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Improved technology for more accurate diagnoses of vaginitis

Nucleic acid amplification test (NAAT) helps you identify the specific cause for more effective treatment

Vaginitis is one of the most common reasons women visit a healthcare provider,1 and 90% of these infections are caused by either bacteria (bacterial vaginosis (BV), yeast (Candida vaginitis (CV), or the parasite Trichomonas vaginalis (TV)2).

Identifying these vaginal infections is important for selecting treatment, and nonspecific and overlapping symptoms can make diagnosis a challenge. Taking a medical history, examination, and laboratory testing using NAAT technology gives you the ability to make a definitive diagnosis.

Doctor working on computer Doctor working on computer

Better diagnostics with NAAT testing

Our understanding of vaginitis—as well as molecular technology—has vastly improved in the last 30 years, and newer, FDA-cleared molecular testing is now available. Based on this, we recommend SureSwab® Advanced, which uses NAAT and has shown to have greater sensitivity compared to the DNA probe.3

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.

Comparing SureSwab Advanced vaginitis NAAT testing to DNA probe
for the 3 most common causes of vaginitis

SureSwab® Advanced

The Aptima® BV assay uses an algorithm to report a qualitative result for BV based on detection of the following organisms:

  • Lactobacillus spp
  • Gardnerella vaginalis
  • Atopobium vaginae
Target and arrow icon
Accurate results

with high sensitivity (95%-97%)
and specificity (86%-90%)5

DNA probe

False positives on the order of

23%-32%

as a result of DNA probe only targeting:
Gardnerella vaginalis6,7

Warning sign icon

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.”2

SureSwab® Advanced

Aptima CV assay qualitatively reports Candida species group (C albicans, C tropicalis, C parapsilosis, and C dubliniensis), and Candida glabrata5

Target and arrow icon
Accurate results

with high sensitivity (93%-98%)
and specificity (83%-92%)5

DNA probe

Letter x icon

NO separate callout for C glabrata4

58 percent icon
Low sensitivity

when compared to diagnostic assays featuring nucleic acid amplification technologies (NAAT)6

SureSwab® Advanced

97 percent icon
Aptima TV Assay has high sensitivity

and specificity (95%-99%), ensuring the provider
and patient always receive an accurate result.7

Green checkmark icon
CDC and ACOG recommend NAATs

to detect TV4,8

DNA probe

46 percent icon
Low sensitivity

means TV is often missed or undercalled
leading to false negatives6

NAAT testing

White checkmark Has higher sensitivity and specificity for bacterial vaginosis

White checkmark Differentiates between Candida glabrata and the Candida species group

White checkmark Provides superior sensitivity for Trichomonas

Contact us to learn more about SureSwab
Advanced and the transition from DNA Probe

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Aptima Multi-Test Collection Kit Image

Aptima Multi-Test Collection Kit Supply # A03

SURESWAB ADVANCED TEST CODES

INDICATED TESTS

CPT CODES

COLLECTION DEVICE FOR SURESWAB

INDICATED TESTS

Bacterial vaginosis
(Lactobacillus spp,
G vaginalis, A vaginae)

CPT CODES

81513

INDICATED TESTS

Candida vaginitis

  • Candida species (C albicans,
    C tropicalis, C parapsilosis,
    and C dubliniensis)
  • Candida Glabrata

CPT CODES

87481*2

INDICATED TESTS

Candida vaginitis
Trichomonas vaginalis

CPT CODES

87481*2

INDICATED TESTS

Bacterial vaginosis
Chlamydia
Gonorrhea

CPT CODES

81513
87491
87591

SURESWAB ADVANCED TEST CODES

10119

SureSwab Advanced
Vaginitis, TMA

INDICATED TESTS

Bacterial vaginosis
Candida vaginitis
Trichomonas vaginalis

CPT CODES

81513
87481*2
87661

INDICATED TESTS

Bacterial vaginosis
Candida vaginitis
Trichomonas vaginalis
Chlamydia
Gonorrhea

CPT CODES

81513
87481*2
87661
87491
87591

Aptima_Multi-Test_CollectionKit

Aptima Multi-Test Collection Kit Supply # A03

SureSwab®, Trichomonas vaginalis RNA, Qualitative, TMA (test code 19550); Chlamydia trachomatis RNA, TMA, Urogenital (test code 11361); Neisseria gonorrhoeae RNA, TMA, Urogenital (test code 11362); Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital (test code 11363)

​References:

  1. Hildebrand JP, Kansagor AT. Vaginitis. Internet. StatPearls Publishing. Published January 2022. Updated November 14, 2022. Accessed December 5, 2022. https://www.ncbi.nlm.nih.gov/books/NBK470302/
  2. ACOG. Vaginitis in nonpregnant patients. practice bulletin No. 215. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2020;135(1):e1-17. doi:10.1097/AOG.0000000000003604
  3. Fredricks DN, Fiedler TL, Thomas KK, et al. Targeted PCR for detection of vaginal bacteria associated with bacterial vaginosis. J Clin Microbiol. 2007;45(10):3270-3276. doi:10.1128/JCM.01272-07
  4. Cartwright CP, Lembke BD, Ramachandran K, et al. Comparison of nucleic acid amplification assays with BD affirm VPIII for diagnosis of vaginitis in symptomatic women. J Clin Microbiol. 2013;51(11):3694-3699. doi:10.1128/JCM.01537-13
  5. Aptima BV Assay package insert #AW-18811. Hologic, Inc., 2021.
  6. Richter SS, Otiso J, Goje OJ, et al. Prospective evaluation of molecular assays for diagnosis of vaginitis. J Clin Microbiol. 2020;58(1):e01264-e01319. doi:10.1128/JCM.01264-19
  7. Muzny CA, Taylor CM, Swords WE, et al. An updated conceptual model on the pathogenesis of bacterial vaginosis. J Infect Dis. 2019;220(9):1399-1405. doi:10.1093/ infdis/jiz342
  8. Aptima CV/TV Assay package insert #AW-18812. Hologic, Inc., 2021.
  9. Aptima Trichomonas vaginalis Assay package insert. #503684. Hologic, Inc.; 2017.
  10. CDC. Sexually transmitted infections treatment guidelines, 2021: trichomoniasis. Updated September 21, 2022. Accessed December 6, 2022. https://www.cdc.gov/std/treatment-guidelines/trichomoniasis.htm

Test codes may vary by location. Please contact your local laboratory for more information.

The CPT® codes provided are based on American Medical Association guidelines and are for informational purposes only.

CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Image content features models and is intended for illustrative purposes only.