Testsealabs H. Pylori Ab Test Infectious Rapid Test Kit with CE Approved

• Type: IVD Reagent
• Certificate: CE ISO 13485
• Storage Temperature: 4-30°c
• Shelf Life: 2 Years
• OEM: Available
• Transport Package: Cartons
• Model NO.: 101013
• Trademark: Testsealabs
• Origin: Hangzhou, China
• Production Capacity: 100000pieces/Day

Product Description

Format	Cassette	Package	Cartons
Specimen	WB/S/P	Certificate	CE ISO 13485
Storage Temperature	4-30°C	Pack	40T
Test Time	15 min	Shelf life	2 years
Sensitivity	97.3%	OEM	Available

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 Antibody Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of H.pylori antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in H.pylori antibody concentration can be determined by this qualitative test.
2.ACCU-TELLH.pylori Antibody Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) will only indicate the presence of H.pylori antibodies in the specimen and should not be used as the sole criteria for the diagnosis of H.pylori infection.
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