Traditional vaginitis testing methods cannot provide the information that molecular diagnostic methods can.
There are two main ways of testing for vaginitis: traditional methods and molecular methods.
Traditional diagnostic methods lack sensitivity, are time-consuming, and require considerable expertise, while molecular tests provide greater levels of sensitivity and specificity for both vaginitis and vaginosis.1-4
And molecular tests can provide results in just a few hours.2,4
Only molecular assays such as BD MAX™ Vaginal Panel provide accurate detection of the main causes of vaginitis.4
There have been efforts over recent years to develop molecular tests that can provide greater sensitivity and specificity as compared to in-clinic testing and laboratory-based traditional methods.3
There are currently 4 FDA-cleared molecular assays that use PCR amplification for the diagnosis of vaginitis and/or bacterial vaginosis – only 2 of these can test for all three main causes of vulvovaginitis at the same time.7-10
Molecular assays offer advantages over traditional methods:
- Greater levels of sensitivity4
- Clear and objective test results7
- Simultaneous detection of organisms associated with BV, VVC, and TV7
- Fast results obtained in less than 24 hours4,5
Traditional methods include in-clinic testing and laboratory-based methods such as culture and Gram staining.
Subjectivity and lack of sensitivity1,4
In-clinic testing can be performed in the physician’s office and are based on patient examination – using the Amsel’s diagnostic criteria – or microscopy observation of a wet-mount preparation, which is subjective and lacks sensitivity.1,4
In-clinic testing for vaginitis is not very accurate and leads to approximately 40% of women failing to receive a proper diagnosis after an initial primary care visit.1,2
Up to 1 week to get a result2
Gram stain (Nugent score)
Requires significant expertise3
Traditional laboratory testing for vaginitis includes cell culture and Gram stain (also called Nugent scoring).2,3 While laboratory-based methods may have a greater sensitivity, they require considerable time and expertise.2,3
For example, cell culture requires the inoculation of a vaginal swab sample on an appropriate culture media and a relatively long waiting time: it takes about 3 days to get a positive Candida culture and 1 week for Trichomonas vaginalis.2
Gram stain, on the other hand, is a laboratory testing method where vaginal smears are plated on a microscopic slide and the number of morphotypes counted using the Nugent scoring system.3 This method requires significant expertise to recognize and quantify multiple bacterial species present on the slide. This means that it may be open to interpretation and result in undetermined results that would require additional testing and costs.3
Traditional methods do not have the capacity to differentiate Candida species, which is a problem. If the right treatment strategy is not used from the start, it may lead to antifungal resistance and recurring vulvovaginal candidiasis.6