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Focus Diagnostics' Plexus™HerpeSelect®1 and 2 IgG is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV-1 and HSV-2 infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-1 and 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, for use by a point of care facility or for use with automated equipment.

The Focus Diagnostics Plexus™HerpeSelect®1 and 2 IgG is a multiplexed immunoassay for qualitatively detecting and differentiating human IgG antibodies to HSV-1 and HSV-2. The Focus Diagnosics Plexus™HerpeSelect®1 and 2 IgG uses an Antigen Bead suspension that contains two distinct HSV antigen bead types that fluoresce at different wavelengths and/or intensities: gG-1 beads. The Focus Diagnostics Plexus 100 HerpeSelect®1 and 2 IgG is a three step procedure. Patient sera are diluted, and the diluted sera are incubated with Antibodies are present, then the 1 . antibodies bind to the corresponding antigen beads. Phycoerythrin-conjugated goat anti-human IgG, (Conjugate) is added, and the Conjugate binds to the bound HSV 2. antibody (if present), and forms a Conjugate-HSV antibody-antigen bead sandwich. Fluorescence from each distinct HSV antigen bead type is measured and compared against a Cut-off Calibrator. 3.

Here's a breakdown of the acceptance criteria and study details for the Plexus HerpeSelect 1 and 2 IgG device, based on the provided document:

Acceptance Criteria and Device Performance

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