The State of Vaginitis Testing in the U.S.: Insights from Real-World Data

A recent study published in AJOG Global Reports¹ offers a crucial look at how vaginitis is currently managed in the United States, finding that many symptomatic patients are not tested for vaginitis, but nevertheless receive vaginitis-related treatment.

According to the study’s authors, “Findings from this study suggest an unmet need for a rapid, accurate point-of-care diagnostic test to improve vaginitis diagnostic efficiency and increase informed prescribing, which may subsequently reduce the future burden of vaginitis.”

The study specifically highlights point-of-care nucleic acid amplification (NAAT) panel tests (BV, VVC, TV) as new diagnostic tools for healthcare providers to consider if they are looking to reduce misdiagnosis and mistreatment of vaginitis.

What is Vaginitis?

Vulvovaginitis (or just “vaginitis”) is a spectrum of conditions that cause various vaginal or vulvar symptoms including inflammation, itching, burning, pain, odor, and vaginal discharge. The most common causes of vaginitis are:^2.3

• Bacterial vaginosis (BV)
• Vulvovaginal candidiasis (VVC)
• Trichomoniasis (TV)

Vaginitis is associated with severe harm, including pregnancy complications, pelvic inflammatory disease, and increased risk of contracting and transmitting HIV and other STIs.⁴

Let's dive into the study¹ findings.

Large Real-world Dataset Reveals the Impact of Vaginitis

Researchers conducted a retrospective analysis leveraging IQVIA outpatient medical claims and longitudinal prescription claims data for patients presenting with vaginitis symptoms or vaginitis between 1 janvier 2018 and 30 septembre 2022. In total, more than 18,7 million people sought care for vaginitis symptoms or vaginitis during the study timeframe, and just over 4 million of these people met the inclusion criteria for further analysis (213 261 pregnant and 3 787 354 non-pregnant).

Low Rates of Testing and High Rates of Empiric Prescribing Lead to Suboptimal Care

Analysis of claims data revealed that approximately 75% of the analytic cohort did not have any claimed test for vaginitis. Alarmingly, despite this lack of testing, around 25% of these untested patients still received vaginitis-related treatment on the same date as their initial visit, suggesting high rates of empiric prescribing.

Empiric prescribing can lead to suboptimal management, as evidenced by the large number of patients who had repeat vaginitis-related clinic visits. The study found that approximately 30% of the analyzed cohort had at least one vaginitis-related repeat visit within 12 months after their initial visit, totaling over 2 million additional clinic visits.

Among the patients analyzed in the study who did receive testing, traditional methods (see box) were the most common in both pregnant and non-pregnant patients, followed in both cohorts by NAAT with only 1-2 targets tested and direct probe testing. NAAT panels, which offer the highest sensitivity and specificity, were the least utilized method, used in just 8.3% of pregnant patients and 6.6% of non-pregnant patients.

The impact of different test types can be seen in the fact that patients who received a NAAT panel at their first visit were less likely to have a repeat visit or require repeat treatments compared to those undergoing other testing methods. While the overall use of NAAT panels was low, these findings underscore the potential of more accurate, multiplexed diagnostics to improve patient outcomes and reduce the need for subsequent healthcare encounters.

e.g., wet mount microscopy, culture, Amsel criteria, Gram stain with Nugent scoring

• Direct probe: detects the presence of specific microbial DNA without amplification
• NAAT: amplifies genetic material of target microbes. NAAT has higher sensitivity and specificity than traditional methods and direct probe testing.

Point-of-Care NAAT is the Future

Due to the strengths of NAAT over traditional methods and direct probe, the 2024 update of the joint laboratory practice guidelines by the Infectious Disease Society of America (IDSA) and American Society for Microbiology (ASM) recommend multiplex NAAT for diagnosis of vaginitis over traditional methods primarily due to higher sensitivity for BV, VVC TV, and mixed infections, and over direct probe due to higher specificity for BV.⁵

Laboratory-based NAAT often requires at least a one-day turnaround, driving clinicians toward empiric prescribing while waiting for results. Misdiagnosis and mistreatment can impact reproductive and sexual health, contribute to antimicrobial resistance and negatively affect women’s overall quality of life.

To address these issues, the authors advocate the adoption of accurate, rapid point-of-care NAAT testing, which would allow clinicians to align treatment with accurate real-time diagnostic results, curb unnecessary repeat visits, and reduce the risk of ongoing or recurrent disease. In turn, this may reduce the healthcare burden of vaginitis while improving outcomes for women across the country.

Advocate for Point-of-Care Vaginitis NAAT Testing

Healthcare providers and administrators can use the following talking points to advocate bringing point-of-care NAAT testing to their facility.

• Improved Diagnostic Accuracy: Multiplex PCR technology allows for the detection and differentiation of the most common causes of vaginitis, including co-infections, leading to more targeted and effective treatment.
• Reduced Return Visits: By providing accurate results at the point of care, you can facilitate appropriate treatment the first time, potentially reducing rates of repeat visits.
• Enhanced Antibiotic Stewardship: Targeted therapy based on accurate diagnosis can minimize the inappropriate use of prescription and over-the-counter medications and contributes to the fight against antimicrobial resistance.
• Potential to Improve Patient Quality of Life: Fast, accurate diagnostic testing at the point of care has the potential to reduce misdiagnosis and mistreatment that can lead to negative health outcomes including the acquisition and forward transmission of STIs and adverse birth outcomes.