Building on the infrastructure and scientific pathways opened by the COVID-19 pandemic, laboratories are well-positioned to meet STI testing demands during the current surge of sexually transmitted diseases in the U.S.
By Ann H. Carlson
Sexually transmitted infections (STIs) have reached an alarmingly high rate in the United States, according to CDC health officials. These STIs encompass a variety of conditions, including gonorrhea and syphilis, the latter of which jumped 26% in 20211.
Despite a steep decline in STI testing during the COVID-19 pandemic, the number of STI cases had already been growing steadily for several years. In 2018 alone, the CDC estimated that 1 in 5 Americans had an active STI2.
In addition to public education, easily accessible testing is the key to counteracting this troubling public health threat.
“The more testing we can provide our communities, the earlier we can catch infections, provide appropriate treatment, institute needed public health measures, and, hopefully, decrease the spread of STIs,” says Denise Heaney, PhD, chief medical partner for molecular lab and infectious disease at Roche Diagnostics. “With testing options that make it easier for patients to be diagnosed early and proven treatment that is readily available, then our numbers should be better.”
The importance of STI testing captured the public’s attention in the summer of 2022, when a surge of U.S. monkeypox cases triggered a ramp-up of testing and vaccination across the country. Although some experts debate whether monkeypox—a virus in the same variola family as smallpox—is an STI in the traditional sense, it is widely acknowledged that the virus is transmissible through sexual activity. Its emergence in the United States has tested the healthcare industry’s response to emerging diseases, as well as opened up discussions about the future of STI diagnostics, in general.
Currently, most STI tests are administered in the healthcare provider’s office and then sent on to a lab, although a gradual shift to at-home collection and testing is highly anticipated.
“One of the potential advances for STI testing is the push for bringing testing to the patients,” Heaney says. “There was a massive effort and success with expanding COVID testing beyond the traditional clinic and lab spaces. This allowed for the expansion into many communities that didn’t have access to testing. Additionally, less invasive and cumbersome sample types for screening and testing individuals are being explored to continue to improve testing for STIs.”
Putting STI Diagnostics to the Test
Some of the most common STIs are chlamydia, gonorrhea, syphilis, and trichomoniasis, and labs also routinely test for HIV, hepatitis B, and hepatitis C. Other common infections include Neisseria meningitidis, Mycoplasma genitalium, Shigella flexneri, and hepatitis A.
When communities were locked down due to the COVID-19 pandemic, most routine STI screenings ground to a halt. Although STI testing numbers are returning to pre-pandemic levels, it will take years to truly understand the impact of that interruption in services.
“There was a big drop in routine STI screening during the pandemic, especially for Chlamydia trachmatis and gonorrhea, but an increase in the percentage of patients testing positive, likely due to the fact that only symptomatic persons were being seen in clinic and tested,” says Damon Getman, PhD, scientific director at Hologic. “Now with the COVID-19 pandemic in decline, it’s likely those asymptomatic infected persons who should be screened are not participating in screening at the same level as they were before. This has implications for new infections to occur and go undiagnosed, possibly leading to adverse outcomes for patients in the future.”
One of the silver linings of the COVID pandemic, however, is that laboratories across the country are much better positioned to meet the diagnostic demand for emerging and existing STIs.
Neelyx Labs—a Wood Dale, Ill.-based molecular biological laboratory developed in 2020 to meet the community demands of the coronavirus pandemic—began offering monkeypox PCR testing in early July 2022.
“There is an incredible amount of molecular testing capacity now compared to 2.5 years ago,” says Shyam Saladi, PhD, founder and lead scientist of Neelyx Labs. “I think the real expectation is that many of these labs will come on board with STI testing because these labs can redeploy their equipment as needed for whatever the current testing requirement is.”
The FDA’s emergency use authorization (EUA) policies played a major role in providing COVID-19 diagnostics and vaccinations to the public, and they continue to play an important part in meeting the demand for monkeypox mitigation.
“Practically speaking, this means that many diagnostic tests [for monkeypox] will need an EUA to be offered going forward,” says Joyce Gresko, JD, partner in Alston & Bird’s Health Care Group. “The FDA intends to prioritize review of EUA requests for high-throughput diagnostic tests, tests with home-specimen collection, and rapid tests from ‘experienced developers.’”
The first EUA for a proprietary monkeypox test was issued to Quest Diagnostics, Secaucus, NJ, on Sept. 7, 20223.
