HerpeSelect
About HerpeSelect
Until recently, there hasn’t been a reliable serologic tool
for differentiating antibodies for HSV type-1 from HSV type-2 infection.
Most commercial methods use shared or type-common antigens, which
react with both type-1 and type-2 antibodies. To be truly type-specific,
a diagnostic method must recognize antibodies to glycoprotein G1,
found only on HSV type-1 virus and glycoprotein G2, found only on HSV type-2
virus.
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 HSV
serology tests for both HSV type-1 and HSV type-2 are FDA-cleared
for expectant mothers and sexually active adults and designed for
use by clinical laboratories.
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Test Kits
HerpeSelect type-specific HSV IgG antibody detection kits
are available in two assay formats:
For type-specific HSV testing in higher volume laboratories:
- HerpeSelect 1 ELISA (96 wells/kit)
- HerpeSelect 2 ELISA (96 wells/kit)
The HerpeSelect ELISA Kit
For differentiating HSV type-1 and HSV type-2 in a single specimen
(low volume testing):
- HerpeSelect 1 & 2 Immunoblot (24 strips/kit)
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|
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The HerpeSelect
Immunoblot Kit |
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A Single HerpeSelect Immunoblot
Patient Strip |
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Performance Characteristics
HerpeSelect assays are designed to:
- Identify individuals, including pregnant women, and their partners
that are 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.
HerpeSelect
ELISA Performance |
Compared
to Western Blot or CDC Panel |
|
HSV type-1 |
HSV type-2 |
|
Sensitivity |
Specificity |
Sensitivity |
Specificity |
Pregnant Women |
96 |
95 |
100 |
96 |
Sexually Active Adults |
91 |
92 |
96 |
97 |
CDC Panel* |
93 |
100 |
100 |
100 |
HerpeSelect
Immunoblot Performance |
Compared
to Western Blot or CDC Panel |
|
HSV type-1 |
HSV type-2 |
|
Sensitivity |
Specificity |
Sensitivity |
Specificity |
Pregnant Women |
100 |
93 |
100 |
94 |
Sexually Active Adults |
99 |
95 |
97 |
98 |
CDC Panel* |
100 |
100 |
100 |
98 |
* The CDC panel results are presented as a means to convey further
information on the performance of this assay with a masked, characterized
serum panel. This does not imply an endorsement of the assay by
the CDC.
Serological tests for HSV only indicate prior infection and cannot
identify the site of infection. These tests may give false-negative
results in the early stages of infection because antibodies may not
reach detectable levels for 8 weeks or longer. False-positive results
can also occur in patients with low likelihood of HSV infection.
Repeat testing or a confirmatory test may be indicated in some cases.
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Equipment Needed
HerpeSelect ELISA:
- 10µl, 100µl, 1ml and 5ml pipettes
- ELISA plate spectophotometer with 450nm wavelength filter
- Optional equipment: automated ELISA reader
HerpeSelect Immunoblot:
- 15µl and 5ml pipettes
- platform rocker
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Kits Inserts
Please click the links below to view the package inserts.
The inserts are available in Adobe Acrobat Portable Document
Format (PDF).
For the latest version of Acrobat Reader please follow the link below:
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Order Information
HerpeSelect Tests are available from Focus Diagnostics.
Click here to go to
Focus Diagnostics' Reference Laboratory Online
Catalog.
To purchase HerpeSelect test kits, contact Focus Diagnostics Customer
Service at (800)838-4548 (within the US), (714)220-1900, or fax
(714)220-1820.
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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) 838-4548 (within the US),
(714) 220-1900 or fax us at (714) 220-1820.
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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.
HerpeSelect assays are cleared for use on automated
instrumentation. The user needs to validate performance on their
equipment.
View FDA clearance letters:
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CPT Codes
2002 CPT Codes are listed for guidance purposes only. For further
reference, please consult the CPT Coding Manual published by the
American Medical Association.
- CPT Code 86695 Antibody, herpes simplex,
type-1
- CPT Code 86696 Antibody, herpes simplex,
type-2
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Frequently Asked Questions
What differentiates HerpeSelect from
other test kits?
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, and the other for HSV type-2 (gG2) IgG.
These tests are appropriate for high volume testing on automated
platforms and individual antibody type testing.
ELISA
- 2 separate kits (HSV type-1 or HSV type-2)
- 96 test wells per kit in breakaway strips
- Numerical result
- CLIA rated highly complex
HerpeSelect 1 & 2 Immunoblot IgG 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.
Immunoblot
- 1 kit for both (HSV type-1 & HSV type-2)
- 24 test strips per kit
- Positive/Negative result visually read on nitrocellulose
strip
- CLIA rated moderately complex
What type of equipment is needed for HerpeSelect testing?
For the ELISA tests, 10ul, 100ul, 1ml and 5ml pipettes are needed.
A microplate (450nm) reader is needed to read the ELISA test result.
HerpeSelect is now FDA-cleared for use on automated instrumentation.
Performance characteristics should be established by the user for
their equipment.
For the Immunoblot test, 15ul and 5ml pipettes are needed, as well
as a platform rocker.
How long does it take to perform HerpeSelect testing?
Both tests are performed in less than 3 hours.
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 much does a HerpeSelect test cost?
For information on kit prices contact Focus Diagnostics at (800)
838-4548.
For information on HerpeSelect testing services from Focus Diagnostics
clinical laboratory, call (800) 445-4032.
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
Can a patient order HerpeSelect Kits?
No. But, for more information on how to get HerpeSelect testing
patients may contact Focus Diagnostics Customer Service at (800)
445-4032 (within the US), (714) 220-1900 or fax (714) 220-1820.
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 HSV type-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.
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