Abstract
Background:
The accuracy of vaginitis diagnoses in usual care varies. This study (clinicaltrials.gov NCT06438575) evaluated the clinical utility of Xpert® Xpress Multiplex Vaginal Panel, a Clinical Laboratory Improvement Amendments-waived nucleic acid amplification test (NAAT), for the diagnosis of vaginal infections at the point-of-care (POC).
Methods:
Women (n = 276) seeking care for vaginal symptoms (discharge, odor, itch, irritation, and discomfort) provided self-collected vaginal samples and were randomized to usual care or POC NAAT. True positives were defined as samples positive for bacterial vaginosis (BV), Candida, or Trichomonas vaginalis (TV) by two concordant Food and Drug Administration-cleared NAATs. The primary endpoint was the proportion of women prescribed appropriate Centers for Disease Control recommended or Food and Drug Administration-approved treatment for the identified conditions within 24 hours of the visit. Groups were compared using Fisher exact test.
Results:
Median participant age was 33 years (range 17–76), with self-reported race of 50% Black, 41% White, and 9% other. Twenty (7%) participants were pregnant. The prevalence of BV, Candida, and TV was 44.7%, 32.0%, and 5.1%, respectively, and 36.9% of women had no pathogens detected. For women having BV, TV, or Candida, 40/77 (51.9%) of the usual care arm received appropriate treatment versus 69/77 (89.6%) of women in the POC NAAT arm (P < 0.001). Among women without pathogens, 21/42 (50.0%) were inappropriately treated with antifungals or antibiotics in the usual care arm versus 13/48 (27.1%) in the POC NAAT arm (P = 0.031).
Conclusion:
POC NAATs have clinical utility for the diagnosis of women with vaginal symptoms, increasing the likelihood of appropriate treatment and reducing over-treatment of women without pathogens compared with usual care.
Bacterial vaginosis (BV), Trichomonas vaginalis (TV) infection, and vulvovaginal candidiasis (VVC) are common among reproductive-age women. The prevalence of BV and TV in the United States are 29% and 3%, respectively, but can vary depending on the study population.1,2 Adverse sequelae associated with BV3–5 and TV6–9 include increased acquisition of sexually transmitted infections, including HIV, and pregnancy complications including preterm birth. While the prevalence of VVC cases is unknown, 20% of women are colonized by Candida species in the absence of signs and/or symptoms10 and most women will experience at least one episode of VVC requiring treatment during their lifetimes.11
The Centers for Disease Control (CDC),12 American College of Obstetrics and Gynecology13 and the joint Infectious Disease Society of America/American Society for Microbiology14 guidelines list the point-of-care (POC) tests that can be performed as an adjunct to a clinical history and physical examination to support diagnosis of vaginitis/vaginosis. These include measurement of vaginal pH, addition of potassium hydroxide to vaginal fluid for assessment of amine odor, and microscopic examination of fresh samples of the discharge to identify the presence of clue cells, motile trichomonads, and/or budding yeast/pseudohyphae. In studies evaluating vaginitis diagnosis by clinicians participating in a research study, the sensitivity of direct microscopy was 57% for Candida and 70% for TV.15 Evaluation of wet mounts requires a high-quality microscope and training in the correct identification of clue cells, pseudohyphae, and motile trichomonads, so quality of implementation of these POC tests can vary considerably. The lack of appropriate POC testing by providers in clinical practice has been reported for decades.16 In one study of 333 physicians and the review of 984 vaginitis patient records, access to POC tools used to diagnose vaginitis varied by practice.17 This study reported that there was limited access to all 3 tools (microscope, pH test strips, and potassium hydroxide solution) and only 66% of patients evaluated for VVC, 45% of patients evaluated for BV, and 17% evaluated for trichomoniasis received an optimal workup. Despite these limitations in accuracy and availability (or access), reliance on these simple POC tools has continued.
