The Qiagen rapid coronavirus test will be launched in the US this year, according to the announcement of the German genetic testing firm.
The Qiagen rapid coronavirus test could potentially be used in airports and stadiums if it gets the appropriate authorizations.
According to Qiagen, it will introduce two versions of the antigen test in the US in 2020: one version will be held in a clinical laboratory and another is portable and can be processed at the point of care.
However, the company has not yet been granted emergency use authorization from the Food and Drug Administration but said it plans to.
The Qiagen rapid coronavirus test is formally called the Access Antigen Test. If it receives FDA authorization for point-of-care use and if it does not have to go through the requirements under the Clinical Laboratory Improvement Amendments,the test could be deployed in high-volume settings such as stadiums and airports to test individuals with symptoms.
“The portable test offers a new combination of speed and scale that marks an important step towards decentralized mass testing that health authorities all over the world have been urgently seeking,” Qiagen said in a release.
The test was produced in collaboration with Australian diagnostics company Ellume and can test up to eight nasal-swab samples simultaneously.
Administrators of the test utilize a small digital platform called eHub, which processes the nasal swabs.
eHub can process results in less than 15 minutes, according to the company. The platform can process an average of about 30 swab samples every hour. Qiagen noted that the test makes the correct diagnosis of a positive coronavirus infection 90% of the time and diagnoses a negative result of 100% of the time.
However, the company did not discuss the methods applied to support the accuracy of the conclusions. The company did not also reveal a price point for the test.
Qiagen CEO Thierry Bernard said the tests are “cost-effective.” Qiagen also did not share any details on the number tests it will be able to manufacture.
“The Access Antigen Test is fast, easy to use and cost-effective and 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,” Bernard said in a statement.
“It will deliver highly accurate results and will complement the gold-standard PCR tests used for the detection of active COVID-19 infection. PCR tests offer a high level of diagnostic accuracy but are time-consuming and lab-bound.”
In Europe, the Roche rapid coronavirus test will launch in September, and it will be used for point-of-care settings for asymptomatic and symptomatic patients.
The Roche rapid coronavirus test usually reveals the results in about 15 minutes. Accordign to the company, the test accurately presents diagnosis of an infected Covid-19 patient more than 96% of the time. It also presents a negative result more than 99% of the time, based on a combined sample size of 426 samples from two different testing centers.
Former Google CEO Eric Schmidt called for more rapid testing in August, emphasizing it can help corporate offices in the US reopen.
“There’s plenty of technology that allows for rapid testing, and with rapid testing corporations could open. People could go to work,” Schmidt told CNBC’s “Squawk Box.”
Schmidt slammed politicians for not promoting rapid testing more prominently in initial relief packages. “In those trillions of dollars, we did not put in place the necessary structures to do rapid testing,” he said.