Point-of-Care Testing for Sexually Transmitted Infections: What Pathologists — and Patients — Should Know

08/27/2026

Nikolina Babic, PhD, DABCC, FADLMSheldon Campbell, MD, PhD, FCAPKate Crawford, MD, PhDNorman Moore, PhD

Article

Why Point-of-Care Testing Matters for STIs

Sexually transmitted infections (STI) have been described since ancient times, and remain a major public health challenge in the United States and globally. Many common STIs—such as Chlamydia trachomatis and Neisseria gonorrhoeae—are frequently asymptomatic, yet untreated infections can lead to serious complications including infertility, ectopic pregnancy, and increased HIV transmission risk.²

Traditional laboratory testing requires specimens to be sent off-site, with results returning hours to days later. Patients may be lost to follow‑up or treated empirically, leading to missed infections, unnecessary antibiotic use, and loss of public health follow-up. Point‑of‑care testing (POCT) offers an alternative: testing performed at or near the patient, with results available during the same visit.

For both clinicians and patients, the promise of POCT is simple; test, diagnose, and treat in a single encounter.

What Is POCT?

POCT are diagnostic assays performed outside the traditional clinical laboratory, nearer to the patient. Results are typically available within minutes to an hour, allowing clinical decisions to be made immediately.²

Recently released STI POCTs are FDA‑cleared and CLIA‑waived, meaning they are designed to be simple to perform with minimal risk of error when used according to manufacturer instructions.

Which STIs Can Be Tested at the POC?

POCTs are currently available for many major STIs, though the type and performance of tests vary by organism.

Rapid antibody or antigen+antibody tests for syphilis and HIV have been available for years and are widely used in both clinical and public health settings. These tests are typically CLIA‑waived and can be performed using fingerstick whole blood, with results in under 30 minutes.

Historically, POC options for C. trachomatis and N. gonorrhoeae were limited by unacceptably low sensitivity. Recent advances in rapid molecular (NAAT‑based) platforms have changed this landscape. FDA‑cleared, CLIA‑waived molecular assays can now detect chlamydia and gonorrhea with laboratory‑level accuracy in approximately 20 minutes.³ Some newer POCT platforms also include targets such as Mycoplasma genitalium and Trichomonas vaginalis. POCT options for herpes virus and human papilloma virus infections are not yet available.

Populations at Increased Risk and Benefits for Vulnerable Populations

Sexually transmitted infections do not affect all populations equally. In the United States, the burden of STIs is disproportionately concentrated among specific demographic and social groups, driven by biological factors, social determinants of health, and barriers to care. The Centers for Disease Control and Prevention (CDC) and other public health agencies consistently identify adolescents and young adults, men who have sex with men (MSM), pregnant individuals, racial and ethnic minority populations, and people with limited access to health care as populations at increased risk for STIs.⁴

Many STIs are asymptomatic, particularly in their early stages, which contributes to ongoing transmission and delayed diagnosis. Young people aged 15–24 years account for a disproportionate share of new STI infections despite representing a smaller fraction of the sexually active population. Biological susceptibility, limited access to confidential care, and lower rates of routine screening all contribute to this elevated risk.

Racial and ethnic minority populations are also disproportionately affected.⁵ These disparities are not explained by individual risk behaviors alone but are closely linked to structural factors such as reduced access to healthcare, stigma, discrimination, and historical inequities in public health investment.

Additional vulnerable populations include individuals experiencing homelessness, migrants, and those with unstable housing or insurance coverage. Studies consistently show higher STI prevalence and significantly lower rates of return for test results in these groups, highlighting the critical role of access and follow‑up.⁶

How POCT Benefits Vulnerable Populations

POCT offers distinct advantages for populations that face barriers to traditional laboratory‑based STI testing. By providing results during the same clinical encounter, POCT reduces reliance on follow‑up visits, which are often missed due to transportation challenges, work constraints, housing instability, or stigma associated with sexual health care.

Same‑day diagnosis enables immediate treatment, which is particularly important for individuals who may not return to receive results. This approach can significantly reduce ongoing transmission and prevent complications such as pelvic inflammatory disease, infertility, and congenital infections.⁷

POCT may also improve acceptability and uptake of STI testing. Studies examining patient perspectives show that rapid testing is often perceived as more convenient, less stigmatizing, and more empowering, particularly when implemented in non‑traditional or community‑based settings. These benefits are especially relevant for adolescents, sexual and gender minorities, and individuals who may avoid care due to concerns about privacy or judgment.⁸

From a public health standpoint, reducing syndromic management through accurate, rapid diagnostics supports antimicrobial stewardship and helps limit unnecessary antibiotic exposure, which disproportionately affects communities already burdened by healthcare inequities.

For pathologists, understanding which populations benefit most from STI POCT is essential for guiding responsible test selection, implementation, and oversight. While POCT does not replace comprehensive laboratory services, it can complement centralized testing strategies in settings where loss to follow‑up is common or rapid treatment is critical.

