Salmonella IgG/IgM Rapid Test Cassette Test Kit

INTENDED USE

The typhoid Test Device is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Salmonella typhi in serum plasma, or whole blood.

TEST PROCEDURE

Step 1: Bring the specimen and test components to room temperature, if refrigerated or frozen. Mix the specimen well prior to assay once thawed.

Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface. Step 3: Be sure to label the device with specimen’s ID number. For detection of Dengue IgG/IgM or Dengue AgNS1 For serum or plasma specimen : Hold the dropper vertically and transfer 3 drops of serum or plasma (appoximately 100μl) to the specimen well(s) of the test device, then start the timer. For whole blood specimen : Hold the dropper vertically and transfer 1 drops of whole blood (appoximately 35μl) to the specimen well(s) of the test device, then add 2 drops of buffer (appoximately 70μl) and start the timer. For detection of Dengue AgNS1 For serum or plasma specimen : Hold the dropper vertically and transfer 3 drops of serum or plasma (appoximately 100μl) to the specimen well(s) of the test device, then start the timer. For whole blood specimen : Hold the dropper vertically and transfer 1 drops of whole blood (appoximately 35μl) to the specimen well(s) of the test device, then add 2 drops of buffer (appoximately 70μl) and start the timer.

Step4: Set up timer.

Step5: Results can be read after 20 minutes. Do not read result after 30 minutes. To avoid confusion, discard the test device after interpreting the result

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