Test Id : VZVPV
Varicella-Zoster Virus, Molecular Detection, PCR, Varies
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
This test should not be used to screen asymptomatic patients.
Method Name
A short description of the method used to perform the test
Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Chickenpox
Herpes Zoster
PCR (Polymerase Chain Reaction)
Shingles
Varicella-Zoster Virus (VZV)
Varicella-Zoster Virus Detection by PCR (Polymerase Chain Reaction), CSF
Varicella-Zoster Virus Detection by Real-Time PCR
VZV Dermal
VZV Detection by Real-Time PCR
Specimen Type
Describes the specimen type validated for testing
Varies
Necessary Information
1. Specimen source is required.
2. Source information must include main anatomical site of collection.
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| VZVS | Specimen Source |
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Submit only 1 of the following specimens:
Specimen Type: Spinal fluid
Collection Container/Tube:
Preferred: Vial number 2
Acceptable: Any vial number
Submission Container/Tube: Sterile screw cap vial
Specimen Volume: 0.5 mL
Collection Instructions: Do not centrifuge.
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Specimen Type: Body fluid
Sources: Pleural, peritoneal, ascites, pericardial, amniotic, or ocular
Container/Tube: Sterile container
Specimen Volume: 0.5 mL
Collection Instructions: Do not centrifuge.
Specimen Type: Swab
Sources: Miscellaneous; dermal, eye, nasal, throat, or genital
Supplies:
-Culturette (BBL Culture Swab) (T092)
-BD E-Swab (T853)
-M4-RT (T605)
Container/Tube: Multimicrobe media (M4-RT, M4, M5, Bartels, or Jiangsu) and E-Swab or Culturette
Collection Instructions: Place swab back into multimicrobe media.
Specimen Type: Respiratory
Sources: Bronchial washing, bronchoalveolar lavage, nasopharyngeal aspirate or washing, sputum, or tracheal aspirate
Container/Tube: Sterile container
Specimen Volume: 1.5 mL
Specimen Type: Fresh tissue
Supplies: M4-RT (T605)
Container/Tube:
Preferred: Multimicrobe media (M4-RT, M4, M5, Bartels, or Jiangsu)
Acceptable: Sterile container with 1 to 2 mL of sterile saline
Specimen Volume: Entire collection
Collection Instructions: Submit only fresh tissue. Fixed tissue is not acceptable.
Forms
If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
Ocular Fluid and Spinal Fluid: 0.3 mL
Body Fluid (pleural, peritoneal, ascites, and pericardial): See Specimen Required
Respiratory Specimens: 1 mL
Tissue: 2 x 2 mm biopsy
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Calcium alginate-tipped swab Wood swab Transport swab containing gel Formalin-fixed and/or paraffin-embedded tissues Heat-inactivated specimen Dry/flocked E-Swab | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Refrigerated (preferred) | 7 days | |
| Frozen | 7 days |
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
This test should not be used to screen asymptomatic patients.
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 clinically (usually in adults 50 years of age and older) 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.
Negative
Reference values apply to all ages.
Interpretation
Provides information to assist in interpretation of the test results
Detection of varicella-zoster virus (VZV) DNA in clinical specimens supports the clinical diagnosis of infection due to this virus.
VZV DNA is not detected in cerebrospinal fluid from patients without central nervous system disease caused by this virus.
This LightCycler polymerase chain reaction assay does not yield positive results with other herpesvirus gene targets (herpes simplex virus, 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 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.
Supportive Data
The following validation data supports the use of this assay for clinical testing.
Accuracy/Diagnostic Sensitivity and Specificity:
LightCycler polymerase chain reaction (PCR) (primers, directed to varicella-zoster virus [VZV], gene 29) 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 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 various specimen type 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 (non-spiked) specimens each of various specimen types; 90% to 100% of the spiked specimens were positive and 100% of the non-spiked specimens were negative.
Analytical Sensitivity/Limit of Detection:
The limit of detection 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
Recommendations for 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, Manji H, Miller R. 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
5. Sauerbrei A. Varicella-zoster virus infections - antiviral therapy and diagnosis. GMS Infect Dis. 2016;4:Doc01. doi:10.3205/id000019
6. Sauerbrei A. Diagnosis, antiviral therapy, and prophylaxis of varicella-zoster virus infections. Eur J Clin Microbiol Infect Dis. 2016;35(5):723-734. doi:10.1007/s10096-016-2605-0
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-base pair 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 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.(Dhiman N, Wright PA, Espy MJ, Schneider SK, Smith TF, Pritt BS. Concurrent detection of herpes simplex and varicella-zoster viruses by polymerase chain reaction from the same anatomic location. Diagn Microbiol Infect Dis. 2011;70(4):538-540. doi:10.1016/j.diagmicrobio.2011.03.014; Espy MJ, Teo R, Ross TK, Scien KA, Wold AD, Smith TF. Diagnosis of varicella-zoster virus infections in the clinical laboratory by LightCycler PCR. J Clin Microbiol. 2000;38[9]:3187-3189)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Sunday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
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
Indicates the location of the laboratory that performs the test
Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
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- Prospective clients should contact their account representative. For assistance, contact Customer Service.
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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.
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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
87798
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| VZVPV | Varicella-Zoster Virus, PCR, Varies | 94584-0 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| VZVS | Specimen Source | 31208-2 |
| 618332 | Varicella-Zoster Virus PCR | 94584-0 |