Rethinking vaginitis testing: Opportunities for improvement in laboratory-enabled care

Vaginitis is the most common vaginal condition among women aged 15–44, and one of the leading causes of OB/GYN visits in the U.S. every year.^1,2 The primary cause of vaginitis, bacterial vaginosis (BV), affects an estimated 21 million women annually in the U.S. alone.³ While women of all ages feel the impact of BV, prevalence is highest among women aged 15–29, with a disproportionate burden observed in certain racial and ethnic groups.^4,5 Left untreated or improperly managed, vaginitis can result in a range of complications, including chronic or recurrent infections, chronic pelvic pain, and pelvic inflammatory disease (PID).^6,7 Among pregnant women, vaginitis, particularly cases caused by BV, has been associated with adverse outcomes such as preterm birth and low birth weight.⁸

Despite its high prevalence and potential for serious complications, BV has historically been perceived as a minor nuisance infection or inconvenience rather than a serious medical concern. Under this view, vaginitis is often treated empirically, with treatment prescribed based on symptoms without confirmatory testing. While many clinicians perceive this method as expedient, it overlooks critical nuances and frequently leads to misdiagnosis. Vaginitis can be caused by a number of different pathogens or dysbiosis of flora, and the symptoms across these different causes often overlap. Additionally, the presence of vaginitis can increase risks to sexual and reproductive health. Re-examining how vaginitis is assessed and treated presents a critical opportunity to improve care through laboratory-based medicine.

Shifting perspectives

Both laboratorians and clinicians need to re-examine the importance of accurately diagnosing BV. Beyond immediate discomfort, the complications associated with BV can be serious. A growing body of evidence indicates associations between BV and other sexually transmitted infections (STIs), including human immunodeficiency virus (HIV).^9,10

One challenge to overcome is that the symptoms of BV, including discharge, odor, and irritation, significantly overlap with those of other infections, including candida vaginitis (CV) caused by fungal pathogens, and trichomoniasis, caused by the parasitic protozoan Trichomonas vaginalis (TV), as well as bacterial STIs. This overlap makes it virtually impossible to differentiate these symptoms reliably solely through clinical presentation.

Recognizing this challenge, professional guidelines for diagnosing BV have shifted towards targeted testing. The Centers for Disease Control and Prevention (CDC) advises that all women diagnosed with BV be evaluated for co-existing STIs.¹¹

Concern for coinfections

The high prevalence of vaginitis and the impact of potential complications on the overall and reproductive health of women is reason enough for clinicians to seek a full understanding of underlying etiologies. However, there is also growing evidence of the role coinfections can play in vaginitis. A recent study of women presenting with symptoms of vaginitis found that 1 in 5 also tested positive for at least one concurrent STI. Among women in the study who tested positive for BV, the causative pathogen of about half of all vaginitis, the rate of concurrent STIs was twice the rate in comparison to women who tested negative for BV.¹² A significant association was also noted between BV infections and Mycoplasma genitalium (M. gen) infection, as well as trichomoniasis. Other studies found as many as 37% of women diagnosed with BV were also infected with TV or CV, and among women positive for HIV and TV, coinfection rates with BV were above 60%.^13,14 Women diagnosed with BV have also been found to be at increased risk of infection with Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).¹⁰

The presence of these co-infections complicates treatment strategies and underscores the need for accurate and reliable laboratory testing to guide appropriate therapy. Without laboratory confirmation, clinicians risk missing important infections, which can lead to persistent symptoms, complications, repeated visits, and further transmission of infections within the community.

Traditional methods fall short

Historically, diagnosis of BV and other vaginitis-related infections has relied on microscopy-based methods such as wet mounts with Amsel criteria, or Gram stains with Nugent scoring. While these approaches have been standard for decades, they suffer from some notable limitations: wet mount microscopy can miss up to 45% of TV infections, while Amsel’s criteria lacks sensitivity, ranging between 37% and 70% for BV.¹⁶

Symptoms overlap extensively between infections with BV, CV, and TV, making empirical diagnosis unreliable. Coinfection rates mean that treatment based on a single presumed etiology is often inadequate. Moreover, manual microscopy methods have inherently lower sensitivity and are highly operator-dependent, introducing variability, potential for misdiagnosis, and reliance on the availability of skilled staff.

