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The Alinity m HSV 1 & 2 / VZV assay is an in vitro real-time polymerase chain reaction (PCR) assay for the qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1), Herpes Simplex Virus 2 (HSV-2) and Varicella Zoster Virus (VZV) DNA from clinician-collected cutaneous or mucocutaneous lesion swab specimens from symptomatic patients suspected of active herpes simplex virus 2 and/or varicella-zoster infection. The Alinity m HSV 1 & 2 / VZV assay is intended to aid in the diagnosis of herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster active cutaneous or mucocutaneous infections. Negative results do not preclude herpes virus type 1, herpes simplex virus type 2 or varicella-zoster virus infections and should not be used as the sole basis for diagnosis, treatment or other management decisions. The Alinity m HSV 1 & 2 / VZV assay is not intended for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV or VZV infections of the central nervous system (CNS). The Alinity m HSV 1 & 2 / VZV assay is not intended for use in prenatal screening.

The Alinity m HSV 1 & 2 / VZV assay is an in vitro real-time polymerase chain reaction (PCR) assay for the qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1), Herpes Simplex Virus 2 (HSV-2) and Varicella Zoster Virus (VZV) DNA from clinician--collected cutaneous or mucocutaneous lesion swab specimens from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. This assay is intended for use with the automated Alinity m System. The steps of the Alinity m HSV 1 & 2 / VZV assay consist of sample preparation, PCR assembly, amplification/detection, and result calculation and reporting. The steps involved in all stages of the Alinity m HSV 1 & 2 / VZV assay procedure are executed automatically by the Alinity m System. No intermediate processing or transfer steps are performed by the user. The Alinity m System is designed to be a random access analyzer that can perform the Alinity m HSV 1 & 2 / VZV assay in parallel with other Alinity assays on the same instrument. The Alinity m HSV 1 & 2 / VZV assay requires two separate assay specific kits as follows: 1) The Alinity m HSV 1 & 2 / VZV AMP Kit (List No. 09N61-095) is comprised of 2 types of multi-well trays: TRAY 1: Alinity m HSV 1 & 2 / VZV AMP TRAY 1 TRAY 2: Alinity m HSV 1 & 2 / VZV ACT TRAY 2. TRAY 1 - Alinity m HSV 1 & 2 / VZV AMP is individually packed in a foil pouch and contains 48 unit-dose liquid amplification reagent wells and 48 unitdose liquid IC wells. One well of each is used per test. · Amplification reagent wells consist of synthetic oligonucleotides, DNA Polymerase, dNTPs, and 0.15% ProClin® 950 in a buffered solution with a reference dye. IC wells consist of plasmid DNA with unrelated IC sequences and poly dA:dT in a TE buffer containing 0.15% ProClin 950 as a preservative. TRAY 2 - Alinity m HSV 1 & 2 / VZV ACT is individually packed in a foil pouch and contains 48 unit-dose liquid activation reagent wells. One reagent well is used per test. · Activation reagent wells consist of magnesium chloride, potassium chloride, and tetramethylammonium chloride. Preservative: 0.15% ProClin 950. 2) The Alinity m HSV 1 & 2 / VZV CTRL Kit (09N61-085) consists of negative controls and positive controls, each supplied as liquid in single-use tubes. Alinity m HSV 1 & 2 / VZV Negative CTRL (List No. 9N61Z) consists of Negative Diluent / TE buffer (containing 0.085% Sodium Azide and 0.087% ProClin 950). Alinity m HSV 1 & 2 / VZV Positive CTRL (List No. 9N61W) consists of linearized plasmid DNA containing HSV-1, HSV-2 and VZV DNA sequences in Negative Diluent / TE buffer (containing 0.085% Sodium Azide and 0.087% ProClin 950). The Alinity m HSV 1 & 2 / VZV assay is to be run on the Alinity m System which is a fully integrated, sample to result automated system that performs real-time PCR test using the Alinity m HSV 1 & 2 / VZV AMP Kit along with the Alinity m HSV 1 & 2 / VZV CTRL Kit.

