CDIA™ Human Enterovirus 71 IgM Test Kit - Creative Diagnostics

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CDIATM Human Enterovirus 71 IgM Test Kit (DTS779)

Intended Use

This test 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.
  • Serum, Plasma or Whole blood
  • Kit
  • The test demonstrated sensitivity of 88.5% (23/26)

Product Introduction

General Description
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 Of The Test
This test employs chromatographic lateral flow device in a cassette format. Colloidal gold conjugated recombinant antigens (Au- Ag) corresponding to EV71 antigens are dry-immobilized at the end of nitrocellulose membrane strip. Anti-human IgM (anti-μ chain) are bond at the Test Zone (T) and goat anti-mouse IgG antibodies are bond at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If present in sample, EV71 IgM antibodies will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by anti-human IgM (anti-μ chain) generating a visible red line. If there are no EV71 IgM antibodies in sample, no red line is formed in the Test Zone (T). The gold conjugate will continue to migrate alone until it is captured in the Control Zone(C) by the goat anti-mouse IgG antibodies aggregating in a red line, which indicates the validity of the test.

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