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31 August 2026

14 Pages

Point-of-Care Testing for Sexually Transmitted Infections: Is the Future Here Yet?

,
,
,
and
1
Department of Medicine and Public Health, University of Wisconsin-Madison, 750 Highland Avenue, Madison, WI 53705, USA
2
Department of Surgery, Mayo Clinic, Rochester, MN 55902, USA
3
Salus Discovery, Madison, WI 53703, USA
*
Author to whom correspondence should be addressed.
Venereology2026, 5(3), 20;https://doi.org/10.3390/venereology5030020
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Abstract

Sexually transmitted infections (STIs) remain a public health challenge, with rising incidence rates and significant loss to follow-up in traditional testing models. Point-of-care (POC) testing promises same-day diagnosis and treatment, potentially transforming STI management. We conducted a narrative review with perspective elements of commercially available POC and near-POC tests for STIs, identifying tests through regulatory and product-specific sources including the Food and Drug Administration (FDA), World Health Organization (WHO) prequalification list, Australia’s Therapeutic Goods Administration (TGA), China’s National Medical Products Administration (NMPA), publicly available European regulatory and manufacturer sources for CE-marked in vitro diagnostic devices under the EU In Vitro Diagnostic Regulation framework, and the published literature. Several nucleic acid amplification test (NAAT)-based platforms now deliver results rapidly with excellent sensitivity and specificity for common bacterial and protozoal STIs, including Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. For viral STIs, POC testing is most mature for human immunodeficiency virus (HIV), with numerous approved rapid antibody tests, although viral load and resistance testing remain laboratory-based. Most NAAT platforms require dedicated instruments, specialized training, and significant infrastructure. At-home testing options are emerging but face challenges with sensitivity, public health surveillance, and regulatory oversight. In conclusion, POC testing for STIs is advancing but not yet fully realized, and true POC tests (those usable at the bedside without laboratory support) remain limited. While rapid NAAT platforms represent significant progress over traditional laboratory-based testing, barriers to true POC implementation persist. Future developments in antimicrobial resistance detection, multiplex testing, instrument-free platforms, and integration of at-home testing with public health surveillance will be critical to achieving broader STI testing and control.

1. Introduction

Sexually transmitted infections (STIs) represent one of the most pressing challenges in global public health. The World Health Organization (WHO) estimates that over 1 million new STI cases occur daily worldwide, with the majority asymptomatic and undiagnosed [1]. In the United States alone, the Centers for Disease Control and Prevention (CDC) reported nearly 2.6 million cases of chlamydia, gonorrhea, and syphilis in 2021, marking continued increases across all three infections for the seventh consecutive year [2]. These rising trends occur despite widespread screening efforts, highlighting fundamental gaps in our approach to STI prevention and control.

1.1. The Burden of STIs and Gaps in Current Testing

The persistent epidemic of STIs stems from multiple interconnected challenges. First, many STIs are predominantly asymptomatic; up to 70% of chlamydia infections in women and 50% in men produce no symptoms [3]. Asymptomatic individuals continue to transmit infection unknowingly, perpetuating community spread. Second, STIs disproportionately affect vulnerable populations, including adolescents, men who have sex with men (MSM), and individuals in resource-limited settings, groups that often face barriers to healthcare access [4,5]. Third, the consequences of untreated STIs extend beyond immediate infection and increased HIV transmission, potentially causing pelvic inflammatory disease, infertility, ectopic pregnancy, and chronic pain [6].
Traditional STI testing models rely on centralized laboratory infrastructure with specimen transport and batch processing. While modern nucleic acid amplification tests (NAATs) offer excellent sensitivity and specificity, results typically require 24–72 h or longer. This delay creates a critical gap: patients must either wait for results before treatment or receive empiric therapy based on clinical suspicion alone. The former approach leads to substantial loss to follow-up, with studies showing that approximately 25–30% of patients with positive STI results have no documented treatment within 30 days [7,8]. Delayed results can still create missed opportunities for same-visit treatment, targeted counseling, partner notification, and interruption of transmission. The latter approach contributes to antimicrobial overuse, particularly problematic given rising antibiotic resistance in Neisseria gonorrhoeae [9].

