Search

Browse by Name

Phone Extensions

_{Laboratory Main Line}	_208-625-5858
_{Point of Care}	_208-625-4218

Fax Extensions

Incoming Orders/Requisitions	208-769-8581
_{General Laboratory}	_208-625-5822
_{Blood Bank}	_208-625-5821
_Microbiology	_208-625-5823

Accreditations

The College of American Pathologists (CAP's) Laboratory Accreditation Program accredits the entire spectrum of laboratory test disciplines with the most scientifically rigorous customized checklist requirements.

The CAP's peer-based inspector model provides a unique balance of regulatory and educational coaching supported by the most respected worldwide pathology organization.

The Laboratory Accreditation Program inspects a variety of laboratory settings from complex university medical centers to physician office laboratories, and covers a complete array of disciplines and testing procedures.

www.cap.org

Regulatory Links

CLIA Certification (2023 to 2025)

CAP Certification

Mayo Clinic Laboratories

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

Secondary ID

63434

Useful For

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

Method Name

Real-Time Polymerase Chain Reaction (RT-PCR)

Reporting Name

Herpes Simplex Virus, PCR, CSF

Specimen Type

CSF

Specimen Required

Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Container/Tube: Plastic vial

Specimen Volume: 0.2 mL

Collection Instructions:

1. Submit from second spinal fluid collection vial.

2. Transfer into aliquot vial using sterile technique.

3. Do not centrifuge or heat inactivate.

Additional Information:

1. The high sensitivity of amplification by polymerase chain reaction (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.

Specimen Minimum Volume

0.1 mL

Specimen Stability Information

Specimen Type	Temperature	Time	Special Container
CSF	Refrigerated (preferred)	7 days
	Frozen	7 days

Reject Due To

Heat-treated spinal fluid

Reject

Clinical Information

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 frequently 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 3200 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

Negative

Interpretation

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

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 Simplexa HSV (herpes simplex virus)-1 and -2 Direct assay, clinical spinal fluid (CSF) 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 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

1. Lawrence C. Herpes Simplex virus. In: Mandell GL, Bennet JE, Dolin R, eds. Principles and Practice of Infectious Diseases. 6th ed. Elsevier, Churchill and Livingstone; 2004:1762-1780

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;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;52(12):4361-4362

Method Description

The Simplexa HSV (herpes simplex virus)-1 and -2 Direct assay system is a real-time polymerase chain reaction (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. 2014;52(12):4361-4362; Package insert: Simplexa HSV 1 & 2 Direct. Diasorin; REF MOL2150. Rev 05. 09/05/2018)

Day(s) Performed

Monday through Sunday

Report Available

Same day/1 to 2 days

Specimen Retention Time

7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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

87529 x 2

87529 (if appropriate for government payers)

LOINC Code Information

Test ID	Test Order Name	Order LOINC Value
HSVC	Herpes Simplex Virus, PCR, CSF	92865-5

Result ID	Test Result Name	Result LOINC Value
36858	HSV 1 PCR, C	16952-4
36859	HSV 2 PCR, C	16960-7

Testing Algorithm

For more information see Meningitis/Encephalitis Panel Algorithm.

Special Instructions

Meningitis/Encephalitis Panel Algorithm

Forms

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

Kootenai Health powered by Mayo Clinic Laboratories