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The ARCHITECT HSV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of specific IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum (collected in serum and serum separator tubes) and plasma (collected in dipotassium EDTA, lithium heparin plasma separator tubes) on the ARCHITECT i System. The ARCHITECT HSV-2 IgG assay is to be used for testing sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lessociated disease manifestations, particularly for primary infection. The predictive value of a reactive or nonreactive result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection. NOTE: The performance of the ARCHITECT HSV-2 IgG assay has not been established for use in the pediatric population, for neonatal screening, or for testing immunosompromised or immunosuppressed patients. The assay has not been FDA cleared or approved for screening blood or plasma donors.

The ARCHITECT HSV-2 IgG assay is an automated, two-step immunoassay for the qualitative detection of IgG antibodies to HSV-2 in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology. The kit contains different components: Reagent (microparticles, conjugate and assay diluent), Calibrator, and external Controls (reactive and nonreactive).

lmmunoassay for the in vitro qualitative determination of IgG class antibodies to HSV-2 in human serum and lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lesions or associated disease manifestations, particularly for primary infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers. This test is not FDA-cleared for screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients or for use at point-of-care facilities.

The Elecsys HSV-2 IgG immunoassay makes use of a sandwich test principle using biotinylated recombinant HSV-2-specific antigens and HSV-2-specific recombinant antigens labeled with a ruthenium complex. The Elecsys HSV-2 IgG immunoassay is intended for the qualitative determination of lgG class antibodies to HSV-2 in human serum and in the presumptive diagnosis of HSV-2 infection. It is intended for use on the cobas e immunoassay analyzers. Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration.

The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the pre-test likelihood of HSV-2 infection. The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.

The SeraQuest® HSV Type 2 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA), which is performed in microwells, at room temperature, and in three thirty-minute incubations. The test detects IgG antibodies which are directed against HSV 2 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 2 Specific IgG test set has been assigned Index values based on an in-house standard. Test results are reported as Index values.

The ADVIA Centaur® Herpes-2 IgG (HSV2) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur systems. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection. The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum and plasma (EDTA and lithium heparin).

The ADVIA Centaur Herpes-2 IgG (HSV2) assay is a fully automated two-step sandwich immunoassay using indirect chemiluminometric technology. The specimen is incubated with the Solid Phase, which contains HSV-2-specific recombinant-gG2 antigen. Antigen-antibody complexes will form if anti-HSV-2 antibody is present in the specimen. The Lite Reagent contains monoclonal anti-human IgG labeled with acridinium ester, and is used to detect HSV-2 IgG in the specimen.

Intended Use: For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection. The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.

The SeraQuest® HSV Type 2 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA) , which is performed in microwells, at room temperature, and in three thirty minute incubations The test detects IgG antibodies which are directed against HSV 2 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 2 Specific IgG test set has been assigned Index values based on an in-house standard. Test results are reported as Index values.

The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing. The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients.

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The LIAISON® HSV-2 Type Specific IgG assay is a chemiluminescent immunoassay to be used with the LIAISON® Analyzer for the qualitative determination of type specific IgG antibodies to Herpes simplex virus Type 2 (HSV-2) in human serum. The assay is indicated for testing sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-2 infection. The LIAISON® HSV-2 Type Specific IgG assay has not been established for use in the pediatrics population, for neonatal screening, or for testing immunocompromised patients. The assay is neither FDA cleared nor approved for testing blood or plasma donors. The LIAISON® Control HSV-2 (negative and positive) are intended for use as assayed quality control samples to monitor the performance of the LIAISON® HSV-2 Type Specific IgG assay.

The method for qualitative determination of specific IgG to HSV-2 is an indirect chemiluminescence immunoassay (CLIA). HSV-2 gG2 recombinant antigen is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody is linked to an isoluminol derivative (isoluminolantibody conjugate), During the first incubation, HSV-2 antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with HSV-2 IgG already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of HSV-2 IgG concentration present in calibrators, samples or controls.

The EUROIMMUN Anti-HSV-1 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against Herpes simplex virus type 1 (HSV-1) specific glycoprotein C1 in human serum. It is intended for the presumptive diagnosis of type specific HSV-1 infection with EUROIMMUN Anti-HSV-2 EUSA (IgG) in persons suspected of herpes viral infection. The EUROIMMUN Anti-HSV-2 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against herpes simplex virus type 2 (HSV-2) specific glycoprotein G2 in human serum. It is intended for the presumptive diagnosis of type specific HSV-2 infection with EUROIMMUN Anti-HSV-1 EUSA (lgG) in persons suspected of herpes viral infection.

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The Trinity Biotech Captia™ Herpes Simplex Virus (HSV) 2 Type Specific IgG kit is an Enzyme-linked Immunosorbent Assay (ELISA) intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-2 in human serum. In conjunction with the Trinity Biotech Captia™ Herpes Simplex Virus (HSV) I Type Specific IgG kit, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. Due to the implications of positive results, it is recommended they be confirmed in a low prevalence population with Western blot. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, or for use with automated equipment. The user is responsible for establishing assay performance in these populations and with automated equipment.

The CaptiaTM HSV 2 IgG Type Specific kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to Herpes simplex Type 2 antigen. The Captia™ HSV 2 IgG Type Specific assay may be used as an aid in the diagnoses of Herpes infection. Purified recombinant HSV gG2 antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present, it will bind to the antibody attached to the antigen on the well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period, the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

MRL Diagnostics' HSV-2 ELISA IgG test is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-2 in human sera. In conjunction with the MRL HSV-1 ELISA IgG, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-2 infection. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, or for use with automated equipment.

In the MRL Diagnostics HSV-2 ELISA IgG assay, the polystyrene microwells are coated with recombinant gG-2 antigen. Diluted serum samples and controls are incubated in the wells to allow specific antibody present in the samples to react with the antigen. Nonspecific reactants are removed by washing, and peroxidase-conjugated anti-human IgG is added and reacts with specific IgG. Excess conjugate is removed by washing. Enzyme substrate and chromogen are added, and the color is allowed to develop. After adding the Stop Reagent, the resultant color change is quantified by a spectrophotometric reading of optical density (OD). Sample optical density readings are compared with reference cut-off OD readings to determine results.