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Test Code LAB5338 Herpes Simplex Virus (HSV) Type 1- and Type 2-Specific Antibodies, IgG, Serum

Important Note

Mayo's test code: HSVG

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Reporting Name

HSV Types 1 and 2 Ab, IgG, S

Specimen Type

Serum


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.


Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Specimen Stability Information

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

Specimen Minimum Volume

0.4 mL

Day(s) Performed

Monday through Friday

Specimen Retention Time

14 days

Report Available

Same day/1 to 2 days

Reference Values

Negative

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.

CPT Code Information

86695

86696

LOINC Code Information

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
HS1G HSV Type 1 Ab, IgG, S 51916-5
HS2G HSV Type 2 Ab, IgG, S 43180-9

Method Description

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° C. After a wash cycle, antihuman IgG antibody conjugated to phycoerythrin (PE) is added to the mixture and incubated at 37° 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)

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

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)

Forms

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

-Infectious Disease Serology Test Request (T916)

-Kidney Transplant Test Request