An overview of FDA-cleared vulvovaginitis and vaginosis tests

There are currently 4 FDA-cleared molecular assays that use PCR amplification for the diagnosis of vaginitis and/or bacterial vaginosis.1-4

  BD MAX™ Vaginal Panel1 Hologic Aptima® BV and CT/TV Assays2,3 Cepheid Xpert® Xpress MVP4
Bacterial Vaginosis (BV) Gardnerella vaginalis
Lactobacillus spp.
L. crispatus and L. jensenii

L. crispatus, L. jensenii, L. gasseri
Atopobium vaginae *
  Reported as BV BV BV
  Reportable results POS
Vulvovaginal candidiasis (VVC) / Trichomonas vaginalis (TV) Candida albicans
Candida tropicalis
Candida parapsilosis
Candida dubliniensis
Candida glabrata
Candida krusei
Trichomonas vaginalis
  Reported as Candida group
C. glabrata
C. krusei
C. vaginalis
Candida species group
C. glabrata
T. vaginalis
Candida spp.
C. glabrata / C. krusei
T. vaginalis
  Reportable results POS
Recommended CPT® Code 81514

*Atopobium spp. (Atopobium vaginae, Atopobium novel species CCUG 55226)


BD MAX™ Vaginal Panel will help you detect a broader range of pathogens responsible for vaginitis as compared to other assays and is eligible for reimbursement.1


Disclaimer: Health economic and reimbursement information provided by BD is gathered from third-party sources and is subject to change without notice. The information contained in this reference is presented for information purposes only and does not constitute reimbursement or legal advice. It is always the provider’s responsibility to determine medical necessity and to submit appropriate codes and changes for services that are rendered. BD recommends that you consult with your payers, reimbursement specialist and/or legal counsel regarding coverage, coding, and payment matters. CPT five-digit codes, description, two-digit modifiers and other data are copyright © 2022 American Medical Association. All rights reserved. The codes referenced here are not all-inclusive and are not intended to represent all coding options options.

BV, bacterial vaginosis; BVAB, bacterial vaginosis-associated bacterium; FDA, Food and Drug Administration; NEG, negative; PCR, polymerase chain reaction; POS, positive; TV, Trichomonas vaginalis; VVC, vulvovaginal candidiasis.

1. BD MAX™ Vaginal Panel Package Insert (P0258).
2. Hologic Aptima® CV/TV Assay Package Insert.
3. Hologic Aptima® BV Assay Package Insert.
4. Cepheid Xpert® Xpress MVP Instructions for Use.