Test Id : HSVPV
Herpes Simplex Virus (HSV), Molecular Detection, PCR, Varies
Useful For
Suggests clinical disorders or settings where the test may be helpful
Aiding in the rapid diagnosis of herpes simplex virus (HSV) infections, including qualitative detection of HSV DNA in nonblood clinical specimens
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
Herpes Simplex Virus Detection by Real-Time PCR
HSV (Herpes Simplex Virus) by PCR (Polymerase Chain Reaction)
HSV Detection by Real-Time PCR
HSV PCR
LightCycler HSV
LHSV
Specimen Type
Describes the specimen type validated for testing
Varies
Ordering Guidance
If herpes simplex virus (HSV) is suspected in blood, order HSVPB / Herpes Simplex Virus (HSV), Molecular Detection, PCR, Blood.
If HSV is suspected in cerebrospinal fluid, order HSVC / Herpes Simplex Virus (HSV), Molecular Detection, PCR, Spinal Fluid.
If varicella-zoster virus is suspected, order VZVPV / Varicella-Zoster Virus, Molecular Detection, PCR, 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 |
|---|---|---|
| HSVS | 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: 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: Genital, dermal, ocular, nasal, throat, or oral
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
Specimen Volume: Entire collection
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: Sterile container containing 1 mL to 2 mL of sterile saline or multimicrobe medium (M4-RT, M4, M5, Bartels, or Jiangsu)
Specimen Volume: Entire collection
Collection Instructions: Submit only fresh tissue. Fixed tissue is not acceptable.
Specimen Type: Urine (newborns < or =35 days old)
Container/Tube: Sterile container
Specimen Volume: 0.5 mL
Forms
If not ordering electronically, complete, print, and send 1 of the following:
-Microbiology Test Request (T244)
-General Request (T239)
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.
Amniotic or ocular fluid: 0.4 mL; Sterile body fluid (Pleural, peritoneal, ascites, pericardial): 0.5 mL; Respiratory Specimen: 1 mL; Swab, tissue, or urine: See Specimen Required
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 specimens Dry/flocked ESwab | 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
Aiding in the rapid diagnosis of herpes simplex virus (HSV) infections, including qualitative detection of HSV DNA in nonblood clinical specimens
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
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 polymerase chain reaction or viral culture.
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)-1
Negative
HERPES SIMPLEX VIRUS (HSV)-2
Negative
Interpretation
Provides information to assist in interpretation of the test results
This is a qualitative assay; results are reported either as negative or positive for herpes simplex virus (HSV) type 1, HSV type 2, or HSV type indeterminate. Results can also be reported as invalid.
An indeterminate result indicates that HSV DNA was detected but the assay is unable to differentiate between HSV-1 and HSV-2. If typing is required, it is suggested that a new specimen be collected for testing by an alternate method.
An invalid result points to the inability to determine presence or absence of HSV-1 or HSV-2 DNA in the sample.
Detection of HSV DNA in clinical specimens supports the clinical diagnosis of infection due to the 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) infection.
Although the reference range is typically "negative" for this assay, this assay may detect viral nucleic acid shedding in asymptomatic individuals. This may be especially relevant when dermal or genital sites are tested since intermittent shedding without noticeable lesions has been described.(1)
This assay is only to be used for patients with a clinical history and symptoms consistent with HSV infection and must be interpreted in the context of the clinical picture.
Supportive Data
Accuracy/Diagnostic Sensitivity and Specificity:
Of 200 specimens processed by both shell vial assay and LightCycler, herpes simplex virus (HSV) was detected in 88 specimens (44%). All 88 positive specimens were detected by LightCycler compared with 69 by the shell vial assay. The 19 discrepant results (LightCycler positive, shell vial assay negative) were resolved as true-positive results by using a polymerase chain reaction (PCR) assay directed to another gene target (thymidine kinase) of the virus.
Supplemental Data (Spiking Studies):
To supplement the above data, approximately 30 negative specimens each of various types were spiked with HSV 1 and HSV 2 plasmid control at the limit of detection (10 copies DNA target/microliter). The spiked specimens were run in a blinded fashion along with approximately 30 negative (non-spiked) specimens each of various specimen types; among the spiked specimen types, the assay was positive in 92% to 100% of the replicates tested. Furthermore, 100% of the non-spiked specimens were negative.
Analytical Sensitivity/Limit of Detection:
The lower limit of detection of this 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 was 100% and 100%, respectively.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Binnicker MJ, Espy MJ, Duresko B, Irish C, Mandrekar J. Automated processing, extraction and detection of herpes simplex virus types 1 and 2: A comparative evaluation of three commercial platforms using clinical specimens. J Clin Virol. 2017;89:30-33
2. Schiffer JT, Corye L. New concepts in understanding genital herpes. Curr Infect Dis Rep. 2009;11(6):457-464
3. 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(2):795-799
4. Espy MJ, Ross TK, Teo R, et al. Evaluation of LightCycler PCR for implementation of laboratory diagnosis of herpes simplex virus infections. J Clin Microbiol. 2000;38(8):3116-3118
5. Sauerbrei A, Eichhorn U, Hottenrott G, Wutzler P. Virological diagnosis of herpes simplex encephalitis. J Clin Virol. 2000;17(1):31-36
6. 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
7. Tang YW, 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
Method Description
Describes how the test is performed and provides a method-specific reference
Viral nucleic acid is extracted by the MagNA Pure 96 automated instrument (Roche Applied Science) from genital, dermal, or tissue specimens. Primers directed to the DNA polymerase of herpes simplex virus (HSV) produce a 215-base pair amplicon. The LightCycler or LightCycler 480 instrument (Roche Applied Science), amplifies and monitors by fluorescence the development of target nucleic acid sequences after the annealing step during polymerase chain reaction (PCR) cycling. This is an automated PCR system that can rapidly detect (30-40 minutes) amplicon development through stringent air-controlled temperature cycling and capillary cuvettes or 96 well plate. 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 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 are 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. Sequence differences between the PCR amplification and probe melting curves are accomplished through the use of LightCycler software.(Binnicker MJ, Espy MJ, Duresko B, Irish C, Mandrekar J. Automated processing, extraction and detection of herpes simplex virus types 1 and 2: A comparative evaluation of three commercial platforms using clinical specimens. J Clin Virol. 2017;89:30-33)
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.
87529 x 2
87529 (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 |
|---|---|---|
| HSVPV | Herpes Simplex Virus, PCR, Varies | 94580-8 |
| 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.
|
|---|---|---|
| HSVS | Specimen Source | 31208-2 |
| 618328 | HSV 1, PCR | 94581-6 |
| 618329 | HSV 2, PCR | 94582-4 |