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HERPES SIMPLEX VIRUS (HSV) 1/2 DNA BY REAL TIME PCR

Mnemonic

HSV DNA PCR

Synonym

Herpes PCR - HSV

Specimen Collection Requirements

Collect

Submit swab from tissue or vesicle fluid in M4, M4-RT or M6 viral transport media. Collect in appropriate container and freeze. Do not collect samples with calcium alginate swabs.

Handling

Refrigerate or freeze within 30 minutes of collection. Freeze for transport to testing lab.

Preferred Volume

1.0 mL

Minimum Volume

0.5 mL

Transport

Frozen in viral transport media

Rejection Criteria

CSF, BAL, plasma or serum, samples collected with calcium alignate swabs, specimens received at room temperature or refrigerated longer than 24 hours

Stability

Ambient: 30 minutes; Refrigerated: 24 hours; Frozen: 3 months

Testing Information

Note

CSF and BAL specimens are sent to a referral lab.

Performed

Mon, Wed, Fri (am)

Reported

1-3 days

Method

Method:

Real-Time Polymerase Chain Reaction (PCR)

Analytical Sensitivity:

100% (n = 20)

Analytical Specificity:

No cross reactivity was observed in samples
spiked with CMV, VZV, normal oral flora, or normal genital flora.

Limit of Detection:

7 copies/µL for HSV1 and HSV2

A negative result indicates no HSV DNA was detected but does not rule out the presence of HSV DNA below the detection limit of the assay and/or presence of inhibitory substances.

Assay methodology is real-time polymerase chain reaction (RT-PCR) performed pursuant to a license agreement with Roche Molecular Systems, Inc.

This test, which uses Analyte Specific Reagents, was developed and its performance characteristics determined by Legacy Laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.

Reference Values

Reference Values

Negative:    HSV DNA not detected by PCR.
Positive:      HSV DNA detected by PCR. Result includes Type 1 or 2.
Interpretation provided.

Comments

A negative result may reflect viral DNA below the level of detection by PCR.

CPT Codes

87529

Last Updated: Thursday, January 5, 2017 03:41:02 AM


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