Herpes Simplex Virus Type 2 (HSV-2), Type-specific Antibodies, IgG

CPT: 86696
Updated on 10/11/2024
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Synonyms

  • HSV-2

Expected Turnaround Time

1 - 3 days


Related Documents


Specimen Requirements


Specimen

Serum


Volume

1.0 mL


Minimum Volume

0.4 mL (Note: This volume does not allow for repeat testing.)


Container

Red-top tube, gel-barrier tube or serum transfer tube


Collection

If tube other than a gel-barrier is used, transfer separated serum to a plastic transport tube.

If tube other than a gel-barrier is used, transfer separated serum to a plastic transport tube.


Storage Instructions

Refrigerate.


Stability Requirements

TemperaturePeriod
Room temperature2 days
Refrigerated7 days
Frozen12 weeks
Freeze/thaw cyclesStable x5

Temperature

Period

Room temperature

2 days

Refrigerated

7 days

Frozen

98 days

Freeze/thaw cycles

Stable x4

TemperaturePeriod
Room temperature2 days
Refrigerated7 days
Frozen12 weeks
Freeze/thaw cyclesStable x5

Causes for Rejection

Gross hemolysis; obvious microbial contamination and/or received outside of specimen and/or storage and/or requirements; heat-inactivated samples

Hemolysis; lipemia; grossly icteric; visible particulate matter; gross bacterial contamination

Gross hemolysis; obvious microbial contamination and/or received outside of specimen and/or storage and/or requirements; heat-inactivated samples


Test Details


Use

This test is used for qualitative detection of IgG antibodies specific to HSV type 2. This test is intended for sexually active individuals and pregnant individuals as an aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lesions or associated disease manifestations, particularly in primary infection. The predictive value of positive an negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The detection of HSV-2 IgG antibodies in a single sample indicates a previous exposure to HSV-2 but does not give information as to the site of HSV infection or the timing of exposure.

This test is used to detect IgG antibodies specific to HSV type 2 infection and confirm or rule out possible infection with herpes simplex type 2 virus in prenatal patients in whom HSV 2 infection can cause serious prenatal disease. In a patient with no history of lesion disease, a positive result for this test may be indicative that the primary infection was asymptomatic. The magnitude of the Index Value is not indicative of the amount of antibody present in the patient sample. Once infected by HSV, it is possible for a patient to shed virus without the development of lesions (asymptomatic shedding). This test does not indicate the site of HSV infection. There is a considerable homology between HSV-1 and HSV-2 antigens, so that antibodies formed against either virus are highly cross-reactive. This assay is based on glycoprotein G-2, purified from HSV-2 infected cells, and is specific for type 2 antibodies.

This test is used for qualitative detection of IgG antibodies specific to HSV type 2. This test is intended for sexually active individuals and pregnant individuals as an aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lesions or associated disease manifestations, particularly in primary infection. The predictive value of positive an negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The detection of HSV-2 IgG antibodies in a single sample indicates a previous exposure to HSV-2 but does not give information as to the site of HSV infection or the timing of exposure.


Limitations

A negative test result does not completely rule out the possibility of an infection with HSV 2. Individuals may not exhibit any detectable IgG antibodies at the early state of acute infection. False negative results may occur when the HSV virus is glycoprotein G (gG) deficient (0.2% HSV isolates were gG deficient). False-positive results may occur. Repeat testing, or testing by a different method, may be indicated in some settings (e.g., patients with low likelihood of HSV-2 infection). The results in HIV patients, in patients undergoing immunosuppressive therapy, or in patients with other disorders leading to immune suppression, should be interpreted with caution. Specimens from neonates, cord blood, pretransplant patients or body fluids other than serum and plasma, such as urine, saliva or amniotic fluid, have not been tested. The results should be assessed in conjunction with the patient's medical history, clinical examination and other findings.

Serum samples 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 14-21 days later and submitted for testing.

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 (e.g., patients with low likelihood of HSV infection).

This test is intended for qualitative determination only. The magnitude of the Index Value is not indicative of the amount of antibody present in the patient sample.

A negative test result does not completely rule out the possibility of an infection with HSV 2. Individuals may not exhibit any detectable IgG antibodies at the early state of acute infection. False negative results may occur when the HSV virus is glycoprotein G (gG) deficient (0.2% HSV isolates were gG deficient). False-positive results may occur. Repeat testing, or testing by a different method, may be indicated in some settings (e.g., patients with low likelihood of HSV-2 infection). The results in HIV patients, in patients undergoing immunosuppressive therapy, or in patients with other disorders leading to immune suppression, should be interpreted with caution. Specimens from neonates, cord blood, pretransplant patients or body fluids other than serum and plasma, such as urine, saliva or amniotic fluid, have not been tested. The results should be assessed in conjunction with the patient's medical history, clinical examination and other findings.


Methodology

Electrochemiluminescience immunoassay (ECLIA)

Chemiluminescent immunoassay (CLIA)

Electrochemiluminescience immunoassay (ECLIA)


References

Miller JM, Binnicker MJ, Campbell S, et al. Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2024 Update by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM). Clin Infect Dis. 2024 Mar 5:ciae104. PubMed 38442248

Workowski KA, Bachmann LH, Chan PH, et al. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recom Rep. 2021 Jul 23;70(4):1-187. PubMed 34292926

American Academy of Pediatrics, American College of Obstetricians and Gynecologists. In: Kilpatrick SJ, Papile LA, eds. Guidelines for Perinatal Care, 8th Edition. ElkGrove, IL, and Washington, D.C.; 2017.
Landry LL. Immunoglobulin M for Acute Infection: True or False? Clin Vaccine Immuol. 2016 Jul 5;23(7):540-545.27193039
Miller JM, Binnicker MJ, Campbell S, et al. A Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2018 Update by the InfectiousDiseases Society of America and the American Society for Microbiology. Clin Infect Dis. 2018 Aug 31;67(6): e1-e94.29955859
US Preventive Services Task Force, Bibbins-Domingo K, Grossman DC, et al. Serologic Screening for Genital Herpes Infection: US Preventive Services Task ForceRecommendation Statement. JAMA. 2016 Dec 20;316(23):2525-2530.27997659
Workowski KA, Bachmann LH, Chan PH, et al. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187.34292926

Miller JM, Binnicker MJ, Campbell S, et al. Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2024 Update by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM). Clin Infect Dis. 2024 Mar 5:ciae104. PubMed 38442248

Workowski KA, Bachmann LH, Chan PH, et al. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recom Rep. 2021 Jul 23;70(4):1-187. PubMed 34292926


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