Materiały źródłowe

• #1 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  For individuals with symptoms of vaginitis, rapid identification of Trichomonas by enzyme immunoassay is considered NOT MEDICALLY NECESSARY. […] Testing for microorganisms involved in vaginal flora imbalance and/or infertility using molecular-based panel testing is considered NOT MEDICALLY NECESSARY. […] All other tests for vaginitis not addressed above is considered NOT MEDICALLY NECESSARY. […] Rationale Vaginitis is characterized by several symptoms including odor, itching, abnormal vaginal discharge, burning and irritation; this inflammatory ailment is considered the most common gynecologic diagnosis in primary care as most women experience vaginitis at least once in their lives (Paladine Desai, 2018). A diagnosis of vaginitis can be given based on a combination of symptoms, physical examination, and office or laboratory-based testing methods.

• #2 Vaginitis: Diagnosis and Treatment | AAFP

  https://www.aafp.org/pubs/afp/issues/2011/0401/p807.html

  Bacterial vaginosis, trichomoniasis, and vulvovaginal candidiasis are the most common infectious causes of vaginitis. Diagnosis is commonly made using the Amsel criteria, which include vaginal pH greater than 4.5, positive whiff test, milky discharge, and the presence of clue cells on microscopic examination of vaginal fluid. […] Symptoms and signs of trichomoniasis are not specific; diagnosis by microscopy is more reliable. […] Most patients with vulvovaginal candidiasis are diagnosed by the presence of vulvar inflammation plus vaginal discharge or with microscopic examination of vaginal secretions in 10 percent potassium hydroxide solution. […] Rapid point-of-care tests are available to aid in accurate diagnosis of infectious vaginitis. […] Physicians traditionally diagnose vaginitis using the combination of symptoms, physical examination, pH of vaginal fluid, microscopy, and the whiff test.

• #3 Vaginitis – Diagnosis & treatment – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/vaginitis/diagnosis-treatment/drc-20354713

  To diagnose vaginitis, your health care provider is likely to: […] Review your medical history. This includes your history of vaginal or sexually transmitted infections. […] Perform a pelvic exam. During the pelvic exam, your health care provider might use an instrument (speculum) to look inside your vagina for inflammation and discharge. […] Collect a sample for lab testing. Your health care provider might collect a sample of cervical or vaginal discharge for lab testing to confirm what kind of vaginitis you have. […] Perform pH testing. Your health care provider might test your vaginal pH by applying a pH test stick or pH paper to the wall of your vagina. An elevated pH can indicate either bacteria vaginosis or trichomoniasis. However, pH testing alone is not a reliable diagnostic test. […] Your family health care provider, gynecologist or another medical practitioner can diagnose and prescribe treatment for vaginitis.

• #4 Vaginitis: Diagnosis and Treatment | AAFP

  https://www.aafp.org/pubs/afp/issues/2011/0401/p807.html

  Bacterial vaginosis, trichomoniasis, and vulvovaginal candidiasis are the most common infectious causes of vaginitis. Diagnosis is commonly made using the Amsel criteria, which include vaginal pH greater than 4.5, positive whiff test, milky discharge, and the presence of clue cells on microscopic examination of vaginal fluid. […] Symptoms and signs of trichomoniasis are not specific; diagnosis by microscopy is more reliable. […] Most patients with vulvovaginal candidiasis are diagnosed by the presence of vulvar inflammation plus vaginal discharge or with microscopic examination of vaginal secretions in 10 percent potassium hydroxide solution. […] Rapid point-of-care tests are available to aid in accurate diagnosis of infectious vaginitis. […] Physicians traditionally diagnose vaginitis using the combination of symptoms, physical examination, pH of vaginal fluid, microscopy, and the whiff test.

• #5 Vaginitis in adults and adolescents: Initial evaluation – UpToDate

  https://www.uptodate.com/contents/approach-to-females-with-symptoms-of-vaginitis

  The initial history questions gather details of the patient’s symptoms. Each symptom is further evaluated separately as more than one condition may be present. However, none of the findings from the history allows a definitive diagnosis since there is considerable overlap in symptoms among the different etiologies of vaginitis. […] The characteristics of the vaginal discharge may suggest the type of infection, if present. Trichomoniasis is classically associated with a greenish-yellow purulent discharge; candidiasis with a thick, white, adherent, „cottage cheese-like” discharge; and BV with a thin, homogeneous, „fishy smelling” gray discharge. […] Vaginitis can result from infectious and noninfectious causes. Infectious vaginitis is much more common and typically results from bacterial vaginosis (BV), Candida vulvovaginitis, and/or trichomoniasis. Noninfectious etiologies include vaginal atrophy/atrophic vaginitis in postmenopausal individuals, foreign body (eg, retained tampon or condom), irritants and allergens, dermatoses, and several rarer entities including some systemic medical disorders. […] Approximately 25 to 40 percent of patients with vaginitis symptoms do not have a specific cause identified on initial diagnostic evaluation. These patients undergo secondary evaluation, preferably at a time when symptoms are present.

• #6 Vaginitis in adults and adolescents: Initial evaluation – UpToDate

  https://www.uptodate.com/contents/vaginitis-in-adults-and-adolescents-initial-evaluation

  Vaginitis is the general term for disorders of the vagina caused by infection, inflammation, or changes in the normal vaginal flora. Symptoms include abnormal vaginal discharge, odor, pruritus, and/or discomfort. The initial evaluation typically consists of a history, physical examination, and tests for specific infections, including sexually transmitted infections (STIs). Individuals whose initial evaluation confirms a diagnosis then receive targeted treatment. Those who remain without a diagnosis, or whose symptoms recur, then go through a more detailed evaluation process. […] The clinical evaluation consists of a history, physical examination, and testing of vaginal discharge for evidence of infection. […] The vaginal discharge is tested for bacterial vaginosis (BV), vulvovaginal candidiasis, and trichomoniasis using either pH testing with microscopy and/or laboratory tests (typically nucleic acid amplification tests).

• #7 Vaginitis: Diagnosis and Treatment | AAFP

  https://www.aafp.org/pubs/afp/issues/2011/0401/p807.html

  Bacterial vaginosis, trichomoniasis, and vulvovaginal candidiasis are the most common infectious causes of vaginitis. Diagnosis is commonly made using the Amsel criteria, which include vaginal pH greater than 4.5, positive whiff test, milky discharge, and the presence of clue cells on microscopic examination of vaginal fluid. […] Symptoms and signs of trichomoniasis are not specific; diagnosis by microscopy is more reliable. […] Most patients with vulvovaginal candidiasis are diagnosed by the presence of vulvar inflammation plus vaginal discharge or with microscopic examination of vaginal secretions in 10 percent potassium hydroxide solution. […] Rapid point-of-care tests are available to aid in accurate diagnosis of infectious vaginitis. […] Physicians traditionally diagnose vaginitis using the combination of symptoms, physical examination, pH of vaginal fluid, microscopy, and the whiff test.

• #8 Diagnosis of Vaginitis – Medical Clinical Policy Bulletins | Aetna

  https://www.aetna.com/cpb/medical/data/600_699/0643.html

  This Clinical Policy Bulletin addresses the diagnosis of vaginitis. […] Diagnosis of vaginitis is based on clinical symptoms, pH of the vaginal fluid and microscopic examination of the discharge. […] The presence of Gardnerella vaginalis on culture can not be used to diagnose BV, since it is present in approximately 50 % of healthy women. […] Physicians have become interested in alternative, office based methods of diagnosing vaginitis. […] DNA probes have been developed to directly detect the presence of candida, trichomonas and Gardnerella, thus providing a more objective diagnosis. […] The Affirm VP III Microbial Identification System (Becton Dickinson) is a commercially available DNA probe office-based test kit that simultaneously detects the presence of Gardnerella, trichomonas and candida.

• #9 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  The squamous epithelium of the vagina in premenopausal women is rich in glycogen, a substrate for lactobacilli, which create an acidic vaginal environment (pH 4.0 to 4.5). This acidity helps maintain the normal vaginal flora and inhibits growth of pathogenic organisms. Disruption of the normal ecosystem by menstrual cycle, sexual activity, contraceptive, pregnancy, foreign bodies, estrogen level, sexually transmitted diseases, and use of hygienic products or antibiotics can lead to development of vaginitis. Bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis are the three most common infections responsible for vaginitis. Other causes include: vaginal atrophy in postmenopausal women, cervicitis, foreign body, irritants and allergens (Sobel, 2023c). […] Laboratory documentation of the etiology of vaginitis is important before initiating therapy, given the nonspecific nature and considerable overlap of the symptoms (Anderson et al., 2004; Ellis et al., 2001; Landers et al., 2004). Diagnostic testing enables targeted treatment, increases therapeutic compliance, and increases the likelihood of partner notification (Sobel, 2023c; Workowski Bolan, 2015).

• #10 Vaginitis: Diagnosis and Treatment | AAFP

  https://www.aafp.org/pubs/afp/issues/2011/0401/p807.html

  Individual symptoms and signs, pH level, and microscopy results often do not lead to an accurate diagnosis of vaginitis. Laboratory tests perform better than standard office-based evaluation for diagnosing causes of vaginitis, but they do not add substantially to the treatment threshold and are justified only in patients with recurrent or difficult-to-diagnose symptoms. […] In clinical practice, bacterial vaginosis is diagnosed by the presence of three out of four Amsel criteria. […] A vaginal pH of more than 4.5 was found to be the most sensitive (89 percent) and a positive whiff test was the most specific (93 percent) method of detecting bacterial vaginosis. […] Vaginal culture should be considered in recurrently symptomatic women with negative microscopy and a normal pH. […] Although lactobacillus probiotics are safe, there is no conclusive evidence that they are superior to or enhance the effectiveness of antibiotics in the treatment of bacterial vaginosis or prevent its recurrence.

• #11 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  The squamous epithelium of the vagina in premenopausal women is rich in glycogen, a substrate for lactobacilli, which create an acidic vaginal environment (pH 4.0 to 4.5). This acidity helps maintain the normal vaginal flora and inhibits growth of pathogenic organisms. Disruption of the normal ecosystem by menstrual cycle, sexual activity, contraceptive, pregnancy, foreign bodies, estrogen level, sexually transmitted diseases, and use of hygienic products or antibiotics can lead to development of vaginitis. Bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis are the three most common infections responsible for vaginitis. Other causes include: vaginal atrophy in postmenopausal women, cervicitis, foreign body, irritants and allergens (Sobel, 2023c). […] Laboratory documentation of the etiology of vaginitis is important before initiating therapy, given the nonspecific nature and considerable overlap of the symptoms (Anderson et al., 2004; Ellis et al., 2001; Landers et al., 2004). Diagnostic testing enables targeted treatment, increases therapeutic compliance, and increases the likelihood of partner notification (Sobel, 2023c; Workowski Bolan, 2015).

