COVID-19 laboratory testing
Understand lab testing and the available options
EUA FDA nod for our SARS-CoV-2 IgG antibody test1
The COV2G antibody test is the first test authorized with a semi-quantitative detection claim to receive Emergency Use Authorization from the U.S. FDA. It is designed to help clinicians assess the level of an individual‘s immune response. The test offers 100% sensitivity2 and 99.9% specificity, which is critical for detecting adaptive, immune response accurately. It also attained the CE-mark and is now broadly available globally.
The importance of testing
Limiting spread and containing outbreaks
A person with the COVID-19 virus on average infects two or more other people.3,4 The tricky part: While they are infectious, people are often not aware that they have the disease because they do not (yet) display any typical symptoms. Given the high infection rate and the environmental stability of the virus, it is vital to identify infected individuals as early as possible, so that they can seek medical guidance and self-isolate. On a larger scale this of course also helps to reduce the overall spread of the virus. PCR tests help here.
Minimizing individual risk and informing action
To understand the bigger picture of the actual disease spread and to determine an individual’s risk, it is also important to know, if a person was already exposed to the virus and infection has resolved. Some tests may detect antibodies that neutralize the virus and growing research shows that these antibodies may indicate immunity.5,6,7 If immunity is proven, such antibody tests could for example help decide if workforce can safely return to a workplace where social distancing is a challenge, in conjunction with PCR testing.
PCR test: Do I have COVID-19?
Our FTD SARS-CoV-21 test is a polymerase chain reaction (PCR) test. It detects viral RNA which is the genetic material of the virus and is used to confirm active COVID-19 infections in both symptomatic people and those that do not display any symptoms yet or at all. To collect a sample of respiratory secretions that can be tested for the virus, it‘s typically medical personnel that swabs a person‘s nose and throat.
Depending on your healthcare provider, it take 2 hours to 5 days results.
Highly accurate tests should maximize sensitivity. Some have 100% sensitivity.
High sensitivity is important because it better detects who has the virus.
You most likely do have a current infection and may give it to others. Quarantine to stop transmission. For additional actions to take, please consult your physician and follow your country's official guidance.
You most likely do not currently have COVID-19 but you could still get it, if you did not already have it. Take steps to protect yourself and others. Take an antibody test to see if you may have been infected but were asymptomatic.
Antibody test: Did I have COVID-19?
When an individual is infected with the SARS-CoV-2 virus, unique antibodies will develop at different stages of the infection. Our total antibody test1 detects antibodies (IgM and IgG) that people develop as part of an immune response to a COVID-19 infection. Our COV2G antibody test1 detects IgG antibodies that persist, and are the basis for an individual’s longer term immune response. The combination of both tests provides a more complete picture of a patient’s serological status for the most accurate results.
on your healthcare provider it may take 30 minutes to 5 days to receive your
Highly accurate tests have over 99.5% specificity and over 90% sensitivity. Some have demonstrated 99.8% specificity and 100% sensitivity. Sensitivity is the test's ability to identify those with antibodies, and specificity is the test's ability to identify those without antibodies.
You likely had COVID-19 and may have some level of immunity to future re-infection. Take a PCR test to confirm you have no active infection. Self-protect and test again regularly to identify whether antibodies are still present.
You likely never had COVID-19 but you could still get it. Take a PCR test. If negative, you may return to the workplace. Self-protect and test again regulary.
These tests have not been FDA cleared or approved. They have been authorized by FDA under an EUA for use by authorized laboratories. The molecular (“PCR”) test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The serology (“antibody”) tests have been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. Both the PCR and antibody tests are 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. Product availability may vary from country to country and is subject to varying regulatory requirements.
100% positive percent agreement (sensitivity) at ≥14 days following a positive PCR test.
Riou J, Althous CL. Euro Surveill. 2020;25(4):2000058. https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2020.25.4.2000058
Liu Y, Gayle AA, Wilder-Smith A, et al. J Travel Med. 2020;27(2). https://doi.org/10.1093/jtm/taaa021
Bao L, Deng W, Gao H, et al. Reinfection could not occur in SARS-CoV-2 infected rhesus macaques. Posted 2020 May 1.
Premkumar et al. 2020; 48(5) https://immunology.sciencemag.org/content/5/48/eabc8413 or Centers for Disease Control and Infection (CDC), section on “Development of Antibodies and Immunity” https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html#anchor_1590264247573
Centers for Disease Control and Infection (CDC), section on “Development of Antibodies and Immunity” https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html#anchor_1590264247573