While skilled nursing facilities and their pharmacy partners work to vaccinate staff and residents against COVID-19, they can’t lose track of the testing that is critical to revealing who might be infected — particularly as positivity rates across the U.S. remain high.
According to county positivity data from the Centers for Medicare and Medicaid Services (CMS) as of January 20 — and downloaded by Skilled Nursing News on January 27 — 1,647 counties are listed as “red.”
This categorization means that the counties are reporting COVID-19 test positivity rates of 10% or greater, without meeting any of the parameters around test numbers that would classify them as “yellow” or “green.”
With so many counties at elevated positivity rates — 300 of the counties are classified as either “large central metropolitan” or “large fringe metropolitan” by the Center for Disease Control and Prevention’s (CDC) National Center for Health Statistics (NCHS) — SNFs need to remain vigilant about maintaining regular testing for COVID-19.
Those located in so-called “red counties” are required to test staffers for COVID-19 twice a week.
“We haven’t seen any decrease at all in the demand,” Becton Dickinson global vice president of medical and scientific affairs Chuck Cooper told SNN on January 15. “In fact the demand is just going up, and I think that is reflected by the surge and increasing cases we see in the United States and other countries around the world. And we don’t really expect demand to decrease moving forward in the near-term … the need for testing is likely to continue for some time.”
Over the course of last summer, the federal government started shipping out rapid antigen tests for COVID-19 to nursing homes, with the goal of providing rapid results amid multiple reports of backlogs for SNFs in securing the gold-standard polymerase chain reaction (PCR) test results early in the pandemic.
And while SNFs are understandably focused on the logistics of vaccination, they cannot afford to slacken on their testing efforts either, Cooper argued.
Cooper has some incentive to make this argument, given that BD manufacturers the Veritor Plus antigen test system, one of the devices sent out to SNFs as a result of the Department of Health and Human Services (HHS) initiative. It was also the device that ended up getting sent to the majority of SNFs.
But he also has a point, given concerns about the pace of vaccination efforts across the country.
The initiative to vaccinate the residents and staff of long-term care facilities appears to be mostly on track, with both CVS Health (NYSE: CVS) and Walgreens Boots Alliance (Nasdaq: WBA) reporting they completed the first round of vaccine clinics at facilities under the Pharmacy Partnership for Long-Term Care Program.
But operators are reporting that vaccine uptake among staff members – those most likely to catch the virus out in the community or within their own households — is significantly lagging, compared to uptake among residents. Given that reality and the high rates of positivity across the U.S., nursing homes will have to continue regular testing.
“Hopefully, we can get enough people vaccinated, but the logistics and adoption and acceptance, all of those things represent things that we have to overcome,” Cooper told SNN. “It’s not clear exactly how long that’s going to take; it’s certainly going to take us a while. And in the meantime, we definitely don’t want to let our guard down.”
To that end, the CDC on January 15 released an update to its chart on “Considerations for Interpretation of Antigen Tests in Long-Term Care Facilities,” an update covered by the nursing home trade group American Health Care Association (AHCA).
If a staff member presents with symptoms but receives a negative result on their antigen test, the facility should perform a confirmatory nucleic acid amplification test (NAAT), which includes PCR tests, according to the CDC. If that test comes back negative in a situation that does not involve an outbreak or a close contact with a COVID-positive person, a staffer can come back to work upon meeting the facility’s criteria to do so.
However, in an outbreak situation, the facility should continue serial testing every three to seven days, following recommendations from CMS and the CDC, even if the NAAT test is negative.
If the NAAT test comes back positive, then the staffer should not come to work, and a facility should initiate its outbreak response if it was in a non-outbreak situation at the time.
Meanwhile, if an antigen test comes back positive for an asymptomatic individual, but the NAAT test comes back negative, the next steps depend on whether there was an outbreak or close contact with a COVID-positive person.
If there is no outbreak and no close contact, then health care personnel can return to work. But in an outbreak situation, serial testing should continue every three to seven days, even if the NAAT test is negative. For close contact situations, residents should should stay in quarantine, while staffers would return to work as risk assessments dictate.
All of this translates to a testing demand that won’t slow down, even as vaccine efforts continue.
But crucially, an employee who has been vaccinated will not trigger a positive antigen test result on the BD Veritor system, according to Cooper.
“We’ve actually received that question quite a bit, since the vaccines have been rolled out,” he told SNN. “So we’ve conducted a very careful and detailed analysis of all the major vaccine candidates, and there isn’t really any chance that they could trigger a false result. They target different proteins than our assay.”
In a follow-up statement sent by email to SNN on January 15, BD spokesman Troy Kirkpatrick explained that BD has evaluated the vaccines from Pfizer, Moderna, Astra-Zeneca/Oxford and Johnson & Johnson and found that they use the mRNA and spike protein components of the virus, which are not targeted by the BD Veritor COVID-19 tests.
The CDC issued similar guidance on December 13, 2020.
“Prior receipt of the Pfizer-BioNTech COVID-19 vaccine will not affect the results of SARS-CoV-2 nucleic acid amplification or antigen tests,” the agency noted on page 31 of a presentation on the Pfizer vaccine.
BD is currently producing about 10 million COVID-19 tests per month, Kirkpatrick said in the statement, with that number projected to increase to 12 million per month by March.
“We don’t have specific numbers of tests being sent to nursing homes, as those are filled through distributors,” he said in the statement. “BD is serving more than 12,000 long term care facilities, and reorders for the tests have been steady after the initial orders through the HHS initiative were filled.”
There are several factors that are going to affect when vaccination starts to make an appreciable effect on testing demand, according to Cooper, including the pace of vaccination as distribution expands to a wider population, as well as vaccine hesitancy in general.
For now, he believes diagnostic testing will remain a critical part of addressing COVID-19 over the next several months at least, to say nothing of how non-traditional sites such as transportation hubs might end up using such tests. This is particularly true for SNFs, which house a population highly vulnerable to COVID-19.
“At what point do we get enough people vaccinated, so that we have enough community-level protective immunity to actually make a difference?” Cooper noted. “There are a lot of unanswered questions. For example, we don’t know yet the duration of immunity that’s induced by these vaccines … there’s always the possibility that these viruses can mutate in a way that allows them to evade vaccine-induced immunity to some degree or another — and other basic things that we don’t know yet, like seasonality.”
