The Food and Drug Administration (FDA) has given emergency approval to a COVID-19 antibody test. The manufacturer of the test is Swiss drug maker Roche. The test boasts near-perfect accuracy according to the company’s press release.
What the test can tell us
Roche said the new test can determine whether someone had a past infection. It has proven 100% accurate at detecting antibodies in the blood. The test is 99.8% accurate at ruling out the presence of antibodies. The company says the test requires intravenous blood draws. The greater blood volume helps with higher accuracy than finger-prick tests.
Thomas Schinecker, the company’s head of diagnostics 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… You have to have very, very high specificity. Even 0.1% or 0.2% makes a difference.”
Schinecker said the tests are an important step in determining whether someone may have immunity. He acknowledges the need for more research to determine if antibodies protect people from re-infection. “Since this virus is not well known, one can hypothesize, but the proof will take longer… Testing these people … is key to seeing whether or not people really have developed immunity.”
What’s different about this test?
The test can be run in high volumes on fully automated equipment. This suggests it could provide more results far faster than other tests available. Thomas Schinecker says, “We are increasing the speed definitely by a factor of 10,” in an interview with Bloomberg News.
The new Roche tests will now be available in markets that accept the European CE-mark certification. They are run on Roche’s widely available Cobas 6800/8800 systems. Results are available within 3.5 hours assuming immediate proximity to the analysis machine. Roche says it would have millions of tests available each month. The company has a commitment to push the limits of its production capacity.
Now we should be able to determine how far from herd immunity we are. When that info comes available a reasoned plan forward becomes possible. The question is how aggressive will our handlers be in actually determining the facts of our situation?
Prudent public health actions require accurate test information
If the test were made available at grocery store parking lots we could have an answer PDQ. We could obtain a statistically significant sample in a day… Certainly, the assertion assumes the availability of a sufficient number of the tests, people, and machines to analyze results.
It also assumes sufficient motivation by public health departments to do the tests. Both tests and phlebotomists should be free. Those willing to volunteer should receive testing. This is an opportunity to quantify risk levels and the portion of the population still at risk.
Thomas Schinecker, Roche’s head of diagnostics, said the company aims to 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. Governments, businesses, and individuals are seeking such blood tests. From them, it may be possible to learn who may have had the disease, who has some immunity, and to craft strategies for ending lockdowns.
Alternatives review
Rival companies have similar antibody tests. The competition includes U.S.-based Abbott Laboratories (ABT.N), Becton Dickinson (BDX.N), and Italy’s DiaSorin (DIAS.MI). Abbott says the specificity and sensitivity of its test are 99.5% and 100% respectively. Diasorin has said its Liason XL test has 97.4% sensitivity and 98.5% specificity.
Roche did not disclose a price for its test. It did say the price would be identical worldwide. Schinecker foresees a high need for testing healthcare workers and their families. He also expects demand from those with exposure and those who show or have shown signs and symptoms.
Antibodies typically confer some immunity. However, Schinecker acknowledges much remains to be learned about the novel coronavirus. Drawing definitive conclusions at this point is premature. “Since this virus is not well known, one can hypothesize, but the proof will take longer… Testing these people … is key to seeing whether or not people really have developed immunity.”