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

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.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world