Advances in highly sensitive nucleic acid amplification tests (NAATs) have provided an opportunity to employ more sensitive and specific methods for the diagnosis of vaginitis and vaginosis.18,19 Commercially available multiplex PCR tests detect specific nucleic acids and have high sensitivity and specificity, are performed on either clinician- or self-collected vaginal specimens, and provide results in <24 hours.15,20–22 The Xpert® Xpress Multiplex Vaginal Panel (MVP) (Cepheid, Sunnyvale, CA) is a Clinical Laboratory Improvement Amendments (CLIA)-waived NAAT that can be performed by non-laboratory staff in a clinical setting at the POC.23 The Xpress MVP detects DNA targets from anaerobic bacteria associated with BV including Atopobium vaginae (now Fannyhessia vaginae),24 BV-associated bacteria 2 (now Amygdalobacter indicium),25 and Megasphaera-1 (now Megasphaera lornae),26 in addition to the Candida species associated with VVC, and Trichomonas vaginalis. When compared with laboratory-based detection methods, the MVP test demonstrated high positive percent agreement ranging from 93.6% to 99.0%, and negative percent agreement ranging from 92.1% to 99.8% for both clinician-collected samples and patient-collected samples.21
Our study had two objectives. First, we performed a clinical trial comparing the appropriateness of treatment among women randomized to receive usual care versus POC NAAT (MVP) for Candida, BV, and TV. Our second objective was to describe the methods being used by providers for diagnosis of vaginitis and vaginosis, and their satisfaction with those methods before the trial, and then to assess provider’s views regarding the use of POC NAAT for women having vaginal symptoms following the clinical trial.
MATERIALS AND METHODS
Pre-Randomized Trial Assessment of Clinicians
A baseline survey, approved by the University of Pittsburgh Institutional Review Board (IRB), was completed by providers whose practice included women having symptoms of vaginitis. The IRB determined that written informed consent was not required for participation in the anonymous baseline survey. Providers answered 16 questions using REDCap for electronic data capture about their demographics, years in practice, credentials, and methods used to diagnose vaginitis in their practices.
Randomized Trial of Usual Care Versus POC NAAT for Vaginal Conditions
Research staff pre-screened electronic schedules to identify individuals seeking care in a single medical center for vaginitis symptoms. Participants were approached at or before the time of the office visit, provided with a brief description of the study, and provided written informed consent approved by the University of Pittsburgh IRB. Inclusion criteria were being 14 years and older, assigned female sex at birth, and seeking care for symptoms of vaginitis (i.e., vaginal discharge, vaginal odor, vulvar, or vaginal itch, vulvar or vaginal discomfort such as irritation, burning, pain, or vulvar edema). A participant questionnaire was administered by study staff including demographics, symptoms, and history of vaginal infections in the past 12 months, and the data were directly entered into REDCap.
Participants were provided written instructions on how to self-collect vaginal swabs for the Xpert® Swab Specimen Collection kit for the Xpert Xpress MVP and the BD Molecular Swab Collection kit for the BD MAX™ Vaginal Panel (BD MAX VP). After swab collection, women were randomized 1:1 in REDCap to receive either usual care (Arm 1) or to POC NAAT for Candida, BV, and TV (Arm 2). Women and their providers were aware of their randomization group. Participants were given a paper card to give to their healthcare provider to inform them of the patient’s participation in the study, the study arm assignment, and when the POC NAAT results would be available. A progress note containing information about the study arm and timeframe for testing results was entered into the electronic medical record. For Arm 1 (usual care), the MVP swab samples were stored at room temperature and tested within 17 days of receiving the sample, as permitted, per manufacturer test instructions. The results of the MVP test were entered into the electronic medical record and directed to the provider for review and provided to the participant through the patient portal after the participant’s 2-week telephone contact. This study which included 90 clinicians across 7 clinics reflected usual care provider practice for women presenting with vaginal symptoms.
Swabs from women assigned to the POC NAAT arm were tested immediately on-site by clinical non-laboratory research staff, and results were available to the provider through the electronic medical record and to the participant through the patient portal in approximately 1 hour. For women in both arms, the BD MAX™ swab was tested in a CLIA-licensed lab for Candida, TV, and BV using the BD MAX VP. The result of this NAAT was not shared with participants or providers but was used to define true positives and negatives. A true positive was defined as having concordant NAAT results (Xpert Xpress MVP and BD MAX VP) for BV, TV, and/or Candida.
