One Step H. Pylori Antigen Test Card

One Step H. Pylori Antigen Test is an in vitro qualitative immunochromatographic assay for the rapid detection of Helicobacter pylori antigens in human stool specimen. The test results are intended to aid in the diagnosis of H. pylori infection, to monitor the effectiveness of therapeutic treatment and to confirm the eradication of H. pylori in peptic ulcer patients.

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Product Description

Producer:

Xiamen Boson Biotech Co., Ltd

Country of production:

China

Article:

1О03С4Т

Brief description:

One Step H. Pylori Antigen Test is an in vitro qualitative immunochromatographic assay for the rapid detection of Helicobacter pylori antigens in human stool specimen. The test results are intended to aid in the diagnosis of H. pylori infection, to monitor the effectiveness of therapeutic treatment and to confirm the eradication of H. pylori in peptic ulcer patients.

Appointment:

Detection of Helicobacter pylori antigens in human stool specimen.

Materials provided:

1. One Step H. Pylori Antigen test in foil pouch
2. Sample bottle Each sample bottle contains 1 ml of stool specimen collection buffer. Store at 4-30°C
3. Product insert

Materials required but not provided:

1. Specimen collection container
2. Timer.

Sensitivity and Specificity

One Step Helicobacter pylori Antigen Test Strip was evaluated on 170 adults. The test results were compared to diagnosis of H. pylori infection by reference tests, urease breath test and histology tests. Patients were considered positive if both rapid urease and histology tests were positive. Patients with both negative urease breath test and histology tests were considered negative. Among fifty (50) positive samples and one hundred and twenty (120) negative samples, Rapid H. pylori Antigen Test showed 94.0% clinical sensitivity and 96.7% specificity. The accuracy is 97.5%.

Reproducibility

Reproducibility of One Step H. pylor Antigen Test was determined using negative, low positive, and high positive samples along with negative and positive controls. These samples were tested in replicates of 8 in a blind study by 5 operators working independently in the same laboratory. The agreement of the expected result was 100%.

Sample Type:

stool

Delivery

Implemented by Nova Poshta. If the order is above 1500 UAH, the sender pays the shipping cost

Instructions for use (PDF) Declaration of Conformity (PDF)