Background:

The Microbiology Division at UCI Health’s Department of Pathology & Laboratory Medicine will switch to the Focus Diagnostics Simplexa HSV-1 & 2 Direct assay. The U.S. Food and Drug Administration-approved assay is a real-time PCR that enables the direct amplification, qualitative detection and differentiation of HSV-1 and/or HSV-2 DNA from unprocessed cerebrospinal fluid (CSF), mucocutaneous and cutaneous swab samples. In contrast to our current assay, extraction and amplification are performed within one protocol with no separate nucleic acid extraction step. This change will improve turnaround time (TAT) and increase test throughput.

Methodology and Reporting:

HSV-1 and HSV-2 will be detected by real-time PCR and reported as HSV-1 and/or HSV-2 (detected or not detected).

Effective date: June 27, 2018

Specimen Requirement and Testing Information:

HSV-1 and HSV-2 by PCR, CSF
Specimen: Spinal Fluid: 1 mL of fluid in a sterile container.
Test Code: SHSVCS

HSV-1 and HSV-2 by PCR, Lesions
Specimen: Mucocutaneous sites: anorectal, genital, urethral, nasal, ocular, oral and skin. Collect on swabs and transport in viral transport media (BD UVT, M4, M4RT, M5, M6 or UTM).

Test Code: SHSVMC
STAT: Available ONLY to the following patient groups:
- Women in labor or women who have delivered without previous prenatal care
- Newborns

Stability:
Ambient: Unacceptable
Refrigerated: Seven days
Frozen: at -70C: three months

Turnaround Time (TAT):
STAT: 120 minutes
Routine: One day
Set-up days: Daily

Rejection Criteria: Specimens that exceed stated stability, unlabeled/ mislabeled/ mismatched specimens and specimens submitted in leaking containers, non-sterile containers.

A summary of all tests offered by our Laboratory Services can be found here: http://www.pathology.uci.edu/services/index.asp

Sincerely,

Cassiana Bittencourt, MD
Director, Division of Clinical Microbiology

Edwin S. Monuki, MD, PhD
Chair, Department of Pathology & Laboratory Medicine