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 Photos
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 finally 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 12 months: one model that is meant to be processed in a medical laboratory and one other that is moveable and will 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, known as the Entry Antigen Check, is granted FDA authorization for point-of-care use and if it is waived from the necessities underneath the Medical Laboratory Enchancment Amendments, Qiagen mentioned, the take a look at might be utilized in high-volume settings reminiscent of airports and stadiums to check folks with signs. Quickly testing symptomatic folks may develop into more and more necessary within the fall and winter as seasonal influenza, which causes lots of the identical early signs as seen in Covid-19, spreads within the Northern Hemisphere.
“The moveable take a look at provides a brand new mixture of velocity and scale that marks an necessary step in direction of decentralized mass testing that well being authorities everywhere in the world have been urgently in search of,” 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, known 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 ends in lower than 15 minutes, the corporate mentioned, and might course of a mean of about 30 swab samples each hour. Qiagen added that the take a look at appropriately diagnoses a optimistic coronavirus an infection 90% of the time and appropriately diagnoses a unfavorable end result 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 worth level for the take a look at, however Qiagen CEO Thierry Bernard known as the assessments “cost-effective.” Qiagen additionally didn’t disclose particulars on what number of assessments will probably be capable of manufacture.
In an announcement, 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, nonetheless, are depending on a strained provide chain of technical laboratory tools, must be processed by skilled scientists and might 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, straightforward to make use of and cost-effective and might be a useful device to deal with the to date unmet high-volume testing wants for SARS-CoV-2 antigens in conditions the place time is of the essence,” Bernard mentioned in an announcement. “It’s going to ship extremely correct outcomes and can complement the gold-standard PCR assessments used for detection of energetic COVID-19 an infection. PCR assessments supply a excessive stage of diagnostic accuracy however are time-consuming and lab-bound.”
— CNBC’s Meg Tirrell contributed to this report.
