Becton Dickinson, which manufactures one of two point-of-care COVID-19 testing models that the federal government has sent directly to nursing homes, is investigating claims of false positives in the long-term care setting, the Wall Street Journal reported this week.
The American Health Care Association, which represents more than 14,000 primarily for-profit nursing facilities across the country, has fielded reports of phantom positive COVID-19 results from BD machines at “roughly a dozen” buildings, according to the WSJ.
“It’s enough to warrant taking it seriously,” AHCA chief medical officer David Gifford told the publication.
Presbyterian Village North, a facility in Dallas, moved eight asymptomatic residents who tested positive on the BD machine to a dedicated COVID-19 unit, only to later find that all eight were negative after ordering more precise molecular tests from a lab, the Journal reported; the facility has since stopped using the BD machines entirely.
“We need more assurances on these before we use them again,” Tim Mallad, CEO of the building’s parent company Forefront Living, told the paper.
The Franklin Lakes, N.J. based BD is aware of the reports, a spokesperson told the Journal, and is working with the affected buildings to investigate the issues; such false positives do not align with company studies of the machines’ efficacy, the company asserted.
The point-of-care antigen testing units form the backbone of the Department of Health and Human Services’ (HHS) plan to curb COVID-19 infections deaths in the nation’s nursing homes.
HHS in July announced an initiative to send antigen testing units from BD and fellow medical device manufacturer Quidel to most of the nursing homes in the country, with the process slated to wrap up in mid-September.
While the industry and public health officials expressed some concern about the antigen units’ relatively lower sensitivity as compared with the “gold standard” polymerase chain reaction (PCR) tests, federal officials generally identified a higher chance of false negatives as the primary risk.
“If you get a positive, these are essentially 100% specific. If you have a positive it is positive: You can bet the farm on it. Never 100%, but literally they are operating at about 99-plus percent specificity. If you get a positive, it’s real,” HHS assistant health secretary Brett Giroir said in July.
The federal effort has been met with some confusion and resistance among operators: Back in August, non-profit senior care trade group LeadingAge found that only about a quarter of its members were actively using the units to test residents; another quarter of survey respondents consisted of facilities awaiting additional instructions, while 15% reported simply setting aside the units once they arrived.
HHS followed up the BD-Quidel push with a parallel initiative to send 750,000 tests from manufacturer Abbott — which do not require a machine to process — to nursing facilities in areas of high community spread.
The direct testing support has also come with strict new rules for testing nursing home staff members. Depending on the rate of community COVID-19 spread in the surrounding county, facilities must test workers up to twice per week or face fines and even the potential termination of their eligibility to participate in Medicare and Medicaid — essentially a threat to put facilities out of business for non-compliance.
Given persistent problems with slow turnaround times for PCR tests — which must be sent to third-party labs for processing — the federal government has positioned repeated point-of-care antigen tests as the only feasible way to meet those guidelines and curb outbreaks in long-term care facilities.
“If you can meet CMS standards with highly sensitive molecular tests using PCR, testing residents and staff as often as twice per week, with a turnaround time of 24 hours or less, and can afford to do that — that’s about $1 billion per month in the industry — it is perfectly appropriate to use molecular PCR tests,” Giroir said at the start of September. “If you cannot, as most nursing homes cannot, point-of-care antigen testing is clearly a life-saving option and is available in quantities of 10 billion per month or more.”