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For the visual or spectrophotometric detection of the vanA and vanB genes in determining vancomycin resistance in enterococci isolated from culture.

The Velogene™ Genomic Identification Assay for VRE (Vancomycin Resistant Enterococci) is an in vitro, DNA probe based, diagnostic device that utilizes Cycling Probe™ Technology (CPT) to generate a spectrophotometric or visual result. Results can be generated 90 minutes after primary isolation. The Velogene™ Genomic Identification Assay for VRE (hereafter may be referred to as the Velogene™ assay) utilizes a fluorescein labeled, biotinylated DNA-RNA-DNA chimeric probe providing an RNase H cleavable linkage when bound to the complementary sequence of the van A or vanB gene. RNase H cleaves the RNA portion of the chimeric probe when it is hybridized to the target DNA. The uncleaved probe (vanA and vanB negative) is detected by binding of the fluoresceinated probe to a solid surface and attachment of an antifluorescein antibody conjugated with horseradish peroxidase, which converts a substrate to a colored end product. Cleavage of the probe (vanA or vanB positive) prevents binding of the probe-anti-fluorescein antibody enzyme complex, thus preventing formation of the colored end product. A vancomycin-resistant isolate (i.e. vanA or vanB gene is present) will produce a colorless result (or OD650 of ≤0.14). A vancomycin-sensitive isolate (i.e. vanA and vanB gene are absent) will produce a distinctly blue color (or OD650 of >0.14). Each Velogene™ assay kit contains supplies sufficient to process 48 samples and consists of two separate reagent kits: a VRE Lysis/Cycle Kit and a VRE Microwell Detection Kit.

The ID Biomedical Velogene™ Rapid MRSA Identification Assay is intended as a qualitative assay for the definitive identification of methicillin resistance in presumptively identified cultures of Staphylococcus aureus by detecting the presence of the mecA gene. The presence of the mecA gene confers resistance to methicillin.

The Velogene™ Rapid MRSA Identification Assay is a DNA probe based diagnostic device that is based on Cycling Probe™ Technology (CPT) to generate spectrophotometric or visual results. The assay consists of two reagent kits, MRSA Lysis/Cycle Kit and MRSA Microwell Detection Kit.