H-pylori Ab Cassette

INTENDED USE

This rapid test (Cassette) is a rapid immune-chromatographic assay for the detection of antibodies of H. Pylori in the human whole blood, serum or plasma. This assay provides aid in the diagnosis of H. pylori infection.

SUMMARY

H. Pylori (Helicobacter Pylori) are a corkscrew-shaped, gram-negative rod that lives in the mucous layer of the stomach. H. Pylori infection is now accepted as the most common cause of gastritis and is etiologically involved in the gastric ulcer, gastric adenocarcinoma, duodenal ulcer, and primary gastric B-cell lymphoma. The organism is very common and has infected at least half of the world’s population. H. Pylori infection is typically acquired in childhood and once acquired; this infection persists chronically, probably continuing in the stomach throughout life. The damage done to the gastric structure and functioning of the stomach is constant and direct.

Approximately one in six of H. Pylori infection can develop peptic ulcer disease and a small portion can lead to gastric cancer. The diagnostic tests for this can be classified into two categories, invasive and noninvasive tests. Direct detection by invasive test procedure requires an endoscopy and biopsy specimens from antrum and stomach body. The presence of H. Pylori is then confirmed by the direct culture, histological examination or rapid urease test. The endoscopy and biopsy specimens directly detect active H. Pylori infections. Although the procedure is highly specific and high positive predictive value, the cost and discomfort to the patients are also very high.

The most widely available noninvasive test is probably the serological based test, it detects H. Pylori specific IgG antibody in the patient’s serum with current or prior infection. Serology test is a simple, convenient test with relatively high sensitivity. The main limitation of this serology test is the inability to distinguish the current and past infections. An antibody may be present in the patient's serum long after the eradication of the organism.

The Urease breath test (UBT) with 14C or 13C labeled urea, is a noninvasive test based on the urease activity of the organism.UBT detects active H. Pylori infection and is highly sensitive and specific. This test requires high density and active bacteria and should not be performed until 4 weeks after the therapy to allow residual bacterial to increase to a sufficient number for detection. H. Pylori Serum Rapid Test (Cassette) is an immune-chromatographic assay that uses double antigen sandwich technology to detect the presence of H. Pylori antibody. The test is simple and easy to perform and the results can be visually interpreted within 10 minutes.

PRINCIPLE OF THE ASSAY

This test kit employs a chromatographic lateral flow test device in a cassette format. Colloidal gold-conjugated H. Pylori antigens are dry-immobilized at the end of nitrocellulose membrane strip. These antigens are bond at the Test Zone (T) when the sample is added; it migrates by the capillary diffusion rehydrating the gold conjugate. If anti H. Pylori antibodies are present in the sample, the antibodies will bind with the gold conjugated antigens forming particles. These particles migrate along the strip till the Test Zone (T) where they are captured by H. Pylori antigens and generate a visible red line. If there are no antibodies in the sample, no red line is formed. A built-in control line will always appear in the Control Zone (C) when the test is performed properly, regardless of the presence or absence of anti H. Pylori antibodies in the specimen.

COMPONENTS

Each kit contains:

• H. Pylori Rapid Test (Cassette) card in foil pouch

• Product inserts

SPECIMEN COLLECTION

• No special preparation of the patient is required before sample collection by approved techniques.

• Fresh serum is preferable. In case of delay testing store the serum at 2 to 8℃ up to 14 days. For long-term storage, freeze the specimen at -20℃ for 12 months or at -70℃ for longer periods.

• Repeated freezing and thawing should be avoided.

• Do not use clotted, haemolysed, contaminated, lipemic and viscous/turbid specimen.

• Specimen containing precipitates or particulate matter must be centrifuged and the clear supernatant should be used for testing.

• Do not heat the inactivated sample

• Shipment of samples should comply with local regulations for the transport of etiologic agents.

STORAGE AND STABILITY

The sealed pouches in the test kit should be stored between 4 to 30℃ till the shelf life as indicated on the pouch.

PRECAUTIONS AND SAFETY

• This kit is used for in vitro diagnostic and professional use only.

• Before performing test go through the instructions carefully.

• This kit does not contain any human source materials.

• Do not use the kit contents after its expiration date.

• Handle all the specimens as potentially infectious.

• Follow standard Lab procedure and bio-safety guidelines for handling and disposing of potentially infective material. When the assay procedure is completed, dispose of the specimens after autoclaving them for at least 20 min at 121℃ or, they can be treated with 0.5% Sodium Hypochlorite for 1 to 2 hours before disposing of.

• Do not pipette reagent by mouth and should avoid smoking or eating while performing the assays.

• Wear gloves during the testing procedure.

ASSAY PROCEDURE

• Bring the kit components at the room temperature before testing.

• Open the pouch and remove the test card.

• Once opened, it must be used immediately.

• Label the test card with patients’ identity.

• Apply 1 drop (20μL) of the whole blood, serum or plasma to the sample well

• Read the results after 10 minutes.

• A strong positive sample can show results early.

RESULT

• Positive: If the C-line and T-line appear, the result shows that IgG antibodies specific to H. Pylori are detected. A faint line in test region indicates a borderline specimen that should be re-tested using an alternative method for confirmation.

• Negative: If only the C-line appears, the test indicates that no antibodies are detected.

• Invalid: When there is no control line within 5 minutes, repeat the test with a new test device.

LIMITATIONS

• The test is for detection of anti-H. Pylori antibodies present in the sample and do not indicate the quantity of the antibodies.

• A definitive clinical diagnosis should not be based on the result of a single test but it should rather be made after all the clinical findings have been evaluated.