(112 days)
HerpeSelect® Express is a rapid test intended for qualitatively detecting the presence or absence of human IgG class antibodies to herpes simplex virus type 2 (HSV-2) in human whole blood (venous or capillary) or serum. The test is indicated for testing sexually active adults or pregnant women to aid in the presumptive diagnosis of HSV-2 infection.
The HerpeSelect® Express IgG device has not been established for use in the pediatrics population, for neonatal screening, or for testing immunocompromised patients. This kit is not intended for self-testing, and this test is neither FDA cleared nor approved for testing blood or plasma donors.
Rapid Lateral Flow assay for the qualitative detection of human IgG class antibodies to HSV-2
Here's a breakdown of the acceptance criteria and study information for the HerpeSelect Express IgG device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the performance characteristics presented in comparison to the predicate device (HerpeSelect 1 and 2 Immunoblot IgG). The document does not explicitly state a pre-defined numerical "acceptance criteria" for sensitivity and specificity. Instead, it presents the device's performance, indicating that these achieved results were deemed acceptable for market clearance.
| Study Population & Sample Type | Criteria | Acceptance Criteria (Implied) | Reported Device Performance (HerpeSelect Express vs. Immunoblot) |
|---|---|---|---|
| Pregnant Women | |||
| Sera | Specificity | Not explicitly stated | 92.3% (108/117) |
| Sensitivity | Not explicitly stated | 96.1% (271/282) | |
| Venous Whole Blood | Specificity | Not explicitly stated | 93.2% (109/117) |
| Sensitivity | Not explicitly stated | 97.2% (274/282) | |
| Capillary Whole Blood | Specificity | Not explicitly stated | 94.9% (111/117) |
| Sensitivity | Not explicitly stated | 95.4% (269/282) | |
| Sexually Active Adults | |||
| Sera | Specificity | Not explicitly stated | 92.9% (210/226) |
| Sensitivity | Not explicitly stated | 91.8% (315/343) | |
| Venous Whole Blood | Specificity | Not explicitly stated | 93.4% (211/226) |
| Sensitivity | Not explicitly stated | 92.4% (317/343) | |
| Capillary Whole Blood | Specificity | Not explicitly stated | 93.8% (212/226) |
| Sensitivity | Not explicitly stated | 91.8% (315/343) | |
| Non-Sexually Active Adults (Low Prevalence) | |||
| Sera | Specificity | Not explicitly stated | 0% (0/2) * (This low sensitivity for positives with few samples is noted to indicate low prevalence)* |
| Sensitivity | Not explicitly stated | 100% (101/101) | |
| Venous Whole Blood | Specificity | Not explicitly stated | 0% (0/2) |
| Sensitivity | Not explicitly stated | 100% (101/101) | |
| Capillary Whole Blood | Specificity | Not explicitly stated | 0% (0/2) |
| Sensitivity | Not explicitly stated | 100% (101/101) | |
| CDC HSV/CMV Panel | |||
| Specificity | Not explicitly stated | 100% (35/35) | |
| Sensitivity | Not explicitly stated | 98.5% (64/65) | |
| Cross-reactivity | Overall Cross-reactivity | Not explicitly stated | 4.2% (9/213) |
| Inter-Lot Reproducibility | %CV | Not explicitly stated |
§ 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).