Qiagen to launch fast coronavirus take a look at it says might be utilized in airports, stadiums
An worker works in a protecting swimsuit in a laboratory of the biotech firm Qiagen in Germany, September 8, 2020.
Fabian Strauch | image alliance | Getty Photographs
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 might ultimately be deployed in airports and stadiums if it receives the suitable authorizations.
The corporate stated 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 stated it plans to.
If the take a look at, referred to as the Entry Antigen Take a look at, is granted FDA authorization for point-of-care use and if it is waived from the necessities beneath the Medical Laboratory Enchancment Amendments, Qiagen stated, the take a look at might be utilized in high-volume settings resembling airports and stadiums to check individuals with signs. Quickly testing symptomatic individuals might develop into more and more vital 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 affords a brand new mixture of pace 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 looking for,” the corporate stated 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 stated. 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 ends in lower than 15 minutes, the corporate stated, and may course of a mean of about 30 swab samples each hour. Qiagen added that the take a look at accurately diagnoses a optimistic coronavirus an infection 90% of the time and accurately diagnoses a unfavourable 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 it is going to be capable of manufacture.
In a press release, Bernard added that the antigen assessments are supposed to complement, not change, the molecular, or PCR, assessments, that are essentially the most correct assessments available on the market. PCR assessments, nevertheless, are depending on a strained provide chain of technical laboratory gear, have to be processed by skilled scientists and may take hours or days to yield outcomes.
The corporate added that it’ll additionally apply for certification in Europe.
“The Entry Antigen Take a look at is quick, simple to make use of and cost-effective and can be a helpful instrument to handle the to date unmet high-volume testing wants for SARS-CoV-2 antigens in conditions the place time is of the essence,” Bernard stated in a press release. “It can ship extremely correct outcomes and can complement the gold-standard PCR assessments used for detection of energetic COVID-19 an infection. PCR assessments provide a excessive stage of diagnostic accuracy however are time-consuming and lab-bound.”
— CAutopresse.eu’s Meg Tirrell contributed to this report.