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Epic Test Code LAB2291 Herpes Simplex Virus (HSV) Type 1- and Type 2-Specific Antibodies, IgG, Serum

Additional Codes

MML Code: HSVG

LIS Code: HSA

NY State Approved

Yes

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Reporting Name

HSV Types 1 and 2 Ab, IgG, S

Method Name

Multiplex Flow Immunoassay (MFI)

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
  Frozen  14 days


Specimen Required


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.


Specimen Type

Serum

Specimen Minimum Volume

0.4 mL

Reference Values

Negative

Report Available

Same day/1 to 2 days

Day(s) Performed

Monday through Saturday

CPT Code Information

86695

86696

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Useful For

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

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

Clinical Information

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.

Interpretation

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

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)

Specimen Retention Time

14 days

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-General Request (T239)

-Infectious Disease Serology Test Request (T916)