When implemented with appropriate quality oversight, training, and integration into healthcare systems, STI POCT can help reduce disparities, improve health equity, and strengthen STI prevention efforts across diverse populations.

Benefits of POCT for Patients and Health Systems

The most significant advantage of POCT is same‑day diagnosis and treatment, which can reduce ongoing transmission and prevent complications. It can also provide operational efficiencies when reduced need for follow-up and additional calls or visits to discuss and act on results are eliminated.

Other benefits include:

Reduced loss to follow‑up, particularly in high‑risk or underserved populations.
Decreased reliance on syndromic management, which is often inaccurate for STIs.
Improved antimicrobial stewardship by avoiding unnecessary empiric therapy.

From a public health perspective, faster diagnosis also supports better surveillance and outbreak control.⁹

Limitations and Challenges

Despite their promise, POCTs are not a universal solution.¹⁰ Important limitations include:

Cost and complexity, particularly for molecular platforms, which may limit adoption
Specimen type restrictions, with limited approval for extragenital testing in some assays
Quality oversight, as waived tests are not error‑proof and require training, competency assessment, and quality control

Additionally, not all care settings are well‑suited for POCT implementation due to workflow, staffing, or volume considerations.

The Critical Role of Pathologists

Pathologists play a central role in the responsible adoption of STI POCT. Their expertise is essential for:

Evaluating test performance and clinical appropriateness
Overseeing quality management and regulatory compliance
Integrating POCT results into laboratory and electronic health record systems
Advising clinicians on test selection and result interpretation

Even when testing moves closer to the patient, laboratory oversight remains essential to ensure accurate, reliable, and clinically meaningful results.

Looking Ahead

Ongoing innovation in STI diagnostics is focused on faster turnaround times, expanded organism panels, resistance detection, and lower costs. Global organizations such as the World Health Organization continue to promote the development of POCTs that meet stringent performance and usability criteria, particularly for broader access across diverse care settings.⁹

Although not always associated with POCT, self-collection is another area of rapid development in STI testing. Self-collection models allow patients to collect specimens in the privacy of their own home, eliminating the need for a clinic visit and reducing the stigma, scheduling barriers, and discomfort that deter many individuals from seeking screening. However, these tests still rely on centralized laboratory analysis: collected specimens are mailed to a CLIA-certified laboratory, with results typically returned within several days. The laboratory remains integral to this workflow, and existing quality oversight and public health reporting structures apply.

A more fundamental shift is now underway. In March 2025, the FDA granted De Novo marketing authorization for the first diagnostic STI test that can be purchased without a prescription and performed entirely at home, delivering results in approximately 30 minutes from a self-collected vaginal swab using PCR.¹¹ The authorized product communicates securely with a companion app that synchronizes test timing, reads and interprets results, and can link positive patients directly to telehealth for follow-up care and prescriptions, creating a closed-loop care pathway from testing through treatment that operates entirely outside the traditional clinical and laboratory infrastructure. Critically, this De Novo authorization also established a new regulatory classification, opening the FDA 510(k) pathway for subsequent similar devices and signaling that additional over-the-counter molecular STI tests from other manufacturers may reach the market in the near future¹². The authorized at-home test is already being distributed through same-day home delivery services in a growing number of US metro areas, further lowering access barriers. For pathologists and laboratory professionals, this represents a paradigm shift: molecular-quality STI testing is moving into patients’ hands, and the frameworks for quality oversight, result reporting, and linkage to public health surveillance have not yet caught up.

As these technologies evolve, collaboration between clinicians, laboratorians, and public health professionals will be key to realizing the full potential of point‑of‑care STI testing.

