Helicobacter pylori Test Kit (Dry Chemical Method)

This product is suitable for qualitative in vitro detection of urease produced by Helicobacter pylori in human tartar. Helicobacter pylori is one of the most common pathogens entering the digestive tract through the oral cavity, and it is the main pathogenic factor leading to chronic gastritis and peptic ulcer. The detection of urease in human tartar provides the basis for the auxiliary diagnosis of a Helicobacter pylori infection. At present, commonly used clinical detection methods include gastric mucosa biopsy and urea breath test, etc.

The Hp test strip in this product is coated with urea and phenol red, the urease produced by Helicobacter pylori in the human tartar sample can quickly catalyze the decomposition of urea into ammonia and carbon dioxide which leads to an increase in pH value and a characteristic color change of the phenol red in the test strip. Without the presence of urease in the tartar sample, no change of color will occur, indicating the absence of Helicoba


Kit contents】

1) The product kit contains a test card and an instruction manual.

2) The test card is composed of a Hp test strip (top cover: urea 1745μg±10μg, phenol red 13.9μg±0.1μg), a pH test strip, a disposable sampling brush and a plastic cartridge.

Please note: Each component in the kit with different batch numbers should not be used interchangeably.

Storage and shelf life

When stored at temperatures between 2℃ and 30℃, the shelf life of the product is 18 months. Once the aluminum foil bag is unsealed, the detection card should be used within 1 hour. Avoid direct exposure to sunlight.

 Applicable instruments】

 No.

Sample requirements】

1. This product is only used to test human tartar samples.

2. Do not drink, eat or brush your teeth before the sample is collected. Exposure of the teeth to acidic or alkaline substances can compromise the test result. Oral acids can cause false negatives, while oral alkalines can cause false positives.

3. Maintain an empty stomach before sample collection.

4. After the tartar between the teeth has been removed with the disposable sampling brush, no further sample treatment is required.

 

Test procedure】

Please read the product manual carefully before use.

1. Preparation: Take the product out of the outer box. Open the aluminum foil bag containing the detection card. Place the detection card on a clean and flat surface with the detection window facing up.

2. Sampling: Use the disposable sampling brush to collect the tartar sample.

3. Detection: Transfer the tartar sample with the sampling brush, in turn, to the pH test paper and the Hp test strip. Immediately afterwards, close the top cover of the detection card. Observe whether the pH test paper and the Hp test strip change color within 3 minutes.

Interpretation of Test results】

Under the condition of pH value of 6.6~7.1, the urease solution of different concentrations was measured by the kit. When the urease concentration was ≥5U/mL, the test strip changed from yellow to red or purplish red, and the test result was interpreted as positive.

Interpretation of test results

1. If the pH test paper color indicates a pH value outside of the range of 6.6-7.1, the test result of the Hp strip is considered unreliable due to interference of the oral environment pH, making a retest necessary.

2. If the pH test paper color indicates a pH value within the range of 6.6-7.1, the test result of the Hp test strip is interpreted as follows.

2.1 If the Hp strip shows a red or fuchsia color, the test result is positive, indicating the presence of Heliobacter pylori in the mouth.

2.2 If the Hp strip shows a yellow color, the test result is negative, indicating that Heliobacter pylori is not present in the mouth.

2.3 1 If the Hp strip only shows a very faint red or fuchsia color, the test should be regarded as inconclusive and needs to be repeated. If in the subsequent retest the Hp test strip shows a faint red or fuchsia color again, the test result should be regarded as positive, indicating the presence of Heliobacter pylori in the mouth. Otherwise, the test result should be considered negative, indicating that Heliobacter pylori is not present in the mouth.

Please note: There may be slight differences between the color palette printed on the aluminum foil bag and the color of the test strip. Please scan the two-dimensional code on the aluminum foil bag and add the Wechat Official Accounts to interpret the result more accurately.

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