[ad_1]
The test would show very few false positives and no false negatives.
Carlos Gustavo Rodríguez Salcedo
Roche has obtained emergency approval from the United States Food and Drug Administration (FDA) for an antibody test that determines whether people have ever been infected with the new coronavirus, the Swiss drug maker said Sunday.
Thomas Schinecker, chief diagnostician at Roche, said the company aims to double test production from about 50 million a month to more than 100 million a month by the end of the year.
Governments, businesses and individuals are trying to perform blood tests to find out who has had the disease, who has some immunity and to develop strategies to help end the confinements.
Roche, which is based in Basel and is also conducting molecular tests to identify active covid-19 infections, said its antibody test has a specificity rate of over 99.8% and a sensitivity of 100%, meaning which would show very few false positives and no false negatives.
A false positive result could lead to the erroneous conclusion that someone has immunity. Roche said its test is based on intravenous blood collection, more precisely than finger prick tests.
“If you draw blood from a finger stick, you will never be able to achieve the same level of specificity that is achieved … when blood is drawn from the vein,” Schinecker said.
“You have to have a very, very high specificity. Even 0.1% or 0.2% makes the difference.”
Similar antibody tests have been developed by companies like Abbott Laboratories in the United States, Becton Dickinson, and DiaSorin in Italy.
Abbott has said that the specificity and sensitivity of his test are 99.5% and 100% respectively. Diasorin has claimed that her Liason XL test has a sensitivity of 97.4% and a specificity of 98.5%.
As the demand for antibody testing increases, a number of distributors with no recognized testing background or competence have also joined companies with experience in a market that is anything but regulated in the United States, according to Reuters research.
Roche did not disclose the price of its test, but said it would be identical worldwide.
By registering you can personalize your content, manage your topics of interest, schedule your notifications and access the cover in the digital version.
