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Epic Test Code LAB3784 Herpes Simplex Virus (HSV), Molecular Detection, PCR, Varies

Additional Codes

MML:HSVPV


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


Specimen source is required.



Specimen Required


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: M4-RT (T605)

Container/Tube: Multimicrobe media (M4-RT)

Specimen Volume: Entire collection

Collection Instructions: Place swab back into multimicrobe media (M4-RT)

Additional Information: Source information must include main anatomical site of collection.

 

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

Sources: Brain, colon, kidney, liver, lung, etc

Supplies: M4-RT (T605)

Container/Tube: Sterile container containing 1 mL to 2 mL of sterile saline or multimicrobe medium (M4-RT)

Specimen Volume: Entire collection

Collection Instructions: Submit only fresh tissue.

Additional Information: Source information should include main anatomical site of collection.

 

Specimen Type: Urine (<1-month old infant)

Container/Tube: Sterile container

Specimen Volume: 0.5 mL


Useful For

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

Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization

Reporting Name

Herpes Simplex Virus, PCR, Varies

Specimen Type

Varies
Bassett Healthcare Network Clinical Laboratories Note:

ACCEPTABLE SWABS: Swabs in media, such as M4-RT, M4 or M5, Bartels FlexTrans, Jiangsu VTM, BBL CultureSwab, E-Swabs in M4 media. 

(dry/flocked E-Swabs are NOT acceptable).

Specimen Minimum Volume

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

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) 7 days
  Frozen  7 days

Reject Due To

Calcium alginate-tipped swab
Wood swab
Transport swab containing gel
Formalin-fixed and/or paraffin-embedded tissues
Heat-inactivated specimens
Reject

Clinical Information

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

HERPES SIMPLEX VIRUS (HSV)-1

Negative

 

HERPES SIMPLEX VIRUS (HSV)-2

Negative

Interpretation

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

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.

Day(s) Performed

Monday through Sunday

Report Available

Same day/1 to 4 days

Specimen Retention Time

1 week

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87529 x 2

87529 (if appropriate for government payers)

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send 1 of the following:

-Microbiology Test Request (T244)

-General Request (T239)