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ARUP Laboratories is transitioning away from the Vaginal Pathogen Panel by DNA Probe (VAGP) assay and replacing it with a more sensitive transcription-mediated amplification (TMA) assay.

 

Why discontinue the VAGP assay?

The VAGP assay, which uses BD Affirm VPIII transport media, is a DNA probe-based multiplex assay that detects three pathogens associated with vaginitis: Gardnerella vaginalis, Candida spp, and Trichomonas vaginalis.

  • The VAGP DNA probe only reports a single bacteria.
  • The VAGP assay is less sensitive and less specific than nucleic acid amplification (NAA)-based assays.
  • The BD Affirm collection kit is only for the VAGP assay, so multiple swabs must be collected if testing for additional sexually transmitted infections (STIs) such as Chlamydia trachomatis and Neisseria gonorrhoeae.

What is replacing the VAGP assay?

ARUP is offering an FDA-approved Vaginitis Panel by TMA.

  • In vitro NAA test
  • Uses TMA on Hologic Panther system
  • Detects ribosomal RNA (rRNA) from Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, Atopobium vaginae, Candida spp, Candida glabrata, and Trichomonas vaginalis

The vaginitis panel enables a single swab collection using the Aptima Multitest Swab Specimen Collection kit. The Aptima Multitest Swab kit is also approved for vaginal collection for Chlamydia trachomatis and Neisseria gonorrhoeae NAA testing on the Hologic Panther system.

Spotlight on Testing: Vaginitis Testing by TMA
Salika M. Shakir, PhD, (DABMM)
Medical Director, Microbial Amplified Detection ARUP Laboratories
Assistant Professor
University of Utah School of Medicine
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When will this transition occur?

The Vaginitis Panel by TMA is currently available (effective May 17, 2021). The VAGP assay will remain active for the next three months so that all pending orders can be completed and will then be inactivated on November 15, 2021. We will continue to provide the BD Affirm VPIII Ambient Temperature Transport System (ARUP Supply #29624) for the VAGP panel upon request until October 15, 2021, or until supplies run out.

Impact on Patient Care

The Vaginitis Panel by TMA:

  • Provides greater sensitivity
  • Is approved for clinician collection or self-collection
  • Enables a single swab collection for multiple STI tests
  • Has a longer stability that minimizes compromised specimens during transport and facilitates retesting if necessary

Assay Comparison Table

  Previous Assay New Assay
Test Code ARUP#: 0065153 ARUP#: 3002581
Test Name Vaginal Pathogen Panel by DNA Probe Vaginitis Panel by TMA
Methodology Qualitative nucleic acid probe Qualitative TMA
TAT 3 days 1–3 days
Organisms Candida spp, Gardnerella vaginalis, and Trichomonas vaginalis Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae
(A single qualitative result is provided based on relative amounts of the above)
PLUS Candida spp, Candida glabrata, Trichomonas vaginalis
Specimen Stability Ambient: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable
Ambient: 30 days
Refrigerated: 30 days
Frozen: 90 days
Client Supply BD Affirm™ VPIII Ambient Temperature
Transport System
ARUP Supply#: 29624
(This item is limited and will be discontinued on October 15, 2021, or when supplies run out)
Aptima Multitest Swab Specimen Collection kit
ARUP Supply#: 55224 PK/50; 55229 PK/10
NOTE: Kit is also approved for vaginal collection for Chlamydia trachomatis and Neisseria gonorrhoeae NAA testing
Category FDA cleared FDA cleared
CPT Code 87480, 87510, 87660 81513, 87481, 87661

Additional Testing Options

ARUP also offers a more targeted approach to vaginitis testing, offering two additional assays that allow clinicians to choose specific groups of microorganisms to test for based on clinical presentation.

Bacterial Vaginosis by TMA

  • FDA-approved in vitro NAA test
  • Uses TMA on Hologic Panther system
  • Detects rRNA from Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae
Test Code ARUP#: 3002582
CPT Code 81513
 

Candida glabrata, Candida species, and Trichomonas vaginalis by TMA

  • FDA-approved in vitro NAA test
  • Uses TMA on Hologic Panther system
  • Detects rRNA from Candida spp, Candida glabrata, and Trichomonas vaginalis
Test Code ARUP#: 3002583
CPT Code 87481, 87661
 