• #12 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  BD MAX Vaginal Panel The BD MAX Vaginal Panel as an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with BV (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. The test utilizes real-time PCR for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA (FDA, 2016). […] Analytical Validity Microscopic examination of normal vaginal discharge reveals a predominance of squamous epithelial cells, rare polymorphonuclear leukocytes (PMNs), and Lactobacillus species. The primary goal of the examination is to look for candidal buds or hyphae, motile trichomonads, epithelial cells studded with adherent coccobacilli (clue cells), and increased numbers of PMNs (Sobel, 2023c). The microscopic evaluation of BV is usually based on Amsel criteria (Amsel et al., 1983). Amsel criteria state that the presence of at least three out of the following four criteria are indicative of a BV diagnosis: increased homogeneous thin vaginal discharge, pH secretion 4.5, amine odor when potassium hydroxide 10% solution is added to a vaginal secretion sample, and the presence of clue cells in wet preparations (Amsel et al., 1983). If clinical criteria are used to define infection, then reported sensitivity may range from 62 to 100 percent (Spiegel, 1991). Using Gram’s stain as the standard for diagnosing BV, the sensitivity of Amsel criteria for diagnosis of BV is over 90 percent and specificity is 77 percent (Landers et al., 2004). The Nugent score is also available as a Gram staining scoring system to diagnose BV based on vaginal swab samples (Amegashie et al., 2017). Because BV represents complex changes in the vaginal flora, vaginal culture has no role in diagnosis. If microscopy is not available, commercial diagnostic testing methods (e.g., rapid antigen and nucleic acid amplification tests) are used for confirming the clinical suspicion of BV. Polymerase chain reaction (PCR)-based assays to quantify BV-associated bacteria (Cartwright et al., 2012; Menard et al., 2008) have good sensitivity and specificity compared with standard clinical tests (Dumonceaux et al., 2009; Menard et al., 2010). However, they are expensive and of limited utility (Sobel, 2023a).

• #13 Vaginitis: Diagnosis and Treatment | AAFP

  https://www.aafp.org/pubs/afp/issues/2011/0401/p807.html

  Diagnosis by microscopy is more reliable for trichomoniasis. […] Polymerase chain reaction analysis of samples from tampons and introital specimens is more accurate than vaginal or cervical swabs and Pap smears, and may be preferable for patient comfort. […] Most patients can be diagnosed by microscopic examination of vaginal secretions with a 10% potassium hydroxide solution.

• #14 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Diagnosis of Vaginitis – CAM 269HB […] Description: Vaginitis is defined as inflammation of the vagina with symptoms of discharge, itching, and discomfort often due to a disruption of the vaginal microflora. The most common infections are bacterial vaginosis, Candida vulvovaginitis, and trichomoniasis (Sobel, 1999). Other causes include vaginal atrophy in postmenopausal women, cervicitis, foreign body, irritants, and allergens (Sobel, 2023c). […] Bacterial vaginosis (BV) is characterized by a shift in microbial species from the normally dominant hydrogen-peroxide producing Lactobacillus species to Gardnerella vaginalis and anaerobic commensals (Eschenbach et al., 1989; Hill, 1993; Lamont et al., 2011; Ling et al., 2010; Sobel, 2023a). […] Vulvovaginal candidiasis (VVC) is usually caused by Candida albicans but can occasionally be caused by other Candida species (CDC, 2021d). It is the second most common cause of vaginitis symptoms (after BV) and accounts for approximately one-third of vaginitis cases (Sobel, 2023b; Workowski Bolan, 2015).

• #15 Vaginitis: Diagnosis and Treatment | AAFP

  https://www.aafp.org/pubs/afp/issues/2018/0301/p321.html

  Vaginitis is defined as any condition with symptoms of abnormal vaginal discharge, odor, irritation, itching, or burning. The most common causes of vaginitis are bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis. Diagnosis is made using a combination of symptoms, physical examination findings, and office-based or laboratory testing. Bacterial vaginosis is traditionally diagnosed with Amsel criteria, although Gram stain is the diagnostic standard. Newer laboratory tests that detect Gardnerella vaginalis DNA or vaginal fluid sialidase activity have similar sensitivity and specificity to Gram stain. The diagnosis of vulvovaginal candidiasis is made using a combination of clinical signs and symptoms with potassium hydroxide microscopy; DNA probe testing is also available. The Centers for Disease Control and Prevention recommends nucleic acid amplification testing for the diagnosis of trichomoniasis in symptomatic or high-risk women. Symptoms alone cannot differentiate between the causes of vaginitis. Office-based or laboratory testing should be used with the history and physical examination findings to make the diagnosis. The most common causes of vaginitis are bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis. The history alone is unreliable for the diagnosis of different causes of vaginitis. Physical examination findings and office-based or laboratory test results should be used with the history to determine the diagnosis. Signs and symptoms that increase the likelihood of vulvovaginal candidiasis vs. bacterial vaginosis are a cheesy, curdy, or flocculent discharge; itching; vulvar or vaginal inflammation or redness; and lack of odor. Office-based tests include microscopy, measurement of vaginal pH, and whiff test. Several studies have demonstrated a strong correlation between samples from patient self-collected swabs and those collected by clinicians for the diagnosis of bacterial vaginosis, with sensitivities of 70% to 100% and specificities of 97% to 100%. Although Gram stain is considered the diagnostic standard, bacterial vaginosis is traditionally diagnosed using the Amsel criteria. Vaginal culture and Papanicolaou (Pap) testing are not useful for diagnosing bacterial vaginosis because it is a polymicrobial infection. Trichomoniasis is a sexually transmitted infection that should be considered in women at risk who present with vaginitis symptoms. It can be diagnosed when motile, flagellated protozoa are observed on saline microscopy. However, the Centers for Disease Control and Prevention (CDC) recommends nucleic acid amplification testing for the diagnosis of trichomoniasis in symptomatic or high-risk women.

• #16 Vaginitis: Diagnosis and Treatment | AAFP

  https://www.aafp.org/pubs/afp/issues/2011/0401/p807.html

  Individual symptoms and signs, pH level, and microscopy results often do not lead to an accurate diagnosis of vaginitis. Laboratory tests perform better than standard office-based evaluation for diagnosing causes of vaginitis, but they do not add substantially to the treatment threshold and are justified only in patients with recurrent or difficult-to-diagnose symptoms. […] In clinical practice, bacterial vaginosis is diagnosed by the presence of three out of four Amsel criteria. […] A vaginal pH of more than 4.5 was found to be the most sensitive (89 percent) and a positive whiff test was the most specific (93 percent) method of detecting bacterial vaginosis. […] Vaginal culture should be considered in recurrently symptomatic women with negative microscopy and a normal pH. […] Although lactobacillus probiotics are safe, there is no conclusive evidence that they are superior to or enhance the effectiveness of antibiotics in the treatment of bacterial vaginosis or prevent its recurrence.

• #17 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  BD MAX Vaginal Panel The BD MAX Vaginal Panel as an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with BV (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. The test utilizes real-time PCR for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA (FDA, 2016). […] Analytical Validity Microscopic examination of normal vaginal discharge reveals a predominance of squamous epithelial cells, rare polymorphonuclear leukocytes (PMNs), and Lactobacillus species. The primary goal of the examination is to look for candidal buds or hyphae, motile trichomonads, epithelial cells studded with adherent coccobacilli (clue cells), and increased numbers of PMNs (Sobel, 2023c). The microscopic evaluation of BV is usually based on Amsel criteria (Amsel et al., 1983). Amsel criteria state that the presence of at least three out of the following four criteria are indicative of a BV diagnosis: increased homogeneous thin vaginal discharge, pH secretion 4.5, amine odor when potassium hydroxide 10% solution is added to a vaginal secretion sample, and the presence of clue cells in wet preparations (Amsel et al., 1983). If clinical criteria are used to define infection, then reported sensitivity may range from 62 to 100 percent (Spiegel, 1991). Using Gram’s stain as the standard for diagnosing BV, the sensitivity of Amsel criteria for diagnosis of BV is over 90 percent and specificity is 77 percent (Landers et al., 2004). The Nugent score is also available as a Gram staining scoring system to diagnose BV based on vaginal swab samples (Amegashie et al., 2017). Because BV represents complex changes in the vaginal flora, vaginal culture has no role in diagnosis. If microscopy is not available, commercial diagnostic testing methods (e.g., rapid antigen and nucleic acid amplification tests) are used for confirming the clinical suspicion of BV. Polymerase chain reaction (PCR)-based assays to quantify BV-associated bacteria (Cartwright et al., 2012; Menard et al., 2008) have good sensitivity and specificity compared with standard clinical tests (Dumonceaux et al., 2009; Menard et al., 2010). However, they are expensive and of limited utility (Sobel, 2023a).

• #18 Vaginitis: Diagnosis and Treatment | AAFP

  https://www.aafp.org/pubs/afp/issues/2011/0401/p807.html

  Individual symptoms and signs, pH level, and microscopy results often do not lead to an accurate diagnosis of vaginitis. Laboratory tests perform better than standard office-based evaluation for diagnosing causes of vaginitis, but they do not add substantially to the treatment threshold and are justified only in patients with recurrent or difficult-to-diagnose symptoms. […] In clinical practice, bacterial vaginosis is diagnosed by the presence of three out of four Amsel criteria. […] A vaginal pH of more than 4.5 was found to be the most sensitive (89 percent) and a positive whiff test was the most specific (93 percent) method of detecting bacterial vaginosis. […] Vaginal culture should be considered in recurrently symptomatic women with negative microscopy and a normal pH. […] Although lactobacillus probiotics are safe, there is no conclusive evidence that they are superior to or enhance the effectiveness of antibiotics in the treatment of bacterial vaginosis or prevent its recurrence.

