High Accuracy H.Pylori (Helicobacter Pylori) Antibody Rapid Diagnostic test Cassette easily and quick operation

High Accuracy H.Pylori (Helicobacter Pylori) Antibody Rapid Diagnostic test Cassette easily and quick operation

Product Name:

H.Pylori Antibody Test (Cassette)

Helicobacter Pylori Antibody Test

INTENDED USE:

The H.Pylori Ab Rapid Test Device (Whole Blood/Serum/ Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H.Pylori in whole blood, serum or plasma to aid in the diagnosis of H.Pylori infection.

INTRODUCTION

H.Pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis. 1,2 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.

The H.Pylori Ab Rapid Test Device (Whole Blood/Serum/ Plasma) is a simple test that utilizes a combination of H.Pylori antigen coated particles and anti-human IgG to qualitatively and selectively detect H.Pylori antibodies in whole blood, serum, or plasma in just minutes.

TEST PRINCIPLE

The H.Pylori Ab Rapid Test Device (Whole Blood/Serum/ Plasma) is a qualitative membrane device based immunoassay for the detection of H.Pylori antibodies in whole blood, serum, or plasma. In this test, specimen or specimen followed by buffer is added to the specimen well of the test device. The specimen migrates chromatographically along the length of the test strip contained within the device and interacts with the reagents on the strip. If the specimen contains H.Pylori antibodies, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain H.Pylori antibodies, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready

to begin testing.

2. Remove the device from the sealed pouch and lay it on a flat and dry surface.

3. Using the provided pipette, add one drop of fresh specimen to the sample well.

4. Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid

cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.

5. Read the result between 15-20minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

Positive:

Two pink lines appear in the result window. This indicates that the specimen contains detectable amount of H. Pylori antibody.

Negative:

Only one pink line appears in the control region (C). This indicates that there is no detectable H. Pylori antibody in specimen.

Invalid:

No colored line appears in the control region regardless of the presence or absence of the test line.

PERFORMANCE STUDY

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.