Helicobacter pylori Monoclonal Antibody for Stool Antigen Rapid Test & CLIA Immunoassay Development
Helicobacter pylori (H. pylori) is a gram-negative, microaerophilic spiral bacterium that colonises the gastric mucosa of approximately 50% of the global population — representing around 4 billion infected individuals. H. pylori infection is the primary cause of peptic ulcer disease, type B chronic active gastritis, and is classified as a WHO Group 1 carcinogen for gastric adenocarcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma.
Gastric cancer is the fifth most common cancer globally and the fourth leading cause of cancer mortality, with H. pylori responsible for approximately 89% of non-cardia gastric cancers. Test-and-treat strategies for H. pylori eradication in high-prevalence regions reduce gastric cancer incidence by up to 50%. For IVD immunoassay development, stool antigen testing is the preferred non-invasive diagnostic method — requiring a high-affinity matched antibody pair that detects H. pylori-specific antigens in stool with sensitivity >90% and specificity >95%.
Sekbio supplies four distinct mouse anti-H. pylori monoclonal antibody clones plus matched antigens, enabling IVD developers to select optimal capture/detection combinations for their specific assay format and required performance characteristics.
Four distinct mAb clones plus matched antigens for complete H. pylori stool antigen and serology immunoassay development.
| Catalog No. | Product Name | Source | Purity | Intended Use | Buffer | Storage |
|---|---|---|---|---|---|---|
| HP-W211 | Mouse Anti-H. pylori mAb (Clone 1) | Mouse mAb | >95% SDS-PAGE | Capture/Detection — LFA / CLIA / ELISA | PBS pH 7.4 | −20°C ±5°C |
| HP-W212 | Mouse Anti-H. pylori mAb (Clone 2) | Mouse mAb | >95% SDS-PAGE | Capture/Detection — LFA / CLIA / ELISA | PBS pH 7.4 | −20°C ±5°C |
| S04-HP-401 | Anti-H. pylori Mouse mAb (Clone 401) | Mouse mAb | >90% SDS-PAGE | Capture — ELISA / CLIA / POCT | PBS pH 7.4 | −20°C |
| S04-HP-402 | Anti-H. pylori Mouse mAb (Clone 402) | Mouse mAb | >90% SDS-PAGE | Detection — ELISA / CLIA / POCT | PBS pH 7.4 | −20°C |
| S05-HPAg-C01 | H. pylori Antigen (Ag 1) | Recombinant | >90% | Positive Control / Calibrator | — | −20°C |
| S05-HPAg-C02 | H. pylori Antigen (Ag 2) | Recombinant | >90% | Positive Control / Calibrator | — | −20°C |
| S05-HPAb-C03 | H. pylori Labelling Antibody | Mouse mAb | >90% | Detection — LFA (colloidal gold) | — | −20°C |
MOQ 1 mg per product. OEM gram-scale supply available. Contact info@sekbio.com for recommended pairing combinations (HP-W211+HP-W212 or S04-HP-401+S04-HP-402) and working concentration data.
Four distinct mAb clones offering multiple epitope coverage options for optimal H. pylori immunoassay performance.
Four distinct mouse anti-H. pylori mAb clones (HP-W211, HP-W212, S04-HP-401, S04-HP-402) allow IVD developers to screen and select optimal capture/detection combinations targeting different H. pylori epitopes for maximum sensitivity and specificity in their specific assay format.
HP-W211 (4.62 mg/mL) and HP-W212 (4.97 mg/mL) are affinity-purified with >95% purity by SDS-PAGE — exceeding standard IVD antibody purity requirements and reducing non-specific binding in stool antigen tests where matrix effects are a primary challenge.
Matched H. pylori antigens (S05-HPAg-C01, S05-HPAg-C02) and dedicated labelling antibody (S05-HPAb-C03) for colloidal gold conjugation are available alongside the antibody pair, providing all components needed for a complete LFA stool antigen test development workflow.
Validated for LFA (stool antigen rapid test), CLIA (laboratory quantitative serology), ELISA, CMIA, and FIA. Mouse IgG isotype supports colloidal gold conjugation for POCT LFA development and standard reporter labelling for CLIA and ELISA analyzer integration.
