Home pregnancy tests, blood glucose readings and HIV tests used to be the only diagnostics that Americans administered to themselves. But the battle against COVID-19 pushed point-of-care testing into the mainstream. Early in the pandemic, the public lined up at drive-through centers and in parking lots to be swabbed. But quality at-home antigen tests soon dominated the landscape, with free government distribution of rapid test kits broadening access.

At Johns Hopkins, Yuka Manabe, a professor in the Division of Infectious Diseases, and her diverse team of skilled researchers at the Center for Innovative Diagnostics for Infectious Diseases (CIDID) helped pave the way for these point-of-care tests — particularly in their key role as evaluators of companies developing these technologies as part of an NIH-funded initiative.

The dizzying trajectory of progress in making point-of-care tests better, cheaper and more broadly available both to medical professionals and the public now raises a new question:

What’s next?

Manabe and her team see deploying the technology more widely to meet unmet needs and deepen public health as the answer. Such advances offer a pathway to reach more effectively into underserved communities in the United States and around the world — particularly in addressing sexually transmitted diseases.

“Innovation without access,” quips Manabe, “is not innovation at all.”

CIDID’s task of developing and reviewing the rapid diagnostic tests used worldwide for a wide range of infectious diseases situates the center at a busy crossroads of competing interests: the rigor of epidemiology versus the flexibility to create a rapid path from diagnosis to treatment, individual imperatives versus broader public health concerns.

The recent successes in point-of-care diagnostics have made it an increasingly contested space. Epidemiologists whose efforts depend on collecting data to track the incidence and spread of disease argue that widespread at-home testing will upend the pipeline for essential data gathering if individuals don’t report their results.

Manabe sees the power of a test that lets you know quickly if you are ill or harbor an infection, however, as foundational in any quest to improve global public health.

“We love the concept of individualized public health,” says Manabe, who has led CIDID since 2019. “I love it that I’m helping a person who will stop transmitting the disease to somebody else. To me, that is our sweet spot.”

‘Almost Like a Dating Service’

CIDID boasts 25 core faculty members drawn from across the Johns Hopkins system. These researchers pursue a wide-ranging program that includes gauging levels of resistance to antibiotics, broadening the role of testing in public health settings and refining the commercial pipeline from concept to commercial release. The center’s work has been supported broadly by federal agencies, including NIH, the Centers for Disease Control and Prevention, and the Department of Defense.

The CIDID team has helped create diagnostic tests for gonorrhea, chlamydia and syphilis — as well as the first point-of-care diagnostic for molecular diagnosis of hepatitis C (HCV), which was approved by the Food and Drug Administration in June 2024. With just a fingerstick, the new test makes it possible for nonmedical personnel to deliver a diagnosis of HCV (a particular risk for injection drug users) within an hour — and potentially start treatment right away.

The significant progress in point-of-care testing’s accuracy and speed promises to boost the effectiveness at clinics that are a lifeline for underserved communities in the U.S. and around the world.

“Rolling out of these kinds of technologies not only increases individual and public health, but it also decreases stigma — and we know that that’s one of the barriers to be overcome in order to try and reverse the tide a little bit,” says CIDID team member Matthew Hamill, an associate professor in the Division of Infectious Diseases and clinical chief of sexually transmitted infections at the Baltimore City Health Department. 

The work of CIDID researchers offers potential to meet other urgent unmet needs. Matthew Robinson, an assistant professor in the Division of Infectious Diseases, works on the emerging crisis in antimicrobial resistance (AMR) in India, where 300,000 people died from AMR-related infections in 2019.

“There are some types of antimicrobial resistance that are 50 times as common in India as they are in the U.S.,” says Robinson. “And with these types of resistance, we are down to one or two antibiotics left — and, in some cases, zero, so we have untreatable infections.” He says that the center’s work on point-of-care testing may offer a “cheap and fast” way to detect AMR and more quickly allow for effective treatment.

