🔒 Accurate Covid-19 antibody test raises spectre of ‘immunity dompass’ – The Wall Street Journal

At last – an accurate anti-body test approved for emergency use which can help guide our response in mitigating the spread and allocating our healthcare resources more efficiently. By June, when South Africa may ease lockdown restrictions further (even though the infection rate will inevitably spike), manufacturing giant Roche says it will be able to produce millions of antibody test kits per month. Why is this important, given that we’re not talking about a vaccine or a cure? Because the experience of third world communities where living cheek-by-jowl in townships is all too common, the Covid-19 infection rate is often inexplicably lower than in surrounding areas. This suggests that living with constant, ubiquitous infections and viruses creates greater immunity among these populations – giving some protection against the coronavirus. Untested; until now. All that remains is clarity about what constitutes ‘emergency use.’ You’d think any tool that prevents death by enabling more accurate mitigation measures qualifies for ‘emergency use.’ While it’s unproven that those who’ve recovered from a Covid-19 infection are fully immune from re-infection, (scientists still don’t know how long antibodies stay in the blood), it opens up a world of potential for those who desperately need to earn money to avoid, at best malnutrition, and at worst starvation. An immunity ‘dompass’ may not be so far-fetched. – Chris Bateman

Roche coronavirus antibody test wins FDA approval for emergency use

By Denise Roland

(The Wall Street Journa) – The Food and Drug Administration has cleared for emergency use an antibody test from diagnostics giant Roche Holding the company said Sunday, a move that could add significant capacity to efforts to determine the wider spread of Covid-19.
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Roche’s test, which identifies antibodies made by the body to fight off the new coronavirus, is designed to tell people whether they have been infected in the past. For many diseases, antibodies remain in the blood for weeks, months or even years after infection. Antibody tests are performed on a blood sample and are different from the swab tests used to diagnose a current infection.

Antibody tests are seen by many governments around the world as key to better understanding the spread of mild and asymptomatic cases of Covid-19, although so far most commercially available tests – around 10 have so far received emergency clearance from the FDA – aren’t deemed accurate enough.

Roche says its test has proven 100% accurate at detecting Covid-19 antibodies in the blood, and 99.8% accurate at ruling out the presence of those antibodies. In other words, only two in every 1,000 samples lacking the antibodies would produce a “false positive” result.

Thomas Schinecker, who leads Roche’s diagnostics business, said in an interview that the company was able to run its test on around 6,000 blood samples, a figure he said was significantly higher than smaller rivals. He said the test reliably detects antibodies when the blood sample is drawn at least 14 days after infection.

Governments around the world hope reliable antibody testing could help gauge how much of the population remains susceptible to the virus, in order to guide decisions about easing lockdowns. Some have even considered issuing “immunity passports” to people who have antibodies that could allow them to, for example, return to work earlier.

In most infectious diseases, the antibodies produced after a first infection act quickly to neutralise any subsequent infection, protecting the person from falling ill again. But even a reliable antibody test may not be a foolproof way of measuring immunity against Covid-19. Because the virus is so new, scientists still don’t know how long antibodies remain in the blood. What’s more, it is unclear whether it is possible to fall ill from Covid-19 a second time, despite the presence of antibodies.

The Swiss health-care giant’s heft means it can ramp up the provision of its antibody test quickly. The test kits are designed to run on the company’s automated machines, which are already installed in more than 100 laboratories across the US. They will be made available immediately.

Roche says it will be able to churn out test kits, made in Germany, in the high double-digit millions per month by June. The company aims to double that capacity by the end of the year, said Mr. Schinecker.

Write to Denise Roland at [email protected]

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