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The Focus Diagnostics Simplexa™ HSV 1 & 2 Direct is intended for use on the 3M Integrated Cycler instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 DNA in cerebrospinal fluid (CSF) samples from patients suspected of herpes simplex virus (HSV) infections of the central nervous system (CNS). This test is intended as an aid in the diagnosis of HSV-1 and HSV-2 infections of the CNS. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions. The assay is not intended for use as a donor screening test. The assay is for professional use only. The Simplexa™ HSV 1 & 2 Positive Control Pack is intended to be used as a control with the Simplexa™ HSV 1 & 2 Direct kit. This control is not intended for use with other assays or systems.

The Simplexa™ HSV 1 & 2 Direct assay system is a real-time PCR that enables the direct amplification, detection and differentiation of HSV-1 and/or HSV-2 DNA from unprocessed CSF specimens without nucleic acid extraction. The system consists of the Simplexa™ HSV 1 & 2 Direct assay, the 3M Integrated Cycler (with 3M Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories. In the Simplexa™ HSV 1 & 2 Direct assay, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify HSV-1, HSV-2 and internal control targets. Well conserved regions of the HSV-1 and HSV-2 DNA polymerase genes are targeted to identify HSV-1 and HSV-2 DNA respectively in the specimen. An internal control is used to detect PCR failure and/or inhibition.

The Focus Diagnostics Simplexa™ HSV 1 & 2 Direct is intended for use on the 3M Integrated Cycler instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 DNA in cerebrospinal fluid (CSF) samples from patients suspected of Herpes Simplex Virus (HSV) infections of the central nervous system (CNS). This test is intended as an aid in the diagnosis of HSV-1 and HSV-2 infections of the CNS. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions. The assay is not intended for use as a donor screening test. The assay is for professional use only. The Positive Control is intended to be used as a control with the Simplexa™ HSV 1 & 2 Direct. This control is not intended for use with other assays or systems.

The Simplexa™ HSV 1 & 2 Direct system is a real-time PCR that enables the direct amplification, detection and differentiation of HSV-2 DNA from unprocessed CSF samples without nucleic acid extraction. The system consists of the Simplexa™ HSV 1 & 2 Direct, the 3M Integrated Cycler (with 3M Integrated Cycler Studio Software), the Direct Amplification Disc and associated accessories. In the SimplexaTM HSV 1 & 2 Direct, bi-functional fluorescent probe-primers are used together with corresponding reverse primers to amplify HSV-1, HSV-2 and DNA internal control (IC) targets. Well conserved regions of the HSV-1 and HSV-2 DNA polymerase genes are targeted to identify HSV-1 and HSV-2 DNA respectively in the specimen. The IC is used to detect PCR failure and/or inhibition. The 3M Integrated Cycler is a real-time PCR thermocycler which uses real-time fluorometric detection to identify targets within the sample wells. The instrument is controlled by an external computer running the Integrated Cycler Studio Software. The Simplexa™ HSV 1 & 2 Direct assay reaction takes place in the DAD consumable. The DAD consumable is compartmentalized into 8 separate wedges and up to 8 separate samples or controls may be processed on each disc. Each wedge can be used only once, however, the disc may be reused until all wedges have been utilized. Each wedge contains sample and reagent input wells, microfluidic channels and laser activated valves to control the fluid flow. and a reaction chamber. The disc is specifically designed to meter the amount of reagent (Reaction Mix) and sample that are placed into specific wells in the disc. To start processing a patient sample, a foil seal is lifted and the user adds 50 µL of Reaction Mix to the reagent input well using a fixed volume pipette. Next, the user adds 50 uL of unextracted specimen to the sample input well. The SimplexaTM HSV 1 & 2 Direct kit contains reagents for 24 reactions. Each vial contains sufficient material for a single reaction. The kit contains the Reaction Mix, the Simplexa™ HSV 1 & 2 Direct Barcode Card with assay specific information, and the Package Insert.