Testsealabs H.pylori Antigen Rapid Test Cassette (Feces)

Short Description:

Detection for: Helicobacter pylori (H. pylori) antigens in human feces.
Specimen volume: Refer to the test procedure
Reading time: 10 minutes
Relative sensitivity: >99.9%(95% CI *:96.2%~100.0%);
Relative specificity: 98.1%(95%CI*:93.2%~99.8%);
Accuracy: 98.9%(95% CI *:96.1%~99.9%)


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Intended Use

H.pylori Antigen Rapid Test Cassette(Feces)is a rapid chromatographic immunoassay for the qualitative detection of H.pylori antigens in human feces specimens to aid in the diagnosis of H.pylori infection.

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Summary

H.Pylori is associated with a variety of gastrointestinal diseases included non-ulcer dyspepsia, duodenal and gastric ulcer and active, chronic gastritis. The prevalence of H. pylori infection could exceed 90% in patients with signs and symptoms of gastrointestinal diseases. Recent studies indicate an association of H. Pylori infection with stomach cancer. H. pylori colonizing in the gastrointestinal system elicits specific antibody responses which aids in the diagnosis of H. Pylori infection and in monitoring the prognosis of the treatment of H. pylori related diseases. Antibiotics in combination with bismuth compounds have been shown to be effective in treating active H. pylori infection. Successful eradication of H. pylori is associated with clinical improvement in patients with gastrointestinal diseases providing a further evidence.

Limitations

1. H.pylori Antigen Rapid Test Cassette (Feces) is for in vitro diagnostic use only. The test should be used for the detection of H. pylori antigens in feces specimens only. Neither the quantitative value nor the rate of increase in H. pylori antigens concentration can be determined by this qualitative test.

2. Hpylori Antigen Rapid Test Cassette (Feces) will only indicate the presence of H.pylori in the specimen and should not be used as the sole criteria for H. pylori to be etiological agent for peptic or duodenal ulcer.

3.As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of H. pylori infection.

5.Following certain antibiotic treatments, the concentration of H. pylori antigens may decrease to the concentration below the minimum detection level of the test. Therefore, diagnosis should be made with caution during antibiotic treatment.

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