Ebola Virus IgG/IgM Ab Rapid Test

CE APPROVED

Intended Use:

The BIOCAN TELL ME FAST Ebola Virus IgG/IgM Antibody Test Device (Serum/Plasma/Whole Blood) is a qualitative test for the detection of IgG and IgM antibodies to Ebola viruses (Zaire Ebola virus, including the Zaire Ebola virus strain detected in the West Africa outbreak 2014, Sudan Ebola virus and Bundibugyo Ebola virus) in human serum, plasma or whole blood. The test provides a differential detection of anti-ebola IgG and IgM antibodies and can be used for the presumptive distinction between a primary and secondary ebola virus infection. This test is for professional research use only and for screening purposes only. All results should be verified with other qualified assays.

Summary and Principle of the assay:

Ebola virus (EBOV) causes severe disease in humans and in nonhuman primates in the form of viral hemorrhagic fever. The name Ebola virus is derived from the Ebola River (a river that was at first thought to be in close proximity to the area in Zaire where the first recorded Ebola virus disease outbreak occurred) and the taxonomic suffix virus. Zaire Ebolavirus is a virological taxon included in the genus Ebolavirus, family Filoviridae, order Mononegavirales. The family Filoviridae (members are called Filovirus or filovirids; filum is derived from Latin meaning filamentous) is a group of several related viruses that form filamentous infectious viral particles (virions) and encode their genome in the form of single stranded negative sense RNA. The family currently includes the three virus genera Cuevavirus, Ebolavirus, and Marburgvirus. The two members of the family that are commonly known are Ebola virus and Marburg virus. Both viruses, and some of their lesser known relatives, cause severe disease in humans and nonhuman primates (NHP) in the form of viral hemorrhagic fevers. All Ebola viruses and Marburg viruses are Select Agents Group 4 Pathogens. Filoviruses have a history that dates back several tens of millions of years. The most recent common ancestor of both the Reston and Zaire species has been estimated to be ~1960. The most recent common ancestor of the Marburg and Sudan species appears to have evolved 700 and 850 years before present respectively. The family Filoviridae represents significant health risks as emerging infectious diseases as well as potentially engineered biothreats. Ebolavirus species Zaire (ZEBOV) causes a highly lethal hemorrhagic fever, resulting in the death of 90% of patients within days. Ebola Zaire attacks every organ and tissue in the human body except skeletal muscle and bone. Ebola is classified as a Level 4 pathogen (higher than AIDS) with a 2 to 21 day (7 to 14 days average) incubation period. There are currently four known strains of Ebola: Zaire, Sudan, Reston and Tai. All of them cause illness in sub-human primates. Only Ebola Reston does not cause illness in humans. The mortality rate of Ebola victims is between 60% and 90%; with Ebola Sudan at 60% and Ebola Zaire at 90%. Ebola virus disease (EVD) is clinically indistinguishable from Marburg virus disease (MVD) and can be easily be confused with many other diseases prevalent in Equatorial Africa, such as other viral hemorrhagic fevers, falciparum malaria, typhoid fever, shigellosis, and rickettsial diseases such as typhus, cholera, gram negative septicemia, borreliosis such as relapsing fever or EHEC enteritis. The most common diagnostic methods are therefore RT PCR in conjunction with antigen capture ELISA which can be performed in the field or mobile hospitals and laboratories. The current 2014 West Africa Ebola outbreak is caused by Zaire ebolavirus species.  

Principle:

Biocan Tell Me Fast Ebola Virus Antibody Test is capable of detecting ebola virus infection including Zaire Ebola virus, including the Zaire Ebola virus strain detected in the West Africa outbreak 2014, Sudan Ebola virus and Bundibugyo Ebola virus. This test uses a unique VP40 Ebola recombinant antigen. Compared with the viral antigens prepared from highly pathogenic viruses such as filoviruses, which must be manipulated in a Biosafety Level 4 facility, the recombinant proteins used in test offers two main advantages: they are safe and easy to prepare and the amount of antigen used in the assays can be easily standardized. Whereas detection of IgG antibodies is the test of choice for large screening of serological surveys, detection of IgM is a useful method for early diagnosis. The BIOCAN TELL ME FAST Ebola Virus IgG/IgM Antibody Test Device is a qualitative test for the detection of IgG and IgM antibodies to ebola virus in human serum, plasma or whole blood. The test provides a differential detection of anti-ebola IgG and anti-ebola IgM antibodies and can be used for the presumptive distinction between a primary and secondary ebola virus infection. First, a specimen is dispensed with sample buffer, the Gold antigen conjugate will bind to anti-ebola IgG and IgM antibodies in the sample. In turn, this complex will bind with Anti-Human IgG and Anti-Human IgM coated on the membrane as two separate lines in the test region as the reagent move across the membrane. The anti-Human antibodies on the membrane will bind the IgG or IgM antigen complex at the relevant IgG and or IgM test lines causing pale or dark pink lines to form at the IgG or IgM region of the test membrane. The intensity of the lines will vary depending upon the amount of antibody present in the sample. The appearance of pink line in a specific test region (IgG or IgM) should be considered as positive for that particular antibody type (IgG or IgM).  

Performance Characteristics:

No cross reactivity has been observed with patient samples positive with Malaria, Chikungunya, HIV-1, HIV-2, S.Typhi, Para Typhi A, HCV, HBsAg, Chagas & Dengue. Currently, no certain level of sensitivity or specificity is claimed since various clinical trials are being conducted and as per internal data available, the sensitivity of the test should be greater than 90% and specificity at 99.5%.

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