September 3, 2025 | An assortment of “hot-button issues” in point-of-care testing (POCT) remain to be sorted out amid rising patient demand for access to rapid and reliable tests results, mounting financial pressures on healthcare systems, and ongoing concerns about the setting and timing of testing to reap the most clinical benefits. Having actionable results, improving connections to care, and balancing patient anonymity with public health reporting in sexually transmitted infection (STI) testing are among the current topics of dialogue, as highlighted during the Next-Generation Dx Summit held last month in Washington, D.C.
A panel discussion moderated by Nicholas Halzak, director of health policy at Roche Diagnostics, brought a trio of panelists to the table to hash it all out: Sheldon Campbell, M.D., Ph.D., professor of lab medicine at Yale School of Medicine and director of clinical laboratories for the VA Connecticut Healthcare System (who has moonlighted as a singing microbiologist on YouTube); Norman Moore, Ph.D., director of medical affairs for diagnostic division at Abbott Laboratories; and Michael Ryan, Ph.D., partner, McDermott Will & Schulte, who advises medical device manufacturers on a variety of legal and regulatory matters.
The issues can differ depending on the clinical setting, and patients have different treatment needs in their 80s than they did in their 20s, says Moore. Hospitals generally understand diagnostic testing guidelines much better than urgent and primary care centers. On the other hand, some urgent care centers employ chief medical officers (CMOs) to oversee POCT, which increasingly includes rapid molecular tests.
Struggles in achieving continuity of care aren’t limited to POCT, which by virtue of its immediacy might be seen as having the “best connections to care,” says Campbell. But even in his own home environment he has quit trying to convince anyone that a negative COVID test doesn’t rule out having COVID. Beyond understanding what tests mean, there are also economic barriers to buying drugs and systemic barriers to getting tests to people and providers who need them.
Although people generally love self-testing at home, they also need an e-health solution like MyChart, the popular patient portal developed by Epic Systems, whereby they can message their primary care provider and perhaps get treated based on the results, Campbell says. But to realize the possibilities with home testing will require working out who will do the connection work and how it will be paid for.
The optimal use of POCT can conflict somewhat with health system values, which include improving and showing high levels of patient satisfaction as well as addressing antimicrobial resistance. In the context of urgent care especially, better training is necessary to equip physicians to “say yes when you mean no,” says Moore, including when dealing with angry parents. That conversational finesse focuses on understanding the patient experience and the “good news” about avoiding the unpleasant side effects of unnecessary antibiotics, to “lead them to a better answer for their health.”
On the subject of “care deserts”, geographies lacking a comprehensive healthcare system, and increasing access to care in rural areas using telehealth and POCT, Moore says they are at the same time indispensable and anxiety-provoking. “There is nothing like a physical exam,” he adds, especially for elderly and other high-risk patient groups.
As some in the laboratory community have pointed out about the limited uptake of rapid HIV testing, says Campbell, “the sensitivity of a test that the recipient never gets is zero.” Accordingly, the performance of a test in a care desert is “better than whatever isn’t there now.”
“While 70% of medical decisions involve lab tests, 100% of medical decisions involve history and physical findings,” he continues. “The number of medical decisions you make solely on the basis of lab tests is very small, so the impact on care deserts of a scattering of point-of-care tests is [going to be] very small.”
McDermott Will & Schulte, as well as Roche and Abbott, are part of the Point of Care Testing Association that deals with private payers on reimbursement issues with POCT. The coverage policies of commercial and managed Medicare plans tend to either center on a discrete list of tests that can be run and billed for or require some types (often molecular tests) to be sent out to an external laboratory for analysis, says Ryan.
The other big issue is that the Medicare fee structure is based on the weighted median cost reported largely by large reference labs whose price points for POCT are lower than other types of clinical laboratories, Ryan says. Since Medicare rates are publicly available, they are the rates commercial payers will use in price negotiations, keeping reimbursement on a “downward spiral.”
Ryan adds that the policies of commercial payers regarding POC antigen testing have also become less restrictive, owing to their lower price points, while the molecular tests are getting more scrutiny. This puts reimbursement policies in conflict with what diagnostic guidelines recommend, he adds.
Of all the POCT now available, STI testing could have the highest impact in the future, according to Campbell. “If you test somebody for flu, you can give them an anti-flu drug that ... helps them a little bit if you get it to them quickly” when they are most contagious during the first 72 hours of illness. STIs such as gonorrhea, chlamydia, and HIV affect a hard-to-reach population and can be transmitted to multiple people over a relatively long period of time, although the therapies for them are all highly effective and prevent transmission and often serious complications later.
