Test ID: VDER
Herpes Simplex Virus (HSV) and Varicella-Zoster Virus (VZV), Molecular Detection, PCR, Dermal
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Rapid diagnosis of herpes simplex virus and varicella-zoster virus infections
Method Name A short description of the method used to perform the test
Detection of HSV and VZV by LightCycler Polymerase Chain Reaction (PCR)
(PCR is utilized pursuant to a license agreement with Roche Molecular System, Inc.)
This test distinguishes HSV-1 from HSV-2 genotypes.
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Varicella-Zoster Virus, Dermal
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Forms: If not ordering electronically, submit a Microbiology Request Form (Supply T244) with the specimen.
Specimen source is required.
Submit only 1 of the following specimens:
Preferred:
Specimen Type: Swab
Sources:
Preferred: Lesion and dermal specimen
Acceptable: Anal/rectal, genital, eye/ocular, urethral
Container/Tube: Culture transport swab
Specimen Volume: Swab
Collection Instructions: Place swab back into swab cylinder.
Acceptable:
Specimen Type: Amniotic fluid
Container/Tube: Amniotic fluid container
Specimen Volume: 0.5 mL
Specimen Type: Body fluid or spinal fluid
Container/Tube: Sterile container
Specimen Volume: 0.5 mL
Specimen Type: Respiratory specimen (upper/lower)
Container/Tube: Sterile container
Specimen Volume: 1 mL
Specimen Type: Tissue
Container/Tube: Sterile container
Specimen Volume: Entire collection
Collection Instructions: Collect fresh tissue specimen.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | Calcium alginate-tipped swab, wood swab, transport swab containing gel |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Refrigerated (preferred) | 7 days |
| Frozen | 7 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Herpes simplex virus (HSV) causes various clinical syndromes. Anatomic sites infected include skin, lips and oral cavity, eyes, genital tract, and central nervous system.(1) Varicella-zoster virus (VZV) causes both varicella (chickenpox) and herpes zoster (shingles). VZV produces a generalized vesicular rash on the dermis (chickenpox) in normal children, usually before 10 years of age. After primary infection with VZV, the virus persists in latent form and may emerge (usually in adults 50 years of age and older) clinically to cause a unilateral vesicular eruption, generally in a dermatomal distribution (shingles).(2)
An automated PCR instrument (LightCycler) is used for nucleic acid amplification in our laboratory. The method has been shown to be more sensitive and rapid than the shell vial assay for the detection of HSV and VZV DNA.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Not applicable
Interpretation Provides information to assist in interpretation of the test results
Detection of herpes herpes simplex virus (HSV) or varicella-zoster virus (VZV) DNA indicates the presence of HSV or VZV in the specimen.
This test, which detects HSV and VZV DNA using an automated PCR instrument (LightCycler) for nucleic acid amplification, is more sensitive and faster than shell vial cell culture.
This LightCycler PCR assay does not yield positive results with other herpesvirus gene targets (HSV, cytomegalovirus, Epstein-Barr virus).
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
A negative result does not eliminate the possibility of herpes simplex virus (HSV) or varicella-zoster virus (VZV) infection. Inhibitors of PCR may be present in some specimens.
The reference range is typically "negative" for this assay. This assay is only to be used for patients with a clinical history and symptoms consistent with VZV and HSV infection, and must be interpreted in the context of the clinical picture. This test is not used to screen asymptomatic patients.
Supportive Data
LightCycler PCR (primers, directed to varicella-zoster virus [VZV], gene 28) testing was compared with shell vial cell cultures for the detection of VZV from 253 dermal specimens. Twenty-three specimens (9.1%) were positive for VZV by LightCycler PCR and by the shell vial cell culture assay. An additional 21 specimens exclusively yielded VZV DNA by LightCycler. These discrepant specimens were resolved as true-positive results by confirmation of results by PCR using primers directed to another gene of VZV. Importantly, there were no instances in which VZV was recovered by the shell vial assay and not detected by LightCycler PCR (specificity 100%).
