HerpeSelect
Description
HerpeSelect is the brand name of two FDA-cleared diagnostic test
kits manufactured by Focus Diagnostics. HerpeSelect tests utilize
highly purified preparations of the HSV type-specific antigens
glycoprotein G1 and glycoprotein G2. These antigens are used to
detect HSV type-specific antibodies. HerpeSelect assays are designed
to:
- Identify individuals, including pregnant women, at risk for
infection,
- Aid in the diagnosis of infected expectant mothers who could
transmit virus during labor and,
- Aid in the diagnosis of individuals, with or without typical
genital symptoms, who could transmit the virus to a sexual
partner.
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Performance Characteristics
HerpeSelect tests had sensitivity and specificity values ranging
from 91-100% in clinical trials with sexually active adults and
pregnant women.
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Availability
HerpeSelect test kits are used in commercial and hospital laboratories
throughout the US. Although many labs offer these assays under
the brand name HerpeSelect others utilize the HerpeSelect test
kit but offer the test under a more generic methodology name such
as HSV type-1 or HSV type-2 type-specific ELISA. Make certain that your healthcare
provider orders an FDA-cleared glycoprotein-G based assay that
accurately discriminates IgG antibodies from HSV type-1 and HSV type-2 infections.
For further information about what labs offer HerpeSelect testing,
please contact Focus Diagnostics’ HSV Information Center
at (800) 505-0536. You can contact Focus Diagnostics online
at
www.focusdx.com.
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FDA Clearance
HerpeSelect HSV type-specific serology tests for both HSV type-1 and HSV type-2 are FDA-cleared for both sexually active adults and expectant mothers.
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