1.2. The Promise of Point-of-Care Testing

Point-of-care (POC) testing offers a potential solution to these limitations by enabling same-visit diagnosis and treatment. The benefits are multifaceted: immediate diagnosis eliminates loss to follow-up; targeted treatment reduces unnecessary antibiotic use; and rapid results enable timely partner notification and treatment. Mathematical modeling suggests that even POC tests with slightly lower sensitivity than laboratory NAATs could substantially reduce STI prevalence by preventing the transmission that occurs during the delays inherent in traditional testing [10].
The WHO has championed POC testing through the ASSURED criteria: Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free, and Deliverable to end-users [11]. Recently updated as REASSURED to include Real-time connectivity and Ease of specimen collection [12], these criteria provide a framework for evaluating whether tests truly meet the needs of diverse clinical settings, particularly in resource-limited environments.

1.3. Defining True Point-of-Care

A critical distinction exists between “rapid” and “true POC” testing. According to the CDC, POC testing is performed “close to or near the patient,” with results available during the clinical encounter [13]. However, many tests marketed as POC still require benchtop instruments, temperature-controlled reagent storage, and trained laboratory personnel. These “near-patient” tests represent progress over send-out laboratory testing but fall short of the vision of truly bedside or clinic-based testing accessible in all care settings.
For this review, we examine the full spectrum of POC and near-POC tests for common STIs, recognizing that the field exists along a continuum from fully instrument-dependent platforms to truly equipment-free lateral flow assays. We focus on tests that can reasonably be performed within or near clinical settings with results available during an extended visit, even if not meeting all ASSURED criteria. This pragmatic approach reflects the current state of the field while highlighting the gap between existing technology and the ideal. We examine commercially available POC tests for the most common bacterial, protozoal, and viral STIs: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Treponema pallidum (syphilis), HIV, herpes simplex virus (HSV), and human papillomavirus (HPV). We assess their performance characteristics, regulatory approval status, practical implementation considerations, and remaining barriers to true POC testing.

2. Methods

We conducted a narrative review with perspective elements of commercially available point-of-care and near-point-of-care diagnostic tests for sexually transmitted infections. The goal was to summarize representative tests, regulatory status, implementation barriers, and remaining diagnostic gaps rather than to conduct a formal systematic review or meta-analysis. Our search strategy encompassed multiple regulatory databases and the published literature to identify tests available globally.
Primary sources included the U.S. Food and Drug Administration (FDA) database of approved in vitro diagnostics, with particular attention to tests granted Clinical Laboratory Improvement Amendments (CLIA) waiver status, which permits use in non-laboratory settings. We also searched publicly available European regulatory and manufacturer sources for CE-marked in vitro diagnostic devices under the European Union In Vitro Diagnostic Regulation framework, Australia’s Therapeutic Goods Administration (TGA) registry, China’s National Medical Products Administration (NMPA) approvals, and the WHO list of prequalified in vitro diagnostics, which represents an independent international endorsement of product quality, safety, and performance. For each identified test, we reviewed manufacturer specifications, package inserts, and published validation studies.
We focused on tests for the most common and clinically significant STIs: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), Treponema pallidum (syphilis), HIV, herpes simplex virus (HSV), and human papillomavirus (HPV). Tests were included if they met at least one of the following criteria: (1) FDA clearance, approval, authorization, or CLIA-waived, (2) regulatory approval or documented commercial availability through CE marking, TGA, or NMPA, (3) WHO prequalification, or (4) demonstrated clinical validation in peer-reviewed publications with clear commercial or regional availability. Tests were excluded from the main tables if they were investigational only, lacked clinical validation in human specimens, were designed exclusively for centralized laboratory workflows without plausible point-of-care or near-patient use, or lacked verifiable regulatory status or commercial availability. Platforms that did not meet these criteria were discussed only briefly when relevant to emerging technologies or remaining diagnostic gaps.
Literature searches were conducted in PubMed and Google Scholar using combinations of terms including “point-of-care,” “rapid test,” “NAAT,” “sexually transmitted infection,” and specific pathogen names. No formal publication date restriction was applied, but we prioritized systematic reviews, meta-analyses, and large validation studies published within the last 10 years, while also including earlier seminal publications that established current testing paradigms. Searches were updated during revision through May 2026. Given the narrative nature of this review rather than a formal systematic review, and the heterogeneity of available data, we did not perform meta-analysis or formal quality assessment, pooled quantitative synthesis, or formal risk-of-bias assessment.

