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). Clinical positive control material.

Interpretation: Results will be reported as DETECTED (positive), INVALID, or Not detected (negative).  Syphilis serology should be reviewed in light of clinical presentation. 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 Micropathology Ltd, Coventry for confirmatory testing (7-10 day turnaround).

Additional Information:

Background information:  Treponema pallidum subspecies pallidum (T. pallidum) is a spirochaete bacterium which is the causative agent of Syphilis, a sexually transmitted disease that can infect a variety of tissues and organs. The typical hallmark of primary Syphilis is the appearance of a cutaneous lesion called a chancre at the site of infection. This usually occurs in the genital regions but can also occur at extra-genital sites of inoculation, including oral-facial sites. Secondary Syphilis is characterised by diffuse rash in the trunk and extremities and can also manifest as mucosal lesions at oral and genital sites. Tertiary Syphilis can result in more serious manifestations including hepatitis, arthritis, neurosyphilis, cardiovascular syphilis, and granulomatous syphilis, if left untreated.