• #19 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  BD MAX Vaginal Panel The BD MAX Vaginal Panel as an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with BV (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. The test utilizes real-time PCR for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA (FDA, 2016). […] Analytical Validity Microscopic examination of normal vaginal discharge reveals a predominance of squamous epithelial cells, rare polymorphonuclear leukocytes (PMNs), and Lactobacillus species. The primary goal of the examination is to look for candidal buds or hyphae, motile trichomonads, epithelial cells studded with adherent coccobacilli (clue cells), and increased numbers of PMNs (Sobel, 2023c). The microscopic evaluation of BV is usually based on Amsel criteria (Amsel et al., 1983). Amsel criteria state that the presence of at least three out of the following four criteria are indicative of a BV diagnosis: increased homogeneous thin vaginal discharge, pH secretion 4.5, amine odor when potassium hydroxide 10% solution is added to a vaginal secretion sample, and the presence of clue cells in wet preparations (Amsel et al., 1983). If clinical criteria are used to define infection, then reported sensitivity may range from 62 to 100 percent (Spiegel, 1991). Using Gram’s stain as the standard for diagnosing BV, the sensitivity of Amsel criteria for diagnosis of BV is over 90 percent and specificity is 77 percent (Landers et al., 2004). The Nugent score is also available as a Gram staining scoring system to diagnose BV based on vaginal swab samples (Amegashie et al., 2017). Because BV represents complex changes in the vaginal flora, vaginal culture has no role in diagnosis. If microscopy is not available, commercial diagnostic testing methods (e.g., rapid antigen and nucleic acid amplification tests) are used for confirming the clinical suspicion of BV. Polymerase chain reaction (PCR)-based assays to quantify BV-associated bacteria (Cartwright et al., 2012; Menard et al., 2008) have good sensitivity and specificity compared with standard clinical tests (Dumonceaux et al., 2009; Menard et al., 2010). However, they are expensive and of limited utility (Sobel, 2023a).

• #20 Core Concepts – Vaginitis – Self-Study Lessons – National STD Curriculum

  https://www.std.uw.edu/go/comprehensive-study/vaginitis/core-concept/all

  Vaginitis is primarily a clinical diagnosis, but a complete history, physical examination, and laboratory evaluation are necessary for accurate diagnosis. […] The following provides a summary of major diagnostic tests used in evaluating women with vaginitis. […] Most of the diagnostic methods at the initial evaluation of vaginitis are not organism-specific, but can provide valuable information when trying to diagnose the cause of vaginitis. […] Gram staining of a vaginal specimen with Nugent scoring has traditionally been considered the gold standard for diagnosing bacterial vaginosis, but it is primarily used only in research settings. […] In the clinical setting, point-of-care testing, such as the Amsel criteria and OSOM BVBlue test, are the most frequently used tests for diagnosing bacterial vaginosis.

• #21 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  BD MAX Vaginal Panel The BD MAX Vaginal Panel as an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with BV (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. The test utilizes real-time PCR for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA (FDA, 2016). […] Analytical Validity Microscopic examination of normal vaginal discharge reveals a predominance of squamous epithelial cells, rare polymorphonuclear leukocytes (PMNs), and Lactobacillus species. The primary goal of the examination is to look for candidal buds or hyphae, motile trichomonads, epithelial cells studded with adherent coccobacilli (clue cells), and increased numbers of PMNs (Sobel, 2023c). The microscopic evaluation of BV is usually based on Amsel criteria (Amsel et al., 1983). Amsel criteria state that the presence of at least three out of the following four criteria are indicative of a BV diagnosis: increased homogeneous thin vaginal discharge, pH secretion 4.5, amine odor when potassium hydroxide 10% solution is added to a vaginal secretion sample, and the presence of clue cells in wet preparations (Amsel et al., 1983). If clinical criteria are used to define infection, then reported sensitivity may range from 62 to 100 percent (Spiegel, 1991). Using Gram’s stain as the standard for diagnosing BV, the sensitivity of Amsel criteria for diagnosis of BV is over 90 percent and specificity is 77 percent (Landers et al., 2004). The Nugent score is also available as a Gram staining scoring system to diagnose BV based on vaginal swab samples (Amegashie et al., 2017). Because BV represents complex changes in the vaginal flora, vaginal culture has no role in diagnosis. If microscopy is not available, commercial diagnostic testing methods (e.g., rapid antigen and nucleic acid amplification tests) are used for confirming the clinical suspicion of BV. Polymerase chain reaction (PCR)-based assays to quantify BV-associated bacteria (Cartwright et al., 2012; Menard et al., 2008) have good sensitivity and specificity compared with standard clinical tests (Dumonceaux et al., 2009; Menard et al., 2010). However, they are expensive and of limited utility (Sobel, 2023a).

• #22 Vaginitis: Diagnosis and Treatment | AAFP

  https://www.aafp.org/pubs/afp/issues/2018/0301/p321.html

  Vaginitis is defined as any condition with symptoms of abnormal vaginal discharge, odor, irritation, itching, or burning. The most common causes of vaginitis are bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis. Diagnosis is made using a combination of symptoms, physical examination findings, and office-based or laboratory testing. Bacterial vaginosis is traditionally diagnosed with Amsel criteria, although Gram stain is the diagnostic standard. Newer laboratory tests that detect Gardnerella vaginalis DNA or vaginal fluid sialidase activity have similar sensitivity and specificity to Gram stain. The diagnosis of vulvovaginal candidiasis is made using a combination of clinical signs and symptoms with potassium hydroxide microscopy; DNA probe testing is also available. The Centers for Disease Control and Prevention recommends nucleic acid amplification testing for the diagnosis of trichomoniasis in symptomatic or high-risk women. Symptoms alone cannot differentiate between the causes of vaginitis. Office-based or laboratory testing should be used with the history and physical examination findings to make the diagnosis. The most common causes of vaginitis are bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis. The history alone is unreliable for the diagnosis of different causes of vaginitis. Physical examination findings and office-based or laboratory test results should be used with the history to determine the diagnosis. Signs and symptoms that increase the likelihood of vulvovaginal candidiasis vs. bacterial vaginosis are a cheesy, curdy, or flocculent discharge; itching; vulvar or vaginal inflammation or redness; and lack of odor. Office-based tests include microscopy, measurement of vaginal pH, and whiff test. Several studies have demonstrated a strong correlation between samples from patient self-collected swabs and those collected by clinicians for the diagnosis of bacterial vaginosis, with sensitivities of 70% to 100% and specificities of 97% to 100%. Although Gram stain is considered the diagnostic standard, bacterial vaginosis is traditionally diagnosed using the Amsel criteria. Vaginal culture and Papanicolaou (Pap) testing are not useful for diagnosing bacterial vaginosis because it is a polymicrobial infection. Trichomoniasis is a sexually transmitted infection that should be considered in women at risk who present with vaginitis symptoms. It can be diagnosed when motile, flagellated protozoa are observed on saline microscopy. However, the Centers for Disease Control and Prevention (CDC) recommends nucleic acid amplification testing for the diagnosis of trichomoniasis in symptomatic or high-risk women.

• #23 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  For individuals with symptoms of bacterial vaginosis (BV), NAAT specific to the diagnosis of BV (e.g., Aptima BV; OneSwab BV Panel PCR with Lactobacillus Profiling by qPCR; SureSwab Advanced BV, TMA) and single or multitarget PCR testing for the diagnosis of BV is considered MEDICALLY NECESSARY. […] NAAT panel testing designed to detect more than one type of vaginitis (VVC, BV, and/or trichomoniasis; e.g., BD MAX Vaginal Panel, NuSwab VG, Xpert Xpress MVP) is considered MEDICALLY NECESSARY. […] For asymptomatic individuals, including asymptomatic pregnant individuals at an average or high risk for premature labor, screening for trichomoniasis and bacterial vaginosis is considered NOT MEDICALLY NECESSARY. […] The following does not meet coverage criteria due to a lack of available published scientific literature confirming that the test(s) is/are required and beneficial for the diagnosis and treatment of a patients illness.

• #24 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Overall, microscopy has lower sensitivities and negative predictive values for BV, candidiasis, and trichomoniasis, and yeast when compared to NAAT and culture, respectively (Sobel, 2023c). The use of established molecular diagnostic tests as an alternative to traditional methods is an opportunity to improve the diagnosis and management of vaginitis; NAAT tests have already improved detection of trichomoniasis (Sobel, 2023c). […] Proprietary Tests DNA hybridization probe tests As previously stated, microscopy, rather than bacterial culture, is the standard of care for diagnosing BV, and commercially available tests are available in the absence of microscopy but are not widely used. A study of 176 women using the Affirm VP III test (a DNA hybridization probe test that identifies high concentrations of G. vaginalis) reported comparable results to wet mount examination with no false positives and only three false negatives for T. vaginalis, and three false positives and four false negatives for G. vaginalis (Briselden Hillier, 1994). This test takes less than one hour to perform and is the best option when findings on physical examination suggest BV but microscopy cannot be performed to look for clue cells (Sobel, 2023a).

• #25 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  SureSwab Advanced Bacterial Vaginosis (BV), TMA The SureSwab (Quest Diagnostics, Inc.) Advanced Bacterial Vaginosis (BV), TMA uses real time TMA to screen for microorganisms involved in BV vaginal flora imbalances, including Lactobacillus species, Atopobium vaginae, and Gardnerella vaginalis from a single vaginal swab. It reports a qualitative result for BV and does not report results for individual organisms. The swab can be collected either by a physician or the patient (Quest, 2022a). […] OSOM BVBlue The OSOM BVBlue chromogenic diagnostic point-of-care test is a CLIA-waived test with a reported 10 minute read time. The test detects elevated vaginal fluid sialidase activity, an enzyme produced by bacterial pathogens associated with bacterial vaginosis including Gardnerella, Bacteroides, Prevotella, and Mobiluncus. 92.8% sensitive, 98% specific versus Gram Stain with a 1-minute hands-on-time, and instant color change provides clear easy-to-read results (Diagnostics, 2023).

• #26 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Sumeksri et al. (2005) conducted a study correlated to the OSOM BVBlue test. 173 pregnant women reported a sensitivity and specificity of 94% and 96% respectively, as compared to Gram stain score. These results were comparable to the previously reported values of 91.7% sensitivity and 97.8% specificity in an earlier, smaller study of non-menstruating women (n = 57) (Myziuk et al., 2003). A larger study (n = 288 women) reported a sensitivity of 88% and specificity of 91% as compared to the Amsel criteria. The authors of this report concluded that women who are not in settings where the conventional diagnostic methods are either practical or possible would greatly benefit from access to rapid and reliable point-of-care tests to improve the diagnosis and management of BV (Bradshaw et al., 2005).

