Recently approved at-home COVID tests could make huge strides in increasing testing access and lessening the burden for laboratories. But like other rapid tests, they’re less accurate, and since they’re done outside a medical setting, they’re also more prone to user error.
“A big benefit of home tests ... is that one can get a quick answer if one is unwell, isolate immediately if positive, and break the chain of transmission going forward,” Dr. Christopher LaRocca, a family physician at Cheshire Medical Center in Keene, said in an email.
Despite community testing being readily available now — compared to earlier in the pandemic when test supplies were limited and reserved for front-line health care workers and other groups — it doesn’t reach everyone, LaRocca noted. A recent poll by Quest Diagnostics shows 74 percent of Americans postponed or skipped COVID-19 testing because of worries about contracting the virus, getting delayed results or not being able to pay for it.
The Food and Drug Administration has approved three at-home tests since November under an emergency-use authorization.
However, while these and other rapid tests are helpful, LaRocca said polymerase chain reaction (PCR) tests — performed most commonly with a six-inch nasal swab, which can be taken at testing sites across the state — remain the most accurate.
Also known as antigen tests, rapid tests use a mucus sample from the nose or throat to reveal whether a person is currently infected with the virus that causes COVID-19 by detecting certain proteins of the virus.
And as with other COVID-19 tests, a small percentage of the at-home test results may be false. Therefore, the FDA says for patients without symptoms, positive at-home results should be treated as presumptively positive until confirmed by another test.
People who test negative may also need additional testing, the agency says, particularly those with COVID-like symptoms.
Conducting the test in an uncontrolled home environment could also affect its accuracy, according to the N.H. Department of Health and Human Services.
“Because of that, we encourage people to contact their medical providers if they test positive for COVID-19 with an at-home test, or if they test negative but have symptoms of COVID-19,” spokeswoman Kathleen Remillard said.
Though they are less accurate, the benefit of these tests is how quickly they can determine — with a reasonable degree of accuracy — if a patient is positive or negative for COVID-19. This is especially important for those who need to return to work or school the same day.
The prices of the three FDA-approved home tests differ. And it’s unknown yet if insurance will cover at-home testing, LaRocca said.
The cost of COVID tests given in medical settings varies dramatically. Though private insurers, Medicare and Medicaid are required under federal law to cover these tests, people with and without insurance can still wind up with bills, according to the Kaiser Family Foundation. In July, the nonpartisan foundation reported that a survey of publicly posted prices at larger hospitals across the United States showed a range of $20 to $850 per out-of-network test.
In New Hampshire, those who are underinsured or uninsured can apply through the state for financial coverage of an on-site test, according to the state health department’s website.
The three tests
The first rapid at-home test, approved on Nov. 17, is by California-based Lucira Health. The “all-in-one” test must be prescribed by a health care provider, in part so clinicians can report test results to state and federal agencies, according to a news release from the FDA.
The test is intended for those 14 and older, but younger patients can use it if a medical professional performs the nasal swab for them, the release says.
The test is also authorized for use in point-of-care settings, like hospitals and urgent care centers, the FDA says.
Lucira users will mix their nasal specimen into a solution, and then plug a vial into a portable, battery-operated device that uses a light to show the test result within 30 minutes.
The company did not respond to The Sentinel’s request for comment on the test’s accuracy or when it would become available, and that information is not readily apparent on its website.
The second rapid test, approved Dec. 15, is by Australia-based Ellume Health. This is the first at-home test that doesn’t require a prescription, and can be used on anyone age 2 or older.
To get the results from the nasal swab, which should show up within 20 minutes, users must download a smartphone app, the FDA says.
LaRocca, of Cheshire Medical, said that because the app automatically reports results to public health authorities, the test provides an “important tool for public health scientists and officials to monitor the pandemic.”
The test will cost about $30, and is expected to hit drugstore shelves by the first week of January, according to company spokeswoman Suzanne Sterns.
Ellume’s test accurately identified 96 percent of positive samples and 100 percent of negative samples for those with symptoms, a separate FDA news release says. In those not showing COVID-19 symptoms, the test accurately identified 91 percent of positive samples and 96 percent of negative samples.
The third rapid home test, approved Dec. 16, is by Illinois-based Abbott.
The company’s original $5 COVID-19 test, launched three months ago, has been widely administered by health care professionals at schools and nursing homes.
The home version — the BinaxNOW COVID-19 Ag Card Home Test — will cost $25, according to the company, and can be ordered with a prescription through the smartphone app Navica. The test is approved for ages 4 and up.
A partnering telehealth company, eMed, will have certified guides supervising administration of the test to ensure patients use the nasal swab correctly, as well as to assist with reading the results, a news release says.
Test results will also be shared with the relevant public health authorities.
The BinaxNOW test is currently available on a limited basis, according to spokeswoman Jackie Lustig, but the company plans to distribute 30 million tests in the first few months of 2021. Another 90 million will be produced in the year’s second quarter, she added.
As for the test’s reliability, its positive results had a 91.7 percent accuracy rate, and it was 100 percent accurate in identifying negative results in people within seven days of symptom onset.
In the coming weeks, the FDA says it plans to work with other distributors to put more at-home COVID-19 tests on the shelves.
Overall, LaRocca said offering at-home tests is a step in the right direction.
“Clearly, if someone would not consider community testing, but would consent to home testing and could afford it, it is a reasonable alternative,” he said, “provided that the individual follow-through with appropriate behaviors when the result is known.”