Newly Published Research Shows that Hologic’s Molecular Assays for Diagnosing Vaginitis are More Effective than Traditional Methods
– More sensitive and specific assays for vaginitis reduce the “incorrect, misguided or prolonged treatment” that can result from older, subjective testing methods –
Vaginitis, a condition that affects millions of women every year, is responsible for up to half of all gynecologic visits in
“As leaders in women’s health, we delivered on the need for new, molecular assays for vaginitis that have higher sensitivity and specificity than traditional methods,” said
The study notes that women suffering from vaginitis “are often underserved by the current paradigm of inaccurate or incomplete diagnosis guiding inadequate or inappropriate treatment.” Prior to the introduction of molecular assays, clinicians had no choice but to analyze fresh vaginal discharge samples using a combination of older, subjective methods – pH, a potassium hydroxide (KOH) “whiff” test and Gram-stained microscopic examination – to identify the underlying cause.
The new Aptima molecular tests circumvent barriers to accurate diagnosis associated with the use of these traditional methods, including absence of proper equipment, lack of training, and access to microscopy in the clinic. These and other barriers can result in many women being misdiagnosed, which the study says can lead to “incorrect, misguided or prolonged treatment.”1 In fact, separate research shows that when treatment is based on diagnosis with these traditional methods, more than half of women with vaginitis experience recurring symptoms.2
“Many women try to self-diagnose and self-treat before eventually visiting a healthcare provider, assuming that abnormal vaginal discharge, itching or irritation is due to a simple yeast infection,” said the study’s corresponding author, Dr.
BV (bacterial vaginosis) is the most common vaginal infection in the U.S., affecting an estimated 21 million women a year.3 Together with CV (vulvovaginal candidiasis) – commonly known as yeast infections – and TV (trichomonas vaginalis), individually or in combination, these three vaginal infections cause about 90 percent of vaginitis infections.2,4 Each cause of vaginitis has its own characteristics, consequences and treatment recommendations, which vary between BV, CV and TV, further reinforcing the need for accurate diagnoses.
Subjects in the multi-center, cross-sectional diagnostic accuracy study for the
Patient- and clinician-collected vaginal swab samples obtained from women with symptoms of vaginitis were tested with the
For more information on the
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This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s diagnostic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales.
- Clinical validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: results from a prospective multi-center clinical study. J Clin Microbiol. 2019.
Hologic. Aptima BV Assay Package Insert. https://www.hologic.com/package-inserts/diagnostic-products?portfolio=136.
Koumans EH, Sternberg M, Bruce C, McQuillan G, Kendrick J, Sutton M, Markowitz LE. The prevalence of bacterial vaginosis in
the United States, 2001-2004; associations with symptoms, sexual behaviors, and reproductive health. External. Sex Transm Dis. 2007 Nov;34(11):864-9.
Hologic. Aptima CV/TV Assay Package Insert. https://www.hologic.com/package-inserts/diagnostic-products?portfolio=136.
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