Multitarget polymerase chain reaction (PCR) testing is proposed as an alternative to currently available laboratory tests to diagnose bacterial vaginosis. Bacterial vaginosis is a condition caused by an imbalance in the normal bacteria vaginal flora. It is a common disorder, especially in women of reproductive age. While there is no single known etiologic agent, there is a shift in vaginal flora that involves a depletion of lactobacillus species and overgrowth of other bacteria. Prevalence of the condition is high, and it is asymptomatic in most cases. When symptomatic, bacterial vaginosis is associated with signs and symptoms including abnormal grayish white discharge and mild itching.
Traditional diagnosis has been by clinical criteria and/or Gram stain. Other test methods include a DNA probe-based test, a proline aminopeptidase test card, an enzyme-based test card, and a polymerase chain reaction (PCR) test (e.g., SureSwab®). Evaluation of the clinical utility of PCR testing for bacterial vaginosis is uncertain and published evidence of the diagnostic accuracy is lacking at this time.
Multitarget polymerase chain reaction (PCR) testing for the diagnosis of bacterial vaginosis is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
Polymerase chain reaction testing to detect several organisms associated with bacterial vaginosis has been utilized in the research setting; however, the evaluation of its clinical utility is not possible at this time due to the scarcity of quality studies.
BlueCross BlueShield Association. Evidence Positioning System. (7:2017). Multitarget polymerase chain reaction testing for diagnosis of bacterial vaginosis. (2.04.127). Retrieved January 25, 2018 from https://www.evidencepositioningsystem.com/. (11 articles and/or guidelines reviewed)
Centers for Disease Control and Prevention. (2015). 2015 Sexually Transmitted Diseases Treatment Guidelines. Diseases characterized by vaginal discharge. Retrieved March 18, 2016 from http://www.cdc.gov/std/tg2015/bv.htm.
Hilbert, D.W., Smith, W.L., Chadwick, S.G., Toner, G., Mordechai, E., Adelson, M.E., et al. (2016). Development and validation of a highly accurate quantitative real-time PCR assay for diagnosis of bacterial vaginosis. Journal of Clinical Microbiology, 54 (4), 1017-1024. (Level 4 evidence)
Kusters, J, Reuland, E., Bouter, S., Koenig, P., Dorigo-Zetsma, J. (2015). A multiplex real-time PCR assay for routine diagnosis of bacterial vaginosis. European Journal of Clinical Microbiology & Infectious Disease, 34, 1779-1785. (Level 3 evidence)
Rumyantseva, T., Bellen, G., Romanuk, T. Shipulina. O., Guschin, A., Shipulin, G., et al. (2015). Utility of microscopic techniques and quantitative real-time polymerase chain reaction for the diagnosis of vaginal microflora alterations. Journal of Lower Genitourinary Tract Disorders 19 (2), 124-128. Abstract retrieved February 20, 2017 from PubMed database.
U.S.Food and Drug Administration. (2016, October). Center for Devices and Radiological Health. Device classification under section 513(f) (2) (de novo). DEN160001. Retrieved January 25, 2018 from https://www.accessdata.fda.gov/cdrh_docs/pdf16/den160001.pdf.
United States Preventive Services Task Force (USPSTF). (2008). Bacterial vaginosis in pregnancy to prevent preterm delivery: screening. Retrieved January 25, 2018 from https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/bacterial-vaginosis-in-pregnancy-to-prevent-preterm-delivery-screening.
ORIGINAL EFFECTIVE DATE: 6/13/2015
MOST RECENT REVIEW DATE: 1/10/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.