Why False Positives Matter, Too

In the high-stakes world of coronavirus testing, one mistake has taken center stage: the dreaded false negative, wherein a test mistakenly deems an infected person to be virus-free.

These troublesome results, experts have said, can deprive a person of treatment and embolden them to mingle with others, hastening the spread of disease.

But false negatives are not the only errors bedeviling coronavirus diagnostics. False positives, which incorrectly identify a healthy person as infected by the virus, can have serious consequences as well, especially in places where the virus is scarce.

Although false positives may seem relatively harmless in comparison with their false-negative cousins, “people can absolutely get hurt,” said Dr. Benjamin Mazer, a pathologist and diagnostics expert at Johns Hopkins University.

False positives are generally very rare among tests that have been vetted by the Food and Drug Administration. But any test can be plagued by contamination, mishandling or technical glitches, leading a device to spot the coronavirus where it is not.

Some rapid tests, which forgo sophisticated laboratory equipment and can deliver results in under an hour, have been criticized for returning high numbers of false positives, especially when used to screen people without symptoms. Even laboratory tests that rely on a very reliable technique called polymerase chain reaction, or P.C.R., have been known to return the occasional false positive.

In places where the virus is relatively scarce, false positives may even outnumber actual positives — eroding trust in tests and, under some circumstances, prompting outbreaks of their own.

A positive result on a coronavirus test sets off a cascade of consequences. According to guidelines published by the Centers for Disease Control and Prevention, people who test positive should immediately isolate for at least 10 days after their symptoms start (if they experience symptoms at all).

That is 10 days spent away from friends and family, and 10 days of potential productivity in a school or workplace lost.

The ever-increasing availability of virtual platforms might make that transition easy for some, Dr. Mazer said. But for people whose work can only be done in person, or who lack a financial buffer, “this could be a huge deal,” he said. “They could lose their paycheck. They could lose their job.”

Caregivers, too, may find themselves put in a precarious position by false positives, which could force them to separate from children, older family members or other vulnerable contacts. Should another person need to come in and take their place, the risks of exposure to the virus could increase for all involved.

And for facilities with limited space, placing a person in unnecessary isolation could shift equipment, medical care and even follow-up tests away from someone who might need those resources more.

Under certain circumstances, a false positive could seed new coronavirus cases. Crowded facilities, such as nursing homes, prisons or hospitals, might isolate coronavirus-positive people together.

In a worst-case scenario, “if someone isn’t actually positive, we could be sending them to their death,” said Dr. Valerie Fitzhugh, a pathologist at Rutgers University.

In early October, officials in Nevada ordered the state’s nursing homes to halt the use of two rapid coronavirus tests until further notice, citing concerns about accuracy. (Nearly 40 percent of the country’s known Covid-19 deaths have come from nursing homes, according to an analysis by The New York Times.) A rash of false positives had been uncovered, according to the directive, which had risked placing uninfected residents into units with infected people, giving the coronavirus more opportunity to spread. Such a scenario “could result in causing harm to a population that we have collectively worked so hard to protect,” officials noted in a follow-up directive. Under pressure from the federal government, Nevada officials revoked the rapid testing prohibition on Oct. 9.

False positives can also be disastrous from a treatment standpoint, said Linoj Samuel, a clinical microbiologist at Henry Ford Health System in Detroit. People with the flu or Covid-19, for example, often show similar symptoms, but may only be tested for one of them at a time. If a patient is given an incorrect diagnosis of Covid-19, that person could be deprived of treatment that could alleviate their illness, or be given a costly therapy that does little to speed their recovery.

“That’s definitely a price you pay,” Dr. Samuel said.

Mounting evidence suggests that most people who have fought off the coronavirus once retain a degree of immunity that can thwart the virus a second time. Scientists do not know how long this immunity lasts, or how it varies from person to person, but the C.D.C. has issued guidelines that note that reinfection is unlikely within 90 days. People who don’t have symptoms within this time window do not need to be tested again, the agency has said.

That could be helpful advice for people who actually contracted the coronavirus. But people who unknowingly receive a false positive on a test might be misled into thinking that they are invincible, said Saskia Popescu, an infection prevention expert at George Mason University.

However, if these people never actually encountered the virus, they would be just as vulnerable as before — if not more, should they choose to forgo masks or physical distancing after assuming their bodies are already bolstered against the virus.

Dr. Catherine O’Neal, an infectious disease specialist at Louisiana State University, expressed similar concerns when discussing a false-positive result given to the University of Alabama football coach Nick Saban this month. Should someone be dropped from routine testing, Dr. O’Neal said, they would not just imperil their own health. A false positive could put an entire group of close contacts at risk.

With so many of the long-term consequences of coronavirus infections unknown, a positive result can understandably take an emotional toll on the person who receives it, Dr. Fitzhugh said. “You hear that news and the first thing you think is, ‘I could die,’” she said.

On a recent call with Adm. Brett Giroir, who has led the nation’s coronavirus testing efforts, Ruth Katz, senior vice president of policy at LeadingAge, an association of nonprofit providers of aging services, noted that the repercussions of false positives had been a source of extra heartache among residents and staff members.

Dr. Mazer noted that false positives on coronavirus tests were likely to evoke some of the same stressful reactions as when other types of clinical screens like mammograms, which search for signs of breast cancer, return incorrect results. “We see the anxiety, the frustration,” he said.

As testing in the United States continues to increase, experts have expressed concerns that frequent and high-profile diagnostic errors could seed disillusionment among the general public.

Tests with a reputation for spitting out incorrect results of any kind might struggle to gain widespread traction. People who are wary of coronavirus tests might even become more hesitant to take other types of tests, for fear that they will not be given the answers they require.

More frequent and accessible testing is needed — but putting it in effect could be more challenging if the public is less willing to engage, Dr. Mazer said. “That could have long-term consequences.”

These concerns and more have prompted several experts to call for more data evaluating how different types of tests perform outside of laboratories and clinics, in places where most sick people go to get a diagnosis. Some tests may be able to effectively screen the healthy and quash outbreaks before they spin out control, while others are ill-suited to for this purpose. Depending on the circumstances, certain tests might need their results to be confirmed with a second, more accurate test.

As testing efforts ramp up nationwide, experts said, people taking tests will need to be well versed not only in the benefits of tests but in their limitations as well.

No test is perfect, Dr. Fitzhugh said. But tests, and the ways in which they are deployed, must still be vetted thoroughly before they are rolled out in large numbers, she said. “People need to know that the tests they receive are the best we have to offer.”

Source: nytimes.com

Tags: health

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