• #27 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Regarding NAATs for BV, the CDC states that BV NAATs should be used among symptomatic women only (e.g., women with vaginal discharge, odor, or itch) because their accuracy is not well defined for asymptomatic women. Despite the availability of BV NAATs, 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. Culture of G. vaginalis is not recommended as a diagnostic tool because it is not specific. Cervical Pap tests have no clinical utility for diagnosing BV because of their low sensitivity and specificity. […] The CDC provides information on multiple BV NAATs that are available and notes that these tests are based on detection of specific bacterial nucleic acids and have high sensitivity and specificity for BV (i.e., G. vaginalis, A. vaginae, BVAB2, or Megasphaera type 1) and certain lactobacilli (i.e., Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri). They can be performed on either clinician- or self-collected vaginal specimens with results available in 24 hours, depending on the availability of the molecular diagnostic platform. Five quantitative multiplex PCR assays are available: Max Vaginal Panel (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). Two of these assays are FDA cleared (BD Max Vaginal Panel and Aptima BV), and the other three are laboratory-developed tests. The Max Vaginal Panel provides results by an algorithmic analysis of molecular DNA detection of Lactobacillus species (L. crispatus and L. jensenii) in addition to G. vaginalis, A. vaginae, BVAB2, and Megasphaera type 1. This test has 90.5% sensitivity and 85.8% specificity for BV diagnosis, compared with Amsel criteria and Nugent score. It also provides results for Candida species and T. vaginalis. The Aptima BV detects G. vaginalis, A. vaginae, and certain Lactobacillus species including L. crispatus, L. jensenii, and L. gasseri, with sensitivity and specificity ranging from 95.0% to 97.3% and 85.8% to 89.6%, respectively (using either clinician- or patient-collected vaginal swabs). The three laboratory-developed tests (NuSwab VG, OneSwab BV Panel PCR with Lactobacillus Profiling by qPCR, and SureSwab BV) have to be internally validated before use for patient care yet have good sensitivity and specificity, similar to FDA-cleared assays.

• #28 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Regarding NAATs for BV, the CDC states that BV NAATs should be used among symptomatic women only (e.g., women with vaginal discharge, odor, or itch) because their accuracy is not well defined for asymptomatic women. Despite the availability of BV NAATs, 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. Culture of G. vaginalis is not recommended as a diagnostic tool because it is not specific. Cervical Pap tests have no clinical utility for diagnosing BV because of their low sensitivity and specificity. […] The CDC provides information on multiple BV NAATs that are available and notes that these tests are based on detection of specific bacterial nucleic acids and have high sensitivity and specificity for BV (i.e., G. vaginalis, A. vaginae, BVAB2, or Megasphaera type 1) and certain lactobacilli (i.e., Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri). They can be performed on either clinician- or self-collected vaginal specimens with results available in 24 hours, depending on the availability of the molecular diagnostic platform. Five quantitative multiplex PCR assays are available: Max Vaginal Panel (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). Two of these assays are FDA cleared (BD Max Vaginal Panel and Aptima BV), and the other three are laboratory-developed tests. The Max Vaginal Panel provides results by an algorithmic analysis of molecular DNA detection of Lactobacillus species (L. crispatus and L. jensenii) in addition to G. vaginalis, A. vaginae, BVAB2, and Megasphaera type 1. This test has 90.5% sensitivity and 85.8% specificity for BV diagnosis, compared with Amsel criteria and Nugent score. It also provides results for Candida species and T. vaginalis. The Aptima BV detects G. vaginalis, A. vaginae, and certain Lactobacillus species including L. crispatus, L. jensenii, and L. gasseri, with sensitivity and specificity ranging from 95.0% to 97.3% and 85.8% to 89.6%, respectively (using either clinician- or patient-collected vaginal swabs). The three laboratory-developed tests (NuSwab VG, OneSwab BV Panel PCR with Lactobacillus Profiling by qPCR, and SureSwab BV) have to be internally validated before use for patient care yet have good sensitivity and specificity, similar to FDA-cleared assays.

• #29 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  The Aptima BV and Aptima Candida/Trichomonas vaginitis (CV/TV) NAAT molecular tests detect and qualitatively report results using a proprietary algorithmic analysis. Pathogens addressed by the test include: Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata, Lactobacillus, Gardnerella vaginalis, Atopobium vaginae, and Trichomonas vaginalis (Hologic, 2022). Hologic announced the FDA approval of the Aptima BV and Aptima CV/TV vaginitis tests in 2019 (Hologic, 2019). Schwebke et al. (2020) performed a multicenter, prospective clinical study to validate the performance of the Aptima BV and Aptima CV/TV test for bacterial vaginosis, vulvovaginal candidiasis, and trichomonas vaginitis. A total of 1,519 subjects were enrolled in the study. The authors reported sensitivity and specificity for the investigational tests when it came to provider-collected samples at 95.0% and 89.6% for BV. When it came to Candida species, sensitivity and specificity was 91.7% and 94.9% respectively; C. glabrata sensitivity and specificity was 84.7% and 99.1%; 96.5% and 94.1% for T. vaginalis. Patient-collected samples showed similar ranges of sensitivity and specificity. In conclusion, the authors wrote, In a secondary analysis, clinicians’ diagnoses, in-clinic assessments, and investigational-assay results were compared to gold standard reference methods. Overall, the investigational assays had higher sensitivity and specificity than clinicians’ diagnoses and in-clinic assessments, indicating that the investigational assays were more predictive of infection than traditional diagnostic methods (Schwebke et al., 2020).

• #30 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Diagnosis of Vaginitis – CAM 269HB […] Description: Vaginitis is defined as inflammation of the vagina with symptoms of discharge, itching, and discomfort often due to a disruption of the vaginal microflora. The most common infections are bacterial vaginosis, Candida vulvovaginitis, and trichomoniasis (Sobel, 1999). Other causes include vaginal atrophy in postmenopausal women, cervicitis, foreign body, irritants, and allergens (Sobel, 2023c). […] Bacterial vaginosis (BV) is characterized by a shift in microbial species from the normally dominant hydrogen-peroxide producing Lactobacillus species to Gardnerella vaginalis and anaerobic commensals (Eschenbach et al., 1989; Hill, 1993; Lamont et al., 2011; Ling et al., 2010; Sobel, 2023a). […] Vulvovaginal candidiasis (VVC) is usually caused by Candida albicans but can occasionally be caused by other Candida species (CDC, 2021d). It is the second most common cause of vaginitis symptoms (after BV) and accounts for approximately one-third of vaginitis cases (Sobel, 2023b; Workowski Bolan, 2015).

• #31 Vaginitis: Diagnosis and Treatment | AAFP

  https://www.aafp.org/pubs/afp/issues/2018/0301/p321.html

  Vaginitis is defined as any condition with symptoms of abnormal vaginal discharge, odor, irritation, itching, or burning. The most common causes of vaginitis are bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis. Diagnosis is made using a combination of symptoms, physical examination findings, and office-based or laboratory testing. Bacterial vaginosis is traditionally diagnosed with Amsel criteria, although Gram stain is the diagnostic standard. Newer laboratory tests that detect Gardnerella vaginalis DNA or vaginal fluid sialidase activity have similar sensitivity and specificity to Gram stain. The diagnosis of vulvovaginal candidiasis is made using a combination of clinical signs and symptoms with potassium hydroxide microscopy; DNA probe testing is also available. The Centers for Disease Control and Prevention recommends nucleic acid amplification testing for the diagnosis of trichomoniasis in symptomatic or high-risk women. Symptoms alone cannot differentiate between the causes of vaginitis. Office-based or laboratory testing should be used with the history and physical examination findings to make the diagnosis. The most common causes of vaginitis are bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis. The history alone is unreliable for the diagnosis of different causes of vaginitis. Physical examination findings and office-based or laboratory test results should be used with the history to determine the diagnosis. Signs and symptoms that increase the likelihood of vulvovaginal candidiasis vs. bacterial vaginosis are a cheesy, curdy, or flocculent discharge; itching; vulvar or vaginal inflammation or redness; and lack of odor. Office-based tests include microscopy, measurement of vaginal pH, and whiff test. Several studies have demonstrated a strong correlation between samples from patient self-collected swabs and those collected by clinicians for the diagnosis of bacterial vaginosis, with sensitivities of 70% to 100% and specificities of 97% to 100%. Although Gram stain is considered the diagnostic standard, bacterial vaginosis is traditionally diagnosed using the Amsel criteria. Vaginal culture and Papanicolaou (Pap) testing are not useful for diagnosing bacterial vaginosis because it is a polymicrobial infection. Trichomoniasis is a sexually transmitted infection that should be considered in women at risk who present with vaginitis symptoms. It can be diagnosed when motile, flagellated protozoa are observed on saline microscopy. However, the Centers for Disease Control and Prevention (CDC) recommends nucleic acid amplification testing for the diagnosis of trichomoniasis in symptomatic or high-risk women.

• #32 Candidal Vaginitis – Gynecology and Obstetrics – Merck Manual Professional Edition

  https://www.merckmanuals.com/professional/gynecology-and-obstetrics/vaginitis-cervicitis-and-pelvic-inflammatory-disease/candidal-vaginitis

  Candidal vaginitis is vaginal infection with Candida species, usually C. albicans. Diagnosis is with pelvic examination, vaginal pH, and wet mount. […] Criteria for diagnosing candidal vaginitis include typical discharge (a thick, white, curd-like vaginal discharge), vaginal pH is 4.5, budding yeast, pseudohyphae, or mycelia visible on a wet mount, especially with potassium hydroxide (KOH). […] If symptoms suggest candidal vaginitis but signs (including vulvar irritation) are absent and microscopy does not detect fungal elements, fungal culture is done. Women with frequent recurrences require culture to confirm the diagnosis and to rule out non-albicans Candida.

• #33 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Trichomoniasis can be diagnosed by the presence of motile trichomonads on wet mount, but it is identified in only 60 to 70 percent of culture-confirmed cases. Culture on Diamond’s medium was considered the gold standard method for diagnosing a T. vaginalis infection (Workowski Bolan, 2015); however, nucleic acid amplification tests (Baron et al., 2013) have become the accepted gold standard for the diagnosis of T. vaginalis. One study found the sensitivities for T. vaginalis using wet mount, culture, rapid antigen testing, and transcription-mediated amplification testing were 65, 96, 90, and 98 percent, respectively (Huppert et al., 2007). Coexistence of T. vaginalis and BV pathogens is common, with coinfection rates of 60 to 80 percent (Sobel Mitchell, 2023; Sobel et al., 2013). […] Microscopy is negative in up to 50 percent of patients with culture-confirmed VVC (Sobel, 1985). Since there are no reliable point of care tests for Candida available in the United States (Abbott, 1995; Chatwani et al., 2007; Dan et al., 2010; Hopwood et al., 1985; Marot-Leblond et al., 2009; Matsui et al., 2009), culture must be obtained. PCR methods have high sensitivity and specificity and a shorter turn-around time than culture (Diba et al., 2012; Mahmoudi Rad et al., 2012; Tabrizi et al., 2006; Weissenbacher et al., 2009), but they are costly and offer no proven benefit over culture in symptomatic women (Sobel, 2023b).

