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| Product Name | Combined HE4 and CA125 Risk Assessment Reagent Kit (ROMA Index) |
| Catalog No. | TMTR-HMM-0080 |
| Description | A dual-parameter immunoassay reagent set for the simultaneous quantitative determination of human epididymis protein 4 and cancer antigen 125 in serum or plasma. The kit provides results for both analytes from a single sample run, along with a calculated Risk of Ovarian Malignancy Algorithm index value for menopausal-status-stratified interpretation. This combined format streamlines ovarian mass differential assessment workflows by eliminating the need for separate single-analyte determinations. |
| Intended Use | Simultaneous measurement of HE4 and CA125 with automated ROMA index calculation to support the triage of women presenting with pelvic masses. |
| Principle / Technology | Dual-analyte sandwich chemiluminescent immunoassay |
| Detection Method | Chemiluminescence with algorithmic result reporting |
| Sample Type | Human serum or lithium heparin plasma; separate pre- and post-menopausal reference intervals |
| Performance Range / Specifications | HE4: 15–1500 pmol/L; CA125: 2–1000 U/mL |
| Sensitivity / LOD | HE4: 5 pmol/L; CA125: 1 U/mL |
| Specificity | HE4 specific to WFDC2 gene product; CA125 monoclonal OC125-equivalent specificity |
| Reaction Conditions / Protocol | Sample volume: 30 µL per determination; incubation: dual 18-min cycles at 37 °C |
| Components / Formulation | HE4 antibody-coated magnetic particles, CA125 antibody-coated magnetic particles, acridinium-labeled HE4 tracer, acridinium-labeled CA125 tracer, combined calibrator set (6 levels), combined control set (2 levels), ROMA index calculation software parameters |
| Storage Conditions | 2–8 °C for all components; calibrators and controls stable for 8 weeks after opening |
| Shelf Life | 15 months |
| Package Specifications | 100 dual-determinations kit |
| Product Form | Liquid, ready-to-use reagents; frozen calibrators |
| Quality Control | HE4 calibrators traceable to HE4 EIA reference assay; CA125 traceable to reference preparation; ROMA cutoff validation per clinical decision points |
| Key Features | Single-sample dual-parameter workflow reduces turnaround time; automated ROMA stratification eliminates manual calculation errors |
| Purity | Antibody purity ≥95% by SDS-PAGE; calibrator value assigned against reference standard |
| Concentration | As specified per kit format; calibrator concentrations traceable to internal reference |
| Activity / Unit Definition | Analytical sensitivity and measuring range as stated in IFU |
| Molecular Weight | Antigen-specific; varies per analyte as documented |
| Source / Origin | Monoclonal antibodies from murine hybridoma or recombinant expression; recombinant antigen standards |
| pH Range / Optimal pH | Optimal immunoreaction at pH 7.2–7.6 |
| Shipping Conditions | Cold packs; calibrators and controls may require frozen shipment |
| Expiration Date / Stability | 12–18 months at 2–8 °C; reconstituted calibrators stable per IFU |
| Regulatory / Compliance | For IVD use; manufactured under ISO 13485; CE-marked configurations available |
| Compatibility | Compatible with automated chemiluminescence, ELISA, and immunoturbidimetric platforms |
| Recommended Buffer System | PBS-based assay buffer; ProClin or sodium azide preservative |
| Application Notes / Precautions | Follow IFU for calibrator reconstitution; avoid repeated freeze-thaw; verify QC values within acceptable range before reporting results |
| Batch-to-Batch Consistency | Calibrator value assignment within ±10% of master reference; inter-lot CV ≤10% |
For research use only, not for clinical use.
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