Facility, cost, and some caves

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Home testing for COVID-19 shows great convenience, but pathology experts warn that false positives, false positives, out-of-pocket costs, and the potential for inappropriate sampling from people who are swabbing the nose or mouth itself to damage results.

Experts agree that the COVID-19 test has been challenging and has improved over the past year.

“It’s a very important day,” Kisha Mitchell Richards, MD, FCAP, director of pathology and laboratory at Greenwich Hospital, Greenwich, Connecticut, said at a webinar on March 11 on COVID-19. The webinar was sponsored by the American College of Pathologists (CAP).

“1 year ago today the World Health Organization declared COVID-19 a pandemic and basically set in a year-long stone that was going to change our lives perhaps forever,” Richards said. .

During that time, “PCR testing” became more of a home term, community and preoperative testing changed and expanded, and more home trials received emergency use approval from the U.S. Food and Drug Administration (FDA) . These include the first molecular-based home test, which was agreed earlier in the week.

However, the number and nuances of COVID-19 testing have questioned some people. “People are still having difficulty understanding the tests. This could be due to the shift in focus to the vaccines and / or being overwhelmed and overwhelmed by the amount of information available. is available, “said Patrick Godbey, MD, FCAP, president of CAP and laboratory director of Southeastern Pathology Associates and Southeast Georgia Health System, Brunswick, Georgia.

“Nearly 2 out of 3 Americans, 67%, would like more information about COVID-19 test error,” he said during the webinar.

Screen but Confirm

Tests at home are good screening tools, said Kalisha Hill, MD, MBA, FCAP, CAP governor and chief regional medical officer at Amita Health St. Medical Center. Joseph, Joliet, Illinois. However, she said a laboratory-performed real-time PCR test is the most sensitive and accurate test for SARS-CoV-2.

“The most important thing to recognize is if you have symptoms or suspect you have COVID-19, it is very important to see your healthcare provider and get a real-time PCR test for confirmation,” Hill said.

Godbey shared an adage that applies to all types of testing for COVID-19, including home testing: “Bad data is worse than no data at all.”

False or negative results are not specific to home tests, and remain a concern.

“If you think you’re positive and you’re not, that changes everything you do,” Godbey said. “False negatives are even worse. You see your grandmother, and you go to the office, thinking you don’t have the virus, and that’s it.”

Self-swabbing less sure

“Like the test we do in the hospital and in our laboratories, we need to make sure that the public who do this at home understand the importance of proper collection and storage. , “Carey August, MD, FCAP, president of the board of directors, Foundation of the American College of Pathologists, said during the webinar.” Did he sit in the sun? Did you put it on the heater? All of these measures can contribute to a false negative, which is what we don’t want. “

Proper collection and handling of samples is “critical” to accuracy, said August, medical director of laboratories at the Illinois Candidate Masonry Medical Center, Chicago, Illinois.

“Sometimes people refer to pathologists as a little persnickety about sample collection and sample retention, but there’s a reason for that, and it’s the health of the people we serve,” she said.

It is still important to distinguish between the two main types of home testing, both of which can be problematic. In one type of home test, users swab and send a sample to a lab the same day. Labeling and handling can make a difference, August said.

With the other type of test, the kittens give results at home, but to report results often requires a smartphone or laptop. Some cases may go unreported, and not everyone has access to a smartphone or digital device, Godbey said.

“This could be a problem in vulnerable numbers,” he said.

The out-of-pocket cost associated with COVID-19 tests at home can also be a factor, especially for people who re-test them themselves, Richards said.

“On a purely practical level, cost can also be an issue,” she said. “Some of these tests, unlike the hospital-based laboratory tests or other commercial tests, may not be available. covered by insurance. “

Potential for virus variables

Routine laboratory tests are sensitive to the COVID-19 anxiety variables, such as those from the United Kingdom, South Africa, or Brazil, the panelists agreed. Home trials are similarly looking for these variables, although CAP and the FDA have requested additional information from manufacturers to determine their sensitivity and specificity.

“They’re likely to find the variables, but that’s a question that every manufacturer needs to answer,” Godbey said.

“Some may be sicker if they have one particular variant than another,” Hill said, “and that’s a cause for concern.” So it’s very important that our test platforms are able to to find all these variables. “

Hill reiterated that, particularly in light of changes, the results of people who test positive at home should be confirmed by a PCR test. She recommended getting this diagnosis as soon as possible “so that you can be treated earlier, just in case you have a variant that may be sicker to you than the original type of virus.”

Richards said she did not want to reduce the convenience of home testing, but “there are other things to consider.” For example, if a suspect on COVID-19 is being tested in a laboratory and has a question or concern, “you can contact my laboratory and you can talk to me .

“I can talk to you about your test. I can reassure you. We are accessible,” she said.

COVID-19 collaboration to continue?

One clear area that emerged last year was the higher collaboration among health care providers from different hospital departments, August said. They were cooperating before the pandemic, she said, but the need to communicate and keep everyone as safe as possible greatly enhanced the experience.

“We wanted to make sure we were all working safely and keeping an eye out for each other. It was good to see that this interaction and collaboration in our hospital has continued. through the pandemic, “August said.

“It was there before, but I think it’s going to be very special going on now,” she said.

Damian McNamara is a Miami-based staff journalist. It covers a wide range of medical specialties, including infectious diseases, gastroenterology and neurology. Follow Damian on Twitter: @MedReporter.

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