Test ID: LVZV
Varicella-Zoster Virus, Molecular Detection, PCR
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 (qualitative) detection of varicella-zoster virus DNA in clinical specimens for laboratory diagnosis of disease due to this virus
Method Name A short description of the method used to perform the test
Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
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
Herpes Zoster
PCR (Polymerase Chain Reaction)
Varicella-Zoster Virus Detection by PCR (Polymerase Chain Reaction), CSF
VZV Dermal
VZV Detection by Real-Time PCR
Varicella-Zoster Virus Detection by Real-Time PCR
Varicella-Zoster Virus (VZV)
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.
Specimen source is required.
Submit only 1 of the following specimens:
Preferred:
Specimen Type: Body or ocular fluid
Container/Tube: Sterile container
Specimen Volume: 0.5 mL
Specimen Stability Information: Refrigerated (preferred)/Frozen
Specimen Type: Dermal or eye
Container/Tube: Culture transport swab
Specimen Volume: Swab
Collection Instructions:
1. Swab lesion.
2. Return swab to swab cylinder.
Specimen Stability Information: Refrigerated (preferred)/Frozen
Specimen Type: Genital
Sources: Cervix, rectum, urethra, vagina, other genital site
Container/Tube: Culture transport swab
Specimen Volume: Swab
Collection Instructions: Return swab to swab cylinder.
Specimen Stability Information: Refrigerated (preferred)/Frozen
Specimen Type: Respiratory
Sources: Bronchial washing, bronchoalveolar lavage, nasopharyngeal aspirate or washing, sputum, tracheal aspirate
Container/Tube: Sterile container
Specimen Volume: 1.5 mL
Specimen Stability Information: Refrigerated (preferred)/Frozen
Specimen Type: Spinal fluid
Container/Tube: Sterile vial
Specimen Volume: 0.5 mL
Collection Instructions: Do not centrifuge.
Specimen Stability Information: Refrigerated (preferred)/Frozen
Specimen Type: Tissue
Sources: Brain, liver, lung, etc.
Container/Tube: Sterile container with 1 to 2 mL of sterile saline or multi-microbe medium (M5) (Supply T484)
Specimen Volume: Entire collection
Collection Instructions: Submit only fresh tissue.
Specimen Stability Information: Refrigerated
Acceptable:
Specimen Type: Amniotic fluid
Container/Tube: Amniotic fluid container
Specimen Volume: 0.5 mL
Specimen Stability Information: Refrigerated (preferred)/Frozen
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, or transport swab containing gel; formalin-fixed and/or paraffin-embedded tissues |
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 | Varies | 7 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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).
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 varicella-zoster virus DNA in clinical specimens supports the clinical diagnosis of infection due to this 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 exclude the possibility of varicella-zoster virus (VZV) infection.
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 infection, and must be interpreted in the context of the clinical picture. This test is not used to screen asymptomatic patients.
Supportive Data
The following validation data supports the use of this assay for clinical testing.
Accuracy/Diagnostic Sensitivity and Specificity:
LightCycler PCR (primers, directed to varicella-zoster virus [VZV], gene 28) 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. 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%). Of 100 cerebrospinal fluid specimens tested by both conventional PCR and LightCycler PCR VZV DNA was detected in 49 specimens by both methods; 1 specimen was positive only by the conventional PCR assay. Fifty specimens were found to be negative for VZV DNA by both techniques.
Supplemental Data (Spiking Studies):
To supplement the above data, 30 negative specimens each of various types were spiked with VZV plasmid at the limit of detection (10-20 targets/microliter). The spiked specimens were run in a blinded fashion along with approximately 30 negative (nonspiked) specimens each of various specimens types; 90% to 100% of the spiked specimens were positive and 100% of the nonspiked specimens were negative
Analytical Sensitivity/Limit of Detection (LoD):
The LoD of this assay is 10 to 20 DNA target copies per microliter in specimen matrix.
Analytical Specificity:
No PCR signal was obtained from extracts of 27 bacterial, viral, and fungal isolates that could be found as normal flora in sites normally tested for this organism or that could cause similar symptoms.
Precision:
Interassay precision was 100% and intraassay precision was 97%.
Reportable Range:
This test is a qualitative assay and results are reported as negative or positive for targeted VZV DNA.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. 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 Dis 1997;25(3):634-639
2. 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
3. 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
4. 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
Viral nucleic acid is extracted by the MagNA Pure automated instrument (Roche Applied Science) from clinical specimens. Primers directed to target DNA (ss DNA binding proteins [gene 29]) produce a 202 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 detect (30-40 minutes) amplicon development though stringent air-controlled temperature cycling in capillary cuvettes. The detection of amplified products is based on the fluorescence resonance energy transfer (FRET) 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. Melting curve analysis is performed following PCR amplification. Starting at 45 degrees C, the temperature in the thermal chamber is slowly raised to 80 degrees C, and the fluorescence is measured at frequent intervals. Analysis of the PCR amplification and probe melting curves is accomplished through the use of LightCycler software. (Espy MJ, Teo R, Ross TK, et al: Diagnosis of varicella-zoster virus infections in the clinical laboratory by LightCycler PCR. J Clin Microbiol 2000;38(9):3187-3189)
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 Saturday; varies
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.
87798
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 |
|---|---|---|
| SRC70 | Specimen Source | 31208-2 |
| 81241 | Result | 11483-5 |
| 6176 | Special Information | 48767-8 |
| 6177 | Report Status | N/A |
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