The ReEBOV Antigen Rapid Test is a point-of-care assay intended to quickly diagnose EBV in patients with signs and symptoms who may have been exposed to the Ebola virus.
According to the manufacturer, the test is a dipstick immunoassay intended to detect the presence of the VP40 antigen from Ebola virus strains Zaire, Sudan, and Bundibugyo. The Ebola Zaire strain is the strain detected in the West Africa 2014 outbreak. The assay is run on whole blood samples obtained from a fingerstick sample or venous draw or on plasma samples. (See link to the manufacturer's IFU under Selected References and Resources.) Test results can be obtained within 15 to 25 minutes. Test results are qualitative rather than quantitative and do not indicate the severity or stage of EBV infection. The assay is packaged with test dipsticks, sample buffer, both negative and positive controls (negative human serum; VP40 antigen-spiked negative human serum), test tubes and rack, and a ReEBOV Rapid Test Results Card. The card is used to interpret the test results that appear on the dipstick or to determine whether the test result is invalid. The test reagents should be kept under refrigeration (2o to 8oC) and should not be frozen. (See link to the manufacturer's IFU under Selected References and Resources.)
The test is described as being less sensitive than an Ebola nucleic acid test and may return both false positives and false negatives. This assay is not intended for, or approved for, use in general EBV screening. Additionally, the assay is intended for use only in individuals who meet "clinical and epidemiologic criteria for testing suspect specimens."
Purported Benefits/Advantages According to Manufacturers' Information*
"[The ReEBOV™ Antigen Rapid Test] is designed to be used in any clinical or field lab to determine in a matter of minutes if a patient is infected with Ebola."
"A positive test result from the ReEBOV™ Antigen Rapid Test indicates that the patient is presumptively infected with Ebola Zaire virus."
"The ReEBOV™ Antigen Rapid Test has been designed to minimize the likelihood of false positive test results."
"A negative test presumes that Ebola virus …was not present at the detection level of the assay. However, negative results do not preclude Ebola virus infection, and should not be used as the sole basis for treatment, public health, or other patient management decisions."
*Note: This is a list of the main benefits described by the manufacturer and does not imply endorsement or validation by ECRI Institute.