Gibson Laboratories Achieves CE Mark Conformity for Tri-Valent™ Swab

Gibson Bioscience Tri-Valent™ Swabs  have achieved CE Mark conformity with the In Vitro Diagnostic Medical Device Directive 98/79/EC. The Tri-Valent™ swab is used for quality control testing in the Clinical industry. It is used specifically with the BD Affirm™ VPIII Microbial Identification System DNA Probe Detection Kit. Each Tri-Valent™ Swab consists of whole stabilized cells of Trichomonas vaginalis, Gardnerella vaginalis and Candida albicans to function as a tri-analyte swab.

The Tri-Valent™ swab is specially designed for use with Becton Dickinson’s Affirm™ VPIII Microbial Identification System; specifically with the DNA Detection Kit. The Affirm™ VPIII Microbial Identification Test is the first direct specimen RNA probe-based diagnostic test for the differential detection and identification of the causative agents for vaginitis including Candida species, Gardnerella vaginalis and Trichomonas vaginalis. The Tri-Valent™ Swab provides the positive and negative controls to ensure test quality for the DNA Detection Kit.

Obtaining CE Mark Conformity allows the Tri-Valent™ Swab to be shipped in the European Economic Area. Naomi Bowling, Vice President of Gibson Bioscience, states “Having CE Mark conformity for the Tri-Valent™ will be a great asset to Gibson Bioscience. We’re excited to introduce this unique product line to the global marketplace.” Bowling continues, “Clinical Bioscience world-wide can use this product easily and efficiently.”

Gibson Bioscience is a subsidiary of Microbiologics, Inc. Brad Goskowicz, Microbiologics Chief Marketing Officer, explains, “There’s a lot of potential for the Tri-Valent™ Swab in the European market. Conforming to CE Mark regulation is critical to successfully launching this product globally.”