The Savanna HSV 1+2/VZV Assay is an automated, rapid multianalyte real-time PCR test for the simultaneous qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated from human cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. This in vitro diagnostic test is intended to aid in the diagnosis of patients with signs or symptoms of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus infection. The Savanna HSV 1+2/VZV Assay is intended to aid in the diagnosis of herpes simplex virus 1, herpes simplex virus 2 and varicella-zoster virus active infections. The results of this test should not be used as the sole basis for diagnosis, treatment or other management decisions and must be combined with clinical observations, patient history and/or epidemiological information. Negative results do not preclude herpes simplex virus type 1, herpes simplex virus type 2, or varicella-zoster virus infection that is not detected by a cutaneous or mucocutaneous lesion swab specimen. Positive results do not rule out co-infection with other organisms. Additional laboratory testing (e.g., viral culture, immunoassay, serology) may be necessary for patient evaluation. Savanna HSV 1+2/VZV Assay is for professional use. The Savanna HSV 1+2/VZV Assay is intended for use only with the Savanna instrument. Warning: The Savanna HSV 1+2/VZV Assay is not intended for use with the cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV or VZV infections of the central nervous system (CNS). The Savanna HSV 1+2/VZV Assay is not intended for use in prenatal screening.

The Savanna HSV 1+2/VZV Assay consists of a single, self-contained assay cartridge employing real-time PCR technology for use with the Savanna instrument to detect and differentiate DNA from herpes simplex virus type 1, herpes simplex virus type 2 and varicella-zoster virus. In approximately 24 minutes, this platform extracts, amplifies and detects DNA present in cutaneous or mucocutaneous lesion swab specimens obtained from symptomatic patients and placed in transport media. To initiate the assay, a patient cutaneous or mucocutaneous lesion swab specimen in transport medium is transferred via the supplied transfer pipette to the Liguid Sample Port of the Test Cartridge. The user closes the Sample Port and inserts the Test Cartridge into the Savanna instrument, initiating sample processing. The sample containing human DNA is pushed out of the Sample Port by lysis buffer, which then rehydrates the Process Internal Control (IC), and together with the paramagnetic nucleic acid binding particles, are pumped into the extraction chamber. The solution is mixed, and virus and/ or bacteria are further lysed by sonication within the extraction chamber. Specimen and IC DNA are bound to, washed and then eluted off the paramagnetic particles. The purified specimen DNA and IC solution is used to rehydrate four individual lyophilized master mixes. Each master mix is pumped into a PCR chamber and Taq-man® multiplex real-time PCR reactions are carried out under optimized conditions, generating amplicons for the targeted pathogen (if present) and the Process Internal Control (IC). Each master mix contains primers and dual-labeled probes unique for the pathogen targets and the IC. The probes are labeled with a fluorophore on one end and a quencher on the other end. Target DNA sequences are amplified by pathogen-specific primers and detected by correspondingly specific fluorescence probes. The IC targets are also amplified by specific primers and detected by an IC-specific fluorescence probe. A polymerase included in the master mix cleaves the probes bound to complementary DNA sequences, separating the fluorophore from the quencher. This step generates a signal and if it surpasses multiple defined thresholds, the sample is reported as positive for the detected target sequence. The Savanna instrument will display the test results (Positive or Invalid) on the main bay screen.

The DiaSorin Molecular Simplexa™ VZV Swab Direct assay is intended for use on the LIAJSON® MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection. This test is intended as an aid in the diagnosis of VZV infection. Negative results do not preclude VZV infection and should not be used as the sole basis for treatment or other patient management decisions. The Simplexa™ VZV Positive Control Pack is intended to be used as a control with the Simplexa™ VZV Direct kit and the Simplexa™ VZV Swab Direct kit on the LIAISON® MDX Instrument. It is not intended for use with other assays or systems.

