(155 days)
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
| Study | Acceptance Criteria (Implicit from reported performance) | Reported Device Performance (Plexus HerpeSelect 1 IgG) | Reported Device Performance (Plexus HerpeSelect 2 IgG) |
|---|---|---|---|
| Expectant Mothers (Indicated population) | Agreement with positives: High (e.g., >90%) | 96.5% (164/170) | 94.3% (115/122) |
| Agreement with negatives: High (e.g., >90%) | 92.2% (118/128) | 95.5% (168/176) | |
| Sexually Active Adults (Indicated population) | Agreement with positives: High (e.g., >90%) | 91.0% (142/156) | 96.3% (105/109) |
| Agreement with negatives: High (e.g., >90%) | 96.5% (137/142) | 97.4% (184/189) | |
| CDC HSV/CMV Panel | Agreement with positives: 100% | 100% (54/54) | 100% (36/36) |
| Agreement with negatives: 100% | 100% (32/32) | 100% (32/32) | |
| Low Prevalence Population | Agreement with negatives: High (e.g., >95%) | 97.9% (46/47) | 100% (71/71) |
| Cross-reactivity with CMV, EBV and VZV. | Cross-reactivity: Low (e.g., |
§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).