CDOS

HERPES SIMPLEX VIRUS, NAAT

Test Code: LAB917

Test Link (Copy)

Synonym

HSV NAAT ; HSV Detection and Differentiation by Real-time PCR; HSV; Herpes; Molecular; Herpes Simplex Virus I and II Detection and Differentiation by PCR

Specimen Type

CSF or swabs of lesions from anorectal, genital, nasal, ocular, oral, urethral, cutaneous placed in viral transport media

Preferred Volume

0.2 mL for CSF or for swabs in transport media

Minimum Collection Volume

0.08 mL for CSF or for swabs in transport media

Specimen Handling

CSF in sterile polypropylene tube. (Do not place in any media) Genital swabs in viral transport media (BD Universal Transport Media, Remel M4, M4RT, M5, M6, and UTM)

Limitations

The detection of viral nucleic acid is dependent upon proper sample collection, transport, handling and storage. Failure to observe proper procedures in any one of these steps can lead to incorrect results.

Unacceptable Conditions

CSF added to viral transport media; calcium alginate swabs; samples that have exceeded stability or that have been received in non-sterile or leaking containers. Blood collection

Temperature

Refrigerated for CSF and swabs in transport media; freeze sample if testing will be delayed more than 7 days.

Methodology

Real-Time PCR

Stability

Room Temp: 2 hours
Refrigerated: 7 days
Freeze at -70C if processing will not occur within 7 days

Test Includes

Herpes Simplex Virus Type 1, Herpes Simplex Virus Type 2

Turn Around Time

1-3 days

Place of Service

SHMC

Department

Microbiology

Additional Information

For routine immune status screening for exposure, order HSVGB/LAB12526 for HSV 1 and 2 IgG antibodies. The Simplexa® HSV 1 & 2 Direct assay system is a real-time PCR that enables the direct amplification, detection and dfferentiation of HSV-1 and/or HSV-2 DNA from unprocessed CSF and vaginal swab specimens without nucleic acid extraction. The utility of PCR of CSF specimens has greatly increased the ability to diagnose infections of the CNS, especially viral infections caused by the herpesviruses. The American Congress of Obstetricians and Gynecologists (ACOG) has recognized that HSV PCR is 1.5-4 times more sensitive than viral culture for the diagnosis of genital HSV infection. This test was developed and its performance characteristics determined by PSHMC. This test is approved by the U.S. Food and Drug Administration (FDA) for CSF and genital swabs in viral transport media; however, the FDA has not approved or cleared this test for genital swab specimens stored in ThipPrep®. FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. PSHMC is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.

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