Participants were contacted by telephone two weeks after their visit (range 10–21 days) to complete a follow-up REDCap questionnaire including current symptoms, compliance with treatment, additional care or treatment for vaginitis, and satisfaction/comfort with self-collection of swabs, and their satisfaction with their diagnosis and treatment.
Approximately 28 days after the enrollment visit, a single research clinician extracted data from the electronic medical record for each participant including provider credentials, demographics, chief complaint, assessment of vaginal discharge, provider impression, and treatment. Any testing performed by the provider was collected including wet mount microscopy, vaginal pH, whiff test, cultures, and sexually transmitted infection testing. Data were entered into REDCap. Appropriate treatment was defined as the participant having received CDC-recommended or Food and Drug Administration (FDA)-approved treatment for BV, TV, or Candida based on diagnosis from concordant NAAT results from the self-collected enrollment swabs. Because it is common in clinical practice to prescribe antifungal therapy prophylactically when prescribing antibiotics for treatment of BV, prophylactic antifungal treatment among women being treated for BV was considered appropriate even when Candida was not detected by NAAT.
Post-Randomized Trial Assessment of Clinicians
At the conclusion of the study, providers who had patients enrolled in the clinical trial were asked to complete a post-study questionnaire approved by the IRB. The survey required informed consent as it included specific providers who had at least one of their patients participate in the study and provided a gift card at survey completion. The responses to the questionnaire from providers were collected anonymously on paper forms. For the post-study questionnaire, there were 13 questions, including demographics, years in practice, how many patients they had in the clinical trial, and their satisfaction with the use of POC testing. Providers were also invited to add open-text comments on their views about the use of the POC NAAT.
Statistical Methods
The primary study endpoint was the proportion of study participants prescribed appropriate treatment at or within 24 hours of the clinic visit as defined by use of a CDC-recommended treatment regimen and/or a treatment approved for that indication by the US FDA for vaginitis/vaginosis. We hypothesized that women in the study arm in which study clinicians and patients were provided with same-day access to MVP would have a higher proportion of women receiving appropriate treatment than women assigned to usual care. A sample size of 150 participants per arm had 91% power to detect a difference of at least 15 percentage points between study arms based on a Fisher exact test evaluated at the 2-sided 0.05 significance level. Due to the abrupt termination of federal funding in February 2025, several study team members were no longer available to support the study, and participant accrual was terminated in March before full accrual of 300 subjects. However, because the difference in the outcomes between the two study arms was greater than 15%, the study retained power to achieve its aims. Fisher exact and Mann–Whitney U tests were used to evaluate differences in participant characteristics and study endpoints. All tests were evaluated at the 2-sided 0.05 significance level.
RESULTS
Pre-Randomized Trial Assessment of Clinicians
Before the randomized trial, 69 care providers including 46 physicians and 23 advanced practice providers (nurse midwives, nurse practitioners, and physician assistants) completed a baseline questionnaire about their preferred methods for diagnosis of vaginitis or vaginosis in their clinical practice. The providers were 87% female, and the median age range was 30 to 39 years. The median years in practice was 6 to 10 years with a range of <1 year to >20 years of practice. Providers most often reported use of the Amsel criteria including wet mount (44/69, 63.7%) for diagnosis of vaginitis/vaginosis, while 11 (15.9%) reported assessment of symptoms alone, 5 (7.2%) reported basing their diagnosis on visual inspection of the vaginal discharge, and 9 (13%) reported using moderate complexity laboratory testing for diagnosis of vaginitis/vaginosis.
At baseline, 82% of providers who relied on use of the wet mount/Amsel criteria for diagnosis of vaginitis/vaginosis reported that they were satisfied with the turnaround time and 86% were confident in the accuracy of this method (Table 1). Reliance on symptom evaluation or visual examination of the vaginal discharge for diagnosis was rated favorably for turnaround time, but providers expressed less confidence in the accuracy of their diagnosis. Providers had high confidence in the accuracy of moderate complexity laboratory testing for diagnosis of vaginitis/vaginosis (100%), but only 44% of providers who ordered testing from the laboratory were satisfied with the turnaround time.
