Vaginitis Pathogens Molecular Testing Panel

Aids in the diagnosis of bacterial vaginosis by detection of Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae

Aids in the diagnosis of vulvovaginal candidiasis and trichomoniasis by detection of Trichomonas vaginalis, Candida glabrata, and other Candida species (C. albicans, C. parapsilosis, C. dubliniensis, and C. tropicalis)

  • Aids in the diagnosis of bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis
  • Components include Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, Atopobium vaginae, Trichomonas vaginalis, Candida glabrata, and other Candida species (C. albicans, C. parapsilosis, C. dubliniensis, and C. tropicalis)
Related Tests

Use to detect T. vaginalis in various specimens

The most common causes of infectious vaginitis are bacterial vaginosis (BV), candida vaginitis (CV), and trichomoniasis (TV). Vaginitis is one of the most frequent reasons women seek medical care, with an estimated 70% of patients diagnosed with bacterial vaginosis, CV/vulvovaginal candidiasis (VVC), or trichomoniases (sexually transmitted).  Women with trichomoniasis or bacterial vaginosis are at a greater risk of acquiring HIV and other sexually transmitted infections such as chlamydia, gonorrhea, and herpes simplex virus (HSV). Premature deliveries and infants with low birth weight have been associated with symptomatic bacterial vaginosis and trichomoniasis in pregnant women. Diagnosis can be especially complicated due to the prevalence of coinfections.

Disease Overview

Incidence

BV is the most common cause of vulvovaginitis in women ages 15-44, implicated in 40-50% of vaginitis cases. The prevalence in the United States is estimated to be 21.2 million (29.2%) among women ages 14-49.

CV or VVC accounts for 20% to 25% of cases in the United States, while TV accounts for 15% to 20%. 

Symptoms

Typical symptoms of infectious vaginitis include pruritus, vaginal soreness, dyspareunia, external dysuria, odor, and abnormal vaginal discharge. These symptoms may be nonspecific.

Test Interpretation

Sensitivity and Specificitya
Component Sensitivity Specificity

BV

95.0%

89.6%

Candida species group

91.7%

94.9%

C. glabrata

84.7%

99.1%

T. vaginalis

96.5%

95.1%

aBased on a multicenter trial study using clinician-collected samples.

Source: Hologic, Aptima BV assay ; Hologic, Aptima CV/TV assay 
Resultsa
Component Result(s)

BV

Positive

Negative

Candida species group

Detected

Not detected

C. glabrata

Detected

Not detected

T. vaginalis

Detected

Not detected

aVaginitis panel includes results for each test component.

Limitations

  • Bacterial species and Candida species targeted by the vaginitis assay may comprise part of the normal microbiome for a significant number of women; a positive result should be interpreted in conjunction with other clinical data available to the clinician.  
  • A positive result is indicative of the presence of target RNA and does not necessarily indicate the presence of viable organisms.  
  • A negative result does not preclude a possible infection.  
  • Collection and testing of patient-collected vaginal swab specimens with the vaginitis assay is not intended to replace clinical examination.  
  • Performance of the assay has not been evaluated in women younger than 14 years of age.  

References

Related Information
Vaginitis - Bacterial Vaginosis, Vulvovaginal Candidiasis, and Trichomoniasis
Sexually Transmitted Infections
Herpes Simplex Virus - HSV
Human Immunodeficiency Virus - HIV