Test ID: HSVG
Herpes Simplex Virus (HSV) Type 1- and Type 2-Specific Antibodies, IgG, Serum
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Determining whether a patient has been previously exposed to herpes simplex virus (HSV) types 1 and 2
Distinguishing between infection caused by HSV types 1 and 2, especially in patients with subclinical or unrecognized HSV infection
Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HS1G | HSV Type 1 Ab, IgG, S | No | Yes |
| HS2G | HSV Type 2 Ab, IgG, S | No | Yes |
Method Name A short description of the method used to perform the test
Multiplex Flow Immunoassay
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
gG-1
gG-2
Herpes Select
Herpes Simplex Antibodies, IgG
Herpes Simplex Serology
HerpeSelect (TM) 1 ELISA IgG
HSV Ab (Herpes Simplex Antibodies)
Herpes Simplex Virus Antibody
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 0.6 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 14 days |
| Frozen | 14 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Herpes simplex virus (HSV) types 1 and 2 are members of the Herpesviridae family, and produce infections that may range from mild stomatitis to disseminated and fatal disease. Clinical conditions associated with HSV infection include gingivostomatitis, keratitis, encephalitis, vesicular skin eruptions, aseptic meningitis, neonatal herpes, genital tract infections, and disseminated primary infection.
Infections with HSV types 1 and 2 can differ significantly in their clinical manifestations and severity. HSV type 2 primarily causes urogenital infections and is found almost exclusively in adults. HSV type 1 is closely associated with orolabial infection, although genital infection with this virus can be common in certain populations.
The diagnosis HSV infections is routinely made based on clinical findings and supported by laboratory testing using PCR or viral culture. However, in instances of subclinical or unrecognized HSV infection, serologic testing for IgG-class antibodies to type-specific HSV glycoprotein G (gG) may be useful. There are several circumstances in which it may be important to distinguish between infection caused by HSV types 1 and 2.(1) For example, the likelihood of reactivation of the infection (type 2 -> type 1) and the method of antiviral therapy may be different depending on the specific type of HSV causing disease. In addition, the results of HSV type-specific IgG testing is sometimes used during pregnancy to identify risks of congential HSV disease and allow for focused counseling prior to delivery.(2-3)
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Negative (reported as positive, negative, or equivocal)
Interpretation Provides information to assist in interpretation of the test results
This assay detects IgG-class antibodies to type-specific herpes simplex virus (HSV) glycoprotein G (gG), and may allow for the differentiation of infection caused by HSV types 1 and 2. The presence of IgG-class antibodies to HSV types 1 or 2 indicates previous exposure, and does not necessarily indicate that HSV is the causative agent of an acute illness.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Detection of IgG-class antibodies to herpes simplex virus (HSV) should not be used routinely as the primary means of diagnosing HSV infection. For patients presenting with presumed acute infection with HSV, a clinical specimen (eg, oral, dermal, or genital lesion) should be sampled and submitted for detection of HSV types 1 and 2 by rapid PCR (LHSV/80575 Herpes Simplex Virus [HSV], Molecular Detection, PCR).
Serum specimens collected too early in the course of infection may not have detectable levels of HSV IgG. In cases of suspected early disease, a repeat serum specimen should be collected 14 to 21 days later and submitted for testing.
The presence of IgG-class antibodies to either HSV type 1 or 2 does not differentiate between remote infection or acute disease.
HSV serology cannot distinguish genital from nongenital infections.
The predictive value of positive or negative results depends on the prevalence of disease and the pretest likelihood of HSV-1 and HSV-2.
False-positive results may occur. Repeat testing, or testing by a different method, may be indicated in some settings (eg, patients with low likelihood of HSV infection.)
Supportive Data
Accuracy:
To evaluate the accuracy of the BioPlex HSV assay, 505 prospective serum samples were tested by EIA (HerpeSelect, Focus Diagnostics, Cypress, CA) and the BioPlex HSV-1/2 IgG assay. Samples that had discordant results after initial testing were repeated by both assays during the same freeze/thaw cycle.
Further discrepancies were evaluated by glycoprotein G (gG) type-specific Western blot (WB) at the University of Washington Virology laboratory (Seattle, WA).