TABLE 1.
Baseline Provider Survey Evaluating Satisfaction With Turnaround Time, Workflow, Overall Satisfaction, and Perceived Accuracy of Primary Methods Used for Diagnosis of Vaginitis and Vaginosis
| Primary Method Used for Diagnosis of Vaginitis/Vaginosis | ||||
|---|---|---|---|---|
| Wet Mount/Amsel; N = 44 Providers | Symptoms Reported; N = 11 Providers | Visual Appearance of Vaginal Discharge; N = 5 Providers | Molecular Tests Ordered From Laboratory; N = 9 Providers | |
| Satisfied with turnaround time for the primary method used | 36 (82%) | 10 (91%) | 5 (100%) | 4 (44%) |
| Satisfied with workflow for the primary method used | 26 (59%) | 7 (63%) | 5 (100%) | 7 (78%) |
| Overall satisfaction with primary method used for diagnosis | 32 (73%) | 7 (63%) | 3 (60%) | 7 (78%) |
| Confident in accuracy of results for primary methods used for diagnosis | 38 (86%) | 8 (73%) | 3 (60%) | 9 (100%) |
Randomized Trial of Usual Care Versus POC Testing for Vaginal Conditions
The trial (clinicaltrials.gov NCT06438575) was conducted between July 2024 and March 2025. A total of 276 women with vaginitis symptoms were enrolled, with 137 women randomized to the usual care group and 139 women randomized to the POC NAAT (MVP) group (Fig. 1). The median participant age was 33 years (range 17–76). Self-reported race and pregnancy were balanced between the two arms (Table 2). The most common symptoms reported by women at presentation were abnormal vaginal discharge and discomfort, followed by vulvar/vaginal itching. Most (71.7%) reported more than one symptom at enrollment, with 81 (29.3%) of the 276 women reporting 3 or more vulvar/vaginal symptoms at the time of their visit (Table 2).
Figure 1.
Disposition of study participants.
TABLE 2.
Participant Characteristics and Self-Reported Symptoms at Randomization in the Two Groups: Usual Care Versus POC NAAT Groups
| Usual Care; N = 137 | POC NAAT (MVP); N = 139 | P Value* | |
|---|---|---|---|
| Age, years | 32 (27, 42) | 33 (26, 39) | 0.588† |
| Race | 0.400 | ||
| White | 55 (40.1%) | 57 (41.0%) | |
| Black/African American | 70 (51.1%) | 67 (48.2%) | |
| Asian | 3 (2.2%) | 3 (2.2%) | |
| Multiracial | 5 (3.6%) | 11 (7.9%) | |
| Other | 4 (2.9%) | 1 (0.7%) | |
| Hispanic/Latino | 9 (6.6%) | 10 (7.2%) | >0.999 |
| Pregnant | 12 (8.8%) | 8 (5.8%) | 0.363 |
| Current symptoms | |||
| Abnormal vaginal discharge | 78 (56.9%) | 80 (57.6%) | >0.999 |
| Abnormal vaginal odor | 51 (37.2%) | 55 (39.6%) | 0.712 |
| Itching | 66 (48.2%) | 73 (52.5%) | 0.547 |
| Discomfort | 76 (55.5%) | 79 (56.8%) | 0.903 |
| Other | 6 (4.4%) | 13 (9.4%) | 0.152 |
| Number of symptoms | 0.167 | ||
| One | 42 (30.7%) | 37 (26.6%) | |
| Two | 62 (45.3%) | 54 (38.8%) | |
| Three | 23 (16.8%) | 39 (28.1%) | |
| Four or more | 10 (7.3%) | 9 (6.5%) | |
| Days with current symptoms | 7 (4, 14) | 10 (5, 14) | 0.253† |
Data displayed as n (%) or median (interquartile range).
P value from Fisher exact test.
P value from Mann–Whitney U test.
