Rapid Test for IgM Antibody to Human Enterovirus 71

Producer:

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd

Country of production:

China

Article:

WJ-2010, WJ-2050, WJ-201500

Brief description:

EV71 IgM Rapid Test (colloid gold) is a single use, rapid device intended for qualitative detection of IgM-class antibodies to human enterovirus-71 (EV71) in serum, plasma or whole blood samples. It is intended to be used in clinical laboratories for early diagnosis and management of patients related to infection with EV71.

Appointment:

Qualitative detection of IgM-class antibodies to human enterovirus-71

Materials provided:

Test Cassette
1.5 ml sample tube
Disposable pipette

Materials required but not provided:

Clock or timer, lancets, alcohol wipes, micropipettes, disposable tips, sample container, centrifuge, biohazard container, sterile gauze or cotton cloth.

Performance characteristics

In total 212 clinical serum samples were tested including 26 EV71 PCR positive samples, 186 non-EV71 hand, foot and mouth diseases samples. The test demonstrated sensitivity of 88.5% (23/26) and specificity of 95.2% (177/186).

Sample Type:

whole blood / serum / plasma