ARISTA™ COVID-19 Antibody Test

Orawell®COVID-19 IgM/IgG Rapid Test

DETERMINING IF YOU HAVE PREVIOUSLY BEEN INFECTED WITH COVID-19

The ARISTA™ COVID-19 Antibody Test and the Orawell® COVID-19 IgM/IgG Rapid Test can aid in determining if an individual had previously been infected with COVID-19. This is especially useful in asymptomatic cases. Our tests can differentiate between IgM and IgG antibodies, yielding results within 10 minutes from blood, serum, or plasma samples.

YIELDING VALUABLE INFORMATION

The ARISTA™ COVID-19 Antibody Test and the Orawell® COVID-19 IgM/IgG Rapid Test, also known as serology tests, detect the presence of antibodies to the SARS-CoV-2 virus that are produced in response to a COVID-19 infection. IgM antibodies serve as a temporary first line of defence and typically start appearing from around 7 days after infection. This is followed by the production of IgG antibodies that serve as a longer-term defence and are the most abundant antibody in our system. They normally appear after 14 days and remain in our bodies for some time thereafter – exactly how long of a period is still unknown at this stage. Our antibody tests are most effective in detecting IgM/IgG antibodies around 15−21 days post-infection.

An understanding of the stages of the body’s production of IgM and IgG antibodies can be a useful indicator of the timing of a prior COVID-19 infection. Aside from determining prior infection, the ARISTA™ COVID-19 Antibody Test and the Orawell® COVID-19 IgM/IgG Rapid Test can play an important role in understanding the transmission dynamics of the virus in the general population, and in identifying groups at higher risk for infection.

ACCESS TO VALUABLE DATA

The ARISTA™ COVID-19 Antibody Test and the Orawell® COVID-19 IgM/IgG Rapid Test is paired to the Viva Life App that allows individuals to optionally store a history all their test records on their phone and generate a digital certificate whenever required. In the case of corporate testing programs, the Viva Life Enterprise Account offers a web-based enterprise solution that enables individual Viva Life App users to sync their test results to an organization dashboard that they are associated with – such as their workplace or school. The organization receives instant data feedback on the health status of their people, which can facilitate the implementation of more effective safety measures.

ARISTA™ COVID-19
Antibody Test

Orawell® COVID-19
IgM/IgG Rapaid Test

The ARISTA™ COVID-19 Antibody Test and the Orawell® COVID-19 IgM/IgG Rapid Test are lateral flow immunoassays based on colloidal gold immunochromatography technology intended for the qualitative detection and differentiation of IgG and IgM antibodies to the SARS-CoV-2 virus in human whole blood, serum or plasma – for professional use at point-of-care.

Performance studies conducted on the ARISTA™ COVID-19 Antibody Test using plasma samples indicated a combined sensitivity of 90.4% and combined specificity of 100% with overall agreement to PCR of 95.1%. This product complies with European In-Vitro Diagnostic Devices Directive 98/79/EC.

Performance studies conducted on the Orawell® COVID-19 IgM/IgG Rapid Test using plasma samples indicated a combined sensitivity of 100% and combined specificity of 94.8% and with overall agreement to PCR of 97.8%. This product is FDA approved for EUA conducted at point-of-care at laboratories certified under CLIA, and complies with European In-Vitro Diagnostic Devices Directive 98/79/EC.

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FDA EUA