• #34 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Policy: […] Application of coverage criteria is dependent upon an individuals benefit coverage at the time of the request. […] For individuals with symptoms of vaginitis, testing of pH, testing for the presence of amines, saline wet mount, hydrogen peroxide (KOH) wet mount, and microscopic examination of vaginal fluids is considered MEDICALLY NECESSARY. […] For individuals with symptoms of vaginitis, direct probe DNA-based identification of Gardnerella, Trichomonas, and Candida (e.g., BD Affirm VPIII) is considered MEDICALLY NECESSARY. […] For individuals with clinical signs and symptoms of vaginitis but with negative findings on wet-mount preparations and a normal pH test, vaginal cultures for Candida species for the diagnosis of vulvovaginal candidiasis is considered MEDICALLY NECESSARY.

• #35 Vaginitis: Diagnosis and Treatment | AAFP

  https://www.aafp.org/pubs/afp/issues/2011/0401/p807.html

  Individual symptoms and signs, pH level, and microscopy results often do not lead to an accurate diagnosis of vaginitis. Laboratory tests perform better than standard office-based evaluation for diagnosing causes of vaginitis, but they do not add substantially to the treatment threshold and are justified only in patients with recurrent or difficult-to-diagnose symptoms. […] In clinical practice, bacterial vaginosis is diagnosed by the presence of three out of four Amsel criteria. […] A vaginal pH of more than 4.5 was found to be the most sensitive (89 percent) and a positive whiff test was the most specific (93 percent) method of detecting bacterial vaginosis. […] Vaginal culture should be considered in recurrently symptomatic women with negative microscopy and a normal pH. […] Although lactobacillus probiotics are safe, there is no conclusive evidence that they are superior to or enhance the effectiveness of antibiotics in the treatment of bacterial vaginosis or prevent its recurrence.

• #36 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Policy: […] Application of coverage criteria is dependent upon an individuals benefit coverage at the time of the request. […] For individuals with symptoms of vaginitis, testing of pH, testing for the presence of amines, saline wet mount, hydrogen peroxide (KOH) wet mount, and microscopic examination of vaginal fluids is considered MEDICALLY NECESSARY. […] For individuals with symptoms of vaginitis, direct probe DNA-based identification of Gardnerella, Trichomonas, and Candida (e.g., BD Affirm VPIII) is considered MEDICALLY NECESSARY. […] For individuals with clinical signs and symptoms of vaginitis but with negative findings on wet-mount preparations and a normal pH test, vaginal cultures for Candida species for the diagnosis of vulvovaginal candidiasis is considered MEDICALLY NECESSARY.

• #37 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Trichomoniasis can be diagnosed by the presence of motile trichomonads on wet mount, but it is identified in only 60 to 70 percent of culture-confirmed cases. Culture on Diamond’s medium was considered the gold standard method for diagnosing a T. vaginalis infection (Workowski Bolan, 2015); however, nucleic acid amplification tests (Baron et al., 2013) have become the accepted gold standard for the diagnosis of T. vaginalis. One study found the sensitivities for T. vaginalis using wet mount, culture, rapid antigen testing, and transcription-mediated amplification testing were 65, 96, 90, and 98 percent, respectively (Huppert et al., 2007). Coexistence of T. vaginalis and BV pathogens is common, with coinfection rates of 60 to 80 percent (Sobel Mitchell, 2023; Sobel et al., 2013). […] Microscopy is negative in up to 50 percent of patients with culture-confirmed VVC (Sobel, 1985). Since there are no reliable point of care tests for Candida available in the United States (Abbott, 1995; Chatwani et al., 2007; Dan et al., 2010; Hopwood et al., 1985; Marot-Leblond et al., 2009; Matsui et al., 2009), culture must be obtained. PCR methods have high sensitivity and specificity and a shorter turn-around time than culture (Diba et al., 2012; Mahmoudi Rad et al., 2012; Tabrizi et al., 2006; Weissenbacher et al., 2009), but they are costly and offer no proven benefit over culture in symptomatic women (Sobel, 2023b).

• #38 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  For individuals with symptoms of vaginitis, measurement of sialidase activity in vaginal fluid for the diagnosis of bacterial vaginosis is considered MEDICALLY NECESSARY. […] For individuals with symptoms of vaginitis, nucleic acid amplification testing (NAAT) or polymerase chain reaction (PCR)-based identification of Trichomonas vaginalis is considered MEDICALLY NECESSARY. […] For individuals with risk factors for trichomoniasis (new or multiple partners; history of sexually transmitted infections (STIs), especially HIV; exchange of sex for payment; incarceration; injection drug use), screening for Trichomonas is considered MEDICALLY NECESSARY. […] For individuals with complicated vulvovaginal candidiasis (VVC), polymerase chain reaction (PCR) based identification of Candida to confirm clinical diagnosis and identify non-albicans Candida MEETS COVERAGE CRITERIA.

• #39 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Combination panel tests for Vaginitis/Vaginosis Aptima CV/TV Aptima CV/TV assays are NAAT tests that identify vulvovaginal candidiasis (Candida vaginitis or CV) and Trichomoniasis (Trichomonas vaginalis or TV) in symptomatic women from one vaginal sample. NAAT detects 3x more mixed infections cases than clinical diagnosis with wet mount and Amsels criteria. These tests detect and qualitatively report results for the following organisms: Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata, Trichomonas vaginalis (Hologic, 2023). […] SureSwab SureSwab Advanced Vaginitis, TMA is a test for vaginitis, including bacterial vaginosis, vulvovaginal candidiasis (Candidiasis species), and trichomoniasis (Trichomonas vaginalis) (Quest, 2022c). In an even more expansive combination test package, Quest offers a SureSwab Advanced Vaginitis Plus, TMA assay which, in addition to detecting organisms associated with BV, trichomoniasis, and candidiasis, also detects Chlamydia trachomatis and Neisseria gonorrhoeae (Quest, 2022b).

• #40 Quest Women’s Health

  https://www.questwomenshealth.com/naat

  SureSwab Advanced can help you to obtain a definitive diagnosis of the 3 most common infectious causes of vaginitis, with just 1 vaginal swab and results in only 1-2 days. […] The Aptima BV assay uses an algorithm to report a qualitative result for BV based on detection of the following organisms: […] Accurate results with high sensitivity (95%-97%) and specificity (86%-90%) […] The American College of Obstetrics and Gynecology (ACOG) has stated that, because a single sentinel organism has not been found that accurately identifies patients with bacterial vaginosis, the diagnostic utility of a test that identifies only a single organism (eg, G vaginalis) …is not currently supported. […] Aptima CV assay qualitatively reports Candida species group (C albicans, C tropicalis, C parapsilosis, and C dubliniensis)

• #41 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Trichomoniasis is caused by the flagellated protozoan Trichomonas vaginalis, which principally infects the squamous epithelium in the urogenital tract: vagina, urethra, and paraurethral glands (Kissinger, 2015; Sobel Mitchell, 2023). […] Regulatory Status A search of the term vaginitis on the FDA Device database on Jan. 29, 2021 yielded 145 records. Additionally, many labs have developed specific tests that they must validate and perform in house. These laboratory-developed tests (LDTs) are regulated by the Centers for Medicare Medicaid Services (CMS) as high-complexity tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88). The U.S. Food and Drug Administration has not approved or cleared this test as an LDT; however, FDA clearance or approval is not currently required for clinical use.

• #42 Vaginitis Panel by TMA | Test Fact Sheet

  https://arupconsult.com/ati/vaginitis-pathogens-molecular-testing-panel

  Aids in the diagnosis of bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis […] Diagnosis can be especially complicated due to the prevalence of coinfections. […] BV is the most common cause of vulvovaginitis in women ages 15-44, implicated in 40-50% of vaginitis cases. […] CV or VVC accounts for 20% to 25% of cases in the United States, while TV accounts for 15% to 20%. […] Typical symptoms of infectious vaginitis include pruritus, vaginal soreness, dyspareunia, external dysuria, odor, and abnormal vaginal discharge. […] A positive result is indicative of the presence of target RNA and does not necessarily indicate the presence of viable organisms. […] A negative result does not preclude a possible infection.

• #43 Vaginitis: Diagnosis and Treatment | AAFP

  https://www.aafp.org/pubs/afp/issues/2018/0301/p321.html

  Vaginitis is defined as any condition with symptoms of abnormal vaginal discharge, odor, irritation, itching, or burning. The most common causes of vaginitis are bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis. Diagnosis is made using a combination of symptoms, physical examination findings, and office-based or laboratory testing. Bacterial vaginosis is traditionally diagnosed with Amsel criteria, although Gram stain is the diagnostic standard. Newer laboratory tests that detect Gardnerella vaginalis DNA or vaginal fluid sialidase activity have similar sensitivity and specificity to Gram stain. The diagnosis of vulvovaginal candidiasis is made using a combination of clinical signs and symptoms with potassium hydroxide microscopy; DNA probe testing is also available. The Centers for Disease Control and Prevention recommends nucleic acid amplification testing for the diagnosis of trichomoniasis in symptomatic or high-risk women. Symptoms alone cannot differentiate between the causes of vaginitis. Office-based or laboratory testing should be used with the history and physical examination findings to make the diagnosis. The most common causes of vaginitis are bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis. The history alone is unreliable for the diagnosis of different causes of vaginitis. Physical examination findings and office-based or laboratory test results should be used with the history to determine the diagnosis. Signs and symptoms that increase the likelihood of vulvovaginal candidiasis vs. bacterial vaginosis are a cheesy, curdy, or flocculent discharge; itching; vulvar or vaginal inflammation or redness; and lack of odor. Office-based tests include microscopy, measurement of vaginal pH, and whiff test. Several studies have demonstrated a strong correlation between samples from patient self-collected swabs and those collected by clinicians for the diagnosis of bacterial vaginosis, with sensitivities of 70% to 100% and specificities of 97% to 100%. Although Gram stain is considered the diagnostic standard, bacterial vaginosis is traditionally diagnosed using the Amsel criteria. Vaginal culture and Papanicolaou (Pap) testing are not useful for diagnosing bacterial vaginosis because it is a polymicrobial infection. Trichomoniasis is a sexually transmitted infection that should be considered in women at risk who present with vaginitis symptoms. It can be diagnosed when motile, flagellated protozoa are observed on saline microscopy. However, the Centers for Disease Control and Prevention (CDC) recommends nucleic acid amplification testing for the diagnosis of trichomoniasis in symptomatic or high-risk women.

