Clinical Diagnostic Test Validated for Bacterial Vaginosis

A clinical study supports validation of a new diagnostic test for bacterial vaginosis (BV).

Laboratory Corporation of America Holdings (LabCorp; Burlington, NC, USA) announced publication of the clinical study in the July 2012 Journal of Clinical Microbiology. A total of 402 women were enrolled in the study between April and October 2011. The studies were completed under institutional review board (IRB) approval in collaboration with the Department of Medicine, University of Alabama at Birmingham School of Medicine (UAB; Birmingham, AL, USA).

During the study, quantitative polymerase chain reaction (PCR) assays were developed for 4 organisms reported previously to be indicators for the diagnosis of bacterial vaginosis (BV) and a single organism that had been implicated as a negative indicator for BV. The new test, which is called Bacterial Vaginosis, is currently available as part of the NuSwabsm series of tests. LabCorp introduced NuSwab in 2011 as a single collection device that improves the convenience and efficacy of sample collection for clinically validated test profiles for targeted women's health clinical conditions.

"Bacterial vaginosis is a common condition, but physicians have limited tools to diagnose it properly," said Dr. Mark Brecher, LabCorp's CMO. "This test will help physicians diagnose BV with more specificity and provide better care. Patients are seeing demonstrable benefits from the NuSwab tests, and we will continue to enhance our NuSwab offerings to support better patient care."

The enhancement to LabCorp's test menu is an adjunct to its women's health test options, which include tests that focus on both screening and diagnosis of disease.
In addition to its women's health services, LabCorp offers a comprehensive menu of individual tests and test combinations to address specific patient needs.

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Department of Medicine, University of Alabama at Birmingham School of Medicine