By Manas Mishra and Carl O'Donnell
(Reuters) - German diagnostic test maker Qiagen on Tuesday said it planned to launch a COVID-19 antigen test that can provide results in 15 minutes and test about 30 samples in an hour.
The company said it will launch two versions of the antigen test, one for labs and one for use at point-of-care use, such as at airports or stadiums, depending on regulatory clearance.
The test has not yet received authorization from U.S. regulators and the company plans to launch it in November.
Antigen tests are faster than molecular diagnostic tests but generally more likely to fail in identifying positive cases of the virus than the gold-standard molecular diagnostic tests, which are conducted in laboratories.
Qiagen said studies showed the test could identify those without disease 100% of the time, and was correct in identifying negative cases at least 90% of the time.
The test would be performed on a small portable device known as an eHub, which can analyze nasal-swab samples from up to eight people at once.
Laboratories in the United States, which has the most number of coronavirus cases globally, have struggled to meet the demand for testing, resulting in delays in test results.
The test "will be a valuable tool to address the so far unmet high-volume testing needs for SARS-CoV-2 antigens in situations where time is of the essence,” said Qiagen's Chief Executive Thierry Bernard.
Bernard told Reuters that Qiagen expects to be able to produce several millions tests per month at the time of launch but aims to scale up to well above 10 million per month in 2021.
(Reporting by Manas Mishra in Bengaluru; Editing by Marguerita Choy)