All H. pylori antibody products are manufactured under ISO 13485 QMS with inter-batch CV <10%. Batch consistency data and CoA documentation support OEM kit manufacturers in meeting CE IVD, NMPA, and WHO prequalification regulatory submission requirements.
H. pylori prevalence exceeds 50% in East Asia (China, Korea, Japan), Middle East, South America, and Africa — Sekbio's primary target markets. OEM supply is optimised for high-volume stool antigen test manufacturers serving these high-incidence regions, with competitive pricing at gram-scale quantities.
H. pylori antibody panel for stool antigen testing, serology, eradication confirmation, and gastric cancer prevention programs.
H. pylori stool antigen testing (SAT) is the recommended non-invasive diagnostic method for both initial diagnosis and post-eradication confirmation per ACG, ESGE, and Asia-Pacific Consensus guidelines. SAT using matched monoclonal antibodies achieves sensitivity >90% and specificity >95%, with performance superior to serology in post-treatment settings where IgG titres persist for months after eradication.
Confirming H. pylori eradication 4–8 weeks after antibiotic therapy is recommended by all major GI guidelines. SAT-based confirmation using Sekbio antibody pair is equivalent to urea breath test (UBT) in post-treatment accuracy (sensitivity ~90%, specificity ~97%), and can be performed at point-of-care settings without specialised equipment. Critical for rising clarithromycin resistance monitoring.
Quantitative CLIA-based H. pylori IgG serology using Sekbio antibodies enables epidemiological seroprevalence studies, population screening programs, and high-throughput clinical laboratory testing. While serology cannot confirm active vs. past infection, it remains valuable for large-scale H. pylori screening in high-incidence regions where test-and-treat strategies are implemented.
WHO and international oncology guidelines recommend H. pylori eradication strategies to prevent gastric cancer in high-incidence regions. Sekbio's H. pylori antibody panel supports OEM manufacturers developing stool antigen test cassettes for mass screening programs in China, Korea, Japan, Turkey, and Middle Eastern markets. ISO 13485 batch documentation facilitates multi-market regulatory submissions.
H. pylori is a gram-negative bacterium colonising the gastric mucosa of ~50% of the global population. It is the primary cause of peptic ulcer disease and a WHO Group 1 carcinogen for gastric cancer. H. pylori stool antigen rapid tests using matched monoclonal antibodies detect active infection with sensitivity >90% and specificity >95%, and are recommended by ACG, ESGE, and Asia-Pacific Consensus guidelines for both initial diagnosis and post-eradication confirmation.
Sekbio supplies: HP-W211 (Clone 1, 4.62 mg/mL, >95% SDS-PAGE), HP-W212 (Clone 2, 4.97 mg/mL, >95% SDS-PAGE), S04-HP-401 (>90%), S04-HP-402 (>90%), plus matched antigens (S05-HPAg-C01, S05-HPAg-C02) and labelling antibody (S05-HPAb-C03). MOQ 1 mg per product.
Validated for LFA (stool antigen rapid test), CLIA, ELISA, CMIA, and FIA. The antibody panel covers both quantitative laboratory testing (CLIA/ELISA) and POCT rapid test development (LFA), with the S05-HPAb-C03 labelling antibody specifically optimised for colloidal gold conjugation in LFA cassettes.
For LFA stool antigen test, the recommended approach is HP-W211 (or S04-HP-401) as capture and HP-W212 (or S04-HP-402) as detection — with HP-W212/S04-HP-402 conjugated to colloidal gold. For serology CLIA/ELISA, contact info@sekbio.com for epitope pairing data and working concentration recommendations to achieve optimal sandwich immunoassay performance.
HP-W211 and HP-W212: >95% purity by SDS-PAGE, affinity-purified. S04-HP-401 and S04-HP-402: >90% purity by SDS-PAGE, purified by caprylic acid and ammonium sulfate methods. All manufactured under ISO 13485 QMS with batch-to-batch CV <10%.
Yes. Sekbio can supply H. pylori detection antibodies (HP-W212 or S04-HP-402) pre-conjugated to colloidal gold (40 nm) for direct LFA cassette integration, as well as the dedicated labelling antibody S05-HPAb-C03. Contact info@sekbio.com for conjugation specifications, or see our full product catalog.
Request antibody pairing data, technical datasheet, or discuss OEM stool antigen test supply with our team.