3. Results

3.1. Current Landscape of Point-of-Care and Near-Point-of-Care STI Testing

The current landscape of POC and near-POC STI tests spans a continuum from fully instrument-dependent molecular platforms to equipment-free lateral flow assays. Rather than catalog every available assay in prose or present formal systematic review results, we highlight the most relevant and topical tests in each category below, and summarize the broader set of representative platforms, including their performance characteristics and regulatory status, in Table 1.
Table 1. Representative point-of-care and near-point-of-care tests for sexually transmitted infections.

3.2. Nucleic Acid Amplification Test (NAAT)-Based Platforms

NAAT-based tests represent the most sensitive and specific platform for STI diagnosis, with several systems now offering near-POC capabilities in under one hour. The Cepheid GeneXpert CT/NG assay is the most widely adopted near-POC NAAT globally, using automated real-time PCR in a self-contained cartridge. It is FDA-approved (CLIA moderate-complexity) across an unusually broad range of specimen types, including vaginal, endocervical, urethral, urine, rectal, and pharyngeal samples, with sensitivity of 97.4–100% for CT and 95.5–100% for NG and specificity > 99% [14,15]. However, the assay is validated on a per-site basis, requiring a separate swab and a separate cartridge for each anatomical site tested; comprehensive screening of an MSM patient, for example, may consume distinct genital, rectal, and pharyngeal swabs. Its leverage of existing tuberculosis testing infrastructure has enabled implementation in emergency departments, family planning clinics, and correctional facilities, although instrument cost and cartridge cold-chain requirements limit truly decentralized use [40,41].
The Visby Medical Sexual Health Test represents a newer, fully integrated, single-use approach. FDA-approved (2021) and CLIA-waived, it detects CT, NG, and TV from a single vaginal swab in under 30 min, with sensitivity of 97.4% for CT, 100% for NG, and 96.6% for TV and specificity > 99% [16,17]. Its ability to return three pathogen results from one swab is a notable workflow advantage over single-target assays. Because all reagents are contained within a disposable device requiring no separate reader, it reduces training requirements and cross-contamination risk. The binx io platform similarly offers rapid (~30 min) PCR-based CT/NG detection from a single vaginal swab or, alternatively, a male urine sample; it performs excellently on vaginal swabs (sensitivity 97.7% CT, 100% NG) but less well on male urine (88.6% CT, 95.2% NG) [18,19]. Additional NAAT platforms, including the isothermal Solana (helicase-dependent amplification) and EasyNAT (cross-priming amplification) systems, are summarized in Table 1; the battery-powered EasyNAT is notable for its potential portability in resource-limited settings, although it is not yet FDA-approved [20,21,22,23].

3.3. Antigen and Antibody-Based Rapid Tests

Non-NAAT POC tests, primarily immunochromatographic lateral flow assays, offer simplicity, low cost, and true equipment-free operation, but generally show reduced sensitivity. The OSOM Trichomonas Rapid Test is an antigen-detection assay requiring no instrumentation, providing results in 10 min from a single vaginal swab with sensitivity of 83–90% and specificity of 98.4–100% [24,25]. Although less sensitive than NAAT, it substantially outperforms wet-mount microscopy (~50% sensitivity) at a cost of only $5–8 per test, and cost-effectiveness analyses favor it over wet mount [26]. For syphilis, multiple rapid treponemal antibody tests (e.g., Determine Syphilis TP, Abbott Diagnostics Medical Co., Ltd., Matsudo-shi, Chiba, Japan; Bioline Syphilis 3.0; Standard Diagnostics, Inc./Abbott Diagnostics Korea, Inc., Yongin-si, Gyeonggi-do, Republic of Korea) provide results in 15–20 min from a finger-stick blood samples rather than a swab, with sensitivity of 96–100% and specificity of 84–99% [27,28]. Their key limitation is an inability to distinguish active from past treated infection, necessitating confirmatory non-treponemal testing; dual treponemal/non-treponemal devices such as the Chembio DPP Syphilis Screen and Confirm Assay partially address this [29]. Rapid syphilis tests have nonetheless demonstrated major public health impact in antenatal screening, where same-day treatment prevents congenital syphilis [42]. The DNA-probe Affirm VPIII, which detects TV, Gardnerella vaginalis, and Candida from a single vaginal swab but requires a dedicated analyzer, is summarized in Table 1 [30,31].

