Timely BV diagnosis - Timely BV diagnosis

Bacterial vaginosis (BV) is a common infectious disease that affects millions worldwide. Women of all ages are at risk for BV and its complications, which include a greater susceptibility to sexually transmitted infections (STIs).

If left undetected and untreated, BV can increase a woman's risk of upper genital tract infections such as pelvic inflammatory disease, salpingitis and endometriosis, which may contribute to infertility. BV is a serious problem for pregnant women and their unborn babies, associated with preterm birth and premature rupture of membranes, which is why screening for BV is increasingly considered in pregnant women.

Clinical information

BV is the most common cause of infectious vaginitis. Normal vaginal flora is dominated by lactobacilli but, in BV, they are replaced by mainly anaerobic microorganisms such as Gardenerella vaginalis, Bacteroides spp., Prevotella spp. and Mobiluncus spp. These pathogens responsible for BV infection produce sialidases - enzymes that cleave sialic residues in oligosaccharides, glycoproteins and glycolipids. Studies such as McGregor, French and Jones et al's 'Bacterial vaginosis is associated with prematurity and vaginal fluid mucinase and sialidase' have shown increased sialidase activity in the vaginal fluid of women who have BV.

Diagnostic methods

Diagnostic testing for BV should be accurate, timely and cost-efficient, but each available approach has its advantages and limitations. Current methods differ in their sensitivity, turnaround time, ease of use, cost and ability to be performed in a variety of point-of-care settings, such as a physician's office or clinic.

The four main methods for diagnosing BV are the Amsel criteria, Gram staining with the Nugent score, molecular testing and OSOM BVBlue.

With the Amsel criteria, a BV diagnosis can be made if three of four criteria are present: thin grey/white vaginal discharge, a vaginal pH higher than 4.5, a positive whiff test (amines) and the presence of more than 20% clue cells on wet mount. This method requires a microscope and trained technologist.

Gram staining with the Nugent score is currently considered the gold standard. It is an accurate method that involves quantifying the bacteria in a stained vaginal smear and scoring the sample, with a score greater than seven considered to be positive for BV. This method can be labour intensive, requiring a microscope and advanced laboratory skills.

Molecular methods detect DNA sequences from microorganisms associated with BV. Methods are very accurate, but this type of testing may not be suitable for clinics due to expense and technical requirements. It is also not amenable to a test-and-treat strategy due to turnaround time.

OSOM BVBlue is a rapid test that detects sialidase activity in a vaginal fluid sample. The assay is designed for use in a clinical setting and allows a test-and-treat approach.

OSOM BVBlue

OSOM BVBlue detects elevated vaginal fluid sialidase activity from the aforementioned pathogens responsible for BV infection. The OSOM BVBlue test is easy to perform, requiring no special skills, training or instrumentation. The test protocol is rapid, allowing the clinician to begin appropriate treatment in the same patient visit. This potentially accelerates the time to diagnosis. It also avoids any delay in the initiation of treatment and minimises the risk of patients not returning for follow-up.

The goal of a BV diagnostic test is to accurately and rapidly detect infection by the organisms causing BV, and thereby enable initiation of appropriate treatment as soon as possible. OSOM BVBlue is an easy-to-use, cost-efficient point-of-care diagnostic test that provides rapid results, allowing a test-and-treat approach to the management of patients with BV.

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Sekisui Diagnostics, LLC
4 Hartwell Place, Lexington
Tel: +1-781-652-7800 email id: questions@sekisui-dx.com
02421
Massachusetts
United States of America

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