Enterovirus 71(EV71) Rapid Tests

Enterovirus 71 (EV71)-IgM antibody
Catalog No.: BG1201C

Packing specification
20 test cards/box

Intended Use
This kit is used to qualitatively detect the EV71- IgM antibody in human blood, serum or plasma samples. It is a diagnosis reagent of EV early infection in clinical diagnosis. Enterovirus type 71 is one of the Picornaviridae virus (enterovirus, EV) genus, group A. It has obvious properties of dermatotropic and neurotropic. Being infected by EV71 can cause hand-foot-mouth disease, Herpes pharyngitis, Aseptic meningitis and encephalitis, encephalitis and the paralysis of poliomyelitis and recessive infection in more cases. Human being is the only known natural host of EV71. The EV71 is mainly infected by the fecal - oral transmission. EV71 has a world-wide distribution. Its epidemic season is summer and autumn, but it can infect during all year. Human is the generally susceptible of EV71, while the infants and young children are more dangerous.

Test Procedure
1.Test preparation: 10μL, 50μL, 100μL micropipettes and matched tips
2.Test process: The temperature of the kit and the test sample should be the same with room temperature before test. Place the test card on a dry horizontal work surface. Add 10μL serum or plasma sample into the sample well (or 50μL whole blood), then add 100 μL of sample dilution immediately. Observe the result in 15-20 minutes after the serum or plasma samples added. The observation is invalid after 20 minutes.

Test results explain

To develop color on C line only: negative; To develop color on both C line and T line: positive; To develop color on T line only: invalid; Not to develop color on both C line and T line: invalid.
Note: Re-detection if the detection result is invalid. The invalid test cards should be dealt as infectious pollutants. The temperature of the kit and the test sample should be the same with room temperature before pre-detection.

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