In a major announcement today, Siemens Healthineers is planning to launch an antibody test on COVID-19. The German company hopes to be able to create a test with more than 99 percent accuracy and able to deliver a result in just 14 minutes. With countries across the world looking to increase or maintain high a testing volume, the company states it hopes to produce more than 25 million tests per month starting in June.
In a statement, the company said: “With a proven sensitivity and specificity of more than 99 per cent, the test is expected to exceed strict FDA quality guidelines.”
The test is currently awaiting approval from regulators in Europe and the US.
Deepak Nath, PhD, President, Laboratory Diagnostics, Siemens Healthineers said: “Siemens Healthineers is working diligently to address the need for high-quality tests in the fight against COVID-19.
“This test is being designed with the precision and controls, sensitivity and specificity that laboratories have come to expect from our immunoassay tests.
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“I am especially proud of the dedication of our colleagues involved in development of this test—many of whom are based at the U.S. epicentre of the pandemic.”
The potential breakthrough comes amid concerns that current antibody tests are inaccurate.
Researchers in Oxford discovered that nine prototypes currently under consideration by the Government performed poorly and were inaccurate.
The confirmation of the inaccurate tests was confirmed this week by Tory MP, Helen Whately.
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Speaking on Sky News, she said: “My understanding from the clinical advisers is that some of the early tests were evaluated and the evaluation is that they weren’t effective enough.
“This is a normal process when you are using a test for an illness when this is a new illness.
“Those that were tested with the test that wasn’t up to scratch have been written to and offered another test.”
Although developing a vaccine remains paramount, providing an antibody test which could identify who has had the coronavirus and therefore show immunity is incredibly valuable.
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By showing immunity, this could give members of the public to be given the all-clear to leave quarantine and return to work.
However, Sir John Bell, Regius professor of medicine at the University of Oxford revealed none of the current tests would be designated as accurate earlier this month.
He said: “We see many false negatives tests where no antibody is detected despite the fact we know it is there and we also see false positives.
“None of the tests we have validated would meet the criteria for a good test.
“This is not a good result for test suppliers or for us.”
Away from antibody testing, the first human trials on the vaccine will begin in Oxford.
This week, Matt Hancock revealed both Oxford University and Imperial College London will receive additional funding to work on a vaccine.
Imperial will be given £22.5million while Oxford an additional £20million to work on a vaccine in order to combat the virus.
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