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Herpes Simplex Virus 1 & 2 (HSV-1 & HSV-2) Quantitative Real-time PCR

Test Code: 8500

Cpt Code:

87530 (x2)

Clinical Utility

HSV-1 and HSV-2 are well known etiologic agents of gingivostomatitis, conjunctivitis, keratitis, herpetic whitlow, and genital infections as well as encephalitis, aseptic meningitis, atypical pneumonias and a wide variety of other clinical conditions. Quantitative HSV DNA PCR is the ideal diagnostic tool for CNS specimens, since HSV will rarely grow from CSF in cell culture. Quantitative PCR can be used to detect the presence of the virus as well as track the course of infections and response to treatment.

Procedure

Extraction of Herpes Simplex viral DNA from specimen followed by amplification and detection using real-time, quantitative PCR. An internal control is added to ensure the extraction was performed correctly and the PCR reaction was not inhibited. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

The HSV-1 and HSV-2 primers and probes used in this assay are specific for HSV-1 & 2 only and detect known HSV-1 & 2 strains based on similarity search algorithms. The individual primers and probes for HSV-1 and HSV-2 are unique and specific, with no cross reactivity between the HSV-1 and HSV-2 primers. Additionally, no cross reactivity was detected when tested against adenoviruses, BKV, CMV, EBV, HHV-6 variant A, HHV-6 variant B, HHV-7, HHV-8, JCV, parvovirus B19, SV-40, and VZV.

Causes For Rejection

Specimens beyond their acceptable length of time from collection as listed in the specimen handling, specimens received in trap containers or specimen types other than those listed.

Turnaround Time

Same day (within 8 to 12 hours of receiving specimen), Monday through Saturday.

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086

Specimen Information

8545 aqueous fluid

NY approved. Assay Range for HSV 1 is 2,176 copies/mL to 1x108 copies/mL. Assay Range for HSV 2 is 748 copies/mL to 1x108 copies/mL. Transfer collected amount to sterile, screw top tube for shipment (minimum volume 0.05 mL). Do not add water, saline or other fluid media to container. Do not ship specimen in syringe. Store frozen and ship on dry ice to Viracor-IBT.

8509 BAL

NY approved.  Assay Range for HSV 1 is 58 copies/mL to 1x108 copies/mL. Assay Range for HSV 2 is 248 copies/mL to 1x108 copies/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Ship frozen on dry ice to Viracor-IBT.

8526 bronch wash

NY approved.  Assay Range for HSV 1 is 58 copies/mL to 1x108 copies/mL. Assay Range for HSV 2 is 248 copies/mL to 1x108 copies/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Ship frozen on dry ice to Viracor-IBT.

8503 CSF

NY approved.  Assay Range for HSV 1 is 50 copies/mL to 1x108 copies/mL. Assay Range for HSV 2 is 71 copies/mL to 1x108 copies/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Store frozen and ship on dry ice for overnight delivery to Viracor-IBT.

8527 eye swab

NY approved.   (CPT Code:87529 X 2) Assay Range: (Detected/Not Detected). Sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube (minimum volume 0.5 mL). Do not use calcium alginate swab or wood shafted swab. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

8528 genital swab

NY approved.  (CPT Code:87529 X 2) Assay Range: (Detected/Not Detected). Sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube (minimum volume 0.5 mL). Do not use calcium alginate swab or wood shafted swab. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

8520 mouth swab

NY approved. (CPT Code:87529 X 2) Assay Range: (Detected/Not Detected). Sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube (minimum volume 0.5 mL). Do not use calcium alginate swab or wood shafted swab. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

8525 NP swab

NY approved.  (CPT Code:87529 X 2) Assay Range: (Detected/Not Detected). Sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube (minimum volume 0.5 mL). Do not use calcium alginate swab or wood shafted swab. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

8501 plasma

NY approved.  Assay Range for HSV 1 is 37 copies/mL to 1x108 copies/mL. Assay Range for HSV 2 is 73 copies/mL to 1x108 copies/mL. Collect 4-5 mL whole blood in EDTA or ACD tube, centrifuge and transfer 2 mL plasma to sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

8521 rectal swab

NY approved.  (CPT Code:87529 X 2) Assay Range: (Detected/Not Detected). Sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube (minimum volume 0.5 mL). Do not use calcium alginate swab or wood shafted swab. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

8510 serum

NY approved.  Assay Range for HSV 1 is 37 copies/mL to 1x108 copies/mL. Assay Range for HSV 2 is 73 copies/mL to 1x108 copies/mL. Collect 4-5 mL whole blood in red top tube, centrifuge and transfer 2 mL serum to sterile, screw top tube (minimum volume 0.5 mL ). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

8529 skin swab

NY approved.  (CPT Code:87529 X 2) Assay Range: (Detected/Not Detected). Sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube (minimum volume 0.5 mL). Do not use calcium alginate swab or wood shafted swab. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

8506 tissue [Qual]

NY approved. (CPT Code:87529 X 2) Assay Range: (Detected/Not Detected). Place fresh tissue in a sterile, screw top container. The preferred handling is to not add water, saline or other fluid media to the tissue container; however, fluid media filled containers will be accepted for qualitative results. Store frozen and ship on dry ice for overnight delivery to Viracor-IBT. Formalin fixed, paraffin embedded tissue will not be accepted.

8505 tissue [Quant]

NY approved.  Assay Range for HSV 1 is 3 copies/mg to 1x107 copies/mg. Assay Range for HSV 2 is 12 copies/mg to 1x107 copies/mg. Place a minimum of 5 mg fresh tissue (approximately ½ of a pencil eraser size) in a sterile, screw top container. Do not add water, saline or other fluid media to container. Store frozen and ship on dry ice for overnight delivery to Viracor-IBT. Formalin fixed, paraffin embedded tissue will not be accepted.

8519 trach asp

NY approved.  Assay Range for HSV 1 is 58 copies/mL to 1x108 copies/mL. Assay Range for HSV 2 is 248 copies/mL to 1x108 copies/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Ship frozen on dry ice to Viracor-IBT.

8548 trach wash

NY approved.  Assay Range for HSV 1 is 58 copies/mL to 1x108 copies/mL. Assay Range for HSV 2 is 248 copies/mL to 1x108 copies/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Ship frozen on dry ice to Viracor-IBT.

8514 vitreous fluid

NY approved. Assay Range for HSV 1 is 2,176 copies/mL to 1x108 copies/mL. Assay Range for HSV 2 is 748 copies/mL to 1x108 copies/mL. Transfer collected amount to sterile, screw top tube for shipment (minimum volume 0.05 mL). Do not add water, saline or other fluid media to container. Do not ship specimen in syringe. Store frozen and ship on dry ice to Viracor-IBT.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Viracor-IBT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

PCR tests are performed pursuant to a license agreement with Roche Molecular Systems, Inc.

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