Special Precautions/Comments:

N.B. This test is part of a multiplex PCR assay for the detection of Herpes Simplex Virus (HSV-1 and HSV-2), Varicella Zoster Virus (VZV) and Treponema pallidum (Syphilis).

The following sample types have not been validated for the current testing process:

• cobas® PCR Media Uni Swab Sample Kit (Yellow top)
• Eye fluid (vitreous or aqueous humor)
• CSF

Interferences:  False negatives may occur if sample is outside of viraemic phase.

Method:  Real-time polymerase chain reaction (qPCR) for the simultaneous detection of HSV-1 and HSV-2, VZV and T. pallidum (Syphilis).  Calibration: N/A.  EQA scheme: QCMD.  IQC: Internal kit control (SpeeDx PlexPCR® VHS assay). External positive control material (Zeptomatrix).

Interpretation: Results will be reported as DETECTED (positive), INVALID, or Not detected (negative).  A negative result does NOT fully exclude infection. Samples resulted as Invalid will be repeated and a further report issued. Samples may remain invalid due to inhibitory substances within the sample. Clinical comment will be provided for positive samples from non-GUM patients as appropriate. Positive samples may be referred to Newcastle Hospitals Virology Service for confirmatory testing (7-10 day turnaround).

Additional Information:

Background information:  Infections of Herpes Simplex Virus serotype 1 and 2 (HSV-1 and HSV-2) in humans can cause lesions at a range of sites including, oral-facial, genital, eye, skin and central nervous system. Lesions can result from primary infection or reactivation of latent infection. HSV1 predominantly causes oral-facial infections while HSV-2 is commonly associated with sexually transmitted infections. Cutaneous specimens include skin and penis, and mucocutaneous specimens include vaginal, eye, and oral sites. In rare occasions, herpes viruses are also associated with viral encephalitis and meningitis, as well as neonatal infections caused by perinatal transmission.