The Ebola Antigen Rapid Test is a rapid, serological, lateral flow chromatographic immunoassay for the qualitative detection of antigens
from Ebola viruses in human whole blood, serum or plasma specimens as an aid in the diagnosis of Ebola virus infection.
SUMMARY
The Ebola virus causes an acute, serious illness which is often fatal if untreated. Ebola virus disease (EVD) first appeared in 1976 in 2
simultaneous outbreaks, one in Nzara, Sudan, and the other in Yambuku, Democratic Republic of Congo. The latter occurred in a
village near the Ebola River, from which the disease takes its name.
Electron micrographs of members of genus Ebolavirus show them to have the characteristic thread-like structure of a filovirus. EBOV
VP30 is around 288 amino acids long. The virions are tubular in general form but variable in overall shape and may appear as the
classic shepherd's crook or eyebolt, as a U or a 6, or coiled, circular, or branched; laboratory techniques, such as centrifugation, may
be the origin of some of these formations. Virions are generally 80 nm in diameter with a lipid bilayer anchoring the glycoprotein which
projects 7 to 10 nm long spikes from its surface. They are of variable length, typically around 800 nm, but may be up to 1000 nm long.
In the center of the virion is a structure called nucleocapsid, which is formed by the helically wound viral genomic RNA complexed with
the proteins NP, VP35, VP30, and L. It has a diameter of 80 nm and contains a central channel of 20–30 nm in diameter. Virally
encoded glycoprotein (GP) spikes 10 nm long and 10 nm apart are present on the outer viral envelope of the virion, which is derived
from the host cell membrane. Between envelope and nucleocapsid, in the so-called matrix space, the viral proteins VP40 and VP24 are
located.
The virus family Filoviridae includes 3 genera: Cuevavirus, Marburgvirus, and Ebolavirus. There are 5 species that have been identified:
Zaire, Bundibugyo, Sudan, Reston and Taï Forest. The first 3, Bundibugyo Ebolavirus, Zaire Ebolavirus, and Sudan Ebolavirus have
been associated with large outbreaks in Africa. The virus causing the 2014 west African outbreak belongs to the Zaire species.
Ebola then spreads through human-to-human transmission via direct contact (through broken skin or mucous membranes) with the
blood, secretions, organs or other bodily fluids of infected people, and with surfaces and materials (e.g., bedding, clothing)
contaminated with these fluids.
The incubation period, that is, the time interval from infection with the virus to onset of symptoms is 2 to 21 days. Humans are not
infectious until they develop symptoms. First symptoms are the sudden onset of fever fatigue, muscle pain, headache and sore throat.
This is followed by vomiting, diarrhoea, rash, symptoms of impaired kidney and liver function, and in some cases, both internal and
external bleeding (e.g., oozing from the gums, blood in the stools). Laboratory findings include low white blood cell and platelet counts
and elevated liver enzymes.
It can be difficult to distinguish EVD from other infectious diseases such as malaria, typhoid fever and meningitis. Confirmation that
symptoms are caused by Ebola virus infection are made using the following investigations:
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antibody-capture enzyme-linked immunosorbent assay (ELISA)
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antigen-capture detection tests
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serum neutralization test
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reverse transcriptase polymerase chain reaction (RT-PCR) assay
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electron microscopy
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virus isolation by cell culture.
Samples from patients are an extreme biohazard risk; laboratory testing on non-inactivated samples should be conducted under
maximum biological containment conditions.
The Ebola Antigen Rapid Test is a simple, visual qualitative test that detects Ebola virus antigen in human whole blood, serum or
plasma specimens. This assay is based on immunochromatography and can give a result at 15-20 minutes.
TEST PRINCIPLE
The Ebola Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of antigens from Ebola viruses in
human whole blood, serum or plasma specimens. After specimen is added to the specimen well (S) on the sample pad, it moves
through the conjugate pad and mobilizes gold anti-Ebola conjugate that is coated on the conjugate pad. The mixture moves along the
membrane by capillary action and reacts with anti-Ebola antibody that is coated on the test line region (T). If the specimen contains
Ebola virus antigen, a colored line will appear in the test line region (T), indicating a positive result. If the specimen does not contain
Ebola virus antigen, a colored line will not appear in this region, indicating a negative result. An internal quality control is included in the
test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient
volume of specimen has been applied to enable migration through the test and control line, regardless of whether there is a test line or
not. If the control line (C) does not appear within the testing time, test result is invalid and the test should be repeated with a new test
device.
MATERIALS PROVIDED
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25 X Test device individually foil pouched with a desiccant
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2 X Sample diluent (6mL)
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25 X Dropper (30 uL)
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1 X Package insert
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