Reference

Additional References
  1. Schwebke JR, et al. Clinical validation of the Aptima bacterial vaginosis and Aptima candida/trichomonas vaginitis assays: results from a prospective multicenter clinical study. J Clin Microbial. 2020;58(2):e01643.
    Multicenter clinical trial of the FDA cleared assays, the Aptima Bacterial Vaginosis (BV) and Aptima Candida/Trichomonas vaginitis (CV/TV) assays. Broad geographic US distribution of enrolled subjects (both self-collected and provider collected). Used multiple reference methods: Nugent score, Amsel criteria for BV, Culture plus PCR/bidirectional sequencing for candidiasis, Culture plus NAAT for T. vaginalis. Sensitivity and specificity was: BV 95%,89.6%, Candida sp 91.7%,94.9%, Candida glabrata 84.7%,99.1%, and T.vaginalis 96.5%,95.1%.
  2. Richter SS, et al. Prospective evaluation of molecular assays for diagnosis of vaginitis. J Clin Microbiol. 2019;58(1):e01264
    Cleveland Clinic prospective study to compare the Hologic Aptima ASR for BV (Lactobacillus and Gardnerella), Aptima IVD for BV (Lactobacillus,Gardnerella, and Atopobium vaginae), Aptima ASR Candida, and BD affirm compared to Nugent score or microscopy. For BV (Aptima IVD), though sensitivity was not significantly different 85% vs 86.7% of Affirm, the specificity of the Aptima IVD for BV was higher than the Affirm assay 86.3% vs 60.6%, respectively. For Candida (Aptima ASR), sensitivity and specificity were 100% and 87%, compared to BD affirm, 76% and 98.8%.
  3. Cartwright CP, 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):3694–9. J Clin Microbiol. 2013 Nov; 51(11): 3694–3699.
    Comparison of NAAT testing for BV, vulvovaginal candidiasis (VVC), and TV with the BD Affirm VPIII assay in 305 patients. BV NAAT test showed 96.9% sensitivity and 92.6% specificity while Affirm VPIII was 90.1% sensitivity and 67.6% specificity. Affirm G. vaginalis test is relatively sensitive but non-specific indicator of the presence of BV, as determined by a combination of Nugent score and Amsel criteria. Candida PR was 97.7% sensitive and 93.2% specific compared to Affirm VP III was 58.1% sensitive and 100% specific. In a cohort of 388 patients, the sensitivity of the TV NAAT assay was 98.1% (53/54) versus 46.3% (25/54) for Affirm VPIII.
  4. Andrea SB and Chapin KC. Comparison of Aptima trichomonas vaginalis transcription-mediated amplification assay and BD Affirm VPIII for detection of T. vaginalis in symptomatic women: performance parameters and epidemiological implications. J Clin Microbiol. 2011 Mar; 49(3): 866–869.
    Comparative study of the Aptima TV assay with BDAffirm VPIII for T.vaginalis detection in 766 patients. The ATV assay was statistically more sensitive than the Affirm assay (100% versus 63.4%, P ‹ 0.0001), identifying 36.6% more positive patients.
  5. Schwebke JR, et al. Diagnostic performance of a molecular test versus clinician assessment of vaginitis. J Clin Microbiol. 2018 Jun; 56(6): e00252-18.
    Cross-sectional study from 1740 women with vaginitis symptoms across 10 sites in the US. Comparison of NAAT test with reference test for BV, Candida, and TV. The investigational test (BDMax PCR) resulted in significantly higher sensitivity and negative predictive value than clinician diagnosis or in-clinic testing. In addition, the investigational test showed a statistically higher overall percent agreement with each of the three reference methods than did clinician diagnosis or in-clinic testing.
  6. Menard JP, et al. Molecular quantification of Gardnerella vaginalis and Atopobium vaginae loads to predict bacterial vaginosis. Clin Infect Dis. 2008;47(1):33–43.
    Development of a quantitative molecular tool to detect BV causing organisms by real time PCR. The molecular quantification of A. vaginae (DNA level, ⩾108 copies/mL) and G. vaginalis (DNA level, ⩾109 copies/mL) had the highest predictive value for the diagnosis of BV, with excellent sensitivity (95%), specificity (99%), and positive (95%) and negative (99%) predictive values
  7. Lamont RF, et al. Recent advances in cultivation-independent molecular-based techniques for the characterization of vaginal eubiosis and dysbiosis. Fac Rev. 2020;9:21. European study to review commercially available FDA cleared invitro diagnostics for vaginitis and the benefits of including candidate organisms for bacterial vaginosis diagnosis by nucleic acid amplification

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