The test will qualitatively detect IgM and IgG antibodies to SARS-CoV-2 using a blood specimen. The presence of antibody Immunoglobulin G and Immunoglobulin M (IgG and IgM) proteins specific for SARS-CoV-2 IgG and IgM antibodies are indicated by a visible line in the specific region indicated on the device. The following graph is for illustration purposes only. Significant differences in the post-infection incubation period required for seroconversion are believed to exist.
N95 respirators and surgical masks (face masks) are examples of personal protective equipment that are used to protect the wearer from airborne particles and from liquid contaminating the face. Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) and Occupational Safety and Health Administration (OSHA) also regulate N95 respirators.
Important:
- The test has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- 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.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- It is not known whether persons having antibodies to SARS-CoV-2 are not infectious, can be re-infected or may experience COVID-19 in the future.
Q & A:
- 1. Q: What is the kit used for?
– A: The kit is suitable for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgM /IgG antibodies
in human serum, plasma, or whole blood. - 2. Q: Should I use the kit?
– A: Since the patient may not know if they are infected, it’s necessary for testing both IgM and IgG. - 3. Q: What is the kits’ limit of detection?
– A: Because antibodies are vary based on different conditions, limit of detection will be different for each person.