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Roche says antibody test for COVID-19 should be ready in May

Company has production capacity needed to make test kits at scale

Roche Basel Switzerland

Roche has completed development of a rapid test to detect if someone has been exposed to coronavirus in the past, and says it could be available as early as next month.

The Elecsys Anti-SARS-CoV-2 serology test could be ready in early May in countries accepting the European CE mark – a self-declared technical validation – and Roche says it is also seeking emergency-use authorisation from the US.

Access to antibody tests that can tell whether someone has been infected with SARS-CoV-2 and recovered – and should therefore have immunity against the coronavirus – could help countries start to relax lockdowns that are hitting economies around the world.

Other antibody tests are starting to become available, but Roche’s announcement carries weight as the company has the production capacity needed to make the test kits at scale. The company says it aims to hit monthly production levels of “high double-digit million tests” by June.

Roche is already providing a lab-based test for active coronavirus infection that involves taking a swab of someone’s nose and throat and checking for the presence of the virus’s genetic material using polymerase chain reaction (PCR) technology, which takes days to get a result.

Antibody tests can be carried out using a blood sample and deliver results within minutes, so are suitable for screening of high risk groups such as healthcare workers and food supply workers, enabling them to continue to work or return to their jobs.

In time, widespread use of the tests could help restart other industries affected by lockdowns as well, helping society return to normal.

“Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available around the world,” said the company. The systems can provide SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour.

Roche’s announcement comes shortly after Abbott, another big diagnostics player, announced it was launching an antibody test prior to FDA emergency-use authorisation. The FDA has also given a green light to serology tests from Cellex, Ortho Clinical Diagnostics and Chembio Diagnostic

Other companies are developing pregnancy test-like kits for coronavirus that could give a yes/no result from a finger prick amount of blood without the need for a lab.

Last month, the UK government was reported to have agreed a deal ‘in principle’ with Derby-based diagnostics firm SureScreen and other companies to buy 3.5m rapid coronavirus test kits, but warned that it could be weeks before these are tested and available.

It also emerged this week that the UK had paid £16m ($20m) for coronavirus antibody tests sourced from two companies in China – AllTest Biotech and Wondfo Biotech – that were found to be ineffective in Oxford University testing.

The government is aiming for 100,000 antigen tests a day by the end of April, but is currently managing only around 16,000.

Article by
Phil Taylor

17th April 2020

From: Research

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