The SARS-CoV-2 lgG/lgM Rapid Test can be used to test serum, plasma, or venipuncture whole blood specimens. The test can be ordered by a healthcare provider to detect an immune response to SARS-CoV-2 exposure.
A positive test result with the SARS-CoV-2 IgG/IgM Rapid Test indicates that antibodies to SARS-CoV-2 were detected, and the patient has potentially been exposed to COVID-19.
When IgM antibodies are present, they can indicate that a patient has an active or recent infection of SARS- CoV-2. IgG antibodies develop later following infection, and generally do not begin to appear until 7 – 10 days after infection. When IgG antibodies are present, it often indicates a past infection but does not exclude recently infected patients who are still contagious, especially if detected with IgM antibodies. It is unknown how long IgM or IgG antibodies to SARS-CoV-2 will remain present in the body after infection and if they confirm immunity to infection.
Risk of false positive to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially SARS- CoV-2 infected patients, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms.
Risks to a patient of a false negative result includes: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.
At present there are no FDA cleared or approved SARS- CoV-2 Antibody Tests. There are many companies that are selling various products at various prices. During our vetting process of manufacturers we have ensured that we are getting our products from a reliable company. The company we have chosen has many other devices that the FDA has approved and being utilized in the United States. At production time we have randomly tested the kits at the assembly line level. We have also conducted a third party testing prior to selling the product. Details of these results are available upon request.