• #44 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  For the evaluation of vulvovaginal candidiasis, the CDC recommends: Examination of a wet mount with KOH preparation should be performed for all women with symptoms or signs of VVC, and women with a positive result should be treated. For those with negative wet mounts but existing signs or symptoms, vaginal cultures for Candida should be considered. […] For the evaluation of trichomoniasis, the CDC recommends: Diagnostic testing for T. vaginalis should be performed for women seeking care for vaginal discharge. Wet-mount microscopy traditionally has been used as the preferred diagnostic test for T. vaginalis among women because it is inexpensive and can be performed at the POC; however, it has low sensitivity (44% 68%) compared with culture. More highly sensitive and specific molecular diagnostic options are available, which should be used in conjunction with a negative wet mount when possible. NAATs are highly sensitive, detecting more T. vaginalis infections than wet-mount microscopy among women. The OSOM trichomonas rapid test (Diagnostics) is an antigen-detection test that uses immunochromatographic capillary flow dipstick technology that can be performed at the POC by using clinician-obtained vaginal specimens. Results are available in approximately 10 15 minutes, with sensitivities of 82% 95% and specificity of 97% 100%, compared with wet mount, culture, and transcription-mediated amplification. The Solana trichomonas assay (Quidel) is another rapid test for the qualitative detection of T. vaginalis DNA and can yield results 40 minutes after specimen collection. The Amplivue trichomonas assay (Quidel) is another rapid test providing qualitative detection of T. vaginalis that has been FDA cleared for vaginal specimens from symptomatic and asymptomatic women and the Affirm VP III (Becton Dickinson) is an oligonucleotide probe test that detects high concentrations of G. vaginalis nucleic acids (5 x 105 CFU of G. vaginalis/mL of vaginal fluid) for diagnosing BV, Candida species, and T. vaginalis. This test has been reported to be most useful for symptomatic women in conjunction with vaginal pH measurement and presence of amine odor.

• #45 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Trichomoniasis can be diagnosed by the presence of motile trichomonads on wet mount, but it is identified in only 60 to 70 percent of culture-confirmed cases. Culture on Diamond’s medium was considered the gold standard method for diagnosing a T. vaginalis infection (Workowski Bolan, 2015); however, nucleic acid amplification tests (Baron et al., 2013) have become the accepted gold standard for the diagnosis of T. vaginalis. One study found the sensitivities for T. vaginalis using wet mount, culture, rapid antigen testing, and transcription-mediated amplification testing were 65, 96, 90, and 98 percent, respectively (Huppert et al., 2007). Coexistence of T. vaginalis and BV pathogens is common, with coinfection rates of 60 to 80 percent (Sobel Mitchell, 2023; Sobel et al., 2013). […] Microscopy is negative in up to 50 percent of patients with culture-confirmed VVC (Sobel, 1985). Since there are no reliable point of care tests for Candida available in the United States (Abbott, 1995; Chatwani et al., 2007; Dan et al., 2010; Hopwood et al., 1985; Marot-Leblond et al., 2009; Matsui et al., 2009), culture must be obtained. PCR methods have high sensitivity and specificity and a shorter turn-around time than culture (Diba et al., 2012; Mahmoudi Rad et al., 2012; Tabrizi et al., 2006; Weissenbacher et al., 2009), but they are costly and offer no proven benefit over culture in symptomatic women (Sobel, 2023b).

• #46 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Trichomoniasis can be diagnosed by the presence of motile trichomonads on wet mount, but it is identified in only 60 to 70 percent of culture-confirmed cases. Culture on Diamond’s medium was considered the gold standard method for diagnosing a T. vaginalis infection (Workowski Bolan, 2015); however, nucleic acid amplification tests (Baron et al., 2013) have become the accepted gold standard for the diagnosis of T. vaginalis. One study found the sensitivities for T. vaginalis using wet mount, culture, rapid antigen testing, and transcription-mediated amplification testing were 65, 96, 90, and 98 percent, respectively (Huppert et al., 2007). Coexistence of T. vaginalis and BV pathogens is common, with coinfection rates of 60 to 80 percent (Sobel Mitchell, 2023; Sobel et al., 2013). […] Microscopy is negative in up to 50 percent of patients with culture-confirmed VVC (Sobel, 1985). Since there are no reliable point of care tests for Candida available in the United States (Abbott, 1995; Chatwani et al., 2007; Dan et al., 2010; Hopwood et al., 1985; Marot-Leblond et al., 2009; Matsui et al., 2009), culture must be obtained. PCR methods have high sensitivity and specificity and a shorter turn-around time than culture (Diba et al., 2012; Mahmoudi Rad et al., 2012; Tabrizi et al., 2006; Weissenbacher et al., 2009), but they are costly and offer no proven benefit over culture in symptomatic women (Sobel, 2023b).

• #47 Quest Women’s Health

  https://www.questwomenshealth.com/naat

  Accurate results with high sensitivity (93%-98%) and specificity (83%-92%) […] Aptima TV Assay has high sensitivity and specificity (95%-99%), ensuring the provider and patient always receive an accurate result. […] CDC and ACOG recommend NAATs to detect TV […] NAAT testing has higher sensitivity and specificity for bacterial vaginosis […] Differentiates between Candida glabrata and the Candida species group […] Provides superior sensitivity for Trichomonas

• #48 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Combination panel tests for Vaginitis/Vaginosis Aptima CV/TV Aptima CV/TV assays are NAAT tests that identify vulvovaginal candidiasis (Candida vaginitis or CV) and Trichomoniasis (Trichomonas vaginalis or TV) in symptomatic women from one vaginal sample. NAAT detects 3x more mixed infections cases than clinical diagnosis with wet mount and Amsels criteria. These tests detect and qualitatively report results for the following organisms: Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata, Trichomonas vaginalis (Hologic, 2023). […] SureSwab SureSwab Advanced Vaginitis, TMA is a test for vaginitis, including bacterial vaginosis, vulvovaginal candidiasis (Candidiasis species), and trichomoniasis (Trichomonas vaginalis) (Quest, 2022c). In an even more expansive combination test package, Quest offers a SureSwab Advanced Vaginitis Plus, TMA assay which, in addition to detecting organisms associated with BV, trichomoniasis, and candidiasis, also detects Chlamydia trachomatis and Neisseria gonorrhoeae (Quest, 2022b).

• #49 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  For the evaluation of vulvovaginal candidiasis, the CDC recommends: Examination of a wet mount with KOH preparation should be performed for all women with symptoms or signs of VVC, and women with a positive result should be treated. For those with negative wet mounts but existing signs or symptoms, vaginal cultures for Candida should be considered. […] For the evaluation of trichomoniasis, the CDC recommends: Diagnostic testing for T. vaginalis should be performed for women seeking care for vaginal discharge. Wet-mount microscopy traditionally has been used as the preferred diagnostic test for T. vaginalis among women because it is inexpensive and can be performed at the POC; however, it has low sensitivity (44% 68%) compared with culture. More highly sensitive and specific molecular diagnostic options are available, which should be used in conjunction with a negative wet mount when possible. NAATs are highly sensitive, detecting more T. vaginalis infections than wet-mount microscopy among women. The OSOM trichomonas rapid test (Diagnostics) is an antigen-detection test that uses immunochromatographic capillary flow dipstick technology that can be performed at the POC by using clinician-obtained vaginal specimens. Results are available in approximately 10 15 minutes, with sensitivities of 82% 95% and specificity of 97% 100%, compared with wet mount, culture, and transcription-mediated amplification. The Solana trichomonas assay (Quidel) is another rapid test for the qualitative detection of T. vaginalis DNA and can yield results 40 minutes after specimen collection. The Amplivue trichomonas assay (Quidel) is another rapid test providing qualitative detection of T. vaginalis that has been FDA cleared for vaginal specimens from symptomatic and asymptomatic women and the Affirm VP III (Becton Dickinson) is an oligonucleotide probe test that detects high concentrations of G. vaginalis nucleic acids (5 x 105 CFU of G. vaginalis/mL of vaginal fluid) for diagnosing BV, Candida species, and T. vaginalis. This test has been reported to be most useful for symptomatic women in conjunction with vaginal pH measurement and presence of amine odor.

• #50 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Trichomoniasis can be diagnosed by the presence of motile trichomonads on wet mount, but it is identified in only 60 to 70 percent of culture-confirmed cases. Culture on Diamond’s medium was considered the gold standard method for diagnosing a T. vaginalis infection (Workowski Bolan, 2015); however, nucleic acid amplification tests (Baron et al., 2013) have become the accepted gold standard for the diagnosis of T. vaginalis. One study found the sensitivities for T. vaginalis using wet mount, culture, rapid antigen testing, and transcription-mediated amplification testing were 65, 96, 90, and 98 percent, respectively (Huppert et al., 2007). Coexistence of T. vaginalis and BV pathogens is common, with coinfection rates of 60 to 80 percent (Sobel Mitchell, 2023; Sobel et al., 2013). […] Microscopy is negative in up to 50 percent of patients with culture-confirmed VVC (Sobel, 1985). Since there are no reliable point of care tests for Candida available in the United States (Abbott, 1995; Chatwani et al., 2007; Dan et al., 2010; Hopwood et al., 1985; Marot-Leblond et al., 2009; Matsui et al., 2009), culture must be obtained. PCR methods have high sensitivity and specificity and a shorter turn-around time than culture (Diba et al., 2012; Mahmoudi Rad et al., 2012; Tabrizi et al., 2006; Weissenbacher et al., 2009), but they are costly and offer no proven benefit over culture in symptomatic women (Sobel, 2023b).

• #51 Vaginitis: Laboratory Testing for Diagnosis and Management | Clinical Focus | Quest Diagnostics Vaginitis: Laboratory Testing for Diagnosis and Management Vaginitis: Laboratory Testing for Diagnosis and Management

  https://testdirectory.questdiagnostics.com/test/test-guides/CF_Vaginitis/vaginitis-laboratory-testing-for-diagnosis-and-management

  Clinical testing of vaginal discharge specimens has historically been used to evaluate vaginitis and is still recommended, if available. Clinical testing includes pH measurement, the potassium hydroxide „whiff test,” and microscopy. While these tests can be performed at the point of care, their performance for detecting BV, VC, and TV can be low compared to reference methods and other molecular tests. Clinical testing has particularly low sensitivity for detecting coinfections, which are present in up to 25% of women with vaginitis. […] If microscopy is not available or clinical testing cannot be performed as recommended, guidelines indicate that molecular tests, such as NAATs, can be used instead. Advantages of NAATs for evaluating vaginitis include (1) the ability to test for multiple infections using the same swab, (2) high sensitivity and specificity, and (3) comparable performance on both clinician-collected and self-collected swabs. Additionally, NAATs can better detect coinfections and mixed infections with other STIs.

• #52 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Combination panel tests for Vaginitis/Vaginosis Aptima CV/TV Aptima CV/TV assays are NAAT tests that identify vulvovaginal candidiasis (Candida vaginitis or CV) and Trichomoniasis (Trichomonas vaginalis or TV) in symptomatic women from one vaginal sample. NAAT detects 3x more mixed infections cases than clinical diagnosis with wet mount and Amsels criteria. These tests detect and qualitatively report results for the following organisms: Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata, Trichomonas vaginalis (Hologic, 2023). […] SureSwab SureSwab Advanced Vaginitis, TMA is a test for vaginitis, including bacterial vaginosis, vulvovaginal candidiasis (Candidiasis species), and trichomoniasis (Trichomonas vaginalis) (Quest, 2022c). In an even more expansive combination test package, Quest offers a SureSwab Advanced Vaginitis Plus, TMA assay which, in addition to detecting organisms associated with BV, trichomoniasis, and candidiasis, also detects Chlamydia trachomatis and Neisseria gonorrhoeae (Quest, 2022b).

• #53 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  For individuals with symptoms of bacterial vaginosis (BV), NAAT specific to the diagnosis of BV (e.g., Aptima BV; OneSwab BV Panel PCR with Lactobacillus Profiling by qPCR; SureSwab Advanced BV, TMA) and single or multitarget PCR testing for the diagnosis of BV is considered MEDICALLY NECESSARY. […] NAAT panel testing designed to detect more than one type of vaginitis (VVC, BV, and/or trichomoniasis; e.g., BD MAX Vaginal Panel, NuSwab VG, Xpert Xpress MVP) is considered MEDICALLY NECESSARY. […] For asymptomatic individuals, including asymptomatic pregnant individuals at an average or high risk for premature labor, screening for trichomoniasis and bacterial vaginosis is considered NOT MEDICALLY NECESSARY. […] The following does not meet coverage criteria due to a lack of available published scientific literature confirming that the test(s) is/are required and beneficial for the diagnosis and treatment of a patients illness.

• #54 Clear vaginitis diagnosis in one test | BD Vaginal Panel | BD Womens Health Solutions

  https://womens-health-solutions.bd.com/vaginitis/bd-vaginal-panel/vaginitis-diagnosis-made-simple-and-clear

  Vaginitis diagnosis made simple and clear. Get objective vaginitis results that strategically inform therapeutic choices. The BD Vaginal Panel is a comprehensive diagnostic test that directly detects the 3 most common infectious causes of vaginitis bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis (TV) in one test, with one swab. BD Vaginal Panel is designed to avoid any confusion related to ambiguous output results by reporting a clear positive or negative result for each condition. In addition, it provides separate results for Candida glabrata and C. krusei, two Candida species that are known to carry resistance to traditional antibiotics. […] BD Vaginal Panel is ACCURATE. PCR-based design provides great levels of sensitivity. Designed with a proprietary, microbiome-based algorithm for BV that provides an accurate BV result in line with the clinical understanding of BV as a polymicrobial condition. Utilizes the highly sensitive and CDC-recommended diagnostic technology, NAAT for TV detection.

• #55 Clear vaginitis diagnosis in one test | BD Vaginal Panel | BD Womens Health Solutions

  https://womens-health-solutions.bd.com/vaginitis/bd-vaginal-panel/vaginitis-diagnosis-made-simple-and-clear

  BD Vaginal Panel is OBJECTIVE. Provides clear results that remove the subjectivity associated with many traditional vulvovaginitis diagnostic tests. Determines a definitive positive or negative BV result for each patient. […] BD Vaginal Panel is EFFICIENT. Simultaneously detects organisms associated with BV, VVC, and TV to help reduce the need for repeat testing. Can detect co-infecting pathogens which may help improve patient management and inform downstream treatment recommendations. Provides separate results for C. glabrata and C. krusei, two Candida species that may not respond to traditional therapeutics. […] BD Vaginal Panel is FAST. Results obtained in approximately 3 hours. […] BD Vaginal Panel was the first FDA-cleared microbiome-based, PCR assay to directly detect BV, VVC, and TV in one test, with one swab. BD Vaginal Panel offers higher sensitivity and similar specificity compared to traditional tests. The BD Vaginal Panel offers a more accurate vaginitis diagnosis as compared to traditional methods. The sensitivity of BD Vaginal Panel ranges from 90.7% to 96.7% while in-clinic tests have a sensitivity of 56 to 77%. […] The BD Vaginal Panel shows a considerable sensitivity advantage compared to clinician diagnosis for the detection of co-infections, with the added benefit of requiring a single test to achieve these results.

• #56 Vaginitis screening | Hologic Women’s Health

  https://hologicwomenshealth.com/vaginitis/

  Vaginitis is the leading reason for OBGYN visits. Most women will experience an episode of vaginitis at least once in their lifetime. 90% of vaginitis is caused by bacterial vaginosis (BV), yeast infection (CV) and trichomonas vaginalis (TV) infections, either individually or in combination; resulting in approximately 10 million OB/GYN visits each year. Mixed infections and overlapping symptoms make clinical diagnosis a challenge. Appropriate diagnosis is essential to prescribe the optimal treatment for vaginitis and just as crucial to reduce the likelihood of persistence or recurrence. While current guidelines primarily recommend examination of vaginal discharge, microscopy, and culture methods, they are not sufficient to accurately diagnose vaginitis, especially when multiple pathogens are present. Accurate testing is essential for patients to receive the right diagnosis the first time. The Aptima BV and Aptima CV/TV assays are NAAT tests that identify bacterial vaginosis (BV), vulvovaginal candidiasis (Candida vaginitis or CV) and Trichomoniasis (Trichomonas vaginalis or TV) in symptomatic women from one vaginal sample. NAAT detects 3x more mixed infections cases than clinical diagnosis with wet mount and Amsels criteria. Women who presented with symptoms of vaginitis had at least 1 STI. BV-positive women had a 2x higher STI infection rate compared to BV-negative women. TV and M. gen are significantly associated with BV. Chlamydia (CT) and Gonorrhea (NG) are less common than M. gen and TV in women with BV. Women should still be tested for CT and NG as these are serious STIs that can cause significant health problems if left untreated.

• #57 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Regarding NAATs for BV, the CDC states that BV NAATs should be used among symptomatic women only (e.g., women with vaginal discharge, odor, or itch) because their accuracy is not well defined for asymptomatic women. Despite the availability of BV NAATs, 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. Culture of G. vaginalis is not recommended as a diagnostic tool because it is not specific. Cervical Pap tests have no clinical utility for diagnosing BV because of their low sensitivity and specificity. […] The CDC provides information on multiple BV NAATs that are available and notes that these tests are based on detection of specific bacterial nucleic acids and have high sensitivity and specificity for BV (i.e., G. vaginalis, A. vaginae, BVAB2, or Megasphaera type 1) and certain lactobacilli (i.e., Lactobacillus crispatus, Lactobacillus jensenii, and Lactobacillus gasseri). They can be performed on either clinician- or self-collected vaginal specimens with results available in 24 hours, depending on the availability of the molecular diagnostic platform. Five quantitative multiplex PCR assays are available: Max Vaginal Panel (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). Two of these assays are FDA cleared (BD Max Vaginal Panel and Aptima BV), and the other three are laboratory-developed tests. The Max Vaginal Panel provides results by an algorithmic analysis of molecular DNA detection of Lactobacillus species (L. crispatus and L. jensenii) in addition to G. vaginalis, A. vaginae, BVAB2, and Megasphaera type 1. This test has 90.5% sensitivity and 85.8% specificity for BV diagnosis, compared with Amsel criteria and Nugent score. It also provides results for Candida species and T. vaginalis. The Aptima BV detects G. vaginalis, A. vaginae, and certain Lactobacillus species including L. crispatus, L. jensenii, and L. gasseri, with sensitivity and specificity ranging from 95.0% to 97.3% and 85.8% to 89.6%, respectively (using either clinician- or patient-collected vaginal swabs). The three laboratory-developed tests (NuSwab VG, OneSwab BV Panel PCR with Lactobacillus Profiling by qPCR, and SureSwab BV) have to be internally validated before use for patient care yet have good sensitivity and specificity, similar to FDA-cleared assays.

• #58 Quest Women’s Health

  http://www.questvaginitis.com/

  SureSwab Advanced for accurate diagnoses of vaginitis […] High sensitivity and specificity help deliver excellence in womens health diagnostics […] Vaginitis is the most common gynecologic diagnosis in the primary care setting. […] Most women have at least 1 episode of vaginitis during their lives, but diagnosing its cause can be challenging. […] The 3 diseases most frequently associated with vaginitis are bacterial vaginosis (BV), caused by an overgrowth of bacteria including Gardnerella vaginalis and anaerobes; vaginal trichomoniasis (TV), caused by Trichomonas vaginalis; and vulvovaginal candidiasis, usually caused by Candida albicans. […] Advanced testing with excellent accuracy for optimized patient care […] Featuring a nucleic acid amplification test (NAAT) as its underlying technology, SureSwab Advanced helps you obtain a definitive diagnosis of the 3 most common infectious causes of vaginitis.

• #59 Quest Women’s Health

  http://www.questvaginitis.com/

  NAAT has been shown to have greater sensitivity compared to the non-amplified DNA probe. […] Accurate diagnosis is critical. […] Up to 75% of women experience vaginitis in their lifetimes and 40%-45% will experience 2 or more cases. […] The FDA-cleared Aptima and Candida offerings by Hologic deliver excellent sensitivity and specificity, detecting multiple infections, including bacterial vaginosis, Candida, chlamydia, gonorrhea, and trichomonas with just 1 vaginal swab. […] Our collection of clinically proven vaginitis assays give you the flexibility to order the right SureSwab Advanced testing for your patients.

• #60 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Centers for Disease Control and Prevention (CDC) The CDC published updated guidelines for diseases characterized by vulvovaginal itching, burning, irritation, odor or discharge in their Sexually Transmitted Infections Treatment Guidelines, 2021 (CDC, 2021b). These guidelines state that obtaining a medical history alone has been reported to be insufficient for accurate diagnosis of vaginitis and can lead to inappropriate administration of medication. Therefore, a careful history, examination, and laboratory testing to determine the etiology of any vaginal symptoms are warranted. Information regarding sexual behaviors and practices, sex of sex partners, menses, vaginal hygiene practices (e.g., douching), and self-treatment with oral and intravaginal medications or other products should be elicited.

