HSV- 1 and HSV - 2 by Real Time PCR

CERNER / EPIC MNEMONIC:

HSVPCRRT

CPT CODE:

87529 x 2

TEST INFORMATION:

This test includes detection of HSV-1 and HSV-2.  Herpes simplex virus detected in CSF.  Herpes simplex identified in a child < 1 year old.  Detects HSV-1 and HSV-2 in skin and genital specimens.

DAYS PERFORMED:

Monday, Wednesday, and Friday

TURNAROUND TIME:

Maximum of 72 hours

SPECIAL INSTRUCTIONS:

Specimen should be received by the laboratory as soon as possible.

CONTAINER TYPE:

CSF collection tube ; M4 transport media for swabs

COLLECTION:

Specimens should be collected in the acute stage of the disease, preferably within 3 days and no longer than 7 days after onset of illness.  Specimens should be collected on a sterile swab and placed into M4 transport medium immediately after collection.
Endocervical:  Clean the cervical area of mucus with a sterile swab and discard the cleaning swab.   Place a second sterile swab into the cervical os and rotate to collect epithelial cells.  Place the swab into M4 transport medium immediately after collection.
Vesicular lesions:  Wash the surface of vesicles with sterile saline.  Carefully open several vesicles and soak up the vesicular fluid with a swab.  If vesicles are absent, vigorously swab the BASE of the lesion.  The specimen should be collected during the first 3 days of eruption.  Place the swab into M4 transport medium immediately after collection.
CSF:  Cerebrospinal fluid should be collected by a physician using standard sterile technique.

SPECIMEN REQUIREMENTS:

Specimen depends upon the type of infection:
Viral Encephalitis or Meningitis: 1 ml of CSF in a sterile tube from the lumbar puncture kit.
Genital (vesicle fluid, lesion, endocervical), skin (vesicle fluid, lesion), oropharynx (vesicle, lesion)

REJECTION CRITERIA:

Specimen not received in a sterile sealed container; specimen not closed properly and leaked into transport container; excessive delay in transport; inappropriate specimen container; specimen unlabeled or mislabled.

MINIMUM VOLUME:

1 mL of CSF or one swab in M4 transport media

HANDLING INSTRUCTIONS:

The specimen should be transported to the laboratory as soon as possible.  When transportation is delayed, refrigerate.

REFERENCE RANGE:

No HSV-1 or  HSV-2 detected

LIMITATIONS OF TEST:

Reliable results are dependent on appropriate specimen collection, transport, storage, and processing procedures.  No detection limits have been established for other specimen types or transport media.

METHODOLOGY:

Isolation of target DNA, real-time PCR with detection by target specific probes for HSV-1 and HSV-2.

ADDITIONAL INFORMATION:

In house studies have shown the analytical sensitivity of this assay is 10 copies/PCR reaction and 250 copies/patient specimen.  The genes that are amplified and detected in this assay are surface glycopeptide gG (HSV-1) and gD (HSV-2).
The detection of Herpes simplex virus type 1 (HSV-1) and Herpes simplex virus type 2 (HSV-2) DNA is based upon the real-time amplification and detection of specific HSV genomic DNA sequences by PCR from total DNA extracted from the specimen.  Probes specific for HSV-1 and HSV-2 are used to identify and differentiate the products of the PCR amplification.
The diagnosis of HSV-1 and HSV-2 infection should not rely solely upon the result of a PCR assay.  A positive PCR result should be considered in conjunction with clinical presentation and additional established diagnostic tests prior to establishing a diagnosis.  A negative PCR result indicates the absence of HSV-1 or HSV-2 DNA in a sample tested and does not exclude the diagnosis of disease.  
This test or one or more of its components was developed and its performance characteristics determined by RML Laboratories, Division of Clinical Microbiology.  It has not been cleared or approved by the U.S. Food and Drug Administration (FDA).  The FDA has determined that such clearance or approval is not necessary.  This test is performed pursuant to a license agreement with Roche Molecular Systems. Inc.

LAST UPDATED:

5-27-2014

TEST SYNONYM(S):HSV 1 & 2 detection by real time PCR; Herpes simplex virus by real time PCR; Herpes simplex