An worker works in a protecting go well with in a laboratory of the biotech firm Qiagen in Germany, September 8, 2020.Fabian Strauch | image allian
An worker works in a protecting go well with in a laboratory of the biotech firm Qiagen in Germany, September 8, 2020.
Fabian Strauch | image alliance | Getty Pictures
German genetic testing firm Qiagen introduced Tuesday that it plans to launch a brand new antigen take a look at for the coronavirus that it says may ultimately be deployed in airports and stadiums if it receives the suitable authorizations.
The corporate mentioned it plans to launch two variations of the antigen take a look at within the U.S. later this yr: one model that is meant to be processed in a scientific laboratory and one other that is moveable and may be processed at level of care. The corporate has not but utilized for emergency use authorization from the Meals and Drug Administration however mentioned it plans to.
If the take a look at, referred to as the Entry Antigen Check, is granted FDA authorization for point-of-care use and if it is waived from the necessities below the Medical Laboratory Enchancment Amendments, Qiagen mentioned, the take a look at may very well be utilized in high-volume settings equivalent to airports and stadiums to check folks with signs. Quickly testing symptomatic folks may turn into more and more vital within the fall and winter as seasonal influenza, which causes lots of the similar early signs as seen in Covid-19, spreads within the Northern Hemisphere.
“The moveable take a look at presents a brand new mixture of velocity and scale that marks an vital step in the direction of decentralized mass testing that well being authorities everywhere in the world have been urgently searching for,” the corporate mentioned in a launch.
The take a look at, which was developed in collaboration with Australian diagnostics firm Ellume, can display as much as eight nasal-swab samples concurrently, the corporate mentioned. Directors of the take a look at use a small digital platform, referred to as an eHub, which was launched in August with Qiagen’s antibody take a look at, to course of the nasal swabs.
The platform can yield leads to lower than 15 minutes, the corporate mentioned, and may course of a mean of about 30 swab samples each hour. Qiagen added that the take a look at appropriately diagnoses a constructive coronavirus an infection 90% of the time and appropriately diagnoses a unfavorable outcome 100% of the time. The corporate didn’t elaborate on the strategies used to reach on the accuracy conclusions.
The corporate has not but disclosed a value level for the take a look at, however Qiagen CEO Thierry Bernard referred to as the assessments “cost-effective.” Qiagen additionally didn’t disclose particulars on what number of assessments will probably be in a position to manufacture.
In a press release, Bernard added that the antigen assessments are supposed to complement, not change, the molecular, or PCR, assessments, that are probably the most correct assessments available on the market. PCR assessments, nevertheless, are depending on a strained provide chain of technical laboratory gear, should be processed by skilled scientists and may take hours or days to yield outcomes.
The corporate added that it’s going to additionally apply for certification in Europe.
“The Entry Antigen Check is quick, simple to make use of and cost-effective and might be a beneficial software to deal with the thus far unmet high-volume testing wants for SARS-CoV-2 antigens in conditions the place time is of the essence,” Bernard mentioned in a press release. “It is going to ship extremely correct outcomes and can complement the gold-standard PCR assessments used for detection of lively COVID-19 an infection. PCR assessments supply a excessive degree of diagnostic accuracy however are time-consuming and lab-bound.”
— CNBC’s Meg Tirrell contributed to this report.