• #61 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  The CDC notes that in the clinicians office, the cause of vaginal symptoms can often be determined by pH, a potassium hydroxide (KOH) test, and microscopic examination of a wet mount of fresh samples of vaginal discharge. However, the guidelines conclude that in settings where pH paper, KOH, and microscopy are unavailable, a broad range of clinical laboratory tests can be used. […] For the evaluation of BV, the CDC recommends that BV can be diagnosed by the use of clinical criteria (i.e., Amsels Diagnostic Criteria) or by determining the Nugent score from a vaginal Gram stain. Additional tests are available: The Osom BV Blue test (Diagnostics) detects vaginal sialidase activity. The Affirm VP III (Becton Dickinson) is an oligonucleotide probe test that detects high concentrations of G. vaginalis nucleic acids (5 x 105 CFU of G. vaginalis/mL of vaginal fluid) for diagnosing BV, Candida species, and T. vaginalis. This test has been reported to be most useful for symptomatic women in conjunction with vaginal pH measurement and presence of amine odor. Finally, the FemExam Test Card (Cooper Surgical) measures vaginal pH, presence of trimethylamine (a metabolic by-product of G. vaginalis), and proline aminopeptidase. This test has primarily been studied in resource-poor settings, and although it has been reported to be beneficial compared with syndromic management, it is not a preferred diagnostic method for BV diagnosis. The guidelines also state that due to insufficient evidence, routine screening for BV among asymptomatic pregnant women at high or low risk for preterm delivery for preventing preterm birth is not recommended, which is in compliance with the 2008 USPSTF recommendations.

• #62 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  American College of Obstetrics and Gynecology (ACOG) ACOG published recommendations (ACOG, 2006) for the evaluation of vaginitis in 2006, and reaffirmed in 2017, which state: Evaluation of women with vaginitis should include a focused history about the entire spectrum of vaginal symptoms, including change in discharge, vaginal malodor, itching, irritation, burning, swelling, dyspareunia, and dysuria. Further, During speculum examination, samples should be obtained for vaginal pH, amine (whiff) test, and saline (wet mount) and 10% potassium hydroxide (KOH) microscopy. The pH and amine testing can be performed either through direct measurement or by colorimetric testing. With a Level B recommendation, ACOG states, Microscopy is the first line for diagnosing vulvovaginal candidiasis and trichomoniasis. In selected patients, culture for yeast and T. vaginalis should be obtained in addition to standard office-based testing. Additionally, a vaginal Gram stain for Nugent scoring of the bacterial flora may help to identify patients with BV. Other currently available ancillary tests for diagnosing vaginal infections include rapid tests for enzyme activity from BV-associated organisms, Trichomonas vaginalis antigen, and point-of-care testing for DNA of G. vaginalis, T. vaginalis, and Candida species; however, the role of these tests in the proper management of patients with vaginitis is unclear. Depending on risk factors, DNA amplification tests can be obtained for Neisseria gonorrhoeae and Chlamydia trachomatis.

• #63 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  The ACOG published in 2020 Practice Bulletin Number 215 on vaginitis in nonpregnant patients. In these guidelines, the ACOG made these recommendations for diagnostic testing based on good and consistent scientific evidence (Level B): […] The use of Amsel clinical criteria or Gram stain with Nugent scoring is recommended for the diagnosis of bacterial vaginosis. […] Nucleic acid amplification testing is recommended for the diagnosis of trichomoniasis. […] In a symptomatic patient, diagnosis of vulvovaginal candidiasis requires one of the following two findings: 1) visualization of spores, pseudohyphae, or hyphae on wet-mount microscopy or 2) vaginal fungal culture or commercial diagnostic test results positive for Candida species. […] The ACOG also published recommendations based on limited or inconsistent scientific evidence (Level B), along with a series of recommendations based on consensus and expert opinion (Level C). Those relating to diagnostic testing are reported below:

• #64 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  Patients should be retested within 3 months after treatment for T vaginalis because of the high rates of infection recurrence. (Level B) […] Pap tests are not reliable for the diagnosis of vaginitis. Diagnostic confirmation is recommended for incidental findings of vulvovaginal candidiasis, bacterial vaginosis, or trichomoniasis on a Pap test. (Level B) […] A complete medical history, physical examination of the vulva and vagina, and clinical testing of vaginal discharge (i.e., pH testing, a potassium hydroxide [KOH] whiff test, and microscopy) are recommended for the initial evaluation of patients with vaginitis symptoms. (Level C) […] The ACOG mentions in Bulletin Number 215 that an advanced single-swab panel test that combines multiplex PCR and DNA probe technology could be a promising alternative to microscopy for BV, trichomoniasis, and candidiasis.

• #65 Diagnosis of Vaginitis

  https://www.southcarolinablues.com/web/public/brands/medicalpolicyhb/external-policies/diagnosis-of-vaginitis/

  In 2018, the AAFP published the following guidelines: […] Symptoms alone cannot differentiate between the causes of vaginitis. Office-based or laboratory testing should be used with the history and physical examination findings to make the diagnosis. (C evidence rating) […] Do not obtain culture for the diagnosis of bacterial vaginosis because it represents a polymicrobial infection. (C evidence rating) […] Nucleic acid amplification testing is recommended for the diagnosis of trichomoniasis in symptomatic or high-risk women. (C evidence rating) […] U.S. Preventive Services Task Force Recommendations (USPSTF) In 2020, the USPSTF published recommendations discouraging the use of screening for BV in pregnancy: The USPSTF recommends against screening for bacterial vaginosis in pregnant persons not at increased risk for preterm delivery. On a similar note, the USPSTF maintains its 2008 recommendation stating that the current evidence is insufficient to assess the balance of benefits and harms of screening for bacterial vaginosis in pregnant persons at increased risk for preterm delivery.

• #66 Vaginitis in adults and adolescents: Initial evaluation – UpToDate

  https://www.uptodate.com/contents/vaginitis-in-adults-and-adolescents-initial-evaluation

  History, physical examination, and laboratory testing are all required for diagnosis. […] The initial history questions gather details of the patient’s symptoms. Each symptom is further evaluated separately as more than one condition may be present. […] The presentation and diagnosis of these infections is discussed in detail elsewhere. […] Approximately 25 to 40 percent of patients with vaginitis symptoms do not have a specific cause identified on initial diagnostic evaluation. […] Given the nonspecific nature of vaginitis symptoms, identifying the etiology is mandatory before initiating therapy. […] Diagnostic testing enables targeted treatment, increases therapeutic compliance, and increases the likelihood of partner notification. […] Individuals with a confirmed diagnosis are treated as indicated. If the patient’s symptoms resolve, no further evaluation or treatment is warranted.

• #67 Vaginitis: Diagnosis and Treatment | AAFP

  https://www.aafp.org/pubs/afp/issues/2011/0401/p807.html

  Individual symptoms and signs, pH level, and microscopy results often do not lead to an accurate diagnosis of vaginitis. Laboratory tests perform better than standard office-based evaluation for diagnosing causes of vaginitis, but they do not add substantially to the treatment threshold and are justified only in patients with recurrent or difficult-to-diagnose symptoms. […] In clinical practice, bacterial vaginosis is diagnosed by the presence of three out of four Amsel criteria. […] A vaginal pH of more than 4.5 was found to be the most sensitive (89 percent) and a positive whiff test was the most specific (93 percent) method of detecting bacterial vaginosis. […] Vaginal culture should be considered in recurrently symptomatic women with negative microscopy and a normal pH. […] Although lactobacillus probiotics are safe, there is no conclusive evidence that they are superior to or enhance the effectiveness of antibiotics in the treatment of bacterial vaginosis or prevent its recurrence.

• #68 Vaginitis: Laboratory Testing for Diagnosis and Management | Clinical Focus | Quest Diagnostics Vaginitis: Laboratory Testing for Diagnosis and Management Vaginitis: Laboratory Testing for Diagnosis and Management

  https://testdirectory.questdiagnostics.com/test/test-guides/CF_Vaginitis/vaginitis-laboratory-testing-for-diagnosis-and-management

  Clinical testing of vaginal discharge specimens has historically been used to evaluate vaginitis and is still recommended, if available. Clinical testing includes pH measurement, the potassium hydroxide „whiff test,” and microscopy. While these tests can be performed at the point of care, their performance for detecting BV, VC, and TV can be low compared to reference methods and other molecular tests. Clinical testing has particularly low sensitivity for detecting coinfections, which are present in up to 25% of women with vaginitis. […] If microscopy is not available or clinical testing cannot be performed as recommended, guidelines indicate that molecular tests, such as NAATs, can be used instead. Advantages of NAATs for evaluating vaginitis include (1) the ability to test for multiple infections using the same swab, (2) high sensitivity and specificity, and (3) comparable performance on both clinician-collected and self-collected swabs. Additionally, NAATs can better detect coinfections and mixed infections with other STIs.

• #69 Advancing the Diagnosis of Vaginitis | Clinical Lab Products

  https://clpmag.com/diagnostic-technologies/molecular-diagnostics/advancing-the-diagnosis-of-vaginitis/

  Experts have raised awareness of how essential correct diagnoses are to prevent both under- and overdiagnosis of vaginitis and the negative consequences of inappropriate treatment. Recently updated American College of Obstetricians and Gynecologists (ACOG) Practice Guidelines recommend NAAT be used for diagnosis of trichomoniasis and suggest that these methods can also be used as an alternative to the recommended Amsel and Nugent criteria tests for BV. […] Molecular-based NAAT tests using vaginal swabs collected by clinicians or patients can accurately diagnose the most common bacterial, fungal, and protozoan vaginitis infections. The NAAT assays offer sensitive and specific detection of vaginitis and provide accurate diagnoses of multiple pathogens, an advance over prior vaginitis testing methods. These tests provide objective tools for the clinician to differentiate among vaginitis pathogens to confidently diagnose and treat patients. Effective treatment and cure of vaginitis reduces risk of recurrent or persistent infections, helps prevent consequences of untreated infections, and reduces spread of certain STIs.

• #70 Diagnostic performance of an automated microscopy and pH test for diagnosis of vaginitis | npj Digital Medicine

  https://www.nature.com/articles/s41746-023-00815-w

  Detecting the etiology of both infectious and non-infectious vaginal disorders provides an unprecedented diagnostic spectrum. To our knowledge, our results are the first ever reported for any automated tool to aid in diagnosing either vaginal atrophy or cytolytic vaginosis. […] The evaluated investigational test provides fast in-clinic results from a single specimen within 5 minutes from scan initiation. This is done by automating the entire recommended practice of reported symptoms consideration, pH measurement, slide preparation, and slide scanning, and by harnessing deep-learning computer-vision image classification to support the providers diagnosis. […] The presented results suggest that using an in-office automated tool that relies on a combination of inputs (automated microscopy, automated pH, and patients reported symptoms) can improve patients evaluation and treatment, regardless of caregivers training and skills. This may result in reducing empirical treatment, as well as resolving both subjective intra and inter-observer variability between caregivers who do perform microscopy.

• #71 Diagnostic performance of an automated microscopy and pH test for diagnosis of vaginitis | npj Digital Medicine

  https://www.nature.com/articles/s41746-023-00815-w

  Given the above-described limitations of the current point-of-care diagnosis of vaginitis, the investigational test presents a potential for a marked improvement in the first-line evaluation of vaginitis and will hopefully guide a more appropriate treatment while decreasing healthcare costs and improving patients quality of life.

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