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Herpes Virus 1 IgG

Alternate Name: Hsv1 IgG_Atellica

SAL Code:

835

CPT:

86695

Loinc:

5206-8

Turn Around Time:

1 day

Setup:

Mon-Sat

Department:

HSV

Methodology:

The Atellica IM HSV1 assay is a fully automated two-step sandwich immunoassay using indirect chemiluminescent technology. The sample is incubated with the Solid Phase, which contains HSV-1-specific recombinant-gG1 antigen. Antigen-antibody complexes will form if anti-HSV-1 antibody is present in the sample. The Lite Reagent contains monoclonal anti-human IgG labeled with acridinium ester, and is used to detect HSV-1 IgG in the sample. A result of reactive or nonreactive is determined according to the Index Value established with the calibrators.

Specimen Requirements:

Primary Tube:

SST

Primary Substance:

Serum

Temperature

Period

Stable Ambient:

24 Hours

Stable Fridge:

7 days

Clinical Info:

The Atellica® IM Herpes-1 IgG (HSV1) assay is for in vitro diagnostic use in the qualitative determination of IgG antibodies to herpes simplex virus type 1 (HSV-1) in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM Analyzer. The test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of
HSV infection. The predictive value of a positive or negative result depends on the prevalence of HSV-1 infection in the population and the pre-test likelihood of HSV-1 infection. The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum and plasma (EDTA and lithium heparin).

Test Limitations:

-Patient specimens may contain heterophilic antibodies that can react in immunoassays to give falsely elevated or depressed results. Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed. Additional
information may be required for diagnosis.
- The Atellica IM HSV1 assay is limited to the detection of IgG antibodies to HSV-1 virus in human serum or plasma (EDTA and lithium heparin).
- The presence of IgG antibodies to HSV-1 virus in a single specimen is not sufficient to distinguish between active or past infection.
- Patients suspected of having recent infection should be tested for the presence of IgM antibodies to HSV.
A nonreactive test result does not exclude the possibility of exposure to or infection with HSV-1. Human HSV-1 IgG antibodies may be undetectable in some stages of the infection and in some clinical conditions.
- The results in HIV patients, in patients undergoing immunosuppressive therapy, or in patients with other disorders leading to immunosuppression, should be interpreted with caution.
- Assay performance characteristics have not been established when the Atellica IM HSV1 assay is used in conjunction with other manufacturers' assays for specific HSV serological markers.
- The performance of the Atellica IM HSV1 assay has not been established with immunocompromised or immunosuppressed patients, pre-transplant patients, cord blood, neonatal specimens, cadaver specimens, heat-inactivated specimens, or body fluids other than serum or plasma (EDTA and lithium heparin), such as saliva, urine, amniotic fluid,
or pleural fluid.
- As with any chemical reaction, you must be alert to the possible effect on results of unknown interferences from medications or endogenous substances. The laboratory and physician must evaluate all patient results in light of the total clinical status of the patient. Additional information may be required for diagnosis.

Test Information:

Components: