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Medical Policy  

Policy Num:     11.001.038
Policy Name:    Multitarget Polymerase Chain traction Testing for Diagnosis of Bacterial Vaginosis
Policy ID:          [11.001.038]  [Ar / L / M+ / P-]  [2.04.127]

Last Review:     January 15, 2025
Next Review:     Policy Archived
 

Related Policies:

11.001.007 - Identification of Microorganisms Using Nucleic Acid Probes

Multitarget Polymerase Chain traction Testing for Diagnosis of Bacterial Vaginosis

Summary

Description

Bacterial vaginosis (BV) is a common medical condition resulting from an imbalance in the normal vaginal flora. Although the identification of Gardnerella vaginalis has traditionally been associated with BV, there is no single etiologic agent. Most cases are asymptomatic, and most symptomatic cases can be diagnosed using clinical and microscopic evaluation. Multitarget polymerase chain reaction (PCR) testing is proposed as an alternative to currently available laboratory tests to diagnose BV. This test may improve outcomes if it is a more accurate and reliable method to diagnose BV.

Summary of Evidence

In individuals who have signs or symptoms of BV who receive multitarget PCR testing, the evidence includes several prospective studies on technical performance and diagnostic accuracy. The relevant outcomes are test validity, symptoms, and change in disease status. Several studies have evaluated the diagnostic accuracy of multitarget PCR tests for BV, including 5 studies evaluating commercially available tests. The studies found sensitivities between 84% and 95% and specificities between 85% and 97% compared with standard methods of diagnosis. Most studies used a combination of the Amsel criteria and Nugent scoring as the reference standard. There is a lack of direct evidence on the clinical utility of PCR testing for BV (ie, studies showing that testing leads to better patient management decisions and/or better health outcomes than current approaches). Moreover, a chain of evidence does not currently support multitarget testing because most symptomatic women can be diagnosed with a standard workup. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information

Clinical Input. "There exists a small group of patients where a clinical diagnosis is unavailable to be met, either because of atypical presentations, frequent recurrence, or treatment failures."

Objective

The objective of this evidence review is to evaluate whether the technical performance, diagnostic accuracy, and clinical utility of multitarget polymerase chain reaction testing improve net health outcomes in patients with signs or symptoms of BV.

Policy Statements

Multitarget polymerase chain reaction testing for the diagnosis of bacterial vaginosis is considered investigational.

*** In a small subgroup of patients where a clinical diagnosis is unable to be met, either because of atypical presentations, frequent recurrence of the infection, or treatment failures. In this small subgroup of symptomatic patients, PCR testing may be considered medically necessary.

Policy Guidelines

Evidence review 11.001.007 addresses the use of direct or amplified nucleic acid probes with or without quantification to detect microorganisms of clinical significance, including single microorganisms associated with BV.

Coding

See the Codes table for details.

Benefit Application

BlueCard/National Account Issues

No applicable information.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Bacterial Vaginosis

BV is a condition caused by an imbalance in the normal bacteria vaginal flora. It is common, especially in women of reproductive age. While there is no single known etiologic agent, there is a shift in vaginal flora that involves depletion of hydrogen peroxide-producing Lactobacillus species with a rise in vaginal pH and overgrowth of other bacteria, including Gardnerella vaginalis, Mycoplasma hominis, Peptostreptococcus, Mobiluncus species, and other anaerobic gram-negative rods.

Vaginal culture is not an appropriate diagnostic method to identify BV because BV is not caused by the presence of a particular bacterial species.

Various commercial tests provide rapid and accurate pH evaluation and amine detection. For example, automated devices that measure the volatile gases produced from vaginal samples and a colorimetric pH test are commercially available.

Nucleic acid probes of DNA fragments are available to detect and quantify specific bacteria in vaginal fluid samples. Polymerase chain reaction (PCR) methods extract and amplify the DNA fragments using either universal or specific primers. The result can be qualitative (to assess whether a specific microorganism is present) or quantitative (to assess how many microorganisms are present). The technology can be used to measure multiple organisms (eg, those known to be associated with BV) at the same time and is commercially available as multitarget PCR testing.

(Evidence review 2.04.10 addresses the use of direct or amplified nucleic acid probes with or without quantification to detect microorganisms of clinical significance, including single microorganisms associated with BV.

Multitarget PCR Tests

Five quantitative multiplex PCR assays are available: BD Max (Becton Dickinson), Aptima BV (Hologic), NuSwab VG (LabCorp), OneSwab BV Panel PCR with Lactobacillus Profiling by qPCR (Medical Diagnostic Laboratories), and SureSwab BV (Quest Diagnostics).

The SureSwab Total test involves obtaining vaginal swab specimens, extracting total DNA, and quantitating the 4 types of bacteria using PCR. Results are reported as log cells per milliliter for each organism and concentrations of all Lactobacilli species are reported together then classified into 1 of the following 3 categories: not supportive, equivocal, and supportive.

A classification of not supportive of BV diagnosis is based on:

• The presence of Lactobacillus species, G. vaginalis levels <6.0 log cells/mL, and absence of Atopobium vaginae and Megasphaera species; or

• The absence of Lactobacillus species, G. vaginalis levels <6.0 log cells/mL, and absence of A. vaginae and Megasphaera species; or

• The absence of all targeted organisms.

A classification of equivocal is based on:

• The presence of Lactobacillus species, plus G. vaginalis at least 6.0 log cells/mL, and/or presence of A. vaginae and/or Megasphaera species.

A classification of supportive of BV diagnosis is based on the absence of Lactobacillus species, and presence of G. vaginalis levels of at least 6.0 log cells/mL, and presence of A. vaginae and/or Megasphaera species.

The BD Max (Becton, Dickinson), tests for markers of BV and vaginitis. The test uses a similar process to that described for SureSwab. Vaginal swab specimens are collected, DNA is extracted, and real-time PCR is used to quantitate targeted organisms. Results of BV marker tests are not reported for individual organisms. Instead, qualitative BV results are reported as positive or negative for BV based on the relative quantity of the various organisms.

The Aptima BV Assay was cleared by the U.S. Food and Drug Administration with the BD Max as the predicate device. The Aptima assay is a nucleic acid amplification test (NAAT) for detection and quantitation of ribosomal RNA.

Medical Diagnostics Laboratory offers a Bacterial Vaginosis Panel. Markers are assessed using real-time PCR and Lactobacillus is profiled using quantitative PCR. GenPath Diagnostics also offers a bacterial vaginosis test.

The NuSwab Select BV test (Laboratory Corporation of America) uses semiquantitative PCR analysis of 3 predictive marker organisms of vaginal dysbiosis to generate a total score that is associated with the presence or absence of BV. In this test system, samples with a total score of 0 to 1 are considered negative for BV, samples with a score of 3 to 6 are positive for BV, and samples with a score of 2 are indeterminate for BV.

Regulatory Status

Two assays are FDA cleared (BD Max and Aptima BV), and 3 (NuSwab VG, OneSwab BV Panel PCR with Lactobacillus Profiling by qPCR, and SureSwab BV) are laboratory-developed tests.

Several of the manufacturers of the BV tests also have extensions that include other causes of vaginitis such as Trichomonas vaginalis and Candidiasis species. For example, the BD Vaginal Panel was cleared in March 2023 with the BD Max as the predicate device. It is intended to aid in the diagnosis of vaginal infections in individuals with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.^1,

Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests must meet the general regulatory standards of the Clinical Laboratory Improvement Act (CLIA). Laboratories that offer laboratory-developed tests must be licensed by the CLIA for high-complexity testing.

Rationale

The evidence review was created in October 2014 and has been updated regularly with searches of the PubMed database. The most recent literature review was performed through November 12 , 2024.

Evidence reviews assess whether a medical test is clinically useful. A useful test provides information to make a clinical management decision that improves the net health outcome. That is, the balance of benefits and harms is better when the test is used to manage the condition than when another test or no test is used to manage the condition.

The first step in assessing a medical test is to formulate the clinical context and purpose of the test. The test must be technically reliable, clinically valid, and clinically useful for that purpose. Evidence reviews assess the evidence on whether a test is clinically valid and clinically useful. Technical reliability is outside the scope of these reviews, and credible information on technical reliability is available from other sources.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population Reference No. 1

Individuals with Signs or Symptoms of Bacterial Vaginosis

Clinical Context and Test Purpose

The purpose of multitarget polymerase chain reaction (PCR) testing in patients who have signs or symptoms of bacterial vaginosis (BV) is as a replacement to current diagnostic strategies so that appropriate treatment is selected and patient outcomes are improved.

This review evaluates whether multimarker PCR testing improves health outcomes compared with standard diagnostic tests. These tests have been proposed as a replacement for standard diagnostic tests such as Amsel criteria and Nugent score.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with signs or symptoms of BV. BV is a condition caused by an imbalance in the normal bacteria vaginal flora. It is common, especially in women of reproductive age. While there is no single known etiologic agent, there is a shift in vaginal flora that involves depletion of Lactobacillus species and overgrowth of other bacteria, including Gardnerella vaginalis, Mycoplasma hominis, Peptostreptococcus, Mobiluncus species, and other anaerobic gram-negative rods. Prevalence of the condition is high, and it is asymptomatic in most cases. According to data from a nationally representative sample of women surveyed from 2001 to 2004, the prevalence of BV among women ages 14 to 49 years in the U. S. was 29%.^2, BV may be confused with nonbacterial causes of vaginitis, including candidiasis and trichomoniasis.

When symptomatic, BV is associated with characteristic signs and symptoms. The most common sign of BV is an abnormal grayish-white vaginal discharge, generally with an unpleasant, often “fishy” smell in association with mild itching or irritation.

BV resolves spontaneously in a high percentage of women, treatment for symptomatic BV is usually a course of oral antibiotics, either metronidazole or clindamycin. Antibiotic treatment results in a high rate of remission of symptoms, but recurrences are common within the first year after treatment.

Interventions

The intervention of interest is a multitarget PCR test for BV. Nucleic acid probes of DNA fragments are available to detect and quantify the bacteria in vaginal fluid samples. Bacterial DNA is extracted and amplified by PCR methods, using either universal or specific primers The result can be qualitative (to assess whether a specific microorganism is present) or quantitative (to assess how many microorganisms are present). The technology can be used to measure multiple organisms (eg, those known to be associated with BV) at the same time and is commercially available as multitarget PCR testing.

Comparators

The comparators of interest are standard diagnostic approaches such as clinical examination and microscopic examination of vaginal specimens.

Gram staining of vaginal discharge samples is the conventional microscopic method of BV diagnosis and requires preparation and analysis of the specimen in the laboratory setting. It remains the historical research criterion standard for diagnosing BV. Gram-stained samples are analyzed using the Nugent criteria or a modified version by Ison and Hay.

For the Nugent criteria, levels of 3 types of bacteria (Lactobacillus, Gardnerella/Bacteroides, and Mobiluncus) in vaginal discharge samples are estimated. Levels of Lactobacillus and Gardnerella/Bacteroides are rated on a scale from 0 to 4 based on the number of cells per field magnified at 100 times, and levels of Mobiluncus are rated on a scale from 0 to 2. A composite score is calculated by summing the 3 subscores, as listed in Table 1.

Table 1. Nugent Criteria

Some clinicians include a third, middle category in Nugent scoring, with a total score of 0 to 3 considered normal, 4 to 6 as intermediate/equivocal, and 7 to 10 as definite BV.
BV: bacterial vaginosis.

Table 2 summarizes the simplified Ison and Hay criteria.

Table 2. Ison and Hay Criteria

In practice, the diagnosis of BV can be made based on the presence of at least 3 Amsel criteria (characteristic vaginal discharge, elevated pH, clue cells, fishy odor),^2, which is simple and has a sensitivity of over 90% and specificity of 77% compared with Gram stain ^4,

More specifically, vaginal discharge is characterized as homogeneous, thin, and whitish-gray; clue cells are squamous epithelial cells that normally have a sharply defined cell border but in BV, have bacteria adherent to their surfaces and appear to be “peppered” with bacteria; pH of vaginal fluid greater than 4.5; and a “fishy” odor of vaginal discharge before or after addition of potassium hydroxide 10%.

Both comparator diagnostic methods (ie, clinical diagnosis using the Amsel criteria and laboratory diagnosis using Nugent or Ison and Hay criteria) ^5,6,   have subjective components and, therefore, may be imprecise. Moreover, Gram stain examination is time-consuming, requires substantial training, and it is difficult to determine an appropriate clinical response for intermediate scores. The 2 methods of diagnosis can also be used in combination to increase diagnostic accuracy.

Outcomes

The primary outcomes of interest are test validity, symptom resolution, and cure rate (absence of symptoms and normal vaginal flora).

Study Selection Criteria

For the evaluation of the clinical validity of the tests, studies that met the following eligibility criteria were considered:

• Reported on the accuracy of the marketed version of the technology (including any algorithms used to calculate scores)

• Included a suitable reference standard (Amsel, Nugent, or Hay/Ison criteria)

• Patient/sample clinical characteristics were described

• Patient/sample selection criteria were described

• Included a validation cohort separate from the development cohort.