Selected References

UK Health Security Agency. STIs through the centuries. Published March 13, 2024. Accessed April 3, 2026. https://ukhsa.blog.gov.uk/2024/03/13/stis-through-the-centuries/
Riegler AN, Larsen N, Amerson-Brown MH. Point-of-Care Testing for Sexually Transmitted Infections. Clin Lab Med. 2023 Jun;43(2):189-207.
Manabe YC, Smith AC, Trow S, Tran A, Van Der Pol B. Point-of-care Tests for Chlamydia trachomatis and Neisseria gonorrhoeae: Review of the Literature. Clin Infect Dis. 2026 Feb 24;82(Supplement_1):S43-S51.
Lim S, Bekemeier B, Pintye J, Grembowski D. The Association Between Social Determinants of Health and Case Rates of Sexually Transmitted Infections at the County Level in the US, 2000-2019. Am J Prev Med. 2025 Oct;69(4):107640.
Centers for Disease Control and Prevention. (2024). Sexually Transmitted Infections Surveillance, 2023. U.S. Department of Health and Human Services. Published 2024. Accessed April 2, 2026. https://www.cdc.gov/sti-statistics/media/pdfs/2025/09/2023_STI_Surveillance_Report_FINAL_508.pdf
Segala FV, Novara R, Panico G, et al. Prevalence of Sexually Transmitted Infections and Predictors for Loss to Follow‑Up among Marginalized Homeless and Migrant Communities: A Cross‑Sectional Study. Ann Glob Health . 2024;90(1):25.
Lewis DA, Lleo MM, Ndowa F, Sadiq T, Wi T. STI point-of care tests: a call for quality-assured evaluation, implementation, innovation, and investment in future technologies. BMC Infect Dis. 2025 Jun 17;25(1):805. doi: 10.1186/s12879-025-11103-1.
Griner SB, Garza SR, Alkhatib SA, et al Point-of-care testing for chlamydia and gonorrhoea: a narrative review of patient perspectives and implementation into non-traditional settings. Sex Transm Infect. Published online April 2, 2026.
World Health Organization. Laboratory and Point of Care Diagnostic Testing for STIs. 2023
Ortiz DA, Loeffelholz MJ. Practical Challenges of Point-of-Care Testing. Clin Lab Med. 2023 Jun;43(2):155-165. doi: 10.1016/j.cll.2023.02.002. Epub 2023 Mar 22.
US Food and Drug Administration. FDA grants marketing authorization of first home test for chlamydia, gonorrhea, and trichomoniasis. FDA News Release. Published March 28, 2025. Accessed June 7, 2026. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-home-test-chlamydia-gonorrhea-and-trichomoniasis
Johnson M. Visby Medical pauses clinical point-of-care test sales to ramp up over-the-counter Dx business. 360Dx. Published October 22, 2025. Accessed [add access date]. https://www.360dx.com/business-news/visby-medical-pauses-clinical-point-care-test-sales-ramp-over-counter-dx-business

Authors

Nikolina Babic, PhD, DABCC, FADLM

Nikolina Babic, PhD, DABCC, FADLM, is a board-certified clinical chemist and Professor of Pathology and Laboratory Medicine at the Medical University of South Carolina, where she serves as Medical Director of Clinical Chemistry Laboratories and Point-of-Care (POC) Testing. She received her PhD in chemistry from the University of Washington and completed a postdoctoral fellowship in clinical chemistry and immunology at Mayo Clinic. Dr. Babic has authored numerous peer-reviewed publications and has served on committees for several professional societies, including the College of American Pathologists POC Testing Committee. Her clinical and research interests center on value-based laboratory medicine, working closely with clinicians to implement emerging technologies and evidence-based diagnostic pathways that improve patient care. She is particularly interested in using POC testing to expand access to timely, equitable diagnosis, especially for sexually transmitted infections.

Sheldon Campbell, MD, PhD, FCAP

Sheldon Campbell M.D., Ph.D. FCAP is Professor of Laboratory Medicine at Yale School of Medicine and Director of Clinical Laboratories for the VA Connecticut Healthcare System. He completed his M.D. and Ph.D. degrees in the Medical Scientist Training Program at Baylor College of Medicine in Houston, and did residency and fellowship in Laboratory Medicine at the Yale School of Medicine. He is board certified in Clinical Pathology and Medical Microbiology by the American Board of Pathology. Dr. Campbell is responsible for microbiology, chemistry, and point-of-care testing for VA Connecticut, and is advisor for several specialty areas for the New England Veteran’s Integrated Service Network laboratories. He has served on the Point of Care, Microbiology, and Checklist committees for the College of American Pathologists, and as Division C Chair and on the Professional Practice and Laboratory Practices committees for the American Society for Microbiology. Dr. Campbell’s research interests include education of pathology residents and medical students, point-of-care testing, HIV testing, mycobacterial diagnostics, and laboratory utilization.

Kate Crawford, MD, PhD

Kate Crawford, MD, PhD, is an Acting Assistant Professor at the University of Washington, where she serves as Assistant Director of Informatics and Infectious Disease Diagnostics and Medical Director of Point of Care Testing. She received her MD and PhD from the University of Washington, where she studied viral evolution with a focus on the interplay between viral surface proteins and host antibody responses. Dr. Crawford subsequently completed her clinical pathology training at the University of Washington, developing expertise in test stewardship and laboratory management. Dr. Crawford is passionate about improving access to high-quality diagnostic testing through innovations in laboratory medicine, clinical informatics, and policies that promote appropriate test utilization and reimbursement.

Norman Moore, PhD

Dr. Moore received his bachelor’s degree in biology and philosophy from Dartmouth College and his PhD in microbiology from the University of New Hampshire. Among other assays, he developed the first ever rapid tests for Legionella and S. pneumoniae, both of which are now recommended by the Infectious Disease Society of America. After being an R&D director for many years, he took the role of Director of Medical Affairs where he works with the medical community. He has served on multiple NIAID grant committees, the CDC guideline group for rapid influenza testing, the College of American Pathology’s and Clinical Laboratory Standards point-of care committees, and CLSI’s infectious disease guideline writing committee. He currently has eight US and 39 non-US patents and numerous publications and presentations. He received the Volwiler Fellowship Award for lifetime achievement in science in 2019.