3.4. Viral STI Point-of-Care Testing

POC testing for viral STIs presents distinct challenges, often requiring antibody detection (indicating exposure) rather than detection of active infection. HIV represents the greatest POC success story, with numerous FDA-approved rapid antibody tests deployed globally. Available POC options include the OraQuick In-Home HIV Test (oral fluid, 20 min) and the INSTI HIV-1/HIV-2 Antibody Test (finger-stick, 1 min) [32,33], while fourth-generation tests such as the Alere HIV Combo additionally detect p24 antigen, shortening the window period to roughly 2 weeks [43]. Antibody-based POC tests are highly accurate in seroconverted individuals (sensitivity > 98%, specificity 98–100%), though all reactive tests require laboratory confirmation [44,45]. Critical gaps remain: POC viral load testing and drug-resistance detection are not yet available outside the laboratory, although the GeneXpert HIV-1 Viral Load assay shows promise as a near-POC option [46,47].
By contrast, POC options for HSV and HPV remain limited. For HSV, the only FDA-approved POC antibody test is the HSV-2 UniGold (sensitivity 96%, specificity 97%), performed using blood rather than a swab, but serology cannot diagnose acute infection or determine lesion etiology; lesion-based NAAT options such as the Solana HSV 1 + 2/VZV assay instead use a single swab of an active lesion but still require a benchtop analyzer [35,48,49]. For HPV, the GeneXpert HPV and Truenat HPV-HR assays detect high-risk genotypes in under one hour from a single cervical swab with good concordance to laboratory testing, but both require dedicated instruments and are deployed primarily in clinic-based laboratories rather than true POC settings [36,37,38,39]. Importantly, most POC HPV tests provide only diagnostic information without integrating with same-visit treatment pathways such as thermal ablation, a key gap given the WHO’s 2020 cervical cancer elimination strategy [50]. Representative viral STI POC tests are included in Table 1.

3.5. Regulatory Endorsement: FDA Approval Versus WHO Prequalification

Beyond national regulatory approval (FDA clearance, CE marking), the WHO operates a prequalification (PQ) program for in vitro diagnostics that provides an independent, internationally recognized assessment of a product’s quality, safety, and performance. WHO PQ is best understood as an endorsement rather than a marketing approval; it is used by United Nations agencies and many low- and middle-income countries to guide procurement. Importantly, PQ is product-specific, not a judgment of testing principles such as REASSURED.
To date, WHO PQ for STI-related diagnostics has concentrated on HIV and syphilis. The SD Bioline HIV/Syphilis Duo (Standard Diagnostics/Abbott Diagnostics Korea Inc., Yongin-si, Gyeonggi-do, Republic of Korea)) was the first WHO-prequalified dual HIV/syphilis rapid test (PQDx 0179-012-00, 2015), and additional dual HIV/syphilis devices have since been assessed [34]. On 10 July 2025, WHO prequalified the Determine Antenatal Care Panel, a bundled set of three rapid diagnostic tests performed from a single finger-stick capillary whole-blood sample for HIV, hepatitis B, and syphilis testing in antenatal settings [51]. In contrast, no POC assay for Chlamydia trachomatis, Neisseria gonorrhoeae, or Trichomonas vaginalis has yet achieved WHO prequalification; these analytes were only slated to enter the WHO PQ assessment process beginning in 2025 [52]. This pattern reflects both the maturity of HIV/syphilis rapid testing and the public health priority of antenatal screening for triple elimination of mother-to-child transmission.
Because REASSURED describes principles rather than products, we additionally rate representative POC tests against the individual REASSURED criteria in Table 2, providing a product-level view of how closely current technologies approach the ideal.
Table 2. Qualitative rating of representative POC STI tests against the REASSURED criteria.

