**For Professional Medical Use Only**
We are a US based manufacturer and distribution center for a rapid results COVID-19 antibody blood test – we are aiming to provide as many testing supplies as possible to healthcare providers to help meet current testing demands.
Includes: 25 Tests Per Box, 25 Pipettes, 1 Vial Buffer Solution
Performance: COVID-19 IgG/IgM Rapid Test Device
- Relative Sensitivity: 93.7%
- Relative Specificity: 99.1%
- Overall Agreement: 97.7%
- Not to be used as sole diagnosis – very high sensitivity and specificity allows providers to make an informed decision for next step of treatment.
Results: Results are displayed as positive/negative within 10 minutes of providing the sample.
FDA EUA Approval – We have been granted Emergency Use Authorization (EUA) with the FDA – CLIA certified facilities will be able to administer and bill this test as a high complexity testing device.
Supply Quality – Our manufacturing facility has been producing high quality, FDA approved / CLIA waived onsite diagnostic kits for 20+ years.
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma.
The test has been reviewed by the FDA and approved under the FDA EUA. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.
What is the difference between an IgM and IgG antibody?
This rapid test screens for both the IgM and IgG antibodies.
The IgM antibody is typically produced in our systems around four days after the initial infection date. IgM antibodies are usually the first antibodies produced in the immune system upon an initial infection. A positive IgM test results reading indicates that the patient has a high chance of a current infection and that the immune system has begun its initial response to the virus.
The IgG antibody typically develops in most patients around seven to 10 days after the initial onset of symptoms for COVID-19. Unlike IgM antibodies, IgG antibodies remain in the blood after the the immune system has effectively fought off the viral infection. A positive result reading for the IgG antibody indicates that the patient may have had recent exposure and response to COVID-19. These are the type of antibodies that are known to protect against future infection. Currently for the COVID-19 virus, it is unknown how long these antibodies remain in our systems and how much protection they might provide against reinfection.
The virus is thought to spread mainly from person-to-person.
- Between people who are in close contact with one another (within about 6 feet).
- Via respiratory droplets produced when an infected person coughs or sneezes.
- These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.
Instructions For Use
This test is conducted by taking a small whole blood sample, placing it in the center well of the cassette followed by adding two drops of the buffer to the buffer well labeled B. Results should appear within 3 minutes and are invalid after 10 minutes.