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Product Details:
Payment & Shipping Terms:
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Method: | Elisa | Format: | 96T/KIT |
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Valid: | 24 Month | Accuracy: | 96% |
Sensitivity: | 96% | Application: | H.Pylori IgG Antibody ELISA |
High Light: | rapid elisa test,elisa assay kit |
H.Pylori IgG Antibody ELISA Test kit,96wells/kit, Elisa Sandwich method, for quantitative measurement
Intended Use:
The HAV IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies to Hepatitis A virus (HAV) in human serum, plasma or whole blood. It is intended to be used by professionals as a screening test and as an aid in the diagnosis of infection with HAV. Any reactive result with the HAV IgG/IgM Rapid Test must be confirmed with alternative testing method(s) and clinical findings.
Summary:
H. pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is associated in the etiology of a variety of gastrointestinal diseases including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis.1,2 H. pylori infection is present in over 90% of duodenal ulcers, 80% of gastric ulcers, and 70% of gastritis. Recently, it has been classified as a Class I carcinogen by the WHO. Although the transmission route for H. pylori is not yet known, it is believed to be transmitted by oral-oral or fecal-oral route. Both invasive and non-invasive methods are used to diagnose H. pylori infection in patients with symptoms of gastrointestinal disease. Specimen-dependent and costly invasive diagnostic methods include gastric or duodenal biopsy followed by urease testing (presumptive), culture, and/or histologic staining.3 Non-invasive techniques include the urea breath test, which requires expensive laboratory equipment and moderate radiation exposure, and serological methods.4,5 Individuals infected with H. pylori develop serum antibodies which correlate strongly with histologically confirmed H. pylori infection.6,7,8 Early in the course of active infection, IgM antibody levels may be detectable. Levels of IgG and IgA antibody rise with the infection and remain constantly high until infection is eliminated. Therefore, the efficacy of antimicrobial therapy can be monitored by detecting changes in the antibody levels. The H. pylori IgG EIA Test Kit is an immunoassay for the qualitative and quantitative detection of the presence of IgG antibodies to H. pylori in serum or plasma specimen. The test utilizes recombinant H. pylori antigens to selectively detect IgG antibodies to H. pylori in serum or plasma.
Regents Provided
Components | Volume / Qty. |
Helicobacter pylori antigen coated microtiter strips | 12 |
Calibrator A (Negative Control) | 2 mL |
Calibrator B (Cut-Off Standard) | 2 mL |
Calibrator C (Weak Positive Control) | 2 mL |
Calibrator D (Positive Control) | 2 mL |
Enzyme Conjugate | 15 mL |
Substrate | 15 mL |
Stop Solution | 15 mL |
Sample Diluent | 60 mL |
Washing Buffer (10 ) | 60 mL |
Plastic bag | 1 |
TEST PRINCIPLE
The H. pylori IgG EIA Test Kit is a solid phase enzyme immunoassay based on indirect principle for the qualitative and quantitative detection of IgG antibodies to H. pylori in human serum or plasma. The microwell plate is coated with H. pylori recombinant antigens. During testing, the specimen diluent and the specimens are added to the antigen coated microwell plate and then incubated. If the specimens contain IgG antibodies to H. pylori, it will bind to the antigens coated on the microwell plate to form immobilized antigen-H. pylori IgG antibody complexes. If the specimens do not contain IgG antibodies to H. pylori, the complexes will not be formed. After initial incubation, the microwell plate is washed to remove unbound materials. The enzyme-conjugated anti-human IgG antibodies are added to the microwell plate and then incubated. The enzyme-conjugated anti-human IgG antibodies will bind to the immobilized antigen-H. pylori IgG antibody complexes present. After the second incubation, the microwell plate is washed to remove unbound materials. Substrate A and substrate B are added and then incubated to produce a blue color indicating the amount of H. pylori IgG antibodies present in the specimens. Sulfuric acid solution is added to the microwell plate to stop the reaction producing a color change from blue to yellow.
TEST PROCEDURE
ASSAY CHARACTERISTICS
Helicobacter pylori ELISA | IgG |
Intra-Assay-Precision | 8.5 % |
Inter-Assay-Precision | 6.3 % |
Inter-Lot-Precision | 3.6 – 10.8 % |
Analytical Sensitivity | 1.16 U/mL |
Recovery | 90 – 93 % |
Linearity | 82 – 118 % |
Cross-Reactivity | No cross-reactivity to Yersinia enterocolitis |
Interferences | No interferences to bilirubin up to 0.3 mg/mL, |
hemoglobin up to 8.0 mg/mL and | |
triglycerides up to 5.0 mg/mL | |
Specificity | 96 % |
Sensitivity | 96 % |
ORIENT NEW LIFE MEDICAL CO., LTD. | |
Contact: | Jerry Meng |
Email: | Jerry @ newlifebiotest .com |
Tel. | +86 18657312116 |
SKYPE | enetjerry |
Contact Person: Jerry Meng
Tel: +8618657312116