HSV SemiQnt Rapid PCR, Swab/CSF

The DiaSorin Simplexa™ HSV 1 & 2 Direct FDA approved assay is a rapid real-time PCR that enables the direct amplification, detection and differentiation of HSV-1 and/or HSV-2 DNA from both cutaneous and mucocutaneous swab specimens and CSF specimens. Well conserved regions of the HSV-1 and HSV-2 DNA polymerase genes are targeted to identify HSV-1 and HSV-2 DNA respectively in the specimen. Results are reported as "detected" or "not detected" and a semi-qualitative result is provided by reporting the PCR Cycle threshold (Ct) value for positive specimens.

For blood or clear, non-cellular fluid samples (e.g., BAL or washing that do not contain visible cellular material), it is acceptable to order quantitative testing. In such cases, refer to HSV Type 1 & 2 Quant PCR, Blood/Eye Fluid [HS12QN].

For tissue biopsy, bone marrow, or cellular fluid samples (e.g., BAL or washing containing visible cellular material), qualitative testing should be ordered. In these instances, refer to HSV Type 1 & 2 Qual PCR, Tissue [HS12QL].

Swab: Acceptable specimen types are cutaneous and mucocutaneous swabs stored in UTM, Remel M4, Remel M4RT, Remel M5, or Remel M6 transport media. Follow the manufacturers’ package inserts for collection media and acceptable swab types. Do not use calcium alginate swabs, as they may contain substances that inhibit PCR testing.

CSF: 1 mL in sterile container

Unacceptable samples: Calcium alginate swabs, as they may contain substances that inhibit PCR testing.

Note: Separate specimens MUST be submitted when both Viral Culture/Serology and PCR testing are ordered.

Minimum sample requirement: 0.1 mL

Swabs: Transport specimens on ice, store at 2 to 8°C for up to 7 days post collection. If there is a greater than 7 days delay before testing of the specimen, store specimen at -60 to -85°C. Do not freeze/thaw.

CSF: If CSF has cellular material, centrifuge & aliquot clear CSF. Transport CSF on ice, store at 2 to 8°C for up to 7 days post collection. If there is a greater than 7 days delay before testing of the specimen, store specimen at -60 to -85°C. Do not freeze/thaw.

Outside Laboratory: Ship samples on dry ice. If -60 to -85°C freezer and/or dry ice is not available, ship immediately at 2-8°C (ice pack). Sample may be stored at 2-8°C (ice pack) for up to 7 days of collection. Samples stored at 2-8°C greater than 7 days old may be rejected. Do not freeze/thaw.