Study Validates Sensitivity of Quidel Rapid Test to Detect Bacterial Vaginosis

Quidel Corporation, in conjunction with key researchers in the U.S. and Canada, have completed a clinical study that proves the proprietary layered thin film (LTF™) QuickVue® Advance pH and Amines rapid test achieves a clinical sensitivity of 92 percent, specificity of 95 percent and overall accuracy of 94 percent when compared to traditional, more time consuming and more technically demanding procedures such as Amsel clinical criteria and Gram Stain for the diagnosis of bacterial vaginosis (BV).

Undiagnosed or untreated bacterial vaginosis may be a risk factor for pelvic inflammatory disease (PID), complications of pregnancy and increased risk of sexually transmitted diseases, including HIV. The QuickVue® Advance test provides physicians with an easy-to-use, reliable and fast test which produces results in one minute after sample application and takes only 30 seconds hands-on time to perform. The test is ideal for use in the physician's office where most of the approximately 10 million office visits take place annually in the U.S. as women seek help for symptoms associated with infectious vaginitis.

LTF™ technology is a revolutionary, new rapid point-of-care test platform that is easy to read, extremely precise and as small and thin as a credit card. The QuickVue Advance® pH and Amines test contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: a pH test and a test that detects alkali volatilizable amines in vaginal fluid. Both tests can be read within 2 minutes. In conjunction with the clinical evaluation of the vaginal fluid, 3 of the 4 Amsel criteria will be assessed.