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| Product Name | Pepsinogen I/II Ratio ELISA Kit for Gastric Cancer Screening |
| Catalog No. | TMTR-HMM-0082 |
| Description | Sandwich ELISA kit for quantitative determination of pepsinogen I (PG I) and pepsinogen II (PG II) in human serum for calculation of the PG I/PG II ratio — a validated serological biomarker for atrophic gastritis and gastric cancer risk assessment. Reduced PG I and PG I/PG II ratio indicates corpus atrophy, a precursor lesion for intestinal-type gastric adenocarcinoma. Separate pre-coated strips for PG I and PG II enable simultaneous measurement from the same serum sample. |
| Intended Use | Serological gastric cancer screening; atrophic gastritis detection and grading; Helicobacter pylori-associated gastric atrophy monitoring; gastric cancer risk stratification in population screening programs; evaluation of gastric mucosal health status. |
| Principle / Technology | Sandwich ELISA with monoclonal capture and detection antibodies specific for pepsinogen I and pepsinogen II respectively; HRP-conjugated secondary antibody with TMB chromogenic detection at 450 nm; PG I and PG II concentrations determined from separate standard curves; PG I/PG II ratio calculated |
| Detection Method | ELISA; absorbance at 450 nm with reference 620 nm; separate standard curves for PG I and PG II |
| Sample Type | Human serum (fasting recommended; pepsinogen levels increase post-prandially); 10 µL serum per test; avoid hemolyzed samples (hemoglobin interferes at 450 nm) |
| Sensitivity / LOD | PG I: LOD 0.5 ng/mL, range 1.5-200 ng/mL; PG II: LOD 0.3 ng/mL, range 1-100 ng/mL; PG I/PG II ratio <3.0 indicates positive screening result for corpus atrophy |
| Specificity | Monoclonal antibodies specific for human PG I (pepsinogen 1-5 isozymogens) and PG II (pepsinogen 6-7); no cross-reactivity with pepsin (activated form), cathepsin E, or other aspartic proteases; cross-reactivity with non-human primate serum ~90% |
| Reaction Conditions / Protocol | Add 10 µL serum + 100 µL sample diluent to pre-coated wells; incubate 60 min at 37 °C; wash 5×; add 100 µL HRP-conjugate; incubate 30 min at 37 °C; wash 5×; add 100 µL TMB substrate; incubate 15 min RT; stop with 50 µL H₂SO₄; read A450 within 30 min |
| Components / Formulation | PG I antibody-coated 96-well strip plate (8-well strips × 12), PG II antibody-coated 96-well strip plate (8-well strips × 12), PG I standards (0, 1.5, 5, 15, 50, 150, 200 ng/mL), PG II standards (0, 1, 3, 10, 30, 100 ng/mL), PG I/PG II controls (low and high), HRP-conjugated detection antibodies (anti-PG I and anti-PG II), sample diluent, wash buffer (20×), TMB substrate, stop solution, plate sealers |
| Storage Conditions | 2-8 °C; do not freeze; bring to RT before use; protect TMB from light |
| Shelf Life | 12 months from manufacture date |
| Package Specifications | 96 tests (48 PG I + 48 PG II or 96 mixed depending on configuration); also available as separate PG I and PG II kits |
| Product Form | Pre-coated strip-well plates with liquid reagents |
| Key Features | Single kit measures both PG I and PG II; monoclonal antibodies ensure high specificity; wide standard range covers clinical spectrum; PG I/PG II ratio improves sensitivity over PG I alone; serum-based standards for matrix-matched quantification; CE-IVD marked; validated in gastric cancer screening populations |
| Purity | Monoclonal antibodies affinity-purified; antigen affinity >10⁹ M⁻¹; BSA-free formulation; sodium azide <0.05% as preservative |
| 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 pack 2-8 °C |
| Expiration Date / Stability | 12 months at 2-8 °C; reconstituted standards stable when aliquoted at -20 °C; do not refreeze thawed serum samples — pepsinogen I is stable for 24 hr at 4 °C, 1 month at -20 °C |
| Regulatory / Compliance | CE-IVD marked (for in vitro diagnostic use in EU/EEA); manufactured under ISO 13485; RUO in regions without IVD registration; serum samples — handle as potentially infectious (BSL-2) |
| Compatibility | Serum samples: fasting recommended; hemolyzed and lipemic samples may produce inaccurate results; pepsinogen levels affected by proton pump inhibitors (PPIs) — discontinue PPIs 2 weeks prior to testing if possible; PG I/PG II ratio interpretation: >3.0 = normal, 2.0-3.0 = borderline, <2.0 = severe atrophy |
| 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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