Test Id : HSVG
Herpes Simplex Virus (HSV) Type 1- and Type 2-Specific Antibodies, IgG, Serum
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
This test should not be used to diagnose active or recent 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
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
gG-1
gG-2
Herpes Simplex Antibodies, IgG
Herpes Simplex Serology
Herpes Simplex Virus Antibody
HSV Ab
HSV Glycoprotein 1 and 2
Specimen Type
Describes the specimen type validated for testing
Serum
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.6 mL
Collection Instructions: Centrifuge and aliquot serum into plastic vial.
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-General Request (T239)
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
0.4 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 14 days | |
| Frozen | 14 days |
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
This test should not be used to diagnose active or recent infection.
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 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 of HSV infections is routinely made based on clinical findings and supported by laboratory testing, primarily using polymerase chain reaction to detect viral DNA. However, in instances of subclinical or unrecognized HSV infection, serologic testing for IgG-class antibodies to type-specific HSV glycoprotein G may be useful. There are several circumstances where it may be important to distinguish between infection caused by HSV types 1 and 2 (eg, risk of reactivation). In addition, the results of HSV type-specific IgG testing are sometimes used during pregnancy to identify risks of congenital HSV disease and allow for focused counseling prior to delivery.
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
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 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 polymerase chain reaction.
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 specimens were tested by enzyme immunoassay (EIA) (HerpeSelect, Focus Diagnostics) and the BioPlex HSV-1/2 IgG assay. Specimens 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 type-specific Western blot (WB) at the University of Washington Virology laboratory.
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 | 5(a) | 0 | 259 | |
| Negative | 2(b) | 240 | 1 | 243 | |
| Equivocal | 0 | 3 | 0 | 3 | |
| Total | 256 | 248 | 1 | 505 | |
a. All 5 specimens were positive by WB
b. Both specimens were positive by WB
Sensitivity=99.2% (254/256); 95% 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 | 9(a) | 2 | 126 | |
| Negative | 1(b) | 376 | 0 | 377 | |
| Equivocal | 1 | 1 | 0 | 2 | |
| Total | 117 | 386 | 2 | 505 | |
a. Two of 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
Recommendations for 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):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(1):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(8):509-515
4. Lafferty WE, Coombs RW, Benedetti J, et al. Recurrences after oral and genital herpes simplex infection. Influence of site of infection and viral type. N Engl J Med. 1987;316(23):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 Vaccine Immunol. 2010;17(2):253-257
6. Nath P, Kabir MA, Doust SK, Ray A. Diagnosis of herpes simplex virus: Laboratory and point-of-care techniques. Infect Dis Rep. 2021;13(2):518-539
Method Description
Describes how the test is performed and provides a method-specific reference
The BioPlex 2200 HSV (herpes simplex virus)-1 and HSV-2 IgG assay uses multiplex flow immunoassay technology. Two different populations of dyed beads are each coated with glycoprotein G -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; Version 665-0533C_EN, 04/2019)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
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
Indicates the location of the laboratory that performs the test
Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
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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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
86695
86696
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| HSVG | HSV Types 1 and 2 Ab, IgG, S | 81621-5 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| HS1G | HSV Type 1 Ab, IgG, S | 51916-5 |
| HS2G | HSV Type 2 Ab, IgG, S | 43180-9 |