3.6. At-Home STI Testing

The COVID-19 pandemic accelerated acceptance of at-home diagnostic testing, and this momentum has extended to STIs. An important distinction exists between truly at-home tests (both sample collection and analysis occur at home) and home collection kits (sample self-collected at home but mailed or transported to a laboratory).
In March 2025, the FDA granted marketing authorization for the Visby Medical Women’s Sexual Health Test, the first fully at-home test for CT, NG, and TV [53]. Unlike home collection kits, the device performs PCR amplification at home and delivers results via smartphone app in approximately 30 min. In the FDA De Novo decision summary, performance data from the regulatory submission showed 97.2% positive agreement and 98.8% negative agreement for CT, 100% positive agreement and 99.1% negative agreement for NG, and 97.8% sensitivity and 98.5% specificity for TV [17,54]. At approximately $150 per test (not insurance-covered), it offers same-day telehealth consultation for positive results [55]. Home collection kits represent a separate category: LetsGetChecked received FDA authorization in 2023 for at-home CT/NG specimen collection with laboratory processing [56], and the Teal Health Wand received FDA De Novo classification in 2025 as a prescription home-collection device that allows users to self-collect and transport vaginal specimens from home or another private setting for laboratory-based HPV molecular testing, rather than performing HPV analysis at home [57]. These kits preserve laboratory-quality testing while improving access and reducing the discomfort associated with clinic visits. In August 2024, FDA granted De Novo marketing authorization to NOWDiagnostics for the First To Know Syphilis Test, the first at-home, over-the-counter rapid antibody test for Treponema pallidum in finger-stick whole blood; positive results are not sufficient to diagnose syphilis and require confirmatory laboratory testing through a healthcare provider [58].
Equity considerations remain central to at-home STI testing. High out-of-pocket costs, variable insurance reimbursement, digital literacy requirements, smartphone access, mailing logistics, and uncertain linkage to treatment may limit the public health impact of at-home testing if implementation is not paired with counseling, treatment access, partner services, and reporting pathways. In high-income settings, these tools may improve privacy and convenience but risk widening disparities if they remain primarily self-pay. In low- and middle-income settings, affordability, supply chains, and linkage to treatment may be even more important determinants of impact than analytic performance alone.

4. Discussion

Are We Truly at Point-of-Care?
Despite significant technological advances, true POC testing for STIs remains incompletely realized. NAAT-based platforms like GeneXpert, Visby, and binx io deliver laboratory-quality results in clinic timeframes, but most require dedicated instrumentation, stable power, and either cold-chain consumables or proprietary single-use devices, with per-test costs of $15–30 in high-income settings. These requirements confine deployment to well-resourced clinics and exclude truly decentralized settings such as mobile outreach vans, correctional facilities, and low-income countries. The distinction between “near-patient” and “true bedside” testing matters: a clinic-laboratory test with a 90 min turnaround still requires patients to wait, whereas a portable, battery-powered device operable by minimally trained staff would extend testing into emergency departments, pharmacies, and community settings. Only a handful of tests (Visby, binx io, Solana, OSOM, OraQuick HIV) have achieved CLIA-waived status; the battery-powered EasyNAT suggests true portability is attainable but is not yet FDA-approved.
For viral STIs, the picture is mixed. HIV POC testing has succeeded remarkably, with equipment-free tests deployed globally, yet POC viral load and resistance testing remain laboratory-based. POC options for HPV and HSV lag substantially behind, requiring benchtop instruments and offering limited clinical integration.