BV was detected in 44.2% of women based on the MVP test versus 45.7% of women using the lab-based BD MAX VP test which relies on detection of the same BV-specific organisms as the MVP test and includes Lactobacillus species (L. crispatus or L. jensenii), with 95.7% concordance between the two NAATs. Candida species, a result which includes C. albicans, C. tropicalis, C. parapsilosis, and C. dubliniensis for both systems were detected in 31.5% of women by MVP and 30.4% of women by BD MAX VP, with a concordance of 94.6% between the two tests. The detection of Candida glabrata/C. krusei are grouped for MVP, whereas they are separate targets for BD MAX VP but these two Candida species were detected at similar frequencies (4.0% vs 4.3%) on the two testing platforms. TV was detected in 5.1% of women by both testing systems, with 100% concordance. Overall, 244 (88.2%) of all tests were concordant on both platforms, leaving an analysis population of 244 women.
Based on the results of the two concordant NAATs, any vaginitis/vaginosis was detected in 154 (63.1%) of the symptomatic women while no positive results were detected for 90 (36.9%) of the women. BV was detected in 188 (44.7%), Candida species in 32.0% of the study population, and TV in 5.1%. Because many women had more than one positive diagnostic NAAT, women were grouped into 5 categories as shown in Table 3, stratified for vulvar/vaginal symptoms. Most women positive by two NAATs had BV alone (30.0%), followed by Candida species alone (18%), mixed infection (14%), and TV (1.3%). While abnormal vaginal odor and abnormal discharge were highest among women with BV, these symptoms were also reported by half of women, having no condition detected (Table 3). Itching and discomfort were reported most frequently among women having Candida, but these symptoms were also frequently reported among women having no vaginal condition detected. The number of vulvar/vaginal symptoms reported by the women did not differ among diagnosis-based groups. At the 2-week telephone follow-up visit, 252/276 (91.3%) of study participants reported that they were comfortable or very comfortable with self-collection of the swabs for the study. Eighty percent of women with a diagnosed condition and 70.1% of those without a diagnosed vaginal condition were asymptomatic at the 2-week follow-up visit.
TABLE 3.
Patient Reported Symptoms Stratified by Diagnosis Based on the Results of Two Concordant FDA-Cleared Molecular Tests for BV, Candida Species and TV
| Symptoms | Result of NAAT Testing | P Value* | ||||
|---|---|---|---|---|---|---|
| BV; N = 73 | Candida; N = 44 | TV; N = 2 | Mixed Infection; N = 35 | No Infection; N = 90 | ||
| Abnormal discharge | 51 (69.9%) | 24 (54.5%) | 2 (100%) | 18 (51.4%) | 44 (48.9%) | 0.045 |
| Abnormal odor | 40 (54.8%) | 6 (13.6%) | 0 | 11 (31.4%) | 36 (40.0%) | <0.001 |
| Itching | 28 (38.4%) | 33 (75.0%) | 1 (50.0%) | 21 (60.0%) | 41 (45.6%) | <0.001 |
| Discomfort | 34 (46.6%) | 32 (72.7%) | 1 (50.0%) | 21 (60.0%) | 54 (60.0%) | 0.064 |
| Other | 2 (2.7%) | 7 (15.9%) | 0 | 0 | 9 (10.0%) | 0.025 |
| Number of symptoms | 0.411 | |||||
| One | 20 (27.4%) | 9 (20.5%) | 1 (50.0%) | 10 (28.6%) | 28 (31.1%) | |
| Two | 29 (39.7%) | 16 (36.4%) | 0 | 17 (48.6%) | 40 (44.4%) | |
| Three | 21 (28.8%) | 15 (34.1%) | 1 (50.0%) | 5 (14.3%) | 14 (15.6%) | |
| Four or more | 3 (4.1%) | 4 (9.1%) | 0 | 3 (8.6%) | 8 (8.9%) | |
Data displayed as n (%).
P value from Fisher exact test.
