Detection Method
Indirect-ELISA
Intended Use
The Human Anti-Sudan Ebola Virus Glycoprotein (SUDV GP) IgM ELISA Kit is an indirect ELISA suitable for quantifying IgM antibody activity specific for Sudan Ebola glycoprotein in serum or plasma of vaccinated, immunized and/or infected hosts.
This immunoassay is suitable for:
• Determining immune status relative to non-immune controls;
• Assessing efficacy of vaccines, including dosage, adjuvantcy, route of immunization and timing;
• Qualifying and standardizing vaccine batches & protocols.
The assay is for research use only (RUO) and is not intended nor validated for diagnosing Ebola virus disease (EVD). Reagents contain no virus or viral antigens.
Contents of Kit
| No. | Components | Size | Storage Conditions |
| 1 | SUDV GP Coated Strip Plate | 8 × 12 | 2-8°C |
| 2 | Anti-SUDV GP Calibrators | 0.65 ml × 4 | 2-8°C |
| 3 | Anti-SUDV GP Positive Control | 0.65 ml × 1 | 2-8°C |
| 4 | Low NSB Sample Diluent (LNSD) | 30 ml × 1 | 2-8°C |
| 5 | Wash Solution Concentrate (100×) | 10ml × 1 | 2-8°C |
| 6 | Sample Diluent Concentrate (20×) | 10ml × 1 | 2-8°C |
| 7 | Anti-Human IgM-HRP Conjugate Concentrate (100×) | 0.15ml × 1 | 2-8°C |
| 8 | TMB Substrate | 12 ml × 1 | 2-8°C |
| 9 | Stop Solution | 12 ml × 1 | 2-8°C |
Storage
The microtiter well plate and all other reagents, if unopened, are stable at 2-8°C until the expiration date printed on the box label. Stabilities of the working solutions are indicated under Reagent Preparation.
General Description
Ebola virus (EBOV) causes severe disease in humans and in nonhuman primates in the form of viral hemorrhagic fever. Ebola Zaire attacks every organ and tissue in the human body except skeletal muscle and bone. Strains of Ebola include: Zaire, Sudan, Reston and Tai. All cause illness in sub human primates. Ebola Reston has not caused illness in humans. The mortality rate of Ebola victims is between 60-90%.
Ebola virions consist of seven structural proteins. At the center is the helical ribonucleocapsid, which consists of the genomic RNA wrapped around a polymer of nucleoproteins (NP). Associated with the ribonucleoprotein is the RNA-dependent RNA polymerase (L) with the polymerase cofactor (VP35) and a transcription activator (VP30). The ribonucleoprotein is embedded in a matrix, formed by the major (VP40) and minor (VP24) matrix proteins. These particles are surrounded by a lipid membrane derived from the host cell membrane. The membrane anchors a glycoprotein (GP1,2) that projects 7 to 10 nm spikes away from its surface. While nearly identical to Marburg virions in structure, Ebola virions are antigenically distinct. Viral proteins (NP, GP, and VP40) are highly immunogenic and could individually or together constitute effective vaccines. Promising vaccine candidates include DNA vaccines or those based on adenoviruses, vesicular stomatitis Indiana virus (VSIV) or filovirus-like particles (VLPs) as all of these candidates could protect nonhuman primates from Ebola virus-induced disease.
Citations
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