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| Product Name | Human Epididymis Protein 4 (HE4) Chemiluminescence Kit |
| Catalog No. | TMTR-HMM-0055 |
| Description | A chemiluminescence immunoassay kit for the quantitative determination of HE4 in human serum. When evaluated together with CA125 in the Risk of Ovarian Malignancy Algorithm, HE4 enhances the accuracy of preoperative pelvic mass assessment. |
| Intended Use | Quantitative serum HE4 measurement for ovarian cancer risk assessment, particularly as a component of the ROMA index in women presenting with a pelvic mass. |
| Principle / Technology | One-step sandwich chemiluminescence immunoassay with magnetic microparticle separation and acridinium ester signal generation. |
| Detection Method | Automated chemiluminescent detection on a compatible analyzer platform |
| Sample Type | Fasting human serum specimen is preferred; grossly hemolyzed or lipemic samples should be recollected; EDTA plasma is not recommended due to potential matrix effects |
| Performance Range / Specifications | 5.0–1500 pmol/L analytical measurement range |
| Sensitivity / LOD | Limit of detection: ≤3.0 pmol/L; functional sensitivity (20% inter-assay CV): ≤10 pmol/L |
| Specificity | Two monoclonal antibodies target distinct epitopes on the WFDC2/HE4 protein; cross-reactivity with other whey acidic protein (WAP) domain-containing proteins is minimal at physiologically encountered concentrations |
| Reaction Conditions / Protocol | One-step protocol: sample, capture antibody-coated magnetic particles, and labeled detection antibody are incubated simultaneously for 20 minutes at 37°C; after magnetic separation and wash, the chemiluminescent signal is measured in a single reading |
| Components / Formulation | R1: anti-HE4 capture antibody-coated magnetic microparticle suspension, R2: acridinium ester-labeled anti-HE4 detection antibody solution, assay buffer; six-level HE4 calibrator set; three-level quality control set |
| Storage Conditions | Store reagents at 2–8°C; calibrators and controls are stable for 8 weeks after opening when stored at 2–8°C; on-board reagent stability is 90 days |
| Shelf Life | 15 months for unopened reagents stored at recommended conditions |
| Package Specifications | 100 tests per reagent cartridge |
| Product Form | Ready-to-use liquid reagents in barcode-labeled cartridges for direct analyzer loading |
| Quality Control | Calibrator value assignment performed against an internal reference preparation using gravimetric methods; tri-level controls monitor analytical performance across low, medium, and high HE4 concentrations; inter-assay precision below 5% CV |
| Key Features | Integration with CA125 measurement enables automatic ROMA index calculation on the analyzer; the 90-day on-board stability minimizes reagent changeover frequency; validated reference ranges for pre-menopausal and post-menopausal women support appropriate clinical interpretation |
For research use only, not for clinical use.
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