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The MultiCode® -RTx HSV 1&2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV1&2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection. Warning: The device is not FDA cleared for the use with cerebral spinal fluid (CSF) or any lesions other than vaginal. This assay is not intended to be used for male penile specimens, for prenatal screening, or for females under the age of 18 years.

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The MultiCode®-RTx HSV 1&2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV1&2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection. Warning: The device is not FDA cleared for the use with cerebral spinal fluid (CSF) or any lesions other than vaginal. This assay is not intended to be used for male penile specimens, for prenatal screening, or for females under the age of 18 years.

The EraGen MultiCode® -RTx Herpes Simplex Virus 1 & 2 kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV) DNA using vaginal swab specimens. Patient vaginal swab specimens are collected in Copan Universal Transport Medium, or identical Copan manufactured media formulations (Becton Dickinson Universal Viral Transport Media, Copan branded Universal Transport Medium for LabCorp, and the Quest Viral Culture Media) and transported to the laboratory. An extractable sample processing control (SPC) target is added to the specimen prior to lysis. The SPC controls for specimen lysis, for recovery of extracted nucleic acid, for inhibitory substances and for PCR reagent and instrument integrity. The specimen is lysed and nucleic acid is extracted using the Roche MagNA Pure LC instrument using the Roche MagNA Pure LC Total Nucleic Acid Isolation Kit. A sample of the extracted nucleic acid is added to the MultiCode® RTx Herpes Simplex Virus 1 & 2 Kit reagents that contain a primer pair specific to HSV-1 and HSV-2 and a second primer pair specific to the SPC sequence. The two specific primer pairs are labeled with distinct fluorophore labels. PCR amplification is performed and assay fluorescence is monitored using the Roche LightCycler 1,2 real-time PCR instrument. Incorporation of the quencher-labeled nucleotide causes a decrease in assay fluorescence. Following amplification, the reaction is slowly heated and fluorescence is monitored. The strands of the amplification products will separate at a specific melting temperature (Tm) that is determined by an increase in fluorescence as the strands are separated. The instrument fluorescence output is analyzed and test results are determined using the MultiCode -RTx Herpes Simplex Virus 1 & 2 Kit Analysis Software. A printed results report is generated.