Arbor Vita announced the availability of its CoVisa™ IgG ELISA-based test for antibodies associated with the novel coronavirus (COVID-19). The test has been found to have a 100 percent sensitivity (positive percentage agreement), and 99.24 percent specificity (negative percentage). Additional validation testing is ongoing in independent laboratories. The company has notified the U.S. Food and Drug Administration under the Emergency Use Authorization (EUA) process.
Arbor Vita's CoVisa™ test presents an opportunity to greatly enhance antibody test availability in the U.S. Currently there are approximately 26,000 high complexity CLIA labs in the U.S. capable of processing COVID-19 antibody tests on ELISA systems. Approximately 200 to 2,000 of those labs have systems that can run currently available tests on a closed platform, that is on a particular manufacturer's laboratory equipment.
CoVisa can be used by the additional 24,000 labs that do not have such equipment. This is especially important since those high complexity CLIA labs will not be able to offer COVID-19 antibody testing after the removal by the FDA of 28 non-functioning antibody tests that do not use the higher accuracy ELISA method.
Arbor Vita has commenced production of all elements of its test including reagents within its U.S facilities and will initially deliver 2,000,000 tests by the end of June and expand production to 1,000,000 per day by the end of July.
"We are excited to add to the existing push to provide high quality antibody testing to more communities by expanding capability to the vast network of community clinical laboratories," said Peter Lu, M.D., chief executive officer of Arbor Vita. "Furthermore, by sourcing all elements of the test from the U.S., we can ensure quality and sustain the manufacturing ramp up without concern regarding elements outside the country."
Antibody testing helps determine if an individual has been previously infected. It can provide more understanding of the virus, including how long antibodies stay in the body and if they provide immunity. This can contribute to the development of treatments and vaccines, and facilitate informed public policy for the sustained reopening of communities.
The CoVisa™ IgG Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a to perform moderate or high complexity tests. The test is stored at 2-8°C and requires no complex equipment.
Results are for the detection of SARS CoV-2 antibodies. IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
False positive results for CoVisa™ may occur due to cross-reactivity from pre-existing antibodies or other possible causes. The CoVisa™ test is only for use under the Food and Drug Administration's Emergency Use Authorization.
Arbor Vita is making the test available as part of the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) pathway outlined in Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. As with all coronavirus antibody tests the Arbor Vita CoVisa™ blood test should be used consistent with the recently published FDA guidelines.
Arbor Vita will make the CoVisa™ COVID-19 antibody test available in addition to its OncoE6™ Cervical Cancer Test, A/H7N9 Influenza Rapid Test, and the AV Avantage™ A/H5N1 Flu Test.
Arbor Vita's A/H7N9 Influenza Rapid Test, which is FDA-authorized for emergency use, detects the NS1 protein antigen of influenza A/H7N9 vir...
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