>>Apoorva Mandavilli, The New York Times
Published: 2020-10-16 12:43:40 BdST
The study, conducted by scientists at the University of California, San Francisco, is among the first head-to-head comparisons of a rapid test and the PCR diagnostic tool under real-world conditions.
But the number of participants was comparatively small, and the data have not been peer-reviewed or published. A rapid test still cannot conclusively determine that an individual is not infected; the tests are intended primarily to detect the presence of high levels of the virus, rather than its absence, and are authorized only to evaluate symptomatic people.
At the moment, anyone who has been exposed to the virus should be tested by PCR, said Joseph DeRisi, an infectious disease expert at UCSF and a co-leader of the project.
Still, the finding offers hope that rapid tests can be used even more widely to help contain a pandemic that is resurging in the United States. Some epidemiologists have argued that the country relies too heavily on cumbersome PCR tests for screening even as the coronavirus flies through communities.
The new test, Abbott’s BinaxNOW, offers results in 15 minutes, compared with the days or weeks people may have to wait for a PCR result.
The Trump administration already has purchased 150 million BinaxNOW tests and plans to ship them to states for use in schools, nursing homes and meatpacking plants. The tests could also be used to screen people in communities where time, trust and resources are in short supply.
The study assessed the BinaxNOW in one such community, a largely Latino neighbourhood in San Francisco. On three mornings in late September, as commuters emerged from a BART train station in the Mission District, they were offered two nasal swabs: one for a PCR test, the other for the rapid test with a simple readout.
The commuters received only the PCR result, by text, but the researchers compared both tests.
Of the 878 people who took the tests at the train station, only 26 tested positive on the researchers’ PCR. BinaxNOW identified only 15 of them.
But many experts have argued that the PCR test is too sensitive, picking up fragments of the coronavirus lingering in the body long after people have recovered and are no longer infectious. A study by the company Becton Dickinson recently showed that rapid tests correlated better with live virus than PCR.
But when they only considered PCR results that corresponded to high viral loads, the researchers found that the BinaxNOW test detected 15 of the 16 people who were most likely to transmit the virus.
“This card will do pretty well at detecting the most infectious people, the people who are actually spreading virus,” DeRisi said, referring to the BinaxNOW. “On the whole, I’m pretty encouraged and very optimistic.”
Dr Yuka Manabe, an expert in infectious disease diagnostics at the Johns Hopkins Bloomberg School of Public Health, said, “It’s a very nice illustration of how an antigen test could be used in real life and might find those patients who are most likely to transmit disease.”
The new study was led by Unidos En Salud, a collaboration between researchers at UCSF and the Latino Task Force on COVID-19.
A study in April by the same team showed that 11% of Latino participants at another train station tested positive for the virus when PCR was used, compared with 2.6% in the city overall.
About 90% of people who tested positive in that study were essential workers, and 88% made under $55,000 a year, said Jon Jacobo, chair of the health committee for the Latino Task Force. Community members living in the country without legal permission may also not have access to sick pay or to state and federal benefits, he said.
The task force worked with the researchers to design the study and make it financially possible for those who tested positive to isolate. The organization offered two weeks of groceries to those with positive tests, and a community wellness team delivered other necessities.
Beginning July 1, the city guaranteed two weeks of minimum wage, or $1,285, to anyone who should isolate but could not afford to do so. “The important thing is to always truly have a partnership with community,” Jacobo said.
The project benefited from the researchers’ experience conducting HIV studies in sub-Saharan Africa. “Working in rural areas in Africa is all about talking with the community and asking the question, ‘What works for you?’” said Dr. Diane Havlir, an infectious disease expert at UCSF who led the project.
In this case, she said, the community expressed interest in flu vaccination, so the team worked with Walgreens to offer free vaccines at the test site.
Havlir and other experts acknowledged that BinaxNOW had limitations.
Simple as the test may be, it should be used only by people who are trained to interpret the results, cautioned Jennifer Nuzzo, an epidemiologist the Johns Hopkins Bloomberg School of Public Health.
The tests are “supposed to be administered by a health care professional, but occasionally that gets interpreted as ‘as long as a doctor signs off,’” she said.
Nearly half of those with high levels of the virus did not have symptoms, the UCSF researchers found. The number was similar in the group who tested positive by PCR.
That result suggests that “whether you have a high viral load or low viral load doesn’t really matter; you can still equally be asymptomatic” said Dr KJ Seung, chief of strategy and policy for COVID-19 response in Massachusetts.
Most coronavirus tests, including various PCR versions, have not been independently tested or compared against alternatives.
In September, the Food and Drug Administration released results of one effort to assess the tests’ sensitivity. The analysis was imperfect, but it offered some insight into the tests’ sensitivity, experts said.
The FDA panel looked for the tests’ ability to detect the virus in a series of dilutions, as a rough proxy for their sensitivity. The PCR test developed by the Centers for Disease Control and Prevention ranked somewhere in the middle. Another rapid test by Abbott, called ID Now, is near the bottom.
“What’s been difficult as a lab director is that when you look at one package insert compared to the other, the manufacturers weren’t consistent about how they assess their limits of detection,” said Dr Susan Butler-Wu, director of clinical microbiology at the University of Southern California. “So I find this very helpful.”
A representative at Abbott said the ID Now test had been put at a disadvantage in the FDA analysis because of the sample-handling method the agency used.
Rapid tests have received a wave of negative attention following reports of inaccuracies in two such tests used in Nevada. The White House once relied on ID Now to screen visitors, a practice many scientific experts regarded as misguided.
Rapid tests are authorized by the FDA for screening people who are symptomatic and early in the course of their illness.
BinaxNOW is the test that produced negative results on “consecutive days” for President Donald Trump, according to a report Monday from his physician, Dr Sean Conley.
There is no question that rapid tests are less sensitive than PCR, but they are still valuable, said Kelly Wroblewski, director of infectious diseases at the Association for Public Health Laboratories.
“The alternative is that everybody gets a PCR, where then you’re going to have delays in getting a result,” she said.
Epidemiologists have wrestled before with the role that rapid testing should play in a fast-spreading epidemic.
In Guinea, during the Ebola outbreak of 2014, most people who were infected experienced fever, diarrhoea and body aches — symptoms of any number of pathogens that circulate in Africa.
“We could not scale PCR to screen the thousands of people who have those symptoms every single day in West Africa,” recalled Dr Ranu Dhillon, an epidemic response expert at Brigham & Women’s Hospital in Boston.
A rapid test in development was stymied by FDA regulations and by concerns about false positives, he said, and was never deployed.
A study in the journal Nature later estimated that rapid screening could have reduced the scale of the Ebola epidemic by one-third.
© 2020 The New York Times Company