INTENDED USE

The EV71 IgM Rapid Test Kit (Whole Blood/Serum/Plasma) is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of IgM-class antibodies to human Enterovirus 71 (EV71) in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with EV71. Any reactive specimen with the EV71 IgM Rapid Test Kit (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.

SUMMARY

Human Enterovirus 71 (EV71), the newest member of Enterovirudae, is notable for its etiological role in epidemics of severe neurological diseases in children. It appears to be emerging as an important virulent neurotropic enterovirus in the upcoming era of poliomyelitis eradication. The illness usually peaks in June or July. EV71 infection may be asymptomatic or may cause diarrhea and rashes. EV71 one of the major causative agents for hand, foot and mouth disease (HFMD), is sometimes associated with severe central nervous system diseases.
Direct detection of virus is the mainstay of diagnosis. EV71 can be isolated from throat and stool specimens, as well as from skin vesicle fluid. PCR testing provides generally greater sensitivity than culture for throat and stool specimens, and viral RNA has also been detected in vesicular fluid, blood and urine. EV71 specifc serological assays, including tests specific for IgM antibody, have also been developed to assist for early and easier diagnosis of the disease.

PRINCIPLE

The EV71 IgM Rapid Test Kit (Whole Blood/Serum/Plasma) is based on the principle of agglutinating sera on membrane and utilizes the technique of immunochromatography. The sample pad is coated with EV71 antigen. As the test specimen flows through the sample pad assembly of the device, the EV71 antigen complex with the EV71 specific antibodies in the test specimen.
When this complex travels on the conjugated pad which is impregnated with mouse anti-EV71 antibody conjugated to colloidal gold, the EV71 colloidal gold react with the complex then travels on the membrane due to capillary action. This complex moves further on the membrane to the test region (T) where it is immobilized by anti human IgM antibody coated on the membrane, leading to formation of a pink/purple coloured band. The absence of this band in the test region (T) indicates a negative result. The test contains an internal control (C band) which is coated with goat anti-mouse IgG should exhibit a burgundy colored band regardless of the color development on the T band. Otherwise, the test result is invalid and the specimen must be retested with another device.