Review of Evidence

Excluded Publications

A publication by Hilbert et al (2016), funded through Medical Diagnostics Laboratory and evaluating markers in that laboratory’s BV Panel, and Gaspar et al (2019) were not selected because they did not include a validation cohort independent of the development cohort.^7, Two studies were excluded because they did not include a suitable reference standard.^8,9, Other publications were not included because they analyzed data previously reported in Gaydos et al (2017).^10,11,

Clinically Valid

A test must detect the presence or absence of a condition, the risk of developing a condition in the future, or treatment response (beneficial or adverse).

There are no published studies on the diagnostic accuracy of the SureSwab test or the GenPath test, but information is available on the diagnostic accuracy of the BD Max test, the Aptima BV test, and the NuSwab offered by LabCorp.

The characteristics of the studies are shown in Table 3 and the results are shown in Table 4. The studies are briefly described following the tables.

Table 3. Characteristics of Clinical Validity Studies Assessing BV Tests

       BV: bacterial vaginosis; FDA: U.S. Food and Drug Administration; NR: not reported.

Table 4. Results of Clinical Validity Studies Assessing BV Tests

       BV: bacterial vaginosis; FDA: U.S. Food and Drug Administration; NPV: negative predictive value; NR: not reported; PPV: positive predictive value; TPI: test performance issues. a Clinician. b Self.

BD Max Test

The U.S. Food and Drug Administration (FDA) decision summary and Gaydos et al (2017) for the BD Max test includes a description of a prospective clinical diagnostic accuracy study.^14,10, The study included 1763 women with symptoms of BV or vaginitis. Both clinician-collected and self-collected vaginal swabs were obtained and were analyzed independently. A total of 1559 (88%) clinician-detected and 1582 (90%) self-detected samples were available for analysis.

Aguirre-Quiñonero et al (2019) describes the results of the BD MAX in 1000 vaginal swabs from women ≥ 14 years old (median age, 33 years) presenting with or without symptoms from a single institution in Spain.^12, Consistent with the inclusion of asymptomatic women, the prevalence of BD was lower in this study at 19%.

van den Munckhof (2019) compared BD MAX to Amsel and Nugent with microbiota analysis as a reference standard in 60 symptomatic women and 20 women treated for other reasons from a single institution in the Netherlands.^13, Samples were collected at 2 visits approximately 4 weeks apart. It is unclear what treatments women received between the visits. The performance characteristics for samples collected at visit 1 are included in Table 4. The authors used microbiota analysis as the reference standard and therefore performance characteristics of BD MAX may not be comparable to other studies. The confidence intervals for the performance characteristics of Amsel and BD MAX were highly overlapping

NuSwab

Cartwright et al (2012) published data on a multitarget semiquantitative PCR test including 3 organisms: Atopobium vaginae, Megasphaera type 1, and BVAB2.^16, The investigators used separate samples for the development and validation phases and compared the diagnostic accuracy of the multitarget panel with an accepted reference standard. The patient population consisted of 402 women presenting at a clinic for sexually transmitted infections (n=299) or a personal health clinic (n=103). Samples from 169 women were included in the development phase, of which 108 (64%) were positive for BV and 61 (36%) were negative for BV. In the validation phase, the multitarget PCR test was assessed using an additional 227 samples. Results were similar in Cartwright et al (2018), which reported on a multicenter study of 1579 women of whom 538 were positive and 1041 were negative for BV.^15, In this publication, the authors proposed an α-diversity score generated from next-generation sequencing that could be used to resolve discordant PCR and Nugent/Amsel results.

Aptima BV

Schwebke et al (2020) compared the Aptima BV assay (Hologic, Inc.) to Nugent score as reference standard in 1,417 symptomatic women.^17, Both clinician- and patient-collected swabs were assessed. Clinicians utilized modified Amsel criteria for the resolution of indeterminate Nugent scores. Performance characteristics for evaluable samples are included in Table 4.

Richter et al (2019) compared the accuracy of testing with Aptima BV, Hologic Analyte Specific Reagent, and the direct-probe BD Affirm test to Nugent score as the reference standard in 111 symptomatic women.^18, Modified Amsel criteria were used for the resolution of indeterminate Nugent scores. Performance characteristics for the commercially-marketed nucleic acid amplification Aptima BV test are included in Table 4.

The purpose of limitations tables (see Tables 5 and 6) is to display notable limitations identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of the evidence supporting the position statement.

Table 5. Study Relevance Limitations

Table 6. Study Design and Conduct Limitations

Other Tests

Several studies have reported on the validation of multitarget PCR tests not currently commercially available in the U.S.^19,20,21,22,These tests will not be reviewed in full until such time they become available in the U.S.

Section Summary: Clinically Valid

Several studies have evaluated the diagnostic accuracy of multitarget PCR tests for BV, including 5 studies evaluating commercially available tests. The studies found sensitivities of 84% to 95% and specificities of 85% to 97%, compared with a reference standard combination of the Amsel criteria and Nugent or Hay score. Several studies generally included symptomatic women; 2 studies included symptomatic and asymptomatic women.

Clinically Useful

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

Direct Evidence

Direct evidence of clinical utility is provided by studies comparing health outcomes for patients managed with and without the test. Preferred evidence comes from randomized controlled trials.

No published studies were identified that evaluated changes in health outcomes when a multitarget PCR test was used to diagnose BV compared with standard methods of diagnosis.

Chain of Evidence

Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

Diagnostic accuracy studies have found that multitarget PCR tests for BV have a sensitivity ranging from approximately 90% to 95% and specificity ranging from approximately 85% to 90% compared with a reference standard combining Amsel criteria and Nugent score. The studies have not reported the concurrent measurement of the diagnostic accuracy of Amsel criteria alone.

The multitarget PCR tests have also not demonstrated improvement in other health outcomes. The tests are not less invasive nor less burdensome for patients because they use the same type of specimen obtained during a pelvic exam that would be needed for microscopy. The multitarget PCRs test also does not provide a diagnosis with a faster turn-around than using Amsel criteria. Therefore, a chain of evidence to demonstrate an improvement in the net health outcome compared with Amsel criteria cannot be constructed.

Section Summary: Clinically Useful

A useful test provides information to make a clinical management decision that improves the net health outcome. To improve the net health outcome, the multitarget PCR tests should either improve diagnostic accuracy (sensitivity, specificity) or have similar diagnostic accuracy with improvements in other health outcomes such as patient burden or timeliness of diagnosis.

• If the multitarget PCR tests could demonstrate improved diagnostic accuracy, a chain of evidence could be created because improvements in diagnosis should lead to improvements in appropriate treatment and therefore an improvement in health outcomes.

• Nugent is the criterion standard for the diagnosis of BV in research studies of BV. The studies of multitarget PCR tests used Nugent criteria as the reference standard with the Amsel criteria used when Nugent were indeterminate.

• Given that the criterion standard is how true- and false-positives and -negatives are defined, multitarget PCR tests cannot show higher sensitivity or specificity than the Nugent criteria.

• To demonstrate improvement in diagnostic accuracy over the criterion standard would require direct evidence through reporting of health outcomes such as symptom resolution and recurrences.

In the absence of evidence of improved diagnostic accuracy, to demonstrate improvement in the net health outcome, multitarget PCR tests should have similar diagnostic accuracy with improvements in other health outcomes such as patient burden or timeliness of diagnosis.

• In the reported studies, sensitivities ranged from approximately 90% to 95% and specificities ranged from approximately 85% to 90% compared with the Nugent criterion standard.

• Guidelines have recommended that Amsel criteria can be used to diagnose BV in practice. Therefore, to understand the diagnostic accuracy of multitarget PCR tests compared with Amsel criteria, studies should have also concurrently compared Amsel criteria with the Nugent criterion standard. The sensitivity and specificity of Amsel criteria alone compared with the Nugent criterion were not reported.

• The multitarget PCR tests are no less invasive nor less burdensome for patients than Amsel criteria for diagnosis because they use the same type of specimen obtained during a pelvic exam that would be needed for microscopy.

• The multitarget PCRs test also does not provide a diagnosis with a faster turn-around than Amsel criteria.

• Multitarget PCR tests might provide benefits in the differential diagnosis of vaginitis. However, the other most common causes of vaginitis (vulvovaginal candidiasis and trichomoniasis) can also be diagnosed using the clinical information assessed when applying the Amsel criteria (signs/symptoms, vaginal pH, amine test, microscopy).

In summary, the present studies have not demonstrated improvements in diagnostic accuracy or improvements in health outcomes compared with Amsel criteria alone or compared with the Nugent criterion standard.

