MedEx Neotest H Pylori Test Kit

Package Contents: Pouch contents: Test Cassette, Sample dropper, Desiccant; Sample buffer (3 ml) per bottle for 25 tests; Test instruction.
Materials Required (But not provided): Glove; Clock or timer.

Summary and Principle of the Assay: H. pylori is a small, spiral-shaped gram negative bacterium that lives in the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including peptic ulcers, gastritis, duodenitis, extradigestive diseases and in some cases, cancer. Over 80 percent of individuals infected with the bacterium are asymptomatic and it has been postulated that it may play an important role in the natural stomach ecology. Individuals infected with H. pylori have a 10 to 20% lifetime risk of developing peptic ulcers and a 1 to 2% risk of acquiring stomach cancer. Inflammation of the pyloric antrum will likely to lead to duodenal ulcers, while inflammation of the corpus (body of the stomach) will likely to lead to gastric ulcers and gastric carcinoma. However, it is possible that H. pylori plays a role only in the first stage leading to common chronic inflammation, nut not in further stages leading to carcinogenesis. The continued presence of H. pylori is a risk factor for gastric cancer.
Neotest Rapid HP Antibody Test is an antibody-capture immunochromatographic assay, detecting the presence of H. pylori antibody in human whole blood, serum or plasma samples. Specific H. pylori antigens are 1) conjugated with colloidal gold and deposited on a conjugate pad, and 2) immobilized on the test line on the nitrocellulose membrane. When the whole blood, serum or plasma sample is added, the gold-antigen conjugate is rehydrated and the H. pylori antibodies, if any in the sample, will interact with the gold conjugated antigen. The antigen-antibody-gold complex will migrate towards the test window until the Test Zone (T) where they will be captured by immobilized antigens, forming a visible pink line (Test line) which indicates a positive result. If H. pylori antibody is absent in the sample, no pink line will appear in the Test Zone (T) indicating a negative result.
To serve as an internal process control, a control line should always appear at Control Zone (C) after the test is completed. Absence of a pink control line in the Control Zone (C) is an indication of an invalid result.

Neotest Rapid Helicobacter Pylori (H.pylori, or HP) Antibody Test is a rapid and convenient immunochromatographic assay used for the qualitative detection of H.pylori antibody in human whole blood, serum or plasma samples. It is intended for professional use to aid in the diagnosis of peptic ulcers, gastritis, duodenitis, extradigestive diseases and in some cases, cancer. This assay provides only preliminary results. Clinical expertise and professional judgment should be sought to further evaluate the result of the test.

Specimen Preparation: Blood samples may be collected by fingerstick or venipuncture.
Use clear non-hemolyzed specimens only.
For serum samples, collect blood in a tube containing anticoagulant and allow it to clot.
For plasma samples, collect blood in a tube containing anticoagulant.
For whole blood samples, collect blood in a tube containing anticoagulant. Whole blood samples should be tested immediately after collection.
The blood sample may be stored at 2-8°C for up to three days if the tests cannot be performed immediately. Ensure that the blood samples be brought to room temperature prior to use.
Test Procedures: 1. Remove the testing device from the sealed pouch by tearing at the notch and place the testing device on a leveled surface.
2. Hold the sample dropper vertically. Add 1 drop (40 µl) of the specimen without air bubbles into the Sample Well that is marked with an arrow on the testing device;
Wait for 20-30 sec. Add 2 drops (90 µl) of the assay buffer to the same Sample Well of the testing device.
3. Read the results in 10 minutes. Read results as shown under Interpretation of Results.
NOTE: Specimens with high concentrations of H. pylori antibodies may produce positive results in as little as 1 minute. Confirm negatives in 20 minutes.
DO NOT INTERPRET RESULTS AFTER 30 MINUTES.
Result Interpretations: See figure.

Click on icon to see table/diagram/image

Negative: A pink colored band appears only at the control region (C), indicating a negative result for H. pylori Infections.
Positive: A clear pink control band (C) and a detectable test band (T) appears, indicating a positive result for H. pylori infections.
Invalid: No visible band at the control region (C). Repeat with a new test device. If test still fails, contact the distributor with the lot number.
Quality Control: Although the testing device contains an internal quality control (pink colored band in the control region), good laboratory practice recommends the daily use of an outside control to ensure proper testing device performance. Quality control samples should be tested according to the standard quality control requirements established by the laboratory.
Limitations: Humidity and temperature can adversely affect results.
There is always a possibility that false results will occur due to the presence of interfering substances in the specimen or factors beyond the control of the manufacturer, such as technical or procedural errors associated with the testing.
Although the test demonstrates superior accuracy in detecting HP antibody, a low incidence of false results can occur. Therefore, other clinically available tests are required in case of questionable results. 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.

For professional in vitro diagnostic use only.
Do not use after the expiration date shown on the pouch. Do not reuse.
Do not use if the pouch seal or its packaging is compromised.
Do not mix and interchange different specimens.
Wear protective clothing such as laboratory coats, disposable gloves and eye protection while handling potentially infectious materials and performing the assay.
Wash hands thoroughly after finishing the tests.
Do not eat, drink or smoke in the area where the specimens or kits are handled.
Clean up spills thoroughly with appropriate disinfectants.
Handle all specimen as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing procedures.
Dispose of all specimens and used devices in a proper bio-hazard container. The handling and disposal of the hazardous materials should follow local, national or regional regulations.

Test device should be stored at 2-30°C. Do not freeze the test device.
The test device should be kept away from direct sunlight, moisture and heat.

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