-0062 |
| Description | A chemiluminescence immunoassay reagent for the quantitative determination of free, uncomplexed PSA in human serum. The free-to-total PSA ratio provides added diagnostic specificity for differentiating prostate cancer from benign prostatic conditions. |
| Intended Use | Quantitative free PSA measurement for calculation of the free-to-total PSA ratio, aiding in prostate cancer risk stratification in men with elevated total PSA. |
| Principle / Technology | Sandwich CLIA with a monoclonal antibody specifically recognizing the free form of PSA without binding to the PSA-ACT complex. |
| Detection Method | Automated chemiluminescence detection |
| Sample Type | Human serum; specimens should be assayed within 24 hours at 2–8°C or stored at -20°C |
| Performance Range / Specifications | 0.01–50 ng/mL |
| Sensitivity / LOD | ≤0.005 ng/mL limit of detection |
| Specificity | High specificity for free PSA with below 0.1% cross-reactivity toward PSA-ACT complex at equimolar concentrations |
| Reaction Conditions / Protocol | Automated 18-minute one-step sandwich protocol |
| Components / Formulation | Capture antibody-coated magnetic microparticles, acridinium ester-labeled free-PSA-specific antibody, calibrators, controls |
| Storage Conditions | 2–8°C |
| Shelf Life | 18 months |
| Package Specifications | 200 tests per pack |
| Product Form | Ready-to-use liquid reagents |
| Quality Control | Calibrators traceable to WHO PSA standard; inter-assay CV below 6% at clinically relevant free PSA concentrations |
| Key Features | High specificity for free PSA prevents overestimation due to complexed PSA interference; enables accurate free-to-total PSA ratio calculation for prostate biopsy decision support |
For research use only, not for clinical use.
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