From a clinical and public health point of view, the key advantage of STI testing is that the benefit is “long term and substantial,” Campbell says. “It can only be for economic reasons that STI wasn’t the place we started with this point-of-care journey rather than respiratory viruses.”
The number of STI cases is concerningly high, with some breaking pre-COVID records, adds Moore. Even syphilis has been on a significant upward trend, reminiscent of alarming rates seen back in the 1940s. And it can have congenital implications, leading to stillbirth, neonatal death, or long-term health problems in babies.
“It seems we have a very unusual population where we some people are having less sex than ever before and some of them are having a whole lot,” says Moore, in agreeing to the need for near-patient testing. “When you’re 18, you’re invincible” and might not see a doctor for a decade or more at a stretch, so having STI testing options close at hand can help.
The tricky part is balancing the need for better access to STI testing, which comes with some degree of anonymity, with the need for public surveillance and reporting of STIs. From the standpoint of his 16-year-old self, Moore says he “would have traveled six towns over and paid out of pocket” for a condom—then a commodity available in a locked cabinet behind a pharmacy counter. “And maybe I would have been too afraid to test, so I see the benefit of opening [STI testing] up to primary care and urgent care ... especially for anonymity.”
Moore adds that “abstinence-only programs do not work. If you tell a 15-year-old boy to just say no to sex and they have that opportunity, biology wins.”
The simple answer, in Campbell’s view, is that “if I detect one person with an STI and treat them, at the very worst I am preventing any subsequent transmission ... if that is somebody that I would otherwise not have identified because I have an anonymous patient-driven program.” Even without the contact tracing that would happen with a public program potentially identifying and treating a wider network of people, “I am still accomplishing something.”
His “more profound answer” about achieving a balance between anonymity and public health needs is to study the proposed solution. “Maybe anonymous testing doesn’t help or helps a lot less than we hope it will,” says Campbell. “Maybe we need some mix where you anonymously test ... and if you’re positive you sign up to be reported to public health ahead of time, because people are invincible .... [and might unconcernedly] sign up for that.” Some “weaseling,” he playfully adds, may be required.
One of the lessons that can be drawn from the slow uptake of rapid HIV tests is the impact of patient out-of-pocket costs, says Moore, noting that even $25 is too much for some people. But the test’s over-the-counter availability, with roughly 90% sensitivity, is “better than no test.”
That would not necessarily be the case for individuals who are at high risk of a disease transmittable through casual contact (e.g., COVID) and planning to visit their grandmother, Campbell interjects.
Besides the lesson learned regarding the cost of testing, Moore continues, another is “don’t overpromise.” At-home and POC tests for HIV “had an impact but they didn’t change the world. They were part of a whole set of interventions that have decreased undiagnosed HIV rates from about 25% to 10% to 15% now.”
One question is how a CMO, knowing the higher clinical value of molecular tests, reckons with the push to offer more antigen tests that come with lower out-of-pocket costs for patients. Moore’s advice is to at least hit the high-risk groups—e.g., pregnant women, the elderly, and patients with chronic obstructive pulmonary disease—with the gold-standard tests. The caveat here is that urgent care centers won’t necessarily like having two tests available rather than just one.
More certain is that updates to guidelines for strep testing will be forthcoming soon, reports Moore. When they were last published in 2012, molecular strep tests were not yet available. “The focus should be on getting something confirmatory because culture [still the gold standard] takes 24 to 48 hours,” he says, although physicians still commonly treat with antibiotics even when the results come back negative.
As for the future of POCT, patient demand will ensure there will be significantly more of it. “The cat’s out of the bag, given that we’ve been through COVID,” says Ryan. “Right or wrong, medically or not medically supported, people will just expect [rapid tests]” and for conditions beyond respiratory viruses and STIs.
“In the short term, change is always slower than we think it’s going to be,” says Campell. “In the long term, it’s typically faster than we [expect] ... so in the next five years change will be incremental.” One uncertain but potential “gamechanger” is how open the Centers for Disease Control and Prevention will be to the addition of new analytes.
Healthcare systems are financially strapped, and the situation isn’t improving, he adds. Healthcare has three goals—improve quality, reduce cost, and improve access—but only two seem to be simultaneously achievable.
Moore points to his smartwatch measuring various aspects of his health, in speaking to the expectations of younger populations for more comprehensive and accessible testing options. While he admits to having some “anxieties” about a wholesale shift to near-patient testing, he also can’t imagine life without the ease and convenience of options like home pregnancy tests.