A proposal for the antibody test was approved by the US government and Roche Holding AG (Roche) would start examining blood samples of several millions of people to find out if they have immunities that can protect from COVID-19 disease, caused by the coronavirus.
The Swiss drugmaker said on Sunday, May 3, 2020, that the company won an emergency approval from the US Food and Drug Administration (FDA) for an antibody test to determine whether some people were immune from the virus infection.
Roche’s Antibody Tests
The head of diagnostics at Roche, Thomas Schinecker announced that it would conduct blood tests to learn who might have had the disease and who might have some immunity to defend from the virus infection. Keeping this view, the drugmaker said in a statement that it has a target to conduct more than double production of tests from about 50 million a month to significantly more than 100 million a month by the end of the year.
Basel-based Roche, which has been also making molecular tests to identify active COVID-19 infections, said its antibody test has a specificity rate exceeding 99.8% and sensitivity of 100%, which showed that it has very few false positives and no false negatives. It is generally understood that a false-positive result could lead to the mistaken conclusion that someone has immunity.
Roche said the test focused on intravenous blood which has higher accuracy than finger-prick tests. Schinecker said, “If you take blood from a finger prick, you will never be able to achieve the same level of specificity that you will achieve … when you take blood from the vein.” He added, “You have to have very, very high specificity. Even 0.1% or 0.2% makes a difference.”
Competitions from Rivals
A wide range of antibody tests, for the COVID-19 treatments, has also been conducted by drug manufacturing companies including Abbott Laboratories (Abbott), Becton Dickinson, and DiaSorin. While Abbott claimed that the specificity and sensitivity of its test scored 99.5% and 100% respectively and Diasorin has said its Liason XL test has shown 97.4% sensitivity and 98.5% specificity.
Schinecker viewed that the tests would be focusing on healthcare workers, their families for exposure, and those who showed signs and symptoms, to determine if they have antibodies. While antibodies typically confer some immunity, Schinecker, however, claimed that they needed to learn about the coronavirus before any conclusion.
He emphasized, “Since this virus is not well known, one can hypothesize, but the proof will take longer,” adding that “Testing these people … is key to seeing whether or not people really have developed an immunity.”
Meanwhile, a Reuters’ investigation told that the rise of demand for antibody tests had encouraged an array of distributors with no background or established testing competency to join hands with the experienced companies in an all-but-unregulated marketplace in the US.
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