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CTK Biotech OnSite® H. pylori Ab Combo Rapid Test CE, blood
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CAS Number :
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In Stock
Specimen: S, WB, P
Specifications:
| Application | Diagnostic Testing | ||
| Storage Temperature | Room Temperature | ||
| Product Type | Test Kit | Forms | Kit with Various components |
| Product Brand | CTK Biotech | ||
| Product Grade | Medical grade | ||
The OnSite® H. pylori Ab Combo Rapid Test is a lateral flow chromatographic immunoassay designed for the qualitative detection of antibodies against Helicobacter pylori (H. pylori) in human serum, plasma, or whole blood. This non-invasive diagnostic test provides rapid results in just 15 minutes, enabling fast and reliable screening for H. pylori infections without the need for specialized equipment or laboratory facilities.
With high sensitivity (94.6%) and specificity (92.4%), this rapid test offers reliable performance even in the presence of gastric bleeding and has demonstrated no cross-reactivity with 50+ gastrointestinal pathogens. Its ease of use allows minimally trained personnel to perform testing in clinical, point-of-care, and resource-limited settings.
Key Features
- Specimen Types: Human serum, plasma, or whole blood.
- Ease of Use: No equipment required; simple lateral flow procedure.
- Rapid Results: Clear results within 15 minutes.
- Non-Invasive: Uses standard blood collection methods; avoids endoscopic sampling.
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Reliable Performance:
- Sensitivity: 94.6% (95% CI: 91.2–96.7%)
- Specificity: 92.4% (95% CI: 88.2–95.2%)
- Interference Tested: Robust against substances such as albumin, bilirubin, hemoglobin, triglycerides, cholesterol, anticoagulants, caffeine, ethanol, aspirin, and biotin.
- Shelf Life: 24 months at 2–30 °C.
Clinical Performance
- Sensitivity: 94.6%
- Specificity: 92.4%
- Cross-Reactivity: None observed with over 50 gastrointestinal pathogens.
- Interference: No interference with common physiological substances and drugs (see Instructions for Use for full details).
Kit Contents (30 Tests)
- Individually sealed foil pouches with one test cassette + desiccant
- Plastic droppers
- Sample diluent (REF SB-R0191, 5 mL/bottle)
- Instructions for use
Applications
- Clinical Diagnostics: Screening for H. pylori antibodies in healthcare facilities.
- Point-of-Care Testing: Quick results for outpatient and resource-limited settings.
- Epidemiological Studies: Monitoring H. pylori prevalence in populations.
- Public Health Programs: Supporting detection in high-incidence regions.
The OnSite® H. pylori Ab Combo Rapid Test (R0191C) offers a fast, reliable, and user-friendly solution for detecting antibodies against H. pylori in human serum, plasma, or whole blood. With its strong clinical performance, ease of use, and minimal resource requirements, it is an ideal choice for clinical laboratories, point-of-care facilities, and public health programs aiming to diagnose and monitor H. pylori infections quickly and accurately.