The Simplexa™ VZV Swab Direct assay is a real-time PCR system that enables the direct amplification and detection of VZV DNA from unprocessed cutaneous and mucocutaneous lesion swab specimens without nucleic acid extraction. The system consists of the Simplexa™ VZV Swab Direct assay, the LIAISON® MDX (with LIAISON® MDX Studio Software), the Direct Amplification Disc (DAD) and associated accessories. In the Simplexa™ VZV Swab Direct assay, fluorescent probes are used together with corresponding forward and reverse primers to amplify VZV and internal control targets. A well-conserved region of the VZV DNA polymerase gene is targeted to identify VZV DNA in the specimen. An internal control is used to detect PCR failure and/or inhibition.

The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The HSV 1&2 ELITe MGB Assay is not FDA cleared for use with cerebrospinal fluid (CSF) specimens. The assay is not intended to be used for prenatal screening or for screening blood or blood products.

The HSV 1&2 ELITe MGB Assay is a qualitative in vitro diagnostic Real-Time PCR Assay for the direct detection of Herpes Simplex Virus (HSV) DNA (glycoprotein D gene for HSV-1 and glycoprotein G gene for HSV-2) in symptomatic male and female patients using DNA purified from swab specimens collected from individuals with cutaneous or mucocutaneous herpetic lesions. The HSV 1&2 ELITe MGB Assay system is comprised of three major processes: (1) automated preparation of unprocessed sample to extract nucleic acids from primary swab specimens using the ELITe InGenius SP 200 Extraction Cartridge, (2) PCR amplification of target DNA sequences using HSV-1 and HSV-2 specific primers, and (3) real-time detection of fluorescent-labeled HSV-1 and HSV-2 specific oligonucleotide detection probes. An Internal Control (IC), containing unrelated randomized DNA sequence, is added to all samples prior to extraction and monitors the integrity of the reagents, equipment function, and the presence of inhibitors in the samples. A positive signal in the Internal Control channel in the absence of HSV DNA indicates that the PCR has not been inhibited. The amplification reagents, Positive Control and Internal Control are packaged as part of the HSV 1&2 ELITe MGB Assay.

The DiaSorin Molecular Simplexa™ HSV 1 & 2 Direct assay is intended for use on the LIAISON® MDX instrument for the qualitative detection and differentiation of herpes simplex virus (HSV-2) DNA present in mucocutaneous and cutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection. This test is an aid in the differential diagnosis of HSV-1 and HSV-2 infections. The assay is not intended for use as a screening test for the presence of HSV-2 in blood or blood products. The assay is for professional use only. Simplexa™ HSV 1 & 2 Positive Control Pack MOL2160 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 cutaneous and mucocutaneous lesion swab specimens without nucleic acid extraction. The system consists of the Simplexa™ HSV 1 & 2 Direct assay, the LIAISON® MDX (with LIAISON® MDX 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 Solana® HSV 1+2/VZV Assay is an in vitro diagnostic test, using isothermal amplification technology (helicase-dependent amplification, HDA), for the qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. The Solana® HSV 1+2/VZV Assay is intended to aid in the diagnosis of herpes simplex virus 1, herpes simplex virus 2 and varicella-zoster virus active cutaneous or mucocutaneous infections. Negative results do not preclude herpes simplex virus 1, herpes simplex virus 2 and varicella-zoster virus infections and should not be used as the sole basis for diagnosis, treatment or other management decisions. The Solana® HSV 1+2/VZV Assay is intended for use only with the Solana® instrument. Warning: The Solana® HSV 1 + 2/VZV Assay is not intended for use with cerebrospinal fluid or to aid in the diagnosis of HSV or VZV infections of the central nervous system (CNS). The Solana® HSV 1 + 2/VZV Assay is not intended for use in prenatal screening.

