H. pylori Antigen Elisa Test Kit Package Insert

INTENDED USE

The H. pylori Antigen EIA Test Kit is an enzyme immunoassay for the qualitative and quantitative detection of H. pylori antigen in human stool. It is intended as an aid in the diagnosis of possible H. pylori infection and in the follow-up of patients undergoing antimicrobial therapy.

PROCEDURE

SPECIMEN COLLECTION AND PREPARATION

• The H. pylori Antigen EIA Test Kit can be performed using only human stool.
• The patient has to be asked to collect the specimen avoiding any possible contact with urine or water.
• The patient submitted to the test should not be under antibiotic or anti-bacterial treatments as this pharmaceutical therapy is known to affect H. pylori up to a certain extent, depending on the antibiotic used, giving origin to false interpretation.
• Do not leave specimens at room temperature for prolonged periods. Stools may be stored at 2-8°C for up to 24 hours prior to assaying. For long term storage, specimens should be kept frozen below 20°C. Degradation of H. pylori antigen heavily occurs in stool after 24 hrs generating false negative results, even if the specimen is stored at 2-8°C.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed. Specimens should not be frozen and thawed repeatedly.
• If specimens are to be shipped, they should be packed in compliance with local 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