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The artus HSV-1/2 QS-RGQ MDx Kit is an in vitro real-time PCR DNA amplification assay performed on the QIAsymphony RGQ MDx system for the direct qualitative detection and differentiation of herpes simplex virus (HSV-1 and HSV-2) DNA in genital or oral vesicular lesions from male and female patients suspected of HSV infection.

The assay is intended for use as an aid in diagnosis of HSV infection in symptomatic patients.

Warning: The artus HSV-1/2 QS-RGQ MDx Kit is not FDA-cleared for use with cerebrospinal fluid (CSF) or for prenatal screening.

The artus HSV-1/2 QS-RGQ MDx Kit is an in vitro PCR assay for the qualitative detection and differentiation of nucleic acids encoding the Glycoprotein D and UL30 genes isolated from HSV-1 and HSV-2 DNA present in genital or oral lesions from male and female patients. Samples are extracted and prepared for PCR using the QIAsymphony SP/AS instrument with the QIAsymphony DSP Virus/Pathogen Mini Kit. Amplification and detection are carried out using the artus HSV-1/2 QS-RGQ MDx Kit with the Rotor-Gene O MDx (RGO MDx) and Rotor-Gene AssayManager software. The presence of a HSV-1 or HSV-2 target sequence is indicated by the fluorescent signal generated through the use of fluorescently labeled oligonucleotide probes. The probes do not generate a signal unless they are specifically bound to the amplified product. The amplification cycle at which fluorescent signal is detected by the RGQ MDx is inversely proportional to the HSV-1 and/or HSV-2 target concentration present in the original specimen. A plasmid construct containing DNA unrelated to HSV-1 and HSV-2 is introduced into each specimen during sample preparation to serve as an internal control. Run as a separate control, the positive control serves to demonstrate that the HSV-1/2 PCR reagents are functional. In addition, the positive control functions as a process control, to demonstrate that sample preparation has proceeded correctly during the run.

The provided documentation describes the performance characteristics and clinical study results for the artus® HSV-1/2 QS-RGQ MDx Kit, an in vitro real-time PCR assay for the detection and differentiation of HSV-1 and HSV-2 DNA.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative for this type of diagnostic device, revolving around achieving sufficient sensitivity and specificity compared to a predicate device or established methods. The reported device performance is detailed in the tables under "Performance Characteristics - Clinical Studies."

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