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Inquire about how to purchase an at-home Influenza screening test
Learn how to become validated to process the innovative AV Avantage™
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 510(k) clearance for sale in the United States, while the A/H7N9 Influenza Rapid Test has been authorized by the FDA under Emergency Use Authorization.
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.
AV Avantage™ A/H5N1 Flu Test
FDA Approved (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.
AV Avantage™ A/H5N1 Flu Test Package Insert:
The AV Avantage™ A/H5N1 Flu Test is an 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 AV Avantage™ A/H5N1 Flu Test utilizes proprietary PDZ technology to distinguish H5N1 from seasonal influenza A infections.
The AV Avantage™ A/H5N1 Flu Test is based on the detection of the NS1 protein antigen of the influenza virus in specimens from infected individuals. It consists of an immunochromatographic assay in a lateral flow format in which a PDZ domain is used as a capture reagent and highly sensitive monoclonal antibodies are used as detection reagents. Line 1 of the Test or Test Cassette specifically binds NS1 protein from H5N1 Clades 1, 2.1, 2.2, and 2.3. Line 2 preferentially binds NS1 from the seasonal influenza A subtypes, H1N1 and H3N2. The test detects H5N1 influenza viruses originally isolated from infected humans that have been grown in culture as a low passage and spiked into a human negative sample background. The test permits samples to be characterized as H5N1-Positive or H5N1-Negative.
The AV Avantage™ A/H5N1 Flu Test Kit contains cassettes and reagents for 21 tests:
21 Sample Reaction Tubes
1 AV Avantage™ A/H5N1 Flu Test Sample Extraction Buffer
21 AV Avantage™ A/H5N1 Flu Test Cassettes
1 AV Avantage™ A/H5N1 Flu Test Positive Control
Materials required but not supplied
Liquid transfer device (pipette)
Remel Sterile Traditional Flocked Swabs (part of Remel M6™ Kit, Cat. #R12568)
M6™ Viral Transport Media (VTM) (part of Remel M6™ Kit, Cat. #R12568)
Timer or watch
Sterile barrier tips for pipette
Tube rack
Tool to remove crimp caps (optional)
Product Reference
If you have questions about this product, please use Part Number #1000000 as a reference.
Product Certification
FDA 510(k)-cleared
Legal and Disclaimers
The buyer/user has a non-exclusive licence to use AV Avantage™ A/H5N1 Flu Test.
References
• Peiris, J. S., Yu, W. C., Leung, C. W., et al. (2004) Reemergence of fatal human influenza A subtype H5N1 disease. Lancet 363:617–619.
• World Health Organization. (2005) Avian influenza: Assessing the pandemic threat. WHO/CDS/2005.29.
• World Health Organization Global Influenza Program Surveillance Network. (2005) Evolution of H5N1 avian influenza viruses in Asia.Emerg. Infect. Dis. (10):1515-1521.
