An employee works in a protective suit in a laboratory of the biotech company Qiagen in Germany on September 8, 2020.
Fabian Strauch | Image Alliance | Getty Images
The German genetic testing company Qiagen announced on Tuesday that it plans to start a new antigen test for the coronavirus, which it claims could possibly be used at airports and in stadiums if it receives the appropriate permits.
The company plans to launch two versions of the antigen test in the United States later this year: one version that is intended to be processed in a clinical laboratory and another that is portable and can be processed at the point of care . The company has not yet applied for emergency approval from the Food and Drug Administration, but plans to do so.
According to Qiagen, if the test, known as the Access Antigen Test, gains FDA approval for use at the point-of-care location and deviates from the requirements of the clinical laboratory improvement changes, the test could be used in high Volumes such as airports and stadiums to test people with symptoms. Quickly testing symptomatic people could become more important in the fall and winter as seasonal influenza, which causes many of the same early symptoms as Covid-19, spreads to the northern hemisphere.
"The portable test offers a new combination of speed and scalability that represents an important step towards the decentralized mass testing that health officials around the world have been desperately looking for," the company said in a press release.
The test, which was developed in collaboration with the Australian diagnostics company Ellume, can examine up to eight nasal swab samples at the same time. Administrators of the test use a small digital platform called eHub, which was launched in August with the Qiagen antibody test, to process the nasal swabs.
The platform can deliver results in less than 15 minutes and process an average of around 30 swab samples per hour. Qiagen added that the test correctly diagnoses a positive coronavirus infection 90% of the time and correctly diagnoses a negative result 100% of the time. The company did not elaborate on the methods used to reach the conclusions about accuracy.
The company has not yet announced a price for the test, but Qiagen CEO Thierry Bernard described the tests as "inexpensive". Qiagen also didn't reveal details about how many tests it can produce.
In a statement, Bernard added that the antigen tests are intended to complement, not replace, the molecular or PCR tests, which are the most accurate tests on the market. However, PCR tests depend on a tight supply chain of technical laboratory equipment, must be processed by trained scientists, and can take hours or days to produce results.
The company added that it will also apply for certification in Europe.
"The Access Antigen Test is fast, easy to use and inexpensive and will be a valuable tool to meet the previously unmet test needs for SARS-CoV-2 antigens in situations where time is of the essence," said Bernard said in a statement. "It will provide highly accurate results and complement the gold standard PCR tests used to detect active COVID-19 infection. PCR tests offer a high level of diagnostic accuracy, but are time consuming and laboratory-specific."
– CNBC's Meg Tirrell contributed to this report.