Population Reference No. 2

Published in 2012 and reaffirmed in 2018, the American College of Obstetricians and Gynecologists has produced a Practice Bulletin on the prediction of preterm birth.The Bulletin stated that BV testing is not recommended as a screening strategy in asymptomatic pregnant women at increased risk of preterm birth.

Based on clinical Input there exists a small subgroup of patients where a clinical diagnosis is unable to be met, either because of atypical presentations, frequent recurrence of the infection, or treatment failures. In this small subgroup of symptomatic patients, PCR testing may be considered medically necessary.

Supplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American College of Obstetricians and Gynecologists

Published in 2012 and reaffirmed in 2018, the American College of Obstetricians and Gynecologists (ACOG) has produced a Practice Bulletin on the prediction of preterm birth. The Bulletin stated that BV testing is not recommended as a screening strategy in asymptomatic pregnant women at increased risk of preterm birth.^23,

Published in 2020, the ACOG has issued a Practice Bulletin on vaginitis in nonpregnant patients.^24, The Bulletin made the following recommendations on the initial evaluation of patients with symptoms of vaginitis, citing CDC guidelines:

"A complete medical history, physical examination of the vulva and vagina, and clinical testing of vaginal discharge (ie, pH testing, a potassium hydroxide "whiff test," and microscopy) are recommended for the initial evaluation of patients with vaginitis symptoms."

The Bulletin noted that single-swab multiplex PCR testing "may be a promising alternative to microscopy," but that its clinical utility is still under evaluation.

Centers for Disease Control and Prevention

In 2021, the Centers for Disease Control and Prevention updated its guidelines on sexually transmitted infections.^25, Regarding the diagnosis of bacterial vaginosis (BV), the guidelines stated:

“BV can be diagnosed by....clinical criteria (i.e., Amsel’s Diagnostic Criteria) or by determining the Nugent score from a vaginal Gram stain. Vaginal Gram stain, considered the reference standard laboratory method for diagnosing BV, is used to determine the relative concentration of lactobacilli …"

The guidelines state that multiplex PCR assays are available, but noted that traditional methods of BV diagnosis, including the Amsel criteria, Nugent score, and the Affirm VP III assay, remain useful for diagnosing symptomatic BV because of their lower cost and ability to provide a rapid diagnosis. The guidelines also stated that BV nucleic acid amplification tests should be used among symptomatic women only (eg, women with vaginal discharge, odor, or itch) because their accuracy is not well defined for asymptomatic women.

U.S. Preventive Services Task Force Recommendations

The USPSTF (2020) recommendations on screening for BV in pregnancy^26, have stated that:

“The USPSTF recommends against screening for bacterial vaginosis in pregnant persons who are not at increased risk for preterm delivery.” (Grade D recommendation)

“The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for bacterial vaginosis in pregnant persons who are at increased risk for preterm delivery.” (I statement)

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in November 2024 did not identify any ongoing or unpublished trials that would likely influence this review.

References

1. Food and Drug Administration. BD Vaginal Panel. 510(k) K223653. https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223653.pdf. Accessed November 10, 2024.
2. Allsworth JE, Peipert JF. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data. Obstet Gynecol. Jan 2007; 109(1): 114-20. PMID 17197596
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11. Schwebke JR, Gaydos CA, Nyirjesy P, et al. Diagnostic Performance of a Molecular Test versus Clinician Assessment of Vaginitis. J Clin Microbiol. Jun 2018; 56(6). PMID 29643195
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13. van den Munckhof EHA, van Sitter RL, Boers KE, et al. Comparison of Amsel criteria, Nugent score, culture and two CE-IVD marked quantitative real-time PCRs with microbiota analysis for the diagnosis of bacterial vaginosis. Eur J Clin Microbiol Infect Dis. May 2019; 38(5): 959-966. PMID 30903536
14. Food and Drug Administration. Evaluation of Automatic Class III Designation For BD Max Vaginal Panel: Decision Summary. 2016; https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160001.pdf. Accessed November 12, 2024.
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26. U.S. Preventive Services Task Force. Bacterial Vaginosis in Pregnancy to Prevent Preterm Delivery: Screening. 2020; https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/bacterial-vaginosis-in-pregnancy-to-prevent-preterm-delivery-screening#:~:text=The%20USPSTF%20recommends%20against%20screening%20for%20bacterial%20vaginosis,who%20are%20at%20increased%20risk%20for%20preterm%20delivery.. Accessed November 8, 2024.

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Policy History