“It’s an important step in identifying, treating, and, hopefully, eradicating monkeypox as we go forward,” says Damian “Pat” Alagia III, MD, MS, MBA, FACS, FACOG, chief clinical officer for health systems as well as the senior medical director for advanced diagnostics and women’s health for Quest Diagnostics. “About the time we got the EUA, we started to see a flattening of the curve of the trajectory of the disease, primarily because, concurrent with the EUA, we saw vaccinations starting to go up in the at-risk populations.”
As of Sept. 23, 2022, the CDC was reporting 24,846 total confirmed cases of monkeypox in the United States. The numbers appeared to hit their peak in mid-August, with a downward trend beginning in September4.
“The test is working, the turnaround time is rapid, we’re getting people vaccinated, we’re treating them with respect and dignity, and, most importantly, we’re seeing a fall-off in the number of monkeypox cases,” Alagia says. “That’s huge.”
Counteracting STI Testing Stigma
The social stigma associated with STIs can create a barrier to care for some patients, who may be too ashamed to get tested and seek treatment after a potential exposure. This phenomenon has certainly been observed during the recent monkeypox outbreak, which research shows to be more prevalent among men who have sex with men.
“If anything, monkeypox has unnecessarily added to a stigma for certain populations and placed people into ‘bins’ or ‘buckets’ of risk,” Heaney says. “All individuals are at risk for any infection that is spread through sexual or close contact. This includes monkeypox as well as traditional STIs, such as HIV, gonorrhea, and chlamydia. While we may see some populations having higher incidence of a particular disease, labeling infections to a particular population immediately stigmatizes those individuals and allows others ‘outside’ that population to point fingers and ignore the risks.”
Sometimes this stigma can be unintentionally exacerbated by research findings that demonstrate that one group is more susceptible to a disease. Take, for example, the CDC’s recently published report on the prevalence of HIV and STIs among patients with monkeypox5.
“The study provides useful information for the public,” says Maite Sabalza, PhD, scientific affairs manager for EUROIMMUN US. “The study data showed that people with monkeypox have higher than expected rates of HIV and STIs. It was concluded that screening for HIV and other STIs and other preventive care should also be considered for persons evaluated for monkeypox. However, this similarity may indicate an increase in the risk of stigmatization, which could have an impact on testing and disease management.”
Breaking down that social stigma requires public education through health agencies and the media, as well as a team effort from the healthcare community, to correct misperceptions.
“The primary burden lies on healthcare providers to have open, honest, and nonjudgmental conversations with their patients to gain a full sexual health picture and thereby order the correct tests,” Heaney says. “Also, labs and healthcare providers can work with numerous patient advocacy groups to better understand their community needs and how to effectively work with different patient populations.”
Labs also play a role in making sure STI testing is as private as possible.
“One way for labs to counteract the stigma associated with STI testing is by offering affordable, accessible, anonymous, and accurate testing,” Sabalza says. “Self-collection testing and de-identification of samples during testing are good approaches to ensure patient privacy, which help alleviate patient concern.”
Perhaps most importantly, community education campaigns are vital to promoting STI testing as a routine and necessary part of healthcare.
“Normalizing the cultural perception of getting tested for monkeypox and other STIs is necessary for lowering social taboos and preventing the spread of these infections,” Sabalza adds. “Although monkeypox is reported primarily in one population, it can spread to other populations if the outbreak is not contained.”
Following STI Testing Best Practices
When it comes to testing for STIs, there are several best practices for laboratories that emerged during the ramping up of COVID testing. For example, maximizing turnaround times was crucial to successful COVID testing, and providing timely results is just as important for labs that offer STI diagnostics, notes Saladi.
“People don’t want to wait for their results,” he says. “So, we think that’s probably the biggest opportunity for labs. If you’re going to guarantee good turnaround times, that means there are periods of time when not everyone’s working. The way we deal with that is we do a lot of research and development. When folks aren’t working on clinical samples, they’re on the other side of the lab doing research and development. That’s been a really good interplay for us.”
With tens of millions of patients affected by STIs annually—and a shortage of trained laboratory staff—reliable automation is a worthwhile investment to free up precious hands-on technician time.
“Automation is essential for ensuring patient traceability and minimizing operational errors and labor costs,” says Greg Stock, general manager of PerkinElmer’s EUROIMMUN US business. “One strategy is for laboratories to reallocate automated and technical resources previously used for COVID-19 testing to offer improved STI testing capabilities and solutions.”
Perhaps most importantly, labs offering STI diagnostics must be diligent about patient privacy while also providing the proper reporting to health agencies.
“We’ve learned to be very protective of patient information—and I’d say even more so now following COVID,” Alagia says. “STIs are very personal, private, intimate events that people don’t want to have shared. There’s a lot of emotional weight associated with these that we need to respect. But there is also a community impact if someone has an STI, so there are reporting requirements now that protect the individual but also protect society.”
