President Donald Trump has recommended that states step up testing as they begin to relax some of the tough social distancing measures imposed to fight the coronavirus pandemic, which has infected more than 1.3 million people and killed more than 80,000 across the United States, according to data from Johns Hopkins. Some say that America has to run 20 to 30 million tests a day to start bringing the economy back to normal. But there is confusion in the industry as companies pursue various testing methodologies and approaches to tackle this key problem.
Most of the current Covid-19 tests require technology available in the laboratory and require personnel who know how to run the test and resolve problems. There is now a movement to develop simple home tests that can be used by the masses by the end of the summer before the flu season. The goal: to advance technology, so that they can be sensitive enough to report asymptomatic individuals and be friendly so that they can integrate with mobile devices and transmit data to all those who need it.
It’s a big challenge. Last week, the National Institutes of Health told scientists that if they developed such rapid coronavirus tests, they would offer funding and support an inventor or company with promise.
Many companies are trying to answer the call. Alphabet Verily’s life science company has launched a screening and testing site that could help speed up testing for the coronavirus. With the help of company volunteers, he also helped launch on-site tests in California and works with the Rite-Aid pharmacy.
“We are working with federal, state and local officials on the development of smart tests,” Verily medical and scientific director Jessica Mega said on Tuesday at CNBC’s Healthy Returns virtual conference.
Mega said it’s important to understand that the same testing strategies won’t work everywhere.
Rural areas with more social distancing at the start may have lower infection rates, for example, and less need for testing than hotspots. “We have to get the right tests to the right people. It’s not just tests, it’s smart tests,” said Mega. “In hot spots, we will want to test more frequently.”
There have been over 9 million Covid-19 tests and 1.3 million positive tests, according to the COVID monitoring project.
A health worker processes a Covid-19 antibody test for a patient at the Diagnostic and Wellness Center in Torrance, California, May 5, 2020.
Valerie Macon | AFP | Getty Images
Speaking at the CNBC virtual event earlier today, former FDA Commissioner Scott Gottlieb said many antibody tests already available from companies are reliable, but no single test result should only be used for individual patient decision-making, as there has been a high “false positive” rate. He said that no one should think that they were in the clear and that they had developed immunity from an antibody test. Antibody tests must be repeated twice and two positive results obtained to have confidence in the value of the test.
Health experts at the virtual event noted that what may soon happen is a so-called antigen test that can quickly detect active infections by looking for viral surface proteins.
These could theoretically augment PCR tests – polymerase chain reaction tests – which are the standard for Covid-19. These diagnostic tests are widely used today but difficult to extend for mass testing because they require qualified personnel to perform them.
If they evolve and offer a high degree of precision, doctors anticipate that they can be used at home where individuals can get an answer within minutes.
The US Food and Drug Administration released the first emergency use authorization for antigen testing to help quickly detect the coronavirus. These tests quickly detect fragments of proteins called antigens found on or in the virus by testing samples taken from the nasal cavity using buffers and can provide results in minutes.
Becton Dickinson & Company CEO Tom Polen said faster antigen tests are starting to yield faster results, but they should stay mostly in doctors’ offices and pharmacies for at least a few months before becoming easier available for home use.
The workplace is also an environment in which antigen testing decisions will need to be made. Becton Dickinson still has two-thirds of its employees in manufacturing plants, and Polen said it needs to give serious thought to how to protect them and, as antigen testing becomes more widely available, consider testing in real time as employees get to work, or maybe come on a rotating basis.
“Antibodies are the reason we can fight … but it’s not as simple as just having antibodies to know you wouldn’t be at risk,” said Mega, adding, “People have different levels of antibodies, and therefore will do several tests for “How do we get people back to work safely?” It’s not just a simple yes / no phenomenon, green / red light. “
It is also promising to use CRISPR, a gene editing technique to diagnose the new coronavirus as quickly as a pregnancy test, Mega noted during the virtual event.
Health care experts have agreed that it is essential to have a national strategy for testing in a sensitive and fair manner.
Polen noted that while testing improves accuracy, speed and access, it will never replace basic precautions, such as masks and hand washing.