NADAL HAV IgG/IgM
General information about this test:
The NADAL H. pylori Ag Test is a rapid qualitative test for immunological detection of
Helicobacter pylori
-antigens in human stool samples. This test is designed to aid diagnosis of
H. pylori
infection and is intended for professional use only.
Reagents and material supplied:
20 individually packed NADAL H. pylori Ag test cassettes
20 specimen dilution tubes with buffer
1 package insert
Test time:
10 min
Performance characteristics:
The NADAL H. pylori Ag Test shows no cross reactivity with the following microorganisms (at 10
9
organisms/ml concentration):
Staphylococcus aureus, Group C Streptococcus, Candida albicans, Salmonella choleraesius, E. coli, Group B Streptococcus, Hemophilus influenza, Pseudomonas aeruginosa, Gardnerella vaginalis, Chlamydia trachomatis, Enterococcus faecium, Rotavirus etc.
The specificity and sensitivity data for NADAL H. pylori Ag Test were obtained by comparison with Biopsy, Histology and RUT tests.
Relative Sensitivity: >99.9% (97.3% - 100.0%)*
Relative Specificity: >99.9% (97.6% - 100.0%)*
Overall Agreement: >99.9% (98.7% - 98.8%)*
*95% Confidence Interval
Test principles:
The NADAL H. pylori Ag Test is a qualitative immunoassay for the detection of
H.pylori-
antigens in human faecal samples. During the test, the
H.pylori
antigens eventually present in the sample (in the case of positive result) bind to colloidal gold-conjugated antibodies. Further the conjugated mixture moves along the membrane by capillary action and reacts with the reagents present on the test line thus generating a colored line in the test (T) region of the cassette. A colored line should always appear in the control line region (C) which serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred
Clinical significance:
Helicobacter pylori
has been recognized as one of the main reasons for development of gastritis and peptic ulcers – one of the most common human diseases. Although its exact role in development of a gastric ulcer is not known, eradication of H. pylori is associated with the healing of ulcer disease.
As far as The human serological responses to infections with
H. pylori
have been demonstrated, the NADAL H. pylori Antibody Test can be used as a reliable method of diagnosing
H. pylori
infection. Some patients are infected with
H. pylori
without developing the respective symptoms. In such cases NADAL H. pylori Antibody Test is a suitable alternative or supplementation to endoscopy.
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