Oraquick Ebola Rapid Antigen Test: Using Rapid Tests for Ebola
Oraquick Ebola Rapid Antigen Test - Details about the test, and about rapid antigen testing for Ebolavirus
The OraQuick® Ebola Rapid Antigen Test is an in vitro diagnostic single-use immunoassay for the qualitative detection of antigens from viruses within the Ebolavirus genus. It has been granted De Novo 510(k) clearance by the U.S. Department of Health and Human Services.
The test is intended for use with specimens from individuals with epidemiological risk factors with signs and symptoms of Ebola Virus Disease (EVD) or recently deceased individuals with epidemiological risk factors who are suspected to have died of EVD. EVD is a nationally notifiable condition and must be reported to public health authorities in accordance with local, state, and federal regulations.
The OraQuick® Ebola Rapid Antigen Test can be used with venipuncture whole blood and fingerstick whole blood specimens as an aid in diagnosis of EVD in patients suspected of and with signs or symptoms consistent with EVD who have epidemiological risk factor(s) for Ebolavirus exposure (e.g., contact with a known or suspected case, travel to a geographic location at a time when Ebolavirus transmission was known or suspected to have occurred). Performance of the device with Ebolavirus positive fingerstick whole blood was established in a non-human primate model.
Can you use the test on cadavers?
It can also be used with cadaveric oral fluid collected from recently deceased individuals with epidemiological risk factors who are suspected to have died of EVD. Cadaveric oral fluid should be collected directly with the device or collected with oral swabs in viral transport media. The OraQuick® Ebola Rapid Antigen Test is intended as an aid in the determination of EVD as the cause of death to inform decisions on safe handling of cadavers to prevent disease transmission.
It is important to note that test results are presumptive, definitive identification of EVD requires performing additional testing and confirmation procedures in consultation with public health and/or other authorities to whom reporting is required. Negative results were observed in individuals with low levels of circulating virus, therefore negative results do not preclude infection with viruses within the Ebolavirus genus. The level of Ebolavirus antigens that would be present in EVD clinical specimens from individuals with early systemic infection is unknown. Test performance of the OraQuick® Ebola Rapid Antigen Test is associated with the level of Ebolavirus antigens in the patient; therefore, the test is not intended for use in an asymptomatic population for mass-screening purposes (e.g., as the sole means of EVD control at airports or border-crossings) or for testing of individuals at risk of exposure without observable signs of infection.
Who should use the OraQuick RAT?
The OraQuick® Ebola Rapid Antigen Test is intended for use by experienced personnel who have documented device specific training offered by OraSure Technologies Inc., training in the correct use of recommended personal protective equipment (PPE) and expertise in infectious disease diagnostic testing, including the safe handling of clinical specimens potentially containing Ebolavirus. The test is intended for use by laboratory professionals or healthcare workers who have demonstrated availability of biosafety equipment, access to patient containment facilities, and established procedures (e.g., SOP) for coordinating testing and results with public health authorities.
In conclusion, the OraQuick® Ebola Rapid Antigen Test is a rapid diagnostic test for Ebola Virus Disease (EVD) that can be used with various specimens including venipuncture whole blood, fingerstick whole blood and cadaveric oral fluid. It should only be used in accordance with current guidelines provided by the appropriate public health authorities and only by experienced personnel who have the necessary training and expertise in infectious disease diagnostic testing.
What are the advantages of rapid antigen tests?
Rapid diagnostic tests, such as the OraQuick® Ebola Rapid Antigen Test, play an important role in the early detection and management of EVD outbreaks. They provide a fast and efficient way to identify individuals who have been infected with the virus, allowing for prompt isolation and treatment of patients, as well as contact tracing and quarantine measures to prevent further spread of the disease.
One of the major advantages of rapid diagnostic tests is that they can be performed on-site, in areas where laboratory infrastructure may be limited or non-existent. This allows for a faster response to outbreaks, as well as the ability to test a larger number of individuals in a shorter amount of time.
What are the weaknesses of rapid antigen tests?
It is important to note, however, that rapid diagnostic tests are not intended to replace traditional laboratory-based diagnostic tests, such as PCR. These tests are considered the gold standard for EVD diagnosis and are used to confirm the results of rapid diagnostic tests. In addition, rapid diagnostic tests may not be able to detect the virus in the early stages of infection, or in individuals who have a low level of virus in their blood. Therefore, it is essential that testing with the OraQuick® Ebola Rapid Antigen Test is performed in conjunction with other diagnostic tests and under the guidance of public health authorities.
Conclusion
In summary, the OraQuick® Ebola Rapid Antigen Test is a valuable tool for the early detection and management of EVD outbreaks. However, it should only be used in accordance with current guidelines provided by the appropriate public health authorities, and only by experienced personnel who have the necessary training and expertise in infectious disease diagnostic testing. Rapid diagnostic tests, such as the OraQuick® Ebola Rapid Antigen Test, play an important role in the early detection and management of EVD outbreaks, but it is important to use them in conjunction with other diagnostic tests and under the guidance of public health authorities.