Test Catalog

Test Id : HSVC

Herpes Simplex Virus (HSV), Molecular Detection, PCR, Spinal Fluid

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

Aids in the rapid diagnosis of herpes simplex virus (HSV)-1 and HSV-2 infections of the central nervous system

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Meningitis/Encephalitis Panel Algorithm in Special Instructions.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Real-Time Polymerase Chain Reaction (RT-PCR)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Herpes Simplex Virus, PCR, CSF

Aliases
Lists additional common names for a test, as an aid in searching

Herpes simplex

HSV

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Meningitis/Encephalitis Panel Algorithm in Special Instructions.

Specimen Type
Describes the specimen type validated for testing

CSF

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Aliquot Tube, 5 mL (T465)

Container/Tube: Aliquot tube (12- x 75-mm screw cap vial: T465)

Specimen Volume: 0.2 mL

Collection Instructions: Do not centrifuge or heat-inactivate.

Additional Information:

1. The high sensitivity of amplification by PCR requires the specimen to be processed in an environment in which contamination of the specimen by herpes simplex virus DNA is not likely.

2. Specimens that are received with less than the minimum volume required for all testing requested will be canceled.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Heat-treated spinal fluid 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
CSF Refrigerated (preferred) 7 days
Frozen 7 days

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

Aids in the rapid diagnosis of herpes simplex virus (HSV)-1 and HSV-2 infections of the central nervous system

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Meningitis/Encephalitis Panel Algorithm in Special Instructions.

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

Herpes simplex virus (HSV)-1 and HSV-2 are members of the Alpha herpesviridae subfamily. HSV is an enveloped virus with a capsid containing viral DNA. Although HSV-1 and HSV-2 are closely related, the 2 viruses are serologically and genetically distinct.(1,2)

 

HSV-1 and -2 are common causes of dermal and genital infections; however, in some cases, infection with HSV may result in central nervous system (CNS) disease that is considered a medical emergency. HSV infection of the CNS may result in encephalitis (more commonly associated with HSV-1) or meningitis (more commonly associated with HSV-2).

 

Encephalitis is inflammation of the brain associated with clinical evidence of neurologic dysfunction. Of the pathogens reported to cause encephalitis, the majority are viruses.(3) In general, the most commonly identified etiologies in the United States are HSV, West Nile virus, and the enteroviruses, followed by other herpesviruses.(3)

 

HSV causes about 5% to 10% of all encephalitis cases, and is one of the most common causes of identified sporadic encephalitis globally.(3) HSV encephalitis occurs in all ages, and during all seasons. HSV-1 encephalitis is more common in adults, and HSV-2 encephalitis is more common in neonates.(3) One study reported a neonatal herpes rate of 1 case per 3,200 live births in the United States.(4)

 

Clinical features involved with HSV encephalitis include fever, hemicranial headache, language and behavioral abnormalities, memory impairment, and seizures.(3)

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

A positive result suggests the presence of herpes simplex virus (HSV)-1 and/or HSV-2 DNA in the cerebrospinal fluid (CSF) sample.

 

A negative result suggests that HSV-1 and HSV-2 DNA are not present in the CSF sample.

 

An invalid result points to the inability to determine presence or absence of HSV-1 or HSV-2 DNA in the CSF sample.

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

This test is not validated for sample types other than cerebrospinal fluid (CSF).

 

Negative results do not preclude herpes simplex virus (HSV)-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.

 

False-negative results may occur if the viruses are present at a level that is below the analytical sensitivity of the assay or if the virus has genomic mutations, insertions, deletions, or rearrangements, or if the assay is performed very early in the course of illness.

 

For encephalitis patients with a negative herpes simplex PCR result, consideration should be given to repeating the test 3 to 7 days later for patients demonstrating a compatible clinical syndrome or temporal lobe localization on neuroimaging.(3)

 

The performance of this test has not been established for immunocompromised individuals, nor has it been established for monitoring treatment of HSV infection of the central nervous system.

