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

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 dro of fresh specimen to the sample well.

4. Hold the buffer bottle vertically and add 1 dro 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

 

 

Relative	Sensitivity:	>95.0%	(90.0%-			H.Pylori Rapid Test
97.9%)*						+	-	Total
Relative Specificity: >95.7% (92.3%-
				Biopsy/	+	131	7	138
97.9%)*
Overall	Agreement:	>95.4%	(92.8%-	Histology/
					-	10	225	235
97.3%)*				RUT
*95% Confidence Interval
						141	232	373