Earlier studies in our laboratory demonstrated enhanced sensitivity (22% greater) for detection of herpes simplex virus by LightCycler PCR compared with shell vial cell culture using genital and dermal specimen sources.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Schiffer JT, Corye L: New concepts in understanding genital herpes. Curr Infect Dis Rep Nov 2009;11(6):457-464
2. Espy MJ, Uhl JR, Svien KA: Laboratory diagnosis of herpes simplex virus infections in the clinical laboratory by LightCycler PCR. J Clin Microbiol 2000;38(2):795-799
3. Espy MJ, Ross TK, Teo R: Evaluation of LightCycler PCR for implementation of laboratory diagnosis of herpes simplex virus infections. J Clin Microbiol 2000;38(8):3116-3118
4. Sauerbrei A, Eichhorn U, Hottenrott G, Wutzler P: Virological diagnosis of herpes simplex encephalitis. J Clin Virol 2000;17(1):31-36
5. Mitchell PS, Espy MJ, Smith TF, et al: Laboratory diagnosis of central nervous system infections with herpes simplex virus by PCR performed with cerebrospinal fluid specimens. J Clin Microbiol 1997;35(11):2873-2877
6. Yi-Wei T, Mitchell PS, Espy MJ, et al: Molecular diagnosis of herpes simplex virus infections in the central nervous system. J Clin Microbiol 1999;37(7):2127-2136
7. Cinque P, Bossolasco S, Vago L, et al: Varicella-zoster virus (VZV) DNA in cerebrospinal fluid of patients infected with human immunodeficiency virus: VZV disease of the central nervous system or subclinical reactivation of VZV infection? Clin Infect Di1997;25(3):634-639
8. Brown M, Scarborough M, Brink N, et al: Varicella zoster virus-associated neurological disease in HIV-infected patients. Int J STD AIDS 2001;12(2):79-83
9. Studahl M, Hagberg L, Rekabdar E, Bergstrom T: Herpesvirus DNA detection in cerebrospinal fluid: differences in clinical presentation between alpha-, beta-, and gamma-herpesviruses. Scand J Infect Dis 2000;32(3):237-248
10. Iten A, Chatelard P, Vuadens P, et al: Impact of cerebrospinal fluid PCR on the management of HIV-infected patients with varicella-zoster virus infection of the central nervous system. J Neurovirol 1999;5(2):172-180
Method Description Describes how the test is performed and provides a method-specific reference
Herpes Simplex Virus (HSV):
Viral nucleic acid is extracted from genital, dermal, and ocular specimens. Primers directed to the DNA polymerase gene of HSV produce 215-bp and 239-bp amplicons, respectively. The LightCycler instrument amplifies and monitors by fluorescence the development of target nucleic acid sequences after the annealing step during PCR cycling. This is an automated PCR system that can rapidly (30-40 minutes) detect amplicon development through stringent air-controlled temperature cycling and capillary cuvettes. The detection of amplified products is based on the fluorescence resonance energy transfer (FRET) principle. For FRET product detection, a hybridization probe with a donor fluorophore, fluorescein, on the 3’ end is excited by an external light source and emits light that is absorbed by a 2nd hybridization probe with an acceptor fluorophore, LC-Red 640, at the 5' end. The acceptor fluorophore then emits a light of a different wavelength that can be measured with a signal that is proportional to the amount of specific PCR product. LightCycler hybridization probes were designed for HSV type 2, and sequence differences between HSV type 2 and HSV type 1 are detected by melting curve analysis. Melting curve analysis is performed following PCR amplification. Starting at 54 degrees C, the temperature in the thermal chamber is slowly raised to 95 degrees C, and the fluorescence is measured at frequent intervals. Sequence differences between the PCR product and hybridization probes result in shifts in the melting temperatures. (66.7 degrees C fro HSV type 1 and 74.7 degrees C for HSV type 2) that are detected. Analysis of the PCR amplification and probe melting curves is accomplished through the use of LightCycler software. (Espy MJ, Uhl JR, Svien KA, et al. Laboratory diagnosis of herpes simplex virus infections in the clinical laboratory by LightCycler PCR. J Clin Microbiol 2000;38:795-799)
Varicalla-Zoster Virus (VZV):
Viral nucleic acid is extracted from dermal specimens. Primers directed to gene 28 of VZV produce a 287 bp amplicon. The LightCycler instrument amplifies and monitors by fluorescence the development of target nucleic acid sequences after the annealing step during PCR cycling. This is an automated PCR system that can rapidly (30-40 minutes) detect amplicon development through stringent air-controlled temperature cycling and capillary cuvettes. The detection of amplified products is based on the fluorescence resonance energy transfer (FRET) principle. For FRET product detection, a hybridization probe with a donor fluorophore, fluorescein, on the 3' end is excited by an external light source and emits light that is absorbed by a second hybridization probe with an acceptor fluorophore, LC-Red 640, at the 5' end. The acceptor fluorophore then emits a light of a different wavelength that can be measured with a signal that is proportional to the amount of specific PCR product. Analysis of the PCR amplification is accomplished through the use of LightCycler software. (Espy MJ, Uhl JR, Svien KA, et al: Laboratory diagnosis of herpes simplex virus infections in the clinical laboratory by LightCycler PCR. J Clin Microbiol 2000;38:795-799)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Sunday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
87529-HSV-1 and HSV-2
87798-VZV
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| SRC75 | Specimen Source | 31208-2 |
| 82048 | Result | 33027-4 |
| 21085 | Special Information | 48767-8 |
| 21086 | Report Status | N/A |
External
link
PDF
document
Excel
document
Word
document