[PACKAGE SPECIFICATION]

20 tests/kit, 40 tests/kit.

[APPLICATION]

For the clinical test of Helicobacter Pylori (HP) antibody in serum.

[TEST PRINCIPLE]

This assay is a double antigen chromatographic lateral flow immunoassay. The test strip in the device includes: 1) a rose pink-colored conjugate pad containing colloidal gold coupled with H. pylori antigens, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with H. pylori antigens, and the C line is coated with goat anti-H. pylori antibody. The antigens used in this device are from H. pylori cell lysate. When IgG antibodies specific to H. pylori are present in the specimen, the T line will become a rose pink-colored band. If antibodies to H. pylori are not present or are present below the detectable level, no T line will develop. The C line should always appear as a rose pink-colored band regardless of the presence of antibodies to H. pylori. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred.

[MAIN COMPONENTS]                          

[STORAGE AND PERIOD OF VALIDITY]

Stored in a dry place at 2-30°C; 12 months.

[SAMPLE REQUIREMENTS]

Serum can be used as the sample for this test kit. Samples when not used at once may be stored refrigerated (2°C-8°C) for three days, or can be frozen (-20°C) for long-term storage, but should avoid repeated freezing and thawing. Fresh sample is recommended.

[SUCCESSIVE OPERATING PROCEDURES]

1) Before using the kit, make sure that the kit and serum samples are rewarmed to room temperature.

2) Take out the one test card and make sure it will be used within an hour.

3) The card should be put on the clean, dry, flat test stand. Use a droper pipette to drop 1-2 drops of serum sample and 1-2 drops of buffer at the same time in the sample well (S).

4) Read the result in 15 minutes. The result is not valid after 20 minutes.

[RESULTS EXPLANATION]

Positive:If both the C line and T line appear, the result indicates that the IgG antibodies specific to H. pylori are detected and the result is positive.

Negative: If only the C line appears in the control region, the test indicates that no antibodies to H. pylori are detected and the result is negative.

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

Note:The test line may be much paler than the control line, however, the positive result should be reported as long as the red line is visible.

[TEST LIMITATIONS]

1) This test is a qualitative assay for professional in vitro diagnostic use only. A positive result does not distinguish active infection from colonization of H. pylori. Therefore, positive results should always be evaluated with other confirmatory methods available to the physician.

2) Literature references have suggested cross reactivity of IgG antibody with other closely related organisms such as Borrelia burgdorferi and Pseudomonas species. However, performance of this assay has not been evaluated with these organisms. Therefore, the specificity of this device is not known if this organism is encountered.

3) The test kit is for in vitro diagnostic use and the detection of antibodies in serum samples only, the result is just a qualitative analysis, not a quantitative detection.

4) A positive result or a negative result just show that the antibody titre in the sample is above or below the cut-off level of the test, the result cannot be used as the sole evidence of HP infection. If necessary, other methods or equipment are needed tohelp professionals do further tests  so asto make more precise diagnosis.

4)If the samples are whole blood, plasma or those from other parts of the  body, results could be unreliable.

[PERFORMANCE CHARACTERISTICS]

Positive compliance rate: ≥99%;

Intra batch discrepancy: ≤1%;

Inter batch discrepancy: ≤1 %.

[CAUTIONS]

1) The product is for single time use only;

2) The product is for in vitro diagnostic use only;

3) The product should not be used when the package is damaged;

4) The product should not be used when it has expired;

5) Do not use components from different batches;

6) Do not touch the membrane;

7) The waste should be disposed after disinfected.