Supportive Data

Accuracy:

To assess the accuracy of the Diasorin( Focus) Simplexa (herpes simplex virus)-1 and -2 Direct assay, clinical cerebrospinal fluid specimens (n=100) were tested and the results compared to those of the Roche HSV-1/2 analyte specific reagents.(6) Samples showing discordant results were tested by a third method (artus HSV-1/2; Qiagen). The results are summarized below in Tables 1 and 2:

 

Table 1. Comparison of the Simplexa HSV-1 Direct Assay to the Roche ASR using Clinical CSF Samples (n=100)(a).

Simplexa HSV-1

 

Roche HSV-1 ASR (b)

Positive

Negative

Positive

11

0

Negative

0

85

Total

11

85

Sensitivity (95% CI): 100% (70-100)

Specificity (95% CI): 100% (94.8-100)

 

Table 2. Comparison of the Simplexa HSV-2 Direct Assay to the Roche ASR using Clinical CSF Samples (n=100)(a).

Simplexa HSV-2

 

Roche HSV-2 ASR (b)

Positive

Negative

Positive

37

1

Negative

0

58

Total

37

59

Sensitivity (95% CI): 100% (88.8-100)

Specificity (95% CI): 98.3% (90.2-99.9)

 

(a) Only 96 samples are summarized. This is because 4 samples were found to be HSV detected-type indeterminate by the Roche ASR. These results are summarized in footnote b.

(b) One sample was HSV detected-type indeterminate by the Roche ASR and positive for HSV-1 by the Diasorin (Focus) Simplexa assay. In addition, 3 samples were HSV detected-type indeterminate by the Roche ASR but negative by the Simplexa HSV-1 assay. These 3 samples were tested by a third method (artus HSV-1/2; Qiagen) and were negative for HSV-1 and -2. Testing was also repeated by the Roche ASR and the results were negative upon repeat testing.

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

1. Lawrence C: Herpes Simplex virus. In Principles and Practice of Infectious Diseases. Sixth Edition. Edited by GL Mandell, JE Bennet, R Dolin. Philadelphia, Elsevier, Churchill and Livingstone, 2004, pp 1762-1780

2. Szpara ML, Parsons L, Enquist LW: Sequence variability in clinical and laboratory isolates of herpes simplex virus 1 reveals new mutations. J Virol 2010;84(10):5303-5313

3. Tunkel AR, Glaser CA, Bloch KC, et al: The management of encephalitis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis 2008 Aug 1;47(3):303-327

4. Brown ZA, Wald A, Morrow RA, et al: Effect of serologic status and cesarean delivery on transmission rates of herpes simplex virus from mother to infant. JAMA 2003;289(2):203-209

5. Clinical Management Guidelines for Obstetrician-Gynecologists. ACOG Practice Bulletin No. 57, 104 (5 pt 1). 2004;1111-1118

6. Binnicker MJ, Espy MJ, Irish CL: Rapid and direct detection of herpes simplex virus in cerebrospinal fluid using a commercial real-time PCR assay. J Clin Microbiol 2014 Oct 1. PMID 25274992

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

The Simplexa HSV (herpes simplex virus)-1 and -2 Direct assay system is a real-time PCR that enables the direct amplification, detection, and differentiation of HSV-1 and HSV-2 DNA from unprocessed spinal fluid specimens without nucleic acid extraction.

 

In this assay, bifunctional fluorescent probe primers are used together with corresponding reverse primers to amplify HSV-1, HSV-2, and internal control targets. Well-conserved regions of the HSV-1 and HSV-2 DNA polymerase genes are targeted to identify HSV-1 and HSV-2 DNA, respectively, in the specimen. An internal control is used to detect PCR failure or inhibition.(Binnicker MJ, Espy MJ, Irish CL: Rapid and direct detection of herpes simplex virus in cerebrospinal fluid using a commercial real-time PCR assay. J Clin Microbiol. Oct 1. PMID 25274992; Package insert: Simplexa HSV 1 and 2 Direct, Focus Diagnostics, Cypress, CA, 07/07/2014)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

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 Sunday

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.

Same day/1 to 2 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

1 week

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

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.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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.

87529 x 2

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports