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 |
|
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| Atopobium vaginae | |
|
* |
|
| BVAB-2 | |
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| Megasphaera-1 | |
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| Reported as | BV | BV | BV | |
| Reportable results | POS NEG |
POS NEG |
POS NEG |
|
| Vulvovaginal candidiasis (VVC) / Trichomonas vaginalis (TV) | Candida albicans | |
|
|
| Candida tropicalis | |
|
|
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| Candida parapsilosis | |
|
|
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| Candida dubliniensis | |
|
|
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| Candida glabrata | |
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| Candida krusei | |
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|
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| Trichomonas vaginalis | |
|
|
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| 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 NEG |
POS NEG |
DETECTED NOT DETECTED |
|
| 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.