Other traditional approaches, like pH testing and whiff tests, provide only qualitative results and lack the specificity necessary to guide therapy confidently. Furthermore, these older methods do not align with evolving guideline recommendations that emphasize comprehensive, pathogen-directed testing.

Better solutions. Better care.

Nucleic acid amplification tests (NAATs) represent a transformative solution to the challenges of vaginitis testing. By offering high sensitivity and specificity for BV, CV, TV, and potentially other pathogens, NAATs enable a more complete, pathogen-specific understanding of a patient’s infection status. NAATs have been found to detect three times more mixed infections than traditional methods among symptomatic women.¹⁵ Testing with NAATs also builds on efficiencies of the technology in the lab, enabling testing for vaginitis and multiple other infections with one or two samples, as determined by laboratory workflows. Both the CDC and the American College of Obstetricians and Gynecologists (ACOG) recommend NAAT for vaginitis testing.^11,17

For the laboratory, NAATs provide unparalleled flexibility. They enable labs to craft workflows and procedures to fit the needs of the lab and the clinicians they serve, often offering random-access capabilities and walk-away times that free technicians for other tasks while delivering high-volume results seamlessly. The ability to test for multiple pathogens from a single vaginal swab reduces the need for multiple sample collections and minimizes patient burden.^18-21 With minimal samples required for a wide range of assays, requests for additional testing can be easily met with reflex testing of the original sample and minimal disruption to laboratory workflows. Comprehensive NAAT testing can deliver the needed results the first time, reducing repeat testing and the operational burden associated with re-collection and re-processing.

For the clinician, a reliable NAAT-based result empowers precise, timely, and targeted treatment decisions. Accurate identification of coinfections enables clinicians to confidently select the appropriate antibiotic or antifungal therapy. Furthermore, targeted treatment supports antibiotic stewardship by avoiding broad, unnecessary prescriptions and helping to combat the growing threat of antimicrobial resistance. Clinicians can provide more confident, informed care, improving patient satisfaction and treatment adherence through the use of pathogen-specific diagnostics.

For the patient, comprehensive testing offers a clearer path to resolution. Minimal samples and accurate tests reduce the frustration and cost of returning for additional visits or enduring prolonged symptoms. The emotional toll of repeated treatment failures or ongoing uncertainty can be significant, and reliable answers help restore confidence and comfort. The risk of ongoing transmission of infections is also mitigated by selecting the appropriate therapy the first time.

Critically, improved STI detection and treatment through integrated BV testing create a gateway for improved sexual health. Patients benefit from a holistic, pathogen-specific approach rather than a narrow focus on potentially inconclusive symptoms.

Conclusion

The landscape of vaginitis testing is evolving, and laboratories have an opportunity to lead the way by embracing more accurate guideline-based approaches. Moving beyond empirical treatment and outdated manual methods to NAAT-based testing is more than simply a technological upgrade; it is a necessary shift toward data-driven, patient-centered care.

For laboratories, this shift translates to improved workflow efficiency, reduced operational burden, and more streamlined resource utilization. For patients, it means fewer unanswered questions, faster relief, and improved overall care. And for the healthcare system as a whole, it represents a critical step toward reducing unnecessary antibiotic use and curbing the spread of STIs.

By rethinking the needs of vaginitis testing today, we lay the foundation for highly sensitive testing methods that offer objective and accurate diagnostic results that can lead to more patient-focused laboratory services tomorrow.

References

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18. Aptima Combo 2 Assay [package insert]. AW-25929-001, San Diego, CA; Hologic, Inc., 2023. Retrieved November 6, 2025 from: https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng.

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