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| Product Name | CA242 Gastrointestinal Tumor Marker Immunoturbidimetric Detection Kit |
| Catalog No. | TMTR-HMM-0081 |
| Description | A latex-enhanced immunoturbidimetric assay kit for the quantitative detection of CA242 glycoprotein antigen in serum. CA242 is a sialylated carbohydrate epitope expressed on mucin-type glycoproteins that shows elevated levels in pancreatic and colorectal adenocarcinoma. This immunoturbidimetric format is optimized for routine clinical chemistry analyzers, enabling integration into existing laboratory workflows without requiring dedicated immunoassay instrumentation. |
| Intended Use | Quantitative measurement of CA242 antigen concentrations in serum specimens to aid in gastrointestinal tumor management. |
| Principle / Technology | Latex particle-enhanced immunoturbidimetric assay |
| Detection Method | Turbidimetry (570 nm / 800 nm dual wavelength) |
| Sample Type | Human serum; avoid turbid samples |
| Performance Range / Specifications | Measurement range: 0.5–150 U/mL; automatic sample dilution for results exceeding upper limit |
| Sensitivity / LOD | Limit of detection: 0.3 U/mL |
| Specificity | Specific to sialylated Lewis-a related carbohydrate epitope on CA242; no cross-reactivity with CA19-9 above 0.1% |
| Reaction Conditions / Protocol | Sample volume: 3 µL; R1 incubation: 5 min at 37 °C; R2 addition with reading at 10 min |
| Components / Formulation | Reagent 1 (R1): glycine buffer with polymer accelerator; Reagent 2 (R2): anti-CA242 monoclonal antibody-coated latex particle suspension; calibrator set (5 levels); control set (2 levels) |
| Storage Conditions | Unopened: 2–8 °C; opened reagents stable for 30 days on analyzer |
| Shelf Life | 12 months |
| Package Specifications | R1: 2 × 20 mL; R2: 2 × 10 mL; calibrators: 5 × 1 mL; controls: 2 × 1 mL |
| Product Form | Liquid, ready-to-use reagents |
| Quality Control | Calibrators value-assigned against an internal reference standard; within-lot imprecision CV ≤5% |
| Key Features | Open-channel format compatible with major clinical chemistry platforms; no prozone effect up to 1000 U/mL |
| 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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