Name: China Customized H.pylori Antigen Test Manufacturers Suppliers Factory - Wholesale Service - Safecare Biotech
Brand: Safecare
SKU: 277870245

Product Overview

The SAFECARE H. Pylori Antigen Rapid Test Cassette (Feces) is a CE-marked, rapid visual immunoassay designed for the qualitative presumptive detection of Helicobacter pylori (H. pylori) antigens in human fecal specimens. It serves as an auxiliary tool for diagnosing H. pylori infection in professional in vitro diagnostic (IVD) settings.

Disease Background

Helicobacter pylori (H. pylori) is a common pathogenic bacterium that colonizes the human gastric mucosa. It is a major etiological factor for various gastrointestinal diseases, including chronic gastritis, gastric ulcers, duodenal ulcers, and mucosa-associated lymphoid tissue (MALT) lymphoma. If left undiagnosed and untreated, long-term H. pylori infection may significantly increase the risk of developing gastric cancer.

Timely and accurate detection of H. pylori infection is critical for early clinical intervention (e.g., targeted antibiotic therapy) and preventing the progression of related gastric diseases. Fecal-based antigen testing offers a non-invasive alternative to endoscopy or breath tests, improving patient compliance-especially for populations where invasive procedures are less feasible.

Ordering Information

Product Name	Catalog No.	Specimen	Format	Certification
H. Pylori Antigen Rapid Test Cassette	HPAg-5011	Feces	Strip	CE
H. Pylori Antigen Rapid Test Cassette	HPAg-5012	Feces	Cassette	CE

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Product Advantages

Clinical Accuracy: 97.6% sensitivity/98.5% specificity vs endoscopy-confirmed cases

Rapid Results: Visual interpretation in 10 minutes

Convenient Workflow: Room temperature storage (4-30°C), no special equipment required

Non-invasive specimen: Uses fecal samples (no needles or endoscopy required), enhancing patient comfort

Cost-Effective: Eliminates need for invasive endoscopy procedures

Operation Steps

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FAQ

Q: Why might the control band (C) fail to appear?

A: Common reasons include insufficient specimen volume, incorrect operation (e.g., dropping solution into the observation window), or using an expired test. Retest with a new device and follow the procedure strictly.

Q: Does antibiotic treatment affect test results?

A: Yes. Antibiotics may reduce H. pylori antigen levels below the test's minimum detection limit. Use caution when diagnosing during or shortly after antibiotic therapy, and consult clinical findings.

Q: How should fecal specimens be stored if testing is delayed?

A: Test immediately after collection (within 6 hours) for optimal results. If delayed, store specimens at 2-8℃ for up to 7 days. Bring specimens back to room temperature before testing.

Q: What safety precautions should I take when using the kit?

A: Handle all specimens and kit components as potentially infectious (wear lab coats, disposable gloves, and eye protection).
- Avoid eating, drinking, or smoking in the testing area.
- Dispose of used materials (e.g., test devices, applicators) according to local biomedical waste regulations.
- Prevent cross-contamination by using a new collection container for each specimen.

Q: Does the test's color intensity in the test region (T) indicate H. pylori antigen concentration?

A: No. This is a qualitative test-any visible color in (T) confirms a positive result, but intensity does not reflect antigen levels.

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