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Test ID: MHSV
Herpes Simplex Virus (HSV) Antibody Screen, IgM, by EIA, Serum

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Useful For Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of infection with herpes simplex virus

Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)

Test IDReporting NameAvailable SeparatelyAlways Performed
HSMRHSV Ab, IgM, S by IFANoNo

Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.

If herpes simplex virus (HSV) antibody screen, IgM by EIA is reactive, then HSV antibody, IgM by immunofluorescence assay will be performed at an additional charge.

Method Name A short description of the method used to perform the test

MHSV/87998: Enzyme Immunoassay (EIA)

HSMR/26589: Immunofluorescence Assay (IFA)

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

HSV Ab Screen, IgM, S by EIA

Aliases Lists additional common names for a test, as an aid in searching

Central Nervous System (CNS) Screen
Herpes Simplex Antibodies, IgM
Herpes Simplex Serology
Herpes Simplex Virus Antibody Titer
HSV Ab (Herpes Simplex Antibodies)

Specimen Type Describes the specimen type needed for testing

Serum

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Container/Tube: 

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 1 mL

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

0.4 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

NA

Other

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
SerumRefrigerated (preferred)14 days
 Frozen 14 days

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

The herpesvirus family contains herpes simplex virus (HSV) types 1 and 2, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, and human herpesviruses 6 through 8.

 

HSV types 1 and 2 produce infections that are expressed in various clinical manifestations ranging from mild stomatitis to disseminated and fatal disease. The more common clinical conditions 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 1 is closely associated with infections of the mouth and lips, although genital infections can be common in some populations. HSV type 2 is the cause of the majority of urogenital infections and is almost exclusively found in adults.

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 (reported as reactive or negative)

Interpretation Provides information to assist in interpretation of the test results

A positive result (ie, the presence of IgM class herpes simplex virus [HSV] 1 and/or 2 antibodies) indicates recent infection. The presence of HSV 1 and/or 2 antibodies may indicate a primary or reactivated infection, but cannot distinguish between them. Specimens with positive results are automatically tested for IgM antibodies by a second method (immunofluorescence assay [IFA]).

 

The continued presence or level of antibody cannot be used to determine the success or failure of therapy.

 

The prevalence of HSV IgM antibodies can vary depending on a number of factors such as age, gender, geographical location, socio-economic status, race, sexual behavior, testing method used, specimen collection and handling procedures, and the clinical and epidemiological history of individual patients.

 

A negative result does not necessarily rule out a primary or reactivated infection since specimens may have been collected too early in the course of disease, when antibodies have not yet reached detectable levels, or too late, after IgM levels have declined below detectable levels.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Results obtained with this assay serve only as an aid to diagnosis and should not be interpreted as diagnostic in themselves.

 

In pregnant women, this test should not be used as the sole criterion for the diagnosis of current herpes simplex infection. The presence of herpes simplex virus (HSV) should be demonstrated by molecular methods, which detect viral DNA (ie, LHSV/80575 Herpes Simplex Virus (HSV), Molecular Detection, PCR), or by isolation of live virus (ie, viral culture).

 

The performance characteristics of this test have not been established for plasma, for neonates and infants.

 

Due to commonly shared antigens, infections with one type of HSV, in the presence of antibody to the other type, may produce an amnestic response with the level of the pre-existing antibody becoming higher than the antibody titer of the current infection. Definitive diagnosis of HSV type should be made by PCR.

 

Heterotypic IgM antibody responses may occur in patients infected with Epstein-Barr virus and give false-positive results in HSV1 and 2 IgM enzyme immunoassay tests. A heterotypic rise in anti-HSV antibody level may also be observed in a primary or reactivated varicella-zoster virus infection.

 

Since rheumatoid factor (RF) binds to IgG in immunocomplexes, false-positive results may arise in specimens with RF and specific IgG. False-negatives may arise due to specific IgG competing with specific IgM. The goat antihuman IgG in the specimen diluent diminishes RF interference and minimizes competing specific IgG in test specimens. The specimen diluent removes most (>95%) of the IgG at levels up to 1,400 mg/dL. Specimens with IgG levels >1,400 mg/dL should be interpreted with caution.

 

The prevalence of the analyte will affect the assay's predictive value.

 

Results from immunosuppressed patients should be interpreted with caution.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Ashley RL, Wald A: Genital herpes: review of the epidemic and potential use of type-specific serology. Clin Microbiol Rev 1999;12:1-8

2. Brown ZA, Selke S, Zeh J, et al: The acquisition of herpes simplex virus during pregnancy. N Engl J Med 1997;337:509-515

3. Lafferty WE, Coombs RW, Benedetti J, et al: Recurrences after oral and genital herpes simplex infection. N Engl J Med 1987;316:1444-1449

4. Whitley RJ: Herpes simplex viruses. In Fields Virology. Vol.2. 2nd Edition. Edited by BN Fields, DM Knipe. New York, Raven Press, 1990, pp 1843-1887

Method Description Describes how the test is performed and provides a method-specific reference

Diluted samples are incubated with herpes simplex virus (HSV) 1 and 2 antigens bound to the solid surface of a microtiter well. If IgM antibodies against HSV are present in the sample, they will bind to the antigen, forming antigen-antibody complexes. Residual sample is eliminated by aspirating and washing. Conjugate (horseradish peroxide-labeled antihuman IgM) is added and binds to these complexes. Unbound conjugate is removed by aspiration and washing. The substrate is then added and incubated. In the presence of bound enzyme, the substrate is converted to an end product. The absorbance of this end product is read spectrophotometrically at 450 nm (reference 600-630 nm) and is directly proportional to the concentration of IgM antibodies to HSV 1 and 2 antigens present in the sample. (Package insert: HSV 1 and 2 IgM Enzyme Immunoassay Test Kit, DiaMedix Corporation, Miami, FL)

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Monday through Saturday; 9 a.m.

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

Same day/1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

2 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 weeks

Performing Laboratory Location The location of the laboratory that performs the test

Rochester

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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test has been modified from the manufacturer’s instructions. Its performance characteristics were determined 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

86694-HSV EIA

86694-HSV IFA (if appropriate)

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
MHSVHSV Ab Screen, IgM, S by EIA40729-6