The Solana® HSV 1+2/VZV Assay amplifies and detects viral DNA isolated from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection. The assay consists of two (2) major steps: 1) specimen preparation, and 2) amplification and detection of target sequence specific to HSV-1, HSV-2 and/or VZV using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probe. Patient specimen is transferred to a Process Tube, subjected to heat treatment at 95°C for 5 minutes and mixed and vortexed. The processed sample is transferred to a Reaction Tube and mixed. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of specific target sequence. In Solana, the target sequences are amplified by HSV-1, HSV-2 and/or VZV specific primers and detected by HSV-1, HSV-2 and/or VZV specific fluorescence probes included in the Reaction Tube. A competitive process control (PRC) is included in the Process Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC target is amplified by specific primers and detected by a PRC specific fluorescence probe. The target and PRC probes are labeled with a quencher on one end and a fluorophore on the other end. In addition, the target and PRC probes carry a ribonucleic acid. Upon annealing to HSV-1, HSV-2, VZV or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on-board method-specific algorithms. Solana will then report the test results to the user on its display screen, and the results can be printed via an attached printer.

The ARIES® HSV 1&2 Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and HSV 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients. The test is indicated for use as an aid in diagnosis of HSV infection in symptomatic patients. The ARIES® HSV 1&2 Assay is indicated for use on the ARIES® System. WARNING: The ARIES® HSV 1&2 Assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening.

The Luminex ARIES® HSV 1 & 2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus (HSV) DNA using cutaneous and mucocutaneous lesion swab specimens. Patient lesion 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. The specimen is pipetted into a cassette specific to the ARIES® HSV 1&2 Assay. In the cassette the specimen is lysed and nucleic acid is extracted using the ARIES® System and an extraction/ PCR cassette specific to the ARIES® HSV 1&2 Kit. An extractable sample processing control (SPC) target is present in the ARIES® HSV 1&2 assay cassette and is processed with the specimen. The Ct value of the SPC is designed to verify proper specimen lysis and nucleic acid extraction, to identify PCR inhibition, if any, and verify proper function of the extraction system and real-time instrument. The Tm value of the SPC is used as a reference for determining the target Tm. The extracted nucleic acid is transferred via magnetic beads to the ARIES® HSV 1 & 2 Kit lyophilized PCR reagents in the cassette that contain a primer pair specific to HSV 1 and a primer pair specific to the SPC sequence. The specific primer pairs are labeled with distinct fluorophore labels. PCR amplification is performed and assay fluorescence is monitored on the Luminex ARIES® System. 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 sequences between the PCR primer binding sites of the HSV 1 and HSV 2 amplicons have different base compositions that are distinguished by their different Tm. The instrument fluorescence output is analyzed and test results are determined using the ARIES® HSV 1 & 2 Kit assay protocol file. A printed results report is generated. The Luminex ARIES® HSV 1&2 Assay chemistry is based on an expanded genetic alphabet technology, consisting of synthetic DNA base pair 2'-deoxy-5-methyl-isocytidine (iC): 2'deoxyisoguanosine (iG). The isobases ( iC and iG) pair specifically with each other and not with natural nucleotides. In addition isobases are efficiently incorporated during PCR. During PCR amplification, a quencher-modified iGTP is incorporated by the polymerase opposite an iC and a fluorophore reporter attached to a PCR primer. If the target is present and is amplified, assay fluorescence decreases with every cycle as amplification product accumulates. The decrease in assay fluorescence is monitored in real time using the Luminex ARIES® Instrument. Following PCR, the amplification products are thermally denatured and assay fluorescence is monitored. The strands of the amplification products are separated and assay fluorescence increases, thus enabling determination of the melting temperature (Tm) of the amplicon.

The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients. The assay is intended for use in hospital, reference or state laboratory settings. This device is not intended for nonlaboratory point-of-care use. WARNING: illumigene HSV 1&2 is not FDA cleared for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV infections of the central nervous system (CNS). The device is not intended for prenatal screening.

