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SureSwab Vaginosis/Vaginitis Plus

SureSwab Vaginosis/Vaginitis Plus

Test Summary

SureSwab® Vaginosis/Vaginitis Plus

  

Clinical Use

  • Differential diagnosis of vaginitis

  • Guide selection of appropriate therapy

Clinical Background

Vaginitis is characterized by an abnormal vaginal discharge, vulvar itching and irritation, and/or an abnormal vaginal odor. The most common causes of symptomatic vaginitis are bacterial vaginosis (BV) (22% to 50%), vulvovaginal candidiasis typically due to Candida albicans infection (17% to 39%), and trichomoniasis due to Trichomonas vaginalis infection (4% to 35%).2 In many patients, however, vaginitis is asymptomatic. Such is usually the case with sexually transmitted infections (STIs) due to Chlamydia trachomatis or Neisseria gonorrhoeae, which are frequently found concomitantly with other infections of the female genital tract.

Differential diagnosis of vaginitis is important for successful treatment of the patient and, in some cases, the evaluation of her sexual partner. Treatment selection depends on clinical history, symptoms, the presence of coinfection, and the organism(s) identified.3,4

Clinical diagnosis employing history, pelvic examination, pH, wet-prep microscopy, and an amine odor test is difficult. It is only 81% to 85% sensitive and 70% to 99% specific for differentiating BV, candidiasis, and trichomoniasis relative to nucleic acid-based molecular tests.5 Approximately 30% of women with vulvovaginal symptoms remain undiagnosed following these procedures.2 Furthermore, clinical diagnosis cannot detect mixed infections, which are common. To help improve differential diagnosis, Quest Diagnostics offers organism-specific molecular tests available individually or in panels. Because of the close association between STIs and bacterial vaginosis and Candida infection, the SureSwab Vaginosis/Vaginitis Plus panel includes tests for C trachomatis, N gonorrhoeae, and T vaginalis as well as tests for bacterial vaginosis and Candida spp.

Individuals Suitable for Testing

Includes women with3:

  • Symptoms of vaginitis

  • History of high-risk sexual behavior or a previous STI

  • History of pregnancy complications (eg, ectopic pregnancy, premature rupture of the membranes, preterm labor and delivery)

  • Cervicitis, pelvic inflammatory disease, urethritis

  • Chronic pelvic pain, difficult urination, painful intercourse

  • Risk of post-operative gynecologic infection

Method

  • Bacterial vaginosis (includes quantitation of peroxide-producing Lactobacillus spp, Atopobium vaginae, Gardnerella vaginalis, and Megasphaera spp): real-time polymerase chain reaction (PCR)

  • Candida spp (includes C albicans, C glabrata, C parapsilosis, and C tropicalis): real-time PCR

  • C trachomatis, N gonorrhoeae, and T vaginalis: transcription-mediated amplification (TMA)

Reference Range

  • Bacterial vaginosis: not supportive

  • Candida spp: not detected

  • C trachomatis: not detected

  • N gonorrhoeae: not detected

  • T vaginalis: not detected

Interpretive Information

Bacterial Vaginosis

BV is caused not by a single infectious agent but by an imbalance of normal bacterial flora. Thus, normal Lactobacillus flora is replaced by an overgrowth of G vaginalis, A vaginae,6 Megasphaera spp,7 and other bacteria. Results are reported as log cells/mL for each organism and interpreted as follows:

  • Not supportive of BV diagnosis (low likelihood of BV)6,8-12: 1) presence of Lactobacillus spp, G vaginalis levels <6.0 log cells/mL, and absence of A vaginae and Megasphaera spp; or 2) absence of all targeted organisms; or 3) absence of Lactobacillus spp. plus G vaginalis detected at levels <6.0 log cells/mL and absence of A vaginae and Megasphaera spp.

  • Equivocal (results neither support nor refute diagnosis of BV; may represent a transition into or out of BV)6, 8,11,13: presence of Lactobacillus spp plus G vaginalis (≥6.0 log cells/mL) and/or one of the other BV-associated pathogens

  • Supportive of BV diagnosis6,8-11,14: absence of Lactobacillus spp with presence of G vaginalis (≥6.0 log cells/mL) and/or one or both of the other BV-associated pathogens

Other Infections

For Candida spp, C trachomatis, N gonorrhoeae, and T vaginalis, a positive result should be considered presumptive evidence of infection. A “not detected” result suggests that the patient is not infected with the target organism(s), but could also be due to an organism concentration below the assay detection limit or to improper specimen collection and handling.

References

  1. APTIMA® Vaginal Swab Specimen Collection Kit [package insert]. San Diego, CA: Gen-Probe Incorporated; 2011.

  2. Anderson MR, Klink K, Cohrssen A. Evaluation of vaginal complaints. JAMA. 2004;291:1368-1379.

  3. Centers for Disease Control and Prevention, Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010;59(RR-12):1-110. Erratum in: MMWR Recomm Rep. 2011;60:18.

  4. Centers for Disease Control and Prevention Update to CDC’s sexually transmitted diseases treatment guidelines, 2006: fluoroquinolones no longer recommended for treatment of gonococcal infections. MMWR Recomm Rep. 2007;56:332-336.

  5. Lowe NK, Neal JL, Ryan-Wenger NA. Accuracy of the clinical diagnosis of vaginitis compared to DNA probe laboratory standard. Obstet Gynecol. 2009;113:89-95.

  6. Menard JP, Fenollar F, Henry M, et al. Molecular quantification of Gardnerella vaginalis and Atopobium vaginae loads to predict bacterial vaginosis. Clin Infect Dis. 2008;47:33-43.

  7. Zozaya-Hinchliffe M, Martin DH, Ferris MJ. Prevalence and abundance of uncultivated Megasphaera-like bacteria in the human vaginal environment. Appl Environ Microbiol. 2008;74:1656-1659.

  8. Fredricks DN, Fiedler TL, Thomas KK, et al. Targeted PCR for detection of vaginal bacteria associated with bacterial vaginosis. J Clin Microbiol. 2007;45:3270-3276.

  9. Fredricks DN, Fiedler TL, Thomas KK, et al. Changes in vaginal bacterial concentrations with intravaginal metronidazole therapy for bacterial vaginosis as assessed by quantitative PCR. J Clin Microbiol. 2009;47:721-726.

  10. Tamraker R, Yamada T, Furuta I, et al. Association between Lactobacillus species and bacterial vaginosis-related bacteria, and bacterial vaginosis scores in pregnant Japanese women. BMC Infect Dis. 2007;7:128.

  11. Bradshaw CS, Tabrizi SN, Fairley CK, et al. The association of Atopobium vaginae and Gardnerella vaginalis with bacterial vaginosis and recurrence after oral metronidazole therapy. J Infect Dis. 2006;194:828-836.

  12. Jakobsson T, Forsum U. Changes in the predominant human Lactobacillus flora during in vitro fertilisation. Ann Clin Microbiol Antimicrob. 2008;7:14.

  13. Nugent RP, Krohn MA, Hillier SL. Reliability of diagnosing bacterial vaginosis is improved by standardized method of gram stain interpretion. J Clin Microbiol. 1991;29:297-301.

  14. Cartwright CP, Lembke BD, Ramachandran K, et al. Development and validation of a semiquantitative, multitarget PCR assay for diagnosis of bacterial vaginosis. J Clin Microbiol. 2012;50:2321-2329.
     

This test was developed and its performance characteristics have been determined by Quest Diagnostics Nichols Institute. Performance characteristics refer to the analytical performance of the test.

Polymerase chain reaction (PCR) is performed pursuant to a license agreement with Roche Molecular Systems, Inc.

Content reviewed 07/2013
 

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