The results are summarized in Tables 1 and 2 below:
Table 1. Comparison of the Bio-Rad BioPlex HSV-1 IgG assay to the HerpeSelect HSV-1 EIA using prospective serum specimens (n=505).
| HSV-1 by BioPlex |
| HSV-1 by HerpeSelect EIA | |||
| Positive | Negative | Equivocal | Total | ||
| Positive | 254 | 5a | 0 | 259 | |
| Negative | 2b | 240 | 1 | 243 | |
| Equivocal | 0 | 3 | 0 | 3 | |
| Total | 256 | 248 | 1 | 505 | |
a. All 5 of these specimens were positive by WB
b. Both of these specimens were positive by WB
Sensitivity=99.2% (254/256); 95% Confidence Intervals (CI) (97.0, 99.9)
Specificity=96.8% (240/248); 95% CI (93.7, 98.5)
Overall percent agreement=97.8% (494/505); 95% CI (96.1, 98.8)
Table 2. Comparison of the Bio-Rad BioPlex HSV-2 IgG assay to the HerpeSelect HSV-2 EIA using prospective serum specimens (n=505).
| HSV-2 by BioPlex |
| HSV-2 by HerpeSelect | |||
| Positive | Negative | Equivocal | Total | ||
| Positive | 115 | 9a | 2 | 126 | |
| Negative | 1b | 376 | 0 | 377 | |
| Equivocal | 1 | 1 | 0 | 2 | |
| Total | 117 | 386 | 2 | 505 | |
a. Two of these 9 specimens were positive by WB; 2 of these 9 specimens were equivocal by WB.
b. This specimen was negative by WB.
Sensitivity=98.3% (115/117); 95% CI (93.6, 99.9)
Specificity=97.4% (376/386); 95% CI (95.2, 98.7)
Overall percent agreement=97.2% (493/505); 95% CI (95.4, 98.4)
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Ashley RL, Wald A: Genital herpes: review of the epidemic and potential use of type-specific serology. Clin Microbiol Rev 1999;12:1-8
2. Ashley RL, Wu L, Pickering JW, et al: Premarket evaluation of a commercial glycoprotein G-based enzyme immunoassay for herpes simplex virus type-specific antibodies. J Clin Microbiol 1998;36:294-295
3. Brown ZA, Selke S, Zeh J, et al: The acquisition of herpes simplex virus during pregnancy. N Engl J Med 1997;337:509-515
4. Lafferty WE, Coombs RW, Benedetti J, et al: Recurrences after oral and genital herpes simplex infection. N Engl J Med 1987;316:1444-1449
5. Binnicker MJ, Jespersen DJ, Harring JA: Evaluation of three multiplex flow immunoassays to enzyme immunoassay for the detection and differentiation of IgG-class antibodies to herpes simplex virus types 1 and 2. Clin Vac Immunol 2010 Feb;17(2):253-257
Method Description Describes how the test is performed and provides a method-specific reference
BioPlex 2200 Herpes Simplex Virus (HSV)-1 and HSV-2 Kit uses multiplex flow immunoassay technology. Two different populations of dyed beads are each coated with glycoprotein G (gG)-based antigens associated with HSV types 1 or 2. Patient sample is combined with sample diluent and bead set reagent in a reaction vessel. The mixture is incubated at 37 degrees C. After a wash cycle, antihuman IgG antibody, conjugated to phycoerythrin (PE), is added to the mixture and incubated at 37 degrees C. Excess conjugate is removed in another wash cycle and the beads are resuspended in wash buffer. The bead mixture then passes through a detector where the identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity. Three additional dyed beads, an internal standard bead, a serum verification bead, and a reagent blank bead are present in each reaction mixture to verify detector response, the addition of serum to the reaction vessel and the absence of significant nonspecific binding in serum.(Package insert: BioPlex 2200 System HSV-1 and HSV-2 IgG, Bio-Rad Laboratories Clinical Diagnostics Group, Hercules, CA)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Saturday; 9 a.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86695-Herpes simplex, type 1
86696-Herpes simplex, type 2
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| HS1G | HSV Type 1 Ab, IgG, S | 51916-5 |
| HS2G | HSV Type 2 Ab, IgG, S | 43180-9 |
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