090-70-0090-04

HSV (Herpes Simplex Virus) I&II, PCR, Source Specify

1.Genital Swab/Universal Transport Media (UTM) 1 mL, 1 tube or
2. Eye Swab/Universal Transport Media (UTM) 1 mL, 1 tube or
3. Oral Swab/Universal Transport Media (UTM) 1 mL, 1 tube or
4. Throat Swab/Universal Transport Media (UTM) 1 mL, 1 tube or
5. Eye fluid/Sterile Container

1.Genital Swab
2. Eye Swab
3. Oral Swab
4. Throat Swab
5. Eye fluid

Universal Transport Media (UTM) tube or Sterile Container

Specimen is added any preservative solution.

Specimen Type	Temperature	Time
Genital Swab	Refrigerated, 2oC to 8oC	7 days
Eye Swab
Oral Swab
Throat Swab
Eye fluid

090-70-0090-04

HSV (Herpes Simplex Virus) I&II, PCR, Source Specify

Multiplex real-time polymerase chain reaction (PCR)

Test daily

Received specimen to reported within 1 day.

Molecular biology & Genetics, Laboratory Department Tel.14168

7 days

090-70-0090-04

HSV (Herpes Simplex Virus) I&II, PCR, Source Specify

Genital herpes caused by HSV is one of the most common sexually transmitted diseases. HSV primary infection or reactivation of latent disease can cause cutaneous or mucosal lesions. These lesions are usually self-limited but severe disease can occur in compromised patients, pregnant woman and infants. Encephalitis is inflammation of the brain associated with clinical evidence of neurologic dysfunction. Of the pathogens reported to cause encephalitis, the majority are viruses. HSV causes about 5–10% of all encephalitis cases, and is one of the most common causes of identified sporadic encephalitis globally. HSV encephalitis occurs in all ages, and during all seasons. Clinical features involved with HSV encephalitis include fever, hemicranial headache, language and behavioral abnormalities, memory impairment, and seizures. The diagnosis of herpes virus relies predominately on culture or direct fluorescent antibody (DFA) staining methods. However, these methods are labor intensive, time consuming, and subjective. Rapid and accurate testing for HSV infection utilizing molecular detection can be critical for both therapeutic decision-making and infection control.

Test	Reference Value
HSV type 1	Negative
HSV type 2	Negative

1. Results from this test must be considered in conjunction with the clinical history, epidemiological data and other laboratory information available to the clinician evaluating the patient.
2. The detection of viral nucleic acid is dependent upon proper sample collection, transport, handling and storage. Failure to observe proper procedures in any one of these steps can lead to incorrect results.
3. Negative results do not rule out HSV infections of the CNS and should not be used as the sole basis for treatment or other patient management decisions.
4. False-negative results may occur if the viruses are present at a level that is below the analytical sensitivity of the assay or if the virus has genomic mutations, insertions, deletions, or rearrangements or if performed very early in the course of illness.
5. For encephalitis patients with a negative herpes simplex PCR result, consideration should be given to repeating the test 3–7 days later for patients demonstrating a compatible clinical syndrome or temporal lobe localization on neuroimaging.
6. A positive result by this test cannot rule out infections caused by other viral or bacterial pathogens. Viral nucleic acids may persist in vivo independent of virus viability. Detection of target analyte(s) does not imply that the corresponding viruses are infectious or are the causative agent for clinical symptoms.

Manufacturer’s packages insert, Simplexa™ HSV 1 & 2 Direct Rev. E, August 2015, Focus Diagnostics, CA 90630 Cypress, USA.