Span Biotech Ltd.

INTENDED USE        

The Helicobacter-Pylori antigen rapid test kit (stool) is a rapid visual immunoassay for the qualitative detection of helicobacter pylori antigen in human stool specimens. This kit is used as an aid in the diagnosis of H. pylori infection.

INTRODUCTION

Helicobacter pylori (also known as Campylobacter pylori) as a spiral-shaped gram negative bacteria which infects the gastric mucosa. H. pylori to causes several gastro-enteric diseases such as non-ulcerous dyspepsia, gastric and duodenal ulcer, active gastritis and can even increase the risk of stomach adenocarcinoma.

The epidemiologic study shows that more than 50% of the world's population is infected by H. pylori strains. Infection is more prevalent in developing countries. The lowest infection rate is 20%, and the highest infection rate can be 90% in developing countries. H. pylori strains is the major reason to cause chronic gastritis and gastric ulcers, 80%-90% chronic gastritis patients and 95%-100%   gastric ulcers patients are infected by H. pylori strains. So the detection and treatment of H. pylori strains infection is very important.

At present several invasive and non-invasive approaches are available to detect this infection state. Invasive methodologies require endoscopy of the gastric mucosa with histologic, cultural and urease investigation, which are expensive and require some time for diagnosis. Alternatively, non-invasive methods are available such as breath tests, which are extremely complicated and not highly selective, and classical ELISA and immunoblot assays. This Kit belongs to non-invasive approach.

PRINCIPLE

This kit is designed to detect helicobacter pylori through visual interpretation of the color development in the internal strip based on the  specific The membrane was immobilized with antibodies-specific on the test well (T) and corresponding antibodies on the control well(C) .

During testing, the specimen is added to the sample region (S) and reacts with anti-H. pylori antibodies conjugated to colored particles and precoated onto the sample pad of the test. Then, the mixture migrates through the membrane by capillary effect and interacts with reagents on the membrane. If there is sufficient H. pylori antigens in the specimen, a colored band will form at the test well (T) of the membrane, and this colored band indicates a positive result, while its absence indicates a negative result. A colored band at the control well(C) serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

KIT COMPONENTS

MATERIALS REQUIRED BUT NOT PROVIDED

STORAGE AND VALIDITY

·    The kit should be stored at 2-30°C in a cool and dry place, protected from light

·    The validity duration is 12 months

·    Do not freeze.

·    Do not use after the expiration date indicated on the package.

SPECIMEN COLLECTION

·    Sufficient specimen should be collected and extracted.

·    No age limitation to specimen  providers

·    No limitation to specimen collection time.

·    Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 72 hours or frozen at -10°C for long- term storage.

·    Avoiding repeated freezing and unfreezing. Fresh specimen is recommended

·    Specimen can not be used for test once stored more than 72 hours at 2-8°C and repeated freezing and unfreezing more than three times.

PROCEDURE

Read the entire procedure carefully prior to testing. Keep test kit and specimen at room temperature (15-30°C) before use.

1.      Unscrew the specimen tube with extracting solution, collect specimen by inserting the collection stick into the stool to collect the specimen with diameter approximate to 5mm (equivalent to 1/4 of a green bean).

2.        Put the collection stick back into the tube carefully and screw the cap tightly.

3.        Press the bottom of specimen tube strongly; fully shake to mix the specimen and the extraction buffer. Then keep the specimen stationary in two minutes before use.

4.        Take the test cassette out of its sealed pouch, and place it on a clean, dry and flat surface.

5.        Unscrew the top cap of extracting tube. Hold the tube vertically and dispense 2-3 drops of solution into the sample region (S) of the test cassette. The unsealed test cassette should be performed within one hour.

6.        Wait for the colored band(s) to appear. The result should be read right after 15minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

POSITIVE RESULT: Two colored bands appear on the membrane. One band appears in the control well (C) and another band appears in the test well (T). Positive result indicates the specimen with helicobacter pylori antigen.

NEGATIVE RESULT: Only one colored band appears in the control well (C). No apparent colored band appears in the test well (T).Negative result indicates the specimen without helicobacter pylori antigen

INVALID RESULT: Control band fails to appear. Results from any test which has not produced a control band at the specified reading time must be discarded. Please review the procedure and repeat the test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE:

The intensity of the color in test well (T) may vary depending on the concentration of aimed substances present in the specimen. But in the valid time, even the color band is very week, the result shall be regarded as positive.

LIMITATIONS OF THE TEST

1. The intensity of the color in test well (T) may vary depending on the concentration of aimed substances present in the specimen. But in the valid time, even the color band is very week, the result shall be regarded as positive.

2. The test kit is for professional in vitro diagnostic use, and should only be used for the qualitative detection of Helicobacter pylori.

3.As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

PERFORMANCE CHARACTERISTICS

1. Positive Coincidence Rate:100%

2. Negative Coincidence Rate:100%

3. Analytical Specificity:

Cross reactivity with the following organisms. The following organisms produced negative results when testing with the One Step Helicobacter-Pylori Antigen Test Kit (stool)

4. Analytical Sensitivity: The result is positive when testing with 150ng HP antigen/ml dilution.

5. Intra-batch Discrepancy: The test results are the same in one batch

6.Inter-batch Discrepancy: The test results are the same in different batch

7.Comparison: Compared with other famous branded H. Pylori Antigen Test Kit, the coincidence rate is 91.8%, and the clinical coincidence rate is 94.6%

8.Anti-interference Performance: No interference by human hemoglobin 1000mg/dl and Animal hemoglobin 2000mg/dl

PRECAUTIONS

l   For disposable use only

l   For professional in vitro diagnostic use only.

l   The specimen dilution buffer contains sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides. Do not drink or smell it.

l   Do not use the devices when the package damaged

l   Do not interchange or mix reagents from different lots

l   Do not use after the expiration date indicated on the package

l   Do not touch membrane before us

l   After completing assay, dispose the test kit and tube carefully after autoclaving them at 121°C for at least 20mintues. Or treat them with 0.5% sodium hypochloride for 40-60 minutes, or burn them.

Packaging Details:

Pouch+Box+Carton packaging

(1) With our company’s Logo

(2) With the natural package

(3) With OEM package

(4) ODM