TEST CATALOG ORDERING & RESULTS SPECIMEN HANDLING CUSTOMER SERVICE EDUCATION & INSIGHTS
Test Catalog

Test ID: HERPV    
Herpes Simplex Virus 1 and 2, Qualitative PCR, Varies

Useful For Suggests clinical disorders or settings where the test may be helpful

Direct detection and differentiation of HSV-1 and HSV-2 DNA in various specimen types from symptomatic patients

 

Aids in diagnosis of HSV infection in symptomatic patients

 

This test is not intended to be used for prenatal screening.

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Herpes simplex virus types 1 and 2 (HSV-1/2) 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-1 and -2 can differ significantly in their clinical manifestations and severity. HSV-2 primarily causes urogenital infections and is found most often in adults. HSV-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 using polymerase chain reaction (PCR) or viral culture.

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 is a qualitative assay; results are reported either as negative or positive for herpes simplex virus (HSV) type 1 or HSV type 2 nucleic acid.

 

Detection of HSV DNA in clinical specimens supports the clinical diagnosis of infection due to the virus.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

A negative result does not eliminate the possibility of herpes simplex virus (HSV) infection. There is a risk of a false-negative result due to improperly collected, transported, or handled swab samples.

 

There is a risk of a false-positive result due to contamination by target organisms or their nucleic acids, which may be introduced at the point of sample collection or testing. Every effort to minimize the risk of contamination should be taken.

 

The ARIES HSV 1 and 2 assay may not detect a coinfection of HSV-1 and -2 in specimens where the 2 virus types are not equally represented in clinical specimens.

 

The ARIES HSV 1 and 2 assay detects and differentiates between HSV-1 and HSV-2 only. It does not detect or differentiate any other herpes viruses (eg, cytomegalovirus [CMV], Epstein-Barr virus [EBV]). This assay does not distinguish between infectious HSV-1 or -2 and the presence of nucleic acid (ie, noninfectious viral particles).

 

Results should be interpreted in conjunction with other clinical and laboratory findings.

Supportive Data

The following validation data supports the use of this assay for clinical testing.

 

Accuracy/Diagnostic Sensitivity and Specificity:

At least 60-positive (30 each for herpes simplex virus [HSV-1] and HSV-2) and 10-negative specimens from each of the following sample groupings were tested by the ARIES HSV-1/2 assay and Roche HSV-1/2 analyte specific reagents (ASR): dermal/genital swab specimens, sterile body fluids (peritoneal/ascites, pericardial, pleural/thoracentesis, amniotic), eye swabs, ocular fluids, upper respiratory, lower respiratory, fresh tissues, blood and urine. Concordance was 99.2% between these methods.

 

Analytical Sensitivity/Limit of Detection (LoD):

The limit of detection (LoD) was established by spiking analyte-negative specimens with known concentrations of HSV-1 and HSV-2 using whole virus controls from ZeptoMetrix.

 

Sample Grouping

HSV-1 LoD (copies/mL)

HSV-2 LoD (copies/mL)

Genital/dermal swabs

(in viral transport media )

312

78

Sterile body fluids

312

39

Eye Swabs

625

156

Ocular Fluid/CSF

625

156

Upper respiratory

312

39

Lower respiratory

1250

78

Tissue

312

39

Urine

312

78

 

Analytical Specificity:

No cross-reactivity was observed with the Luminex ARIES HSV 1 and -2 assay when tested against the comprehensive specificity panel. This included testing of 5 replicates each of HSV-1 and HSV-2 near the assay's LoD, as well as negative replicates spiked with 61 potential cross-reacting organisms. The reactivity of microbes should not be altered by the specimen source they are present in; therefore, the manufacturer's specificity data that was generated for cutaneous and mucocutaneous lesion specimens are determined to be sufficient for off-label clinical sources.

 

Precision:

Intra-assay precision was 100% (9/9 replicates positive) for both HSV-1 and HSV-2. Cp values for all replicates were within plus or minus 2 cycles of the mean.

 

Reference Range:

The reference value for this assay is negative.

 

Reportable Range:

This is a qualitative test and will be reported as "Positive for HSV-1," "Positive for HSV-2," "Negative," or "Invalid."

Clinical Reference Recommendations for in-depth reading of a clinical nature

1. Filen F, Strand A, Allard A, et al: Duplex real-time polymerase chain reaction assay for detection and quantification of herpes simplex virus type 1 and herpes simplex virus type 2 in genital and cutaneous lesions. Sex Transm Dis 2004;31(6):331-336

2. Jerome KR, Morrow RA: Herpes Simplex Viruses and Herpes B Virus. In Manual of Clinical Microbiology. Tenth edition. Edited by J Versalovic, KC Carroll, G Funke, et al. Washington, DC, ASM Press, 2011, pp 1530-1544

3. Modi S, Van L, Gerwirtzman A, et al: Single day treatment of orolabial and genital herpes: a brief review of pathogenesis and pharmacology. Ther Clin Risk Manag 2008;4:409-417

4. Nadelman CM, Newcomer VD: Herpes simplex virus infections. New treatment approaches make early diagnosis even more important. Postgrad Med 2000;107:189-200

5. Slomka MJ: Current diagnostic techniques in genital herpes; their role in controlling the epidemic. Clin Lab 2000;46:591-607

6. Superti F, Ammendolia MG, Marchetti M: New advances in anti-HSV chemotherapy. Curr Med Chem 2008;15:900-911

7. Tronstein E, Johnston C, Huang ML, et al: Genital shedding of herpes simplex virus among symptomatic and asymptomatic persons with HSV-2 infection. JAMA 2011;305:1441-1449