Infectious Disease

H. pylori Antigen Rapid Test

Detects H. pylori antigen. colloidal-gold. Specimen: Feces.

Target / Analyte	H. pylori antigen
Disease / Indication	H. pylori infection
Series	Infectious Disease
Method	colloidal-gold
Specimen	Feces
Test time	10–15 min (product-specific)
Storage	2–30 °C, sealed pouch with desiccant
Shelf life	24 months (product-specific)
Regulatory	CE (IVDD 98/79/EC)
OEM/ODM	Available — private label & custom panel

Direct Answer

This rapid test detects H. pylori antigen in Feces to support H. pylori infection. It is a colloidal-gold screening test — a reactive result is presumptive and should be confirmed per the intended use.

Intended Use

Detection of H. pylori antigen in feces for active infection.

Clinical Context

Stool antigen detects active H. pylori infection; suitable for diagnosis and post-treatment confirmation (non-invasive).

Test Principle

Colloidal-gold immunochromatography (lateral flow). The device captures the target analyte (antigen or antibody) on a membrane via labeled antibodies, producing a visible test line within minutes. Qualitative or semi-quantitative, intended as a screening/triage aid — not a replacement for confirmatory laboratory testing.

Limitations

Sensitivity can be affected by recent PPI/antibiotic use; confirm equivocal results.

Procurement

Specimen: feces. Format: cassette / dipstick, 25 T. CE-marked line.

Interpretation

Result	Lines	Meaning
Positive	Test + control line	Target detected (presumptive positive)
Negative	Control line only	Below cut-off / not detected
Invalid	No control line	Repeat with a new device

Common misconception

A negative rapid test does not always exclude infection — timing, specimen and pathogen load all matter. Follow up clinically where suspicion is high.

Sources

Screening results are presumptive, not diagnostic. Confirmatory testing follows WHO, CDC and national regulatory guidance — see screening vs confirmatory.

Available SKUs (this series)

Cat. No.	Product	Specimen	Format	Kit Size	Status
IHP-302	H. pylori Antibody Rapid Test Cassette	S / P	Cassette	40 T	CE
IHP-401	H. pylori Antibody Rapid Test Dipstick	WB/S/P	Dipstick	50T	CE
IHP-402	H. pylori Antibody Rapid Test Cassette	WB/S/P	Cassette	40 T	CE
IHP-601	H. pylori Antigen Rapid Test Dipstick	Feces	Dipstick	25 T	CE
IHP-602	H. pylori Antigen Rapid Test Cassette	Feces	Cassette	25 T	CE
IHP-602H	H. pylori Antigen Rapid Test Cassette	Feces	Cassette	1 T	CE0123
ISTY-602	Salmonella Typhi Antigen Rapid Test Cassette	Feces	Cassette	25 T	CE
IHIG-402	HIV p24 Antigen Rapid test Cassette +1 variants	WB/S/P	Cassette	40 T	Non-CE
IMP-502	Mycoplasma pneumoniae Antigen Rapid Test Cassette	Swab	Cassette	20 T	CE
IAD-502	Adenovirus pneumoniae Antigen Rapid Test Cassette	Swab	Cassette	20 T	CE
ISP-102	Streptococcus pneumoniae Antigen Rapid Test Cassette	Urine	Cassette	10 T	CE
IBA-402	Brucella Abortus Antigen Rapid Test Cassette	WB/S/P	Cassette	25 T	CE

Technical Evidence

Analytical performance	Sensitivity, specificity, cut-off and precision are documented per product line in the datasheet and validation report.
Average accuracy	≥96% (overall agreement rate, manufacturer-validated). Per-product sensitivity and specificity are documented in the datasheet.
Clinical performance	Evaluation data (study population, reference method, agreement) available on request.
Cross-reactivity	Documented per analyte — see limitations above.
Documents	IFU · Datasheet · Certificate · Declaration of Conformity — request below.

Buyer Information

MOQ	Product-dependent — low MOQ available on specialty assays
OEM / private label	Custom branding, cut-off, panel and packaging
Samples	Available for evaluation — request via RFQ
Lead time	On request
Documents	IFU · Datasheet · COA · Validation report · CE files · Registration support

Related knowledge

Documentation & quotation — datasheet, IFU, certificate, MOQ and OEM/ODM options on request.

Request IFU / Spec Sheet Request Datasheet Request Certificate

Last reviewed: 2026-09-12