Test Id : HSVSW
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
Specimen Type
Describes the specimen type validated for testing
Varies
Ordering Guidance
If herpes simplex virus (HSV) is suspected in blood, order LHSVB / 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 LVZV / 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 |
|---|---|---|
| HSVS1 | Specimen Source |
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
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) or Universal Transport Medium (UTM) and E-Swab or Culturette
Specimen Volume: Entire collection
Collection Instructions: Place swab back into multimicrobe media (M4-RT, M4, or M5) or Universal Transport Medium (UTM).
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.
See Specimen Required
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Calcium alginate-tipped swab | Reject |
| Wood swab | Reject |
| Transport swab containing gel | Reject |
| Formalin-fixed or paraffin-embedded tissues | Reject |
| 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 | 30 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
Reference values apply to all ages.
Interpretation
Provides information to assist in interpretation of the test results
A positive result suggests the presence of herpes simplex virus (HSV)-1 and/or HSV-2 DNA in the sample.
A negative result suggests that HSV-1 and HSV-2 DNA are not present in the sample.
An invalid result points to the inability to determine presence or absence of HSV-1 or HSV-2 DNA in the sample.
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 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.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Schiffer JT, Corey L. Herpes simplex virus. In: Bennett JE, Dolin R, Blaser MJ, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 9th ed. Elsevier; 2020:1828-1848
2. Szpara ML, Parsons L, Enquist LW. Sequence variability in clinical and laboratory isolates of herpes simplex virus 1 reveals new mutations. J Virol. 2010;84(10):5303-531
3. Workowski KA. Centers for Disease Control and Prevention Sexually Transmitted Diseases Treatment Guidelines. Clin Infect Dis. 2015;61 Suppl 8:S759-S762
4. Omarova S, Cannon A, Weiss W, Bruccoleri A, Puccio J. Genital Herpes Simplex Virus-An Updated Review. Adv Pediatr. 2022;69(1):149-162
5. Gitman MR, Ferguson D, Landry ML. Comparison of Simplexa HSV 1 & 2 PCR with culture, immunofluorescence, and laboratory-developed TaqMan PCR for detection of herpes simplex virus in swab specimens. J Clin Microbiol. 2013;51(11):3765-3769
Method Description
Describes how the test is performed and provides a method-specific reference
The Simplexa HSV (herpes simplex virus)-1 and -2 Direct assay system is a real-time polymerase chain reaction (PCR) that enables the direct amplification, detection, and differentiation of HSV-1 and HSV-2 DNA from unprocessed specimens without nucleic acid extraction.
In this assay, bifunctional fluorescent probe primers are used together with corresponding reverse primers to amplify HSV-1, HSV-2, and internal control targets. Well-conserved regions of the HSV-1 and HSV-2 DNA polymerase genes are targeted to identify HSV-1 and HSV-2 DNA, respectively, in the specimen. An internal control is used to detect PCR failure or inhibition.(Binnicker MJ, Espy MJ, Irish CL. Rapid and direct detection of herpes simplex virus in cerebrospinal fluid by use of a commercial real-time PCR assay. J Clin Microbiol. 2014;52(12):4361-4362; Package insert: Simplexa HSV 1 and 2 Direct, Diasorin; 07/2014)
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.
- 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 has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
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 |
|---|---|---|
| HSVSW | 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.
|
|---|---|---|
| HSVS1 | Specimen Source | 39111-0 |
| 623131 | HSV 1 PCR | 94581-6 |
| 623132 | HSV 2 PCR | 94582-4 |