The illumigene Molecular Diagnostic Test System is comprised of the illumigene® HSV 1&2 DNA Amplification Assay Test Kit, the illumigene HSV 1&2 External Controls Kit, and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene HSV 1&2 molecular assay utilizes loop-mediated amplification (LAMP) technology to detect herpes simplex virus in cutaneous and mucocutaneous lesion swab specimens. Each illumigene HSV 1&2 assay is completed using illumigene Sample Preparation Apparatus III (SMP PREP III), illumigene HSV 1 Test Devices, illumigene HSV 2 Test Devices, Mineral Oil, illumigene Heat Treatment Tubes, and transfer pipettes. Using a transfer pipette, specimens are added to SMP PREP III and dispensed into Heat Treatment Tubes. Samples are heat-treated to make target and control DNA available for amplification. Each heat-treated sample is added to one illumigene HSV 1 and one illumigene HSV 2 Test Device. Mineral oil is added to each illumigene Test Device to prevent evaporation. The illumipro-10™ heats each illumigene HSV 1 and HSV 2 Test Device containing prepared sample and control material, facilitating amplification of target DNA. When HSV-1 or HSV-2 is present in the specimen, a 208 base pair (bp) sequence of the HSV-1 glycoprotein G (US4) gene or a 189 bp sequence of the HSV-2 glycoprotein G (US4) gene is amplified and magnesium pyrophosphate is generated. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10™ monitors the absorbance characteristics of the reaction solutions at the assay Run Start (Signal initial, S initial) and at the assay Run End (Signal final, S final). The illumipro-10™ calculates the change in light transmission between Run End and Run Start (S final; S initial) and compares the ratio to an established cut-off value. The illumipro-10™ performs this ratio calculation to both the TEST chamber and the CONTROL chamber. Fixed cut-off values for the TEST chamber are used to report sample results. TEST chamber S final:S initial ratios less than 82% are reported as 'POSITIVE'; TEST chamber S final:S initial ratios greater than or equal to 82% are reported as 'NEGATIVE'. Numerical values are not reported. Fixed cut-off values for the CONTROL chamber are used to determine validity. CONTROL chamber S final:S initial ratios less than 90% are considered valid and allow for reporting of TEST chamber results (POSITIVE). CONTROL chamber S final:S initial ratios greater than or equal to 90% are considered invalid and prevent reporting of TEST chamber results. Invalid CONTROL chamber reactions are reported as "INVALID'. More stringent cut-off criteria are applied to the CONTROL chamber reaction is not inhibited, reagents are performing as intended and that sample processing was performed appropriately. The illumigene HSV 1&2 External Controls Kit contains a combined HSV-1 and HSV-2 Positive Control and a Negative Control (Negative Control IV) for use in routine Quality Control testing. External Control reagents are provided to aid the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors.

The Lyra™ Direct HSV 1 + 2/VZV Assay is an in vitro multiplex Real-Time PCR test for qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1. herpes simplex virus 2 and/or varicella-zoster infection. The Lyra™ Direct HSV 1 + 2/VZV Assay is intended to aid in the diagnosis of herpes simplex virus 1, herpes simplex virus 2 and varicella-zoster virus active cutaneous or mucocutaneous infections. Negative results do not preclude herpes simplex virus 1, herpes simplex virus 2 and varicella-zoster virus infections and should not be used as the sole basis for diagnosis, treatment or other management decisions. The Lyra™ Direct HSV 1 + 2/VZV Assay is not intended for use with cerebrospinal fluid or to aid in the diagnosis of HSV or VZV infections of the central nervous system (CNS). The Lyra™ Direct HSV 1 + 2/VZV Assay is not intended for use in prenatal screening. The device is not intended for point-of-care use.

The Lyra™ Direct HSV 1 + 2/VZV Assay detects viral nucleic acids from a patient sample. A multiplex Real-Time PCR reaction is carried out under optimized conditions in a single tube or well generating amplicons for HSV-1, HSV-2, VZV, and the Process Control (PRC). Identification of amplicons for HSV-1, HSV-2, VZV, and the PRC occurs by the use of target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of HSV-1, HSV-2, and VZV and to the PRC, respectively.