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Hepatitis A Antibody Total

Alternate Name: HAVT_Atellica

SAL Code:

813

CPT:

86708

Loinc:

13951-9

Turn Around Time:

24 hours

Setup:

Mon- Sun

Units:

Index

Department:

Hepatitis A

Methodology:

The Atellica IM HAVT assay is a fully automated, competitive immunoassay using direct chemiluminescent technology. The assay consists of 3 reagent addition and incubation steps. First, the sample is pretreated with Ancillary Reagent containing cysteine. Next, HAV antigen is added from the ancillary well (Antigen Reagent). Lite Reagent and Solid Phase are then added. The Lite Reagent contains mouse monoclonal antibody to HAV antigen labeled with acridinium ester and biotinylated Fab fragment of a mouse monoclonal antibody to HAV antigen. The Solid Phase contains streptavidin covalently coupled to paramagnetic particles. After the final incubation, the immuno-complex formed is washed with Atellica IM Wash prior to initiation of the chemiluminescent reaction. An inverse relationship exists between the amount of antibody to HAV present in the patient sample and the amount of relative light units (RLUs) detected by the system. A result of reactive or nonreactive is determined according to the Index Value established with the calibrators. Refer to Interpretation of Results.

Specimen Requirements:

Primary Tube:

SST

Primary Substance:

Serum

Temperature

Period

Stable Fridge:

At 2-8 C up to 7 days

Additional Information:

The Atellica® IM Hepatitis A Total (HAVT) assay is for in vitro diagnostic use in the qualitative determination of total antibodies to hepatitis A virus (anti-HAV) in human neonatal, pediatric, and adult serum and plasma (EDTA, lithium heparin, and sodium heparin) using the Atellica® CI Analyzer. This anti-HAV assay is indicated as an aid in the diagnosis of previous or ongoing hepatitis A viral infection or in the identification of HAV-susceptible individuals for vaccination. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients.

Test Limitations:

- The Atellica IM HAVT assay is limited to the detection of total antibodies to hepatitis A virus in human serum and plasma (EDTA, lithium heparin, and sodium heparin).
- The results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture. A nonreactive test result does not exclude the possibility of exposure to hepatitis A virus.
- The Atellica IM HAVT assay does not distinguish among different classes of antibodies. The assay cannot be used to determine if a reactive sample is due to an acute infection or is the result of a previous infection. The sample should be tested in a specific HAV IgM assay to determine if there is an ongoing or recent infection.
- The performance of the assay has not been established with cadaver specimens, heat inactivated specimens, or body fluids other than serum or plasma, such as saliva, urine, amniotic fluid, or pleural fluid.
- The Atellica IM HAVT assay cut-off value is equivalent to 20 mIU/mL standardized to the WHO Second International Reference Standard for Anti-Hepatitis Immunoglobulin (97/646). However, assay results cannot be considered quantitative and no clinical claims for immunity can be determined from the cut-off value.
- The performance of the assay has not been established for populations of
immunocompromised or immunosuppressed patients.
- A reactive HAV Total result does not exclude co-infection by another hepatitis virus.
- Patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. This assay is designed to minimize interference from heterophilic antibodies. Additional information may be required for diagnosis.

Test Information:

Components: