Congratulations!Malaysia MDA approval for EV-71 rapid test

Congralations,our product DIAGNOSTIC KIT FOR IGM ANTIBODY TO ENTEROVIRUS 71(COLLOIDAL GOLD) got Malaysia MDA approval.

Human enterovirus 71 (EV71) belongs to the family Picornaviridae. The genome is a single-stranded positive stranded RNA with a length of about 7400 nucleotides and only one open reading frame. The encoded polyprotein contains about 2190 amino acids. This polyprotein can be further hydrolyzed to P1, P2 and P3 precursor proteins.P1 precursor protein codes structural proteins VP1, VP2, VP3 and VP4; P2 and P3 code 7 nonstructural proteins (2A~2C and 3A~3D). In these 4 structural proteins, except VP4 that is embedded in inner side of viral capsid and closely linked with core, other 3 structural proteins are all exposed on the surface of virus particles. Thus, antigenic determinants are basically located on VP1~VP3.
Hand, foot and mouth disease (HFMD) is a viral skin disease characterized by blisters formed on palm, sole and oral mucosa. Its most common pathogens are coxsackievirus A16 (CoxA16) and human enterovirus 71 (EV71). Echovirus and some other enteroviruses may also be pathogenic. In previous HFMD pandemics, EV71 and Cox-A16 alternately or simultaneously appear, and become the main pathogens of HFMD. As one of main pathogens of HFMD, EV71 has strong infectivity and high pathogenicity rate, with neurotoxicity only secondary to poliovirus. Compared with CoxA16, EV71 may induce various types of diseases such as herpetic angina, aseptic meningitis,encephalitis, brain stem encephalitis, poliomyelitis-like paralysis, neurogenic pulmonary edema or pulmonary hemorrhage, myocarditis, and acute respiratory disease, in addition to above-described symptoms of hand, foot and mouth disease.
This kit is applicable to the in vitro quantitative detection on the content of IgM Antibody to Enterovirus 71 in human whole blood, serum or plasma and is mainly used for implementing auxiliary diagnosis of acute EV71 infection. This kit only provides the test result of IgM Antibody to Enterovirus 71 and the obtained result shall be analyzed in combination with other clinical information.

Post time: May-07-2024