Information on the treatment prescribed by the providers was extracted from the electronic medical record 1 month after the patient was seen in the clinic. Study participants were categorized as having received appropriate or inappropriate treatment based on the diagnosis from the two concordant NAATs. Appropriate treatment for vaginitis/vaginosis was provided to 61/119 (51.3%) women in the usual care group versus 104/125 (83.2%) of women randomized to the POC NAAT (MVP) group, P < 0.001 (Table 4). Provision of appropriate treatment was higher among women randomized to POC NAAT for participants having BV or Candida alone, as well as those having mixed conditions (Table 4). Among women having no condition detected, 50% women were inappropriately treated with antifungals or antibiotics in the usual care arm versus 27% in the POC NAAT arm (P = 0.031). Because only 2 participants in the study had TV as a sole pathogen, both randomized to the usual care group, no statistical comparisons were possible.
TABLE 4.
Provision of Appropriate Treatment for Women Having Symptoms of Vaginitis/Vaginosis Randomized to Usual Care or POC NAAT MVP for BV, Candida Species, and TV
| Appropriate Treatment for Diagnosed Condition as Defined by Use of CDC Recommended and/or FDA Approved Treatments | |||
|---|---|---|---|
| Diagnosis Based on Two Concordant NAATs/Treatment Provided | Usual care | POC NAAT(MVP) | P Value* |
| BV alone/antibiotics for BV provided | 22/39 (56.4%) | 31/34 (91.2%) | 0.001 |
| Candida alone/antifungals provided | 11/20 (55.0%) | 23/24 (95.8%) | 0.002 |
| T. vaginalis alone/antibiotics provided | 1/2 (50.0%) | — | |
| Mixed pathogen/antifungals and/or antibiotics provided | 6/16 (37.5%) | 15/19 (78.9%) | 0.018 |
| No pathogens detected/no treatment given | 21/42 (50.0%) | 35/48 (72.9%) | 0.031 |
| Appropriate treatment overall | 61/119 (51.3%) | 104/125 (83.2%) | <0.001 |
P value from Fisher exact test.
For the women randomized to the usual care group whose providers recorded having done a wet mount for BV, wet mounts had a sensitivity of 35/69 (62.9%) and specificity of 27/31 (87.1%). For the 59 women who had a wet mount for Candida, wet mounts had a sensitivity of 9/18 (50.0%) and a specificity of 31/41 (75.6%). Wet mounts for the detection of motile trichomonads were reported for only 17 women in the usual care group, and the sensitivity was 2/4 (50.0%), and the specificity was 100%. These data suggest that wet mounts are often not performed, and even when performed, have a low level of sensitivity for the detection of vaginal pathogens.
Post-Randomized Trial Assessment of Clinicians
The response rate for the post-trial provider survey was 75/90 (83%). As with the baseline provider survey, most providers were female, and the majority were <40 years of age. For the 53 providers who had a patient in the POC NAAT (MVP) group, 98% were satisfied with the turnaround time for POC NAAT, 85% were satisfied with the workflow, and 87% stated that they would like to include POC NAAT in the future.
DISCUSSION
In this randomized trial of women seeking care for symptoms of vaginitis/vaginosis, the integration of POC NAAT for BV, Candida, and TV significantly increased the provision of appropriate treatment within 24 hours for women having vaginitis/vaginosis, and decreased inappropriate treatment of women without BV, TV, or Candida. These data suggest inaccurate diagnosis of these causes of vaginal symptoms is common, resulting in the provision of inappropriate treatment in approximately half of women seeking care. Although providers expressed confidence in the accuracy of the methods used for diagnosis of vaginitis/vaginosis before the trial, at the conclusion of the study, providers expressed support for integration of POC NAAT into their clinical practice. In the present study, testing was performed by non-laboratory staff after brief training by the Department of Pathology, similar to the training established for the integration of other CLIA-waived tests in clinical settings. In a study of MVP users, the MVP test demonstrated consistent performance across user types and users’ educational status, with all 19 users stating that the instructions were easy to follow and easy to perform.23
The results of this trial are consistent with a previous study conducted in community practice settings, showing that the diagnosis of vaginitis was often inaccurate and resulted in approximately 40% of women receiving inappropriate care.27 In that study, women’s electronic medical records were evaluated for 3 months following enrollment and revealed that women who were prescribed unneeded treatment were significantly more likely to return with symptoms of vaginitis in the subsequent 3 months versus those who were not treated (22% vs 6%, P = 0.02). The 1-month follow-up of study participants in our study limited our capacity to assess whether the provision of inappropriate treatment resulted in a greater number of follow-up patient visits for persistent or recurrent symptoms.
