To combat and contain the COVID-19 pandemic, testing has emerged as the both a lynchpin and one of the most of the significant pain points.
This is true for all parts of the health care continuum in the U.S., but for skilled nursing facilities, the need for widespread testing is acute, given how swiftly the novel coronavirus can spread among patients and staff.
That desperate need has also proven one of the reasons why SNFs have faced such a difficult time battling the virus. A shortage of tests across the country has left providers scrambling as they try to rapidly determine whether a cough, fever, or even simple lethargy in a resident is a sign of COVID-19, which has proven extremely dangerous to both the elderly and patients with underlying health issues — in other words, most of the nursing home population.
But as providers seek to mitigate the shortfall of tests, they have to keep in mind some key facts as they navigate a landscape where the market for COVID-19 testing — or at least the marketing of such tests — has exploded overnight.
How to assess COVID-19 tests
There are two major testing categories: the polymerase chain reaction (PCR) category, which identifies the genetic material in the virus itself, and the serology category, which identifies the presence of antibodies — proteins an individual develops when they have had previous exposure to the virus, Dr. Philip Christian, chief medical officer at the clinical laboratory American Health Associates, explained to SNN.
The PCR testing is “a confirmatory, very accurate diagnostic for the virus itself,” Christian told Skilled Nursing News during an April 24 interview.
Antibody tests for COVID-19 have become a hot topic in both the health care setting and beyond, since they can indicate possible immunity to the coronavirus — and if immunity becomes widespread, it could be a sign that some semblance of normal life might resume. But testing for antibodies has been fraught with issues related to accuracy and reliability, the New York Times reported on April 19, as test makers have flooded the market after the Food and Drug Administration (FDA) permitted the sale of antibody tests without formal federal review or approval.
Aggressive testing, however, is essential to understanding the day-to-day prevalence of COVID-19, Dr. Arif Nazir, the chief medical officer at Louisville, Ky.-based skilled nursing operator Signature HealthCARE noted in an e-mail to SNN dated April 28.
While PCR testing will continue to be the cornerstone for diagnostics, serological testing will be necessary to assure patient and staff immunity, he explained.
But SNFs have to be cautious when it comes to these tests.
“There are many serological testing companies out there, and most are not approved, so we will have to be smart about selecting the ones with valid testing kits,” he said.
That said, there are some ways SNFs should be checking companies who do PCR testing as well.
“You go after PCR testing, or the other DNA, RNA testing companies, and then you look at their sensitivity, specificity ratios and if they are FDA-approved,” Nazir said in an April 21 interview. “Then you talk to them and see how long they’ve been in business, and what kind of clientele they have. Those are some of the things you do to find the right credible partner.”
Serological tests are useful primarily as a supplement to PCR testing, Christian said. These tests look for two antibodies: immunoglobulin M (IGM), which appears first — anywhere from five to 10 days after a person is infected with a virus — and immunoglobulin G (IGG), which appears 14 to 30 days after infection with a virus and gives an indication of a person’s transient immunity to that virus, he explained.
“The antibody testing really gives you a picture of the history of the infection in any individual, and across the course of a longer period of time, you can actually determine how an individual’s immunity is modulating with respect to COVID,” Christian said. “Within a facility, the ability to test serum antibodies for all of your patients gives you a really good indication of how your facility as a whole is handling the spread of the disease. That’s really important for nursing homes, because they have their procedures for isolating patients who’ve been exposed for certain periods of time, their processes for allocating staff to take care of those patients.”
Christian said he appreciates the concerns about false positives in antibody testing — where the result might suggest a person has antibodies, indicating infection and some subsequent level of immunity — emphasizing that PCR testing is not perfect.
The main concern is a so-called “false negative,” Christian noted. The PCR test might produce a negative result, indicating the person tested does not have COVID-19 when he or she actually does — which could prove disastrous for cohorting patients and trying to designate staff to caring for those with COVID-19.
“One of the uses for the antibody test is actually as a secondary confirmation for the PCR test, because the PCR test does have a degree of false negative,” Christian explained. “In combination, the two tests kind of check each other and really put the whole picture together.”
The Miramar, Fla.-based American Health Associates has been working to bring COVID-19 testing in-house, and the antibody tests uses have clinical sensitivity of more 90% and “close to 100%” for the antibody testing — though none of them are exactly 100% clinically sensitive, Christian said. But in terms of its use as secondary confirmation of PCR testing, it is “extremely beneficial.”
Supply issues extend to COVID-19 testing
Supply issues for SNFs have been primarily concentrated in the shortages of personal protective equipment (PPE), but testing supplies have also emerged as a critical concern.
“Most of the states, I would say, are challenged in terms of a nationwide shortage of testing material — not just the PPE, but also the testing materials and nasopharyngeal swabs that are used to collect a specimen, the transport medium you to make sure that the assessment integrity is maintained,” Christian explained.
SNFs need to reach out to their laboratory partners, AHA CEO Christopher Martin advised, as many of the materials needed to perform the testing are in high demand.
Christian echoed that advice, noting that much of the work at AHA involves walking SNFs through the testing guidelines from the Centers for Disease Control and Prevention (CDC) and explaining the different results and interpretations of those results.
“We really function as a partner with the nursing home service, and that’s the capability that labs like LabCorp and Quest, they just don’t have that bandwidth,” he said.
Nazir, for his part, also emphasized the importance of finding the right partners, noting that this includes states, lab companies, and PPE suppliers.
But he also hammered home the need for SNFs to put resources into being proactive and finding those partners — particularly investing in people who are helping to study and vet available COVID-19 test offerings, according to the April 28 e-mail.
“There’s so much noise around all these companies: ‘I want to do 10-minute tests, 15-minute tests,'” Nazir said in the April 21 interview.