4.1. Trade-Offs: Sensitivity, Speed, Cost, and Specimen Type

A fundamental tension exists between test performance and operational simplicity. NAAT-based tests achieve >95% sensitivity and >99% specificity, whereas simple lateral flow assays such as OSOM Trichomonas show 83–90% sensitivity, an excellent result relative to microscopy, but one that still allows false negatives. Mathematical modeling suggests this trade-off may nonetheless favor rapid, somewhat less sensitive tests where loss to follow-up is high: a 90% sensitive test that treats all positives at the same visit can prevent more onward transmission than a 99% sensitive send-out test from which 30% of positive patients are lost [10,59]. Cost shapes the same calculus; in resource-limited settings, an inexpensive rapid test may achieve greater population impact than a costlier NAAT if budgets cap testing volume, and even modestly sensitive POC syphilis tests remain cost-effective in antenatal screening [60].
Specimen type adds further complexity. Specimen type adds further complexity because several POC and near-POC platforms are validated primarily for vaginal swabs or urine, whereas comprehensive screening for MSM and other populations often requires rectal and pharyngeal CT/NG testing. GeneXpert’s validated performance across rectal and pharyngeal specimens is therefore an important advantage, as 30–40% of NG infections in MSM are extragenital and frequently asymptomatic [61]; by contrast, most newer POC platforms remain limited to vaginal swabs or urine and lack approval for rectal and pharyngeal specimens, particularly rectal samples. Self-collection, with demonstrated acceptability and performance comparable to clinician collection for vaginal swabs and urine [62], offers a partial solution, but it does not fully address the need for POC platforms validated across rectal and pharyngeal specimens.

4.2. At-Home Testing: Public Health Opportunities and Challenges

At-home testing introduces a distinct set of opportunities and risks that bear directly on POC strategy. For individuals facing stigma, transportation barriers, or scheduling constraints, at-home testing may enable screening that would otherwise not occur, and modeling suggests that raising overall testing rates, even with some loss of surveillance and linkage, can reduce population prevalence [63]. These benefits, however, are counterbalanced by several concerns. Public health surveillance may be compromised as testing shifts from reportable laboratory results to consumer products, creating blind spots that hinder outbreak detection [64]. Linkage to care and partner notification become more difficult, since the convenience that drives uptake also reduces the touchpoints with the health system that traditionally facilitate treatment and partner services. Test misuse is also possible: users may test within the window period, misinterpret results, or forgo confirmatory testing, with limited pre-test counseling to mitigate these risks [65].
Cost and specimen-type limitations further constrain equity. At roughly $150 per test without insurance coverage, at-home NAAT testing is substantially more expensive than clinic-based screening, potentially excluding the populations with the highest burden. As with clinic-based POC, most at-home options (including Visby) are approved only for vaginal swabs, so MSM requiring anorectal and pharyngeal screening cannot rely on them for comprehensive evaluation. Optimizing at-home testing will therefore require mechanisms for privacy-preserving public health reporting, integration with electronic health records and automated reporting, and partnerships between manufacturers and health departments modeled on COVID-19 testing programs [66]. At-home testing should complement rather than replace clinic-based services: the optimal strategy likely combines clinic-based POC, laboratory NAAT, and at-home options tailored to individual needs and local epidemiology.

4.3. Regulatory Lag and Global Disparities

Test availability varies substantially across regulatory jurisdictions. FDA approval timelines often lag behind CE marking and approvals elsewhere; the EasyNAT system, for instance, has been available in China since 2018 but is not FDA-cleared despite promising portability [22,23]. Many tests validated and used internationally remain unavailable in the United States, while FDA-approved platforms may be cost-prohibitive abroad. WHO prequalification aims to bridge this gap by providing independent validation that guides international procurement, but its STI coverage to date is concentrated in HIV and syphilis, with chlamydia, gonorrhea, and trichomoniasis assays only beginning the PQ process [67,68]. Development of tests specifically designed for resource-limited settings, battery- or solar-powered, heat-stable, and using visual readouts, remains underfunded relative to the global burden.