Many women presenting with vulvar and vaginal symptoms do not have BV, TV, or Candida present. In this study, 37% of symptomatic women presenting for care had negative test results for all three vaginal conditions. Testing for gonococcal and chlamydial infection in this study was performed only when providers noted a risk factor. Of the 90 women without diagnosed vaginal conditions (36%) were tested for cervical pathogens but none had gonorrhea or chlamydial infection. Women having no diagnosed vaginal conditions reported similar frequencies and severity of symptoms as the women presenting with BV, TV, and Candida species; 70% reported symptom resolution at the 2-week telephone follow-up irrespective of antifungal or antibiotic therapy. Half of the women without BV, TV, or Candida detected received antibiotic or antifungal treatment in the usual care group, but so did 27% of the women in the POC NAAT group even though specific testing had demonstrated the absence of conditions treatable with antifungals or antibiotics. The provision of antifungal or antibiotic therapy to symptomatic women despite the availability of testing documenting the absence of BV, TV, or Candida may reflect the physician’s desire to accept a patient’s request for treatment, failure to note the test results in the electronic medical record, or distrust in the accuracy of the testing system. Overuse of antimicrobials when no pathogens are detected should be avoided since it can contribute to antimicrobial resistance, may disrupt the vaginal microbiome, may cause side effects, and adds costs to women and their insurers.
Syndromic management of women having vaginal discharge syndromes with a combination of medications targeting the most common causes of vaginal discharge is common in resource-limited settings, as it allows for immediate treatment at the first patient contact. However, vaginal symptoms were poor predictors of vaginal infections in our study and previously published studies.28 In the present study, approximately 25% of providers reported reliance on symptoms or evaluation of vaginal discharge alone to direct diagnosis of vaginitis/vaginosis, and only half recorded wet mount results in their evaluations. Even for those who performed wet mount, the sensitivity of wet mount for the detection of TV or Candida was only 50%, and the sensitivity of wet mount for the detection of clue cells was only 63%.
A strength of the present study is its randomized design and the integration of POC NAAT testing results into the electronic medical record and patient results portal which allowed for a real-life assessment of how the availability of these results would alter treatment decisions by the provider. The use of two FDA-cleared NAATs for the diagnosis of vaginal infections provided substantial evidence that the POC NAAT results were consistent with the results achieved with testing performed in CLIA-licensed laboratories. The low prevalence of TV in the study population limited our ability to detect differences in usual care versus POC NAAT testing groups. However, the poor sensitivity of microscopy, the primary diagnostic tool for the detection of TV, is well documented.15
Women who seek care for symptoms deserve an accurate diagnosis and appropriate treatment. Although the use of POC testing using microscopy, pH, and amine odor testing has been the mainstay of diagnostic testing for vaginitis for more than 50 years, reliance on these methods which are either unavailable or poorly used do not serve the needs of women. As noted in the 2020 American College of Obstetrics and Gynecology guidelines for BV, NAATs could replace wet mount13 if proven to have clinical utility. The present randomized clinical utility study demonstrates that integration of POC NAATs in clinics serving women with vaginitis symptoms can significantly improve the appropriateness of treatment compared with usual care.
Footnotes
Conflict of Interest and Sources of Funding: This study was supported by an investigator-initiated grant from Cepheid to the University of Pittsburgh and the Clinical and Translational Science Institute at the University of Pittsburgh Grant Number UL1-TR-001857. S.L.H. receives funding from Cepheid through her institution and has received consulting fees from Merck and Freya Biosciences.
Author Contributions: All authors have contributed to the design and/or execution of the study and all have contributed to the development of the manuscript including approval of the submitted work.
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