COVID-19 Detection Tests

CoVisa™ IgG Test

Arbor Vita has notified the U.S. Food and Drug Administration and is pending Emergency Use Authorization (EUA) for the CoVisa™ IgG test. The lab-based serology blood test identifies antibody IgG, which is present in the later stages of infection, and confirms if an individual has previously contracted COVID-19. Enabling widely available ELISA system adds accessibility to testing with the closed testing platforms currently in place. This accurate, fast, ELISA-based antibody test can turn the tide in the battle to contain COVID-19.

Cancer Detection Tests

OncoE6™ Cervical Cancer Test

The only cervical cancer test that provides real-time results at the point of care. To find out more about our innovative flagship product, click here.

OncoE6™ Oral Test

The OncoE6™Oral Test follows the same principle as the OncoE6™ Cervical Test by directly detecting elevated levels of the cancer-causing HPV viral E6 oncoprotein. It is a simple lateral flow test yielding results in about 2.5 hours.

Influenza Detection Tests

Influenza

Influenza, an RNA virus, has the ability to genetically reassort, specifically by antigenic shift, and can therefore mutate into a form that compromises vaccine effectiveness and to which a naive population has no immunity. Avian influenza H7N9 is one example which emerged in March 2013 in China, reappearing again in January 2014. Most had contact with live bird markets, but human-to-human transmission is also suspected. Although it has killed fewer than 200 people, it has a mortality rate of 30%.

Fast and early diagnosis plays an important role in detection and containment of influenza pandemics. In conjunction with the United States Navy, Arbor Vita has developed rapid tests against A/H5N1 and A/H7N9 that could, unlike more equipment-intensive and complicated PCR tests, be used in such critical entry points as airports.

The AV Avantage™ A/H5N1 Flu Test has received 510K clearance for sale in the United States, while the A/H7N9 Influenza Rapid Test has been authorized by the FDA under Emergency Use Authorization. 

A/H7N9 Influenza Rapid Test
Arbor Vita’s A/H7N9 Influenza Rapid Test, which is FDA-authorized for emergency use (see Product Certification below for Conditions of Authorization), detects the NS1 protein antigen of influenza A/H7N9 virus (identified in China in 2013) from nasal swab specimens and viral cultures in patients untypeable for seasonal influenza A. The test consists of a three-line immunochromatographic assay and provides results in less than twenty minutes. This will assist healthcare providers and surveillance teams in the early detection of individuals who may be infected with A/H7N9 (line 1 and 2) or seasonal influenza A (line 1 only). The results will require verification by CDC’s real time PCR for A/H7N9 available at public health laboratories.
 
The AV Avantage™ A/H5N1 Flu Test
 FDA-cleared, rapid test for the detection of the A/H5N1 influenza virus from throat and nasal swab specimens and viral cultures. Arbor Vita received 510(k) clearance from the U.S. Food and Drug Administration in April 2009 for this test. The test requires no equipment or cold storage, is easy to use, and gives results within 30 minutes, critical features in an outbreak. The Arbor Vita AV Avantage™ A/H5N1 Flu Test utilizes proprietary PDZ technology to distinguish H5N1 from seasonal influenza A infections.
 

A/H7N9 Influenza Rapid Test

FDA-authorized for emergency use
The A/H7N9 Influenza Rapid Test is the only FDA-authorized rapid test for the specific identification of the emerging A/H7N9 influenza strain in nasal clinical specimens or viral cultures.

AV Avantage™ A/H5N1 Flu Test

AV Avantage™ A/H5N1 Flu Test
FDA 510(k)-cleared
The AV Avantage™ A/H5N1 Flu Test is the only FDA-cleared rapid test for the specific detection of the A/H5N1 virus.