Creating tests is a complicated process, but many corporations, entrepreneurs and researchers are up for the challenge. CIDID has become a one-stop shop for those who seek help in developing new tests — from initial concept to commercial rollout — including Johns Hopkins faculty members. Currently, the team is either working on or evaluating rapid diagnostics for conditions such as acute febrile illness, sepsis, tuberculosis, diarrheal disease and malaria.

“It’s almost like a dating service,” Manabe says. “We try to link up people who have technology that would apply to a disease that we know has a clinical need.”

The top considerations for developers are accuracy, cost and speed: Studies have shown that most people are willing to wait only 20–30 minutes for a test result. A test also must be easy to use. Can untrained people follow the self-testing instructions correctly? And the test materials must be nontoxic; environmentally friendly components are preferred.

Manabe says CIDID wants all developers who work with the center to succeed if they meet the rigorous demands for accuracy and cost. “We’re agnostic to all devices that come to us,” she says. Competitive pricing is also essential: “If your cost of goods is over a certain amount, we’re not that interested because we just don’t think that that’s going to help the problem.”

William O. Osburn, an assistant professor in the Division of Infectious Diseases, runs the center’s technical core, advising companies and evaluating new innovations appearing on the horizon. While CIDID’s insistence on affordability (under $10 per test, preferably $5) helps the team sift through projects that seek its collaboration, he identifies other hurdles at which the private sector stumbles.

“You have to have a relevant use case too,” Osburn observes. “We’ve brought in companies, and they have these proposals, and it’s like: They never talked to a clinician.”

Effectiveness is essential. “In the end, you’re going to fail or succeed based on your chemistry,” he continues. “You can have the coolest-looking machine that is easiest to use, but if you can’t detect anywhere near what you could do in the lab, it's never going to work [in a clinical context].”

In the Business of Knowing

Manabe is also the associate director of global health research and innovation at the Johns Hopkins Center for Global Health, which is reflected in CIDID’s global reach, with projects now ongoing on four continents.

The center’s long-standing relationships with practitioners and larger health care and government institutions in Uganda are a point of particular pride. Manabe has been building upon these relationships since she spent five years working in the African nation, from 2007–2012, at the Infectious Diseases Institute (IDI) at Makerere College of Health Sciences. That work, she says, “made it clear to me that there is not diagnostic certainty in very many parts of the world.”

The depth of relationships that Manabe and other CIDID researchers have developed and nurtured with Ugandan colleagues ensures an atmosphere of mutual trust and benefit. “If it's not a win/win, we walk away and part friends, and we come together on something else,” she observes. “There’s no room for win/neutral or win/lose.”

That win/win dynamic can generate immense benefits. Manabe points to a recent effort in Uganda to integrate testing for syphilis into existing mandatory HIV testing for pregnant women through a single platform that tests for both infections. “The thing is that the register has a line that says, ‘syphilis positive or negative,’” she observes. “Except that everybody was just not filling it out. They didn’t have the test.”

The costs associated with expanding testing became a barrier when Uganda’s Ministry of Health demurred on paying for syphilis tests. So Manabe and her team offered the tests at government facilities that the IDI supported. Not only did their efforts to scale up the program and educate women about syphilis prove to be a success, but Uganda adopted the new broader testing regime (paid for by national and international funds) in advance of the issuance of World Health Organization guidelines. 

Manabe smiles, “I like to think we were part of that solution.”

The possible impacts that point-of-care testing’s emergence has raised for broader epidemiological study are ever present in the CIDID researchers’ thinking. As part of its efforts, Manabe’s team is working on grants for a “hackathon” aimed at making self-reporting sites easier to use so that essential epidemiological data do not get lost.

CIDID — and the entire community of diagnostics researchers — is on the front lines of contemporary medical practice in the most literal sense. It works on the border of detection and treatment.

“Knowing puts you in a better place than not knowing,” Manabe observes, “so we're just in the business of knowing. This is what we do.”

Karen Blum contributed to this article.