One Step H. Pylori Test Device (Serum/Plasma)

INTENDED USE

   The H. pylori One Step Test Device (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H. pylori in serum or plasma to aid in the diagnosis of H. pylori infection.

Features of H. Pylori Ag Reply test

1. Sensitive
2. Accurate

3. High quality
4. Economic price

5. Reliable and Easy to Use

DIRECTIONS FOR USE

Allow the test device, serum or plasma specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

• Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
• Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 drops of serum or plasma (approx. 100ml) to the specimen well (S) of the test device, and start the timer. Avoid trapping air bubbles in the specimen well (S). Please see the illustration below.
• Wait for the red line(s) to appear. The result should be read at 10 minutes.
• Note: Low levels of H. pylori antibodies might result in a faint line appearing in the test region (T) after an extended period of time; therefore, do not interpret the result after 30 minutes.

Materials Provided

• Test devices
• Disposable specimen droppers
• Package insert

SPECIMEN COLLECTION AND PREPARATION

1.The H. pylori One Step Test Device (Serum/Plasma) can be performed using either serum or plasma.

2.Separate the serum or plasma from blood as soon as possible to avoid hemolysis. Only clear, non-hemolyzed specimens can be used.

3.Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.

4.Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.

5.If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.