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 test kits come in two assay formats.

For type-specific HSV testing in higher volume laboratories:
HerpeSelect ELISA system consists of two micro-plate assays, one for detecting HSV type-1 (gG1) IgG antibodies, and the other for HSV type-2 (gG2) IgG antibodies.

For differentiating type-1 and type-2 in a single specimen (low volume testing):
HerpeSelect Immunoblot is a nitrocellulose strip that contains gG1 and gG2 antigens protein stripe, along with a HSV common antigen strip, (resembles a Western Blot).

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Performance Characteristics

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 virus to a sexual partner.

Both assay formats 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 laboratory utilizes 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. For information about testing at Focus Diagnostics please call Client Service at (800) 445-4032 (within the US), (714) 220-1900 or fax us at (714) 220-1820. 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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Frequently Asked Questions

What differentiates HerpeSelect from other methods?

Many laboratories offer HSV type-1 or HSV type-2 IgG antibody testing, but their tests are not able to deliver reliable type-specific results. Reactivity with shared, type-common antigens is almost always present to some degree, causing inaccurate results to be reported in up to 70% of positive patients. HerpeSelect 1 and 2 kits use glycoprotein G antigens -- gG1 (from HSV type-1) and gG2 (from HSV type-2) – the major antigens known to elicit type-specific antibody responses. HerpeSelect HSV type-1 and HSV type-2 type-specific tests are FDA-cleared.

What is the difference between HerpeSelect ELISA and HerpeSelect Immunoblot?

HerpeSelect ELISA system consists of two micro-plate assays, one for detecting HSV type-1 (gG1) IgG antibodies, and the other for HSV type-2 (gG2) IgG antibodies. These tests are appropriate for high- volume testing on automated platforms and individual antibody type testing.

HerpeSelect HSV type-1 and HSV- 2 Immunoblot is like a simplified Western Blot with gG1 and gG2 bands, a type-common HSV band, and a serum control band all arrayed on a single strip. The test is read visually for HSV type-1 and HSV type-2 results so that instrumentation is not required. It is well suited for lower volume laboratory testing.

Is HerpeSelect immunoblot a confirmatory test for HerpeSelect ELISA?

No. Both formats exhibit sensitivity and specificity values ranging from 91-100% in clinical trials with sexually active adults and pregnant women.

How long after infection will HerpeSelect detect IgG antibodies?

Recent studies show that HerpeSelect can detect HSV IgG antibodies as quickly as 3 weeks after onset of symptoms.

What about HSV IgM testing?

The presence of IgM antibodies in HSV infections is difficult to interpret and may be confusing because, unlike IgG, IgM is not type-specific. The presence of IgM may indicate a true primary infection, a super-infection with the other serotype, or reactivation of a latent HSV infection (HSV type-1 or -2). For this reason, IgM testing is not recommended as a differential diagnostic tool, but may offer information about a particular patient’s antibody response.

How long does it take to perform HerpeSelect testing?

Both tests are performed in less than 3 hours.

Is HerpeSelect reimbursed by payors?

An example of reimbursement is:

Medicare Part B, 2004 Fee Schedule:
HSV type-1    CPT Code 86695    $18.91
HSV type-2    CPT Code 86696    $27.75

How do I know if the laboratory I use offers the HerpeSelect test?

Many laboratories throughout the US use the HerpeSelect test. Many labs offer the test using the HerpeSelect brand name. Other laboratories offer the test using a more generic method name such as HSV type-1 or HSV type-2 type-specific ELISA. Ask to speak to the director of the infectious disease laboratory to verify that their type-specific serology meets these specifications:

• Type-specific for HSV type-1 and HSV type-2 .
• Kit insert specifies glycoprotein-G based technology versus crude antigen.
• FDA-cleared for use in sexually active adults and pregnant women.

For the names of laboratories that are currently using HerpeSelect contact Focus Diagnostics’ HSV Information Center at (800) 505-0536.

How much does a HerpeSelect test cost?

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