Of course, navigating those reporting protocols can be confusing, and some states communicate these requirements better than others. For example, Saladi was surprised that some state public health departments refused to receive the additional saliva testing data that Neelyx Labs had been collecting for suspected monkeypox patients, alongside the required lesion testing results.
“I think the folks at public health have different priorities and they don’t always quite align with what’s needed to handle disease outbreaks,” he says. “These levels of bureaucracy still haven’t been broken down, and they need to be.”
There is also an onus on laboratories to be vigilant about tracking STI strains that are resistant to known treatments.
“There are no readily available tests to determine if a patient’s gonorrhea or Mycoplasma genitalium infection might be resistant to treatment,” Heaney notes. “Both of these illnesses are seeing increases in resistance to primary therapies, leading to patients with prolonged infections, which can lead to multiple poor outcomes.”
Ilana Heckler, PhD, scientific affairs liaison for EUROIMMUN US, agrees that detecting and identifying antibiotic-resistant strains of STIs is a major challenge for laboratories.
“Laboratories need to track resistance and be prepared to adapt their technology to new strains to avoid false-negative results,” she says. “Laboratories commonly face additional challenges, such as contamination, technical errors, and a lack of sample traceability. High-throughput automated solutions will reduce this risk while also meeting demand and providing accurate results.”
Another common obstacle is getting the word out about STI laboratory services to healthcare providers.
“I think the real opportunity for labs is to figure out how to engage with the public directly,” Saladi says. “It’s much, much better to have relationships directly with patients to support patients and the public in their need for information and test results discreetly.”
The Future of At-Home STI Testing
The unprecedented access to at-home testing and telemedicine that was developed during the COVID-19 pandemic will likely inspire similar advancements in the STI diagnostics space over the next few years.
“The option to add self-collection of urogenital specimens in the home or another nonclinical environment to STI screening programs has the potential to significantly increase the effectiveness of STI screening,” Getman says. “There is still much to be decided upon to make home specimen collection for STI testing routine, but we are getting closer to making that commonplace and widely available.”
One question that still needs to be ironed out is how to encourage the reporting of positive results once at-home testing becomes prevalent.
“Direct-to-consumer for STI testing is more appealing to some individuals because many adults and adolescents find it embarrassing to discuss these diseases and their sexual history with a clinician,” Stock says. “It is critical that the patient confirms positive self-testing results through a healthcare professional to receive appropriate care and treatment and also to ensure infections are managed appropriately based on public health guidance.”
There are also technical hurdles to overcome before at-home testing can be widely adopted.
“I think a centralized laboratory testing model will predominate into the foreseeable future,” Getman says. “The basic technology needed to create point-of-care solutions has been available for over 15 years, and still we have not seen viable commercial solutions for point-of-care systems that approach the clinical accuracy of IVD NAATs used in laboratories. […] There are fundamental technical reasons, involving the physical, chemical, and thermodynamic boundaries of molecule-to-molecule interactions, which show why point-of-care testing might never achieve the same level of clinical accuracy as lab IVD tests.”
Still, STI testing is already benefiting from self-collection modalities, according to Erik Munson, PhD, assistant professor of medical laboratory science at Marquette University.
“Frankly, this paradigm has been in place well before the pandemic, perhaps beginning with self-collected vaginal specimens (and even first-void urine before that) and moving toward self-collected penile meatal specimens,” says Munson, who is collaborating with a researcher who conducts a longitudinal surveillance program in which participants self-collect rectal swab specimens. “The thought is that a less invasive means of collection may facilitate more STI screening.”
While at-home STI testing may not happen overnight, Alagia expects that the industry is moving naturally in that direction.
“It’s hard to get to the doctor,” he says. “So, if we’re able to get these tests into the hands of the individual, then you’re going to start to change the diagnostic texture of healthcare, which is going to lead to therapeutic interventions. We always need to diagnose before we treat–so diagnostics is really the beginning of everything.”
ABOUT THE AUTHOR
Ann H. Carlson is a regular contributor to CLP.
- “‘Out of control’ STD situation prompts call for changes.” Stobbe, Mike. Associated Press. Sept. 19, 2022. https://apnews.com/article/monkeypox-science-health-covid-epidemics-aaac64591251293f45c225d3fe963d0c
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- “FDA Authorizes Quest Diagnostics’ Proprietary Monkeypox Test for Emergency Use.” Press release. Quest Diagnostics. Sept 7, 2022. https://newsroom.questdiagnostics.com/2022-09-07-FDA-Authorizes-Quest-Diagnostics-Proprietary-Monkeypox-Test-for-Emergency-Use
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