COVID-19 testingUnderstand COVID-19 testing and the available options
What's new?
COVID-19 Antigen Self-Test12 receives special approval in Germany for self-administration by lay persons
The easy-to-use CLINITEST Rapid COVID-19 Antigen Self-Test provides results in 15 minutes. It’s a test with high sensitivity which means fewer false negatives. Apart from Germany, the personal use of this test – currently time-limited until June 30, 2021 – is permitted in Austria.
The importance of testing
PCR test or antibody test? Watch our video to learn which test does what
Limiting spread and containing outbreaks
A person with COVID-19 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. Antigen tests and 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 antigen testing and/or PCR testing.
Antigen test: Know if you have COVID-19, fast
PCR tests are still the gold standard for SARS-CoV-2 testing when it comes to accuracy. However, they can also present challenges: the delivery of test results may take some time and PCR tests don’t have the high throughput capability of an automated test. That’s where antigen tests come in. There are two types: a simple, visual read test for individual people and a lab-based, automated test for large quantities of patient samples.
Testing individuals fast, at any location
The CLINITEST Rapid COVID-19 Antigen Test8 helps identify infected individuals in just 15 minutes anywhere. The easy-to-use visual read test does not require specialized lab personnel or instruments, offering the flexibility to test in locations that benefit from immediate results but have limited access to laboratory resources. The test only requires a nasal swab from both nostrils. The swab is then washed in a reagent, dissolving a specific protein from the surface of the virus. This liquid is dropped into a well in the test cassette. Within 15 minutes, the test sample flows into the field of view of the cassette and becomes visible by a dash. The position and number of lines indicate whether the test result is positive or negative, or whether something was done incorrectly during the test procedure and the test must be repeated.
- In Germany and Austria, this test is also available for self-testing at home by laypersons. Learn more on our consumer information website (Currently in German language only)
- If you are a healthcare professional, you can find more information on our product pages.
Testing large groups of people fast
When it comes to testing large quantities of patient samples quickly and cost-effectively, our lab-based SARS-CoV-2 Antigen Assay9 is an ideal tool. For example at on-site collection centers for hospital staff, patients and visitors, remote collection facilities for large scale testing of local populations or in dedicated, pop-up labs at airports or large universities. The test was designed with the objective to maximize sensitivity to both current and future SARS-CoV-2 variants. It shows strong alignment to PCR methods with sensitivity exceeding 94% and specificity at 100% for the Atellica IM COVAg test.10 With availability of CoV2Ag on the Atellica IM Analyzer, laboratories can significantly increase the SARS-CoV-2 testing capacity with a platform that can run up to 440 tests per hour.11
PCR test: Do I have COVID-19?
Our scientist Christos Loukas explains how PCR tests work
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.
News
Antibody test: Measure neutralizing antibodies against 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. This test demonstrates the ability to detect neutralizing antibodies and can report quantitative results measuring the amount of neutralizing antibodies present in a patient's blood sample. The combination of both tests provides a more complete picture of a patient’s serological status for the most accurate results.
Depending on your healthcare provider it may take 30 minutes to 5 days to receive your results.
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 to rule out an active infection. Self-protect and test again regulary.
Learn more
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
Not available for sale in the U.S. Product availability may vary by country.
This test has not been reviewed by the FDA. In the US, use of this test is limited to laboratories that are certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. Product availability may vary from country to country and is subject to varying regulatory requirements.
Based on PCR results obtained from symptomatic and asymptomatic patients with the FTD SARS-CoV-2 PCR method. Percent positive agreement with PCR Ct<30 samples (relative sensitivity) was 96.07%, and percent negative agreement with PCR negative samples (relative specificity) was 100%.
Depending on test mix and configuration using the Atellica Solution. The Atellica IM SARS-CoV2Ag assay has a throughput of 200 tests per hour.
Product availability varies by country.