Test Id : LHSVZ
Effective January 13, 2025; This test is temporarily unavailable due to instrument issues. The down time is expected to be approximately 60 days. Order tests HSVPV and VZVPV as alternative tests. See test notification here
Herpes Simplex Virus (HSV) and Varicella-Zoster Virus (VZV), Molecular Detection, PCR, Varies
This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test HSVPV and VZVPV.
Useful For
Suggests clinical disorders or settings where the test may be helpful
Rapid diagnosis of herpes simplex virus and varicella-zoster virus infections
Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| LHSV | Herpes Simplex Virus PCR | Yes | Yes |
| LVZV | Varicella-Zoster Virus PCR | Yes | Yes |
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
This test distinguishes herpes simplex virus (HSV)-1 from HSV-2 genotypes.
Method Name
A short description of the method used to perform the test
LightCycler Polymerase Chain Reaction (PCR)
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
LightCycler VZV/HSV
Varicella-Zoster Virus, Dermal
This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test HSVPV and VZVPV.
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
This test distinguishes herpes simplex virus (HSV)-1 from HSV-2 genotypes.
Specimen Type
Describes the specimen type validated for testing
Varies
Necessary Information
Specimen source is required.
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| SS001 | Specimen Source | |
| SRC70 | 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: Swab
Supplies:
-Culturette (BBL Culture Swab) (T092)
-M4-RT (T605)
Sources: Genital, dermal, eye, or throat
Container/Tube: Multimicrobe media (M4-RT)
Specimen Volume: Swab
Collection Instructions: Place swab back into multimicrobe media (M4-RT, M4, or M5).
Additional Information: Source information should include the main anatomical source of collection.
Supplies: Sarstedt Aliquot Tube 5 mL (T914)
Specimen Type: 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: 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: Tissue
Supplies: M4-RT (T605)
Sources: Brain, colon, kidney, liver, lung, etc
Container/Tube: Sterile container containing 1 mL to 2 mL of sterile saline or multimicrobe medium (M4-RT, M4, or M5)
Specimen Volume: Entire collection
Collection Instructions: Submit only fresh tissue in multimicrobe media (M4-RT) or a sterile container with 1 to 2 mL sterile saline.
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.
Body Fluid or Ocular Fluid: 0.3 mL; Respiratory: 1 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Calcium alginate-tipped swab, wood swab, or transport swab containing gel | 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 |
This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test HSVPV and VZVPV.
Useful For
Suggests clinical disorders or settings where the test may be helpful
Rapid diagnosis of herpes simplex virus and varicella-zoster virus infections
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
This test distinguishes herpes simplex virus (HSV)-1 from HSV-2 genotypes.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Herpes simplex virus (HSV) types 1 and 2 are members of the Herpesviridae family and produce infections that may range from mild stomatitis to disseminated and fatal disease. Clinical conditions associated with HSV infection include gingivostomatitis, keratitis, encephalitis, vesicular skin eruptions, aseptic meningitis, neonatal herpes, genital tract infections, and disseminated primary infection.
Infections with HSV types 1 and 2 can differ significantly in their clinical manifestations and severity. HSV type 2 primarily causes urogenital infections and is found almost exclusively in adults. HSV type 1 is closely associated with orolabial infection, although genital infection with this virus can be common in certain populations.
The diagnosis of HSV infections is routinely made based on clinical findings and supported by laboratory testing using PCR or viral culture. 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 age 10. After primary infection with VZV, the virus persists in latent form and may emerge (usually in adults age 50 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.
HERPES SIMPLEX VIRUS (HSV) PCR
Negative
VARICELLA-ZOSTER VIRUS PCR
Negative
Interpretation
Provides information to assist in interpretation of the test results
Herpes Simplex Virus (HSV) PCR:
This is a qualitative assay; results are reported either as negative, positive, or indeterminate for HSV type 1 or HSV type 2.
Detection of HSV DNA in clinical specimens supports the clinical diagnosis of infection due to the virus.
Varicella-Zoster Virus (VZV) PCR:
Detection of 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 PCR assay does not yield positive results with other herpesvirus gene targets (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 or HSV infection, and must be interpreted in the context of the clinical picture. This test is not used to screen asymptomatic patients.
Supportive Data
Herpes Simplex Virus (HSV)
Accuracy/Diagnostic Sensitivity and Specificity:
To assess the accuracy of the Roche HSV-1/2 analyte specific reagents, clinical specimens (n=50) were tested and the results compared to those of a laboratory-developed reference PCR method.
| Roche HSV-1/2 ASR | | HSV-1/2 LDT | |
| | Negative | ||
| Positive | 20 | 0 | |
| Negative | 0 | 30 | |
| Total | 20 | 30 | |
Sensitivity (95% CI): 100% (81-100)
Specificity (95% CI): 100% (86-100)
Analytical Sensitivity/Limit of Detection (LoD):
The lower limit of detection (LoD) of the HSV assay is 10 DNA target copies per microliter. This was established in anogenital swabs and confirmed in each specimen type accepted for this assay.
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 and intra-assay precision were 100% and 100%, respectively.
Varicella-Zoster Virus (VZV)
Accuracy/Diagnostic Sensitivity and Specificity:
| | | VZV LDT | |
| | Negative | ||
| Positive | 20 | 0 | |
| Negative | 0 | 30 | |
| Total | 20 | 30 | |
Sensitivity (95% CI): 100% (81-100)
Specificity (95% CI): 100% (86-100)
Analytical Sensitivity/Limit of Detection (LoD):
The LoD of the VZV 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 intra-assay precision was 97%.
Reportable Range:
This test is a qualitative assay and results are reported as negative or positive for targeted VZV or HSV DNA.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Schiffer JT, Corye L. New concepts in understanding genital herpes. Curr Infect Dis Rep. 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, Smith TF, Persing DH. 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 Dis. 1997;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
This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test HSVPV and VZVPV.
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-base pair 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 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. 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 40 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 (57.5 degrees C for HSV type 1 and 65.8 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)
Varicella-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)
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
This test is only orderable for clients who send specimens directly to MCL in Jacksonville, FL. All other clients, see Rochester Test HSVPV and VZVPV.
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.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- 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.
87529 x2 HSV-1 and HSV-2
87798-VZV
87999 (if appropriate for government payers)
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 |
|---|---|---|
| LHSVZ | HSV and VZV, PCR | 94585-7 |
| 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.
|
|---|---|---|
| SS001 | Specimen Source | 39111-0 |
| 34797 | HSV 1, PCR | 94581-6 |
| 34798 | HSV 2, PCR | 94582-4 |
| SRC70 | Specimen Source | 39111-0 |
| 36046 | Varicella-Zoster Virus PCR | 94584-0 |