4.4. Critical Gaps and Future Directions

Several priorities emerge for translating current advances into true point-of-care STI control. First and most urgent is POC detection of antimicrobial resistance in Neisseria gonorrhoeae, given widespread ciprofloxacin resistance and emerging azithromycin and cephalosporin resistance [69]. The ResistancePlus GC assay detects ciprofloxacin-resistant mutations in under 60 min [70], but POC cephalosporin resistance detection remains unavailable even as empiric dual therapy becomes less reliable. Second, comprehensive multiplex testing should expand beyond current 2–3 pathogen panels to include syphilis, HSV, Mycoplasma genitalium, HIV, and bacterial vaginosis organisms, while preserving clinical actionability and affordability. Whether such an expanded panel should be used as an initial test, however, is complicated and beyond the scope of this review. M. genitalium is a distinctive point-of-care use case because organism detection alone may be insufficient; treatment decisions increasingly depend on antimicrobial resistance information. Laboratory NAATs for M. genitalium are available, and assays that detect macrolide-resistance mutations, such as ResistancePlus MG, are available in some regions, but resistance testing remains unevenly available and is not yet integrated into a broadly accessible true POC workflow. Therefore, future POC approaches to M. genitalium should prioritize resistance-guided testing rather than simply adding organism detection to broad multiplex panels [71]. Such expansive testing from a single specimen is feasible though, as shown by the GeneXpert MVP vaginitis panel demonstrates feasibility, though cost limits accessibility [72]. Third, expanded specimen validation, especially rectal and pharyngeal specimens for CT/NG testing, will be needed so POC platforms support comprehensive screening rather than partial testing in populations such as MSM. Fourth, real-time connectivity, now an explicit REASSURED criterion, should integrate POC and at-home devices with electronic health records, automated public health reporting, and partner service workflows, with privacy safeguards that scale to decentralized testing [12]. Fifth, truly instrument-free NAAT remains a central goal; isothermal methods such as HDA and cross-priming reduce but do not eliminate instrument needs, while CRISPR-based diagnostics and LAMP with visual detection offer potential paths to equipment-free, NAAT-level performance [73,74]. Finally, implementation science must accompany technology: even excellent tests fail without clinician adoption, patient acceptance, reimbursement pathways, treatment access, and workflow integration, as studies of GeneXpert deployment make clear [34,75].

5. Conclusions

Point-of-care testing for sexually transmitted infections has advanced substantially but remains incompletely realized. Multiple platforms now deliver highly accurate results within 30–90 min, enabling same-visit diagnosis and treatment in well-resourced clinical settings, and the emergence of at-home testing adds a new dimension to the POC landscape. However, challenges persist around cost, insurance coverage, public health surveillance, linkage to care, and specimen type limitations. Integration of POC testing into comprehensive STI control strategies requires continued innovation in technology development, reporting systems, care coordination, and equitable access.
So, is the future of POC STI testing here yet? The answer is: almost, but not quite. Tools are now available that were unimaginable two decades ago: molecular tests providing laboratory-quality results in minutes, at the point of care or even at home. Yet the need for those tools to be widely deployed across the globe has never been greater. The trajectory is promising, with continued innovation in technology, ongoing regulatory evolution, and growing recognition of POC testing’s importance. Full realization awaits further advances in chemistry, miniaturization, and manufacturing, coupled with a commitment to equitable global access. The future is near, but important work remains.

Author Contributions

Conceptualization, R.S. and D.C.; methodology, R.S. and D.C.; software, N/A; validation, R.S. and D.C.; formal analysis, D.C.; investigation, D.C.; resources, D.C.; data curation, D.C.; writing—original draft preparation, D.C.; writing—review and editing, D.C., R.S., S.A., B.M., and J.W.; visualization, R.S.; supervision, R.S.; project administration, R.S.; funding acquisition, N/A. All authors have read and agreed to the published version of the manuscript.

Funding

This research received no external funding.

Data Availability Statement

No new data were created or analyzed in this study. Data sharing is not applicable to this article.

Conflicts of Interest

Authors Brianna Mullins and Jay Warrick were employed by the company Salus Discovery. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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Infectious Diseases, Antimicrobial Resistance, and Diagnostic Stewardship Among Sex Workers in Africa: A Perspective
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