COVID-19 IgG/IgM Rapid Test
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anticoagulated blood (Li+ heparin, K2EDTA and sodium citrate), or serum. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests.
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is only for use under the Food and Drug Administration’s Emergency Use Authorization.
- Utilizes human whole blood, serum, or plasma
- Used in rapid, qualitative and differential detection of IgG and IgM antibodies
- Delivers clinical results within 10 minutes
- Visual interpretation of results
- No special equipment needed
Validation from National Cancer Institute’s (NCI) Frederick National Laboratory for Cancer Research:
A well characterized panel of 30 confirmed SARS-CoV-2 antibody positive, and 80 SARS-CoV-2 antibody negative samples collected prior to 2020 were tested in an independent validation study performed by the NCI.
95% Confidence Interval:
(83.3% - 99.4%)
(88.7% - 100%)
(91.3% - 99.3%)
(95.4% - 100%)
(88.7% - 100%)
(91.3% - 99.3%)
Combined PPV at prevalence = 5%
(35.0% - 88.4%)
Combined NPV at prevalence = 5%
(99.4% - 100%)
This test has been authorized by FDA under an EUA for use by authorized laboratories.
This test has not been FDA cleared or approved.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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.
This product is intended for professional use and not for home use.
Not for the screening of donated blood.
How can I stay informed about the availability of the COVID-19 IgG/IgM test?
Healthcare professionals, institutions, and other interested parties with questions about the Company’s recently licensed COVID-19 IgG/IgM Rapid Test are asked to send email inquiries to COVIDemail@example.com
What is coronavirus and how is it spread?
The term coronavirus refers to a family of viruses, some causing illness in people and others that circulate among animals. The SARS-CoV-2 strain was first identified in Wuhan, China in December 2019. Public health officials have identified the source of this virus in bats and are investigating its spread from animal to human and human to human. It is typically spread by respiratory droplets from coughs or sneezes, similar to the way flu and other respiratory viruses spread.
What is the incubation period for COVID-19?
Infectious disease experts have determined that symptoms can begin within 2-14 days of initial exposure to the virus.
What are the primary symptoms?
Primary symptoms are:
- Shortness of breath
Look for emergency warning signs for COVID-19. If someone is showing any of these signs, seek emergency medical care immediately:
- Trouble breathing
- Persistent pain or pressure in the chest
- New confusion
- Inability to wake or stay awake
- Bluish lips or face
What is the best way to seek care?
Remember, this is a highly contagious virus. It is not recommended that you enter a healthcare facility, potentially exposing many other individuals. If you feel you have been exposed, call your doctor or call 911 and let them know about your symptoms.
How is COVID-19 diagnosed?
SARS-CoV-2 antibody tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, by detecting antibodies to SARS-CoV-2 in human blood specimen.
How is COVID-19 treated?
- There are two EUA vaccines available to prevent coronavirus disease 2019 (COVID-19).
- The best way to prevent illness is to avoid being exposed to this virus.
What can I do to prevent COVID-19?
Take the following precautions:
- Wash your hands frequently with soap and water
- Avoid close contact with people who are sick
- Maintain 6 feet of distance between yourself and people who don’t live in your household.
- Cover your mouth and nose when coughing/sneezing
- Refrain from touching your eyes, nose or mouth with unwashed hands
- Stay home from work or school if you feel unwell
- Monitor your daily health
- Vaccines have the potential to prevent or treat a wide range of infectious diseases. Make sure that everyone in your house (including yourself) has received the flu shot to stay healthy and safe.
- Wear a mask in public settings and when around people who don’t live in your household, especially when other social distancing measures are difficult to maintain.
For additional information and updates on COVID-19, visit these sites:
- Centers for Disease Control and Prevention
- World Health Organization — International Summary
- National Institutes of Health