Gibson Laboratories LLC has announced its Tri-Valent Swab product line has 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 stabilised 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.
In January 2009 Gibson Laboratories became a subsidiary of Microbiologics; the two companies will join forces to market the Tri-Valent Swab internationally.
Microbiologics currently has a global distribution network of nearly 125 companies servicing approximately 110 countries around the world.
