Qiagen to launch speedy coronavirus take a look at it says might be utilized in airports, stadiums
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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 transportable and might 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 Take a look at, is granted FDA authorization for point-of-care use and if it is waived from the necessities underneath the Scientific Laboratory Enchancment Amendments, Qiagen mentioned, the take a look at might be utilized in high-volume settings akin to airports and stadiums to check individuals with signs. Quickly testing symptomatic individuals might turn out to be more and more essential within the fall and winter as seasonal influenza, which causes most of the identical early signs as seen in Covid-19, spreads within the Northern Hemisphere.
“The transportable take a look at presents a brand new mixture of velocity and scale that marks an essential 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, 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 leads to lower than quarter-hour, 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 constructive 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 exams “cost-effective.” Qiagen additionally didn’t disclose particulars on what number of exams it will likely be capable of manufacture.
In a press release, Bernard added that the antigen exams are supposed to complement, not change, the molecular, or PCR, exams, that are essentially the most correct exams available on the market. PCR exams, nevertheless, 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 Take a look at is quick, simple to make use of and cost-effective and can be a helpful device to deal with the up to now 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 should ship extremely correct outcomes and can complement the gold-standard PCR exams used for detection of energetic COVID-19 an infection. PCR exams provide a excessive degree of diagnostic accuracy however are time-consuming and lab-bound.”
— CNBC’s Meg Tirrell contributed to this report.