Test Directory

Physician Portal
Patient Portal
Book Your Lab Draw Now

Hepatitis A IgM Antibody

Alternate Name: aHAVM_Atellica

SAL Code:

845

CPT:

86709

Loinc:

13950-1

Turn Around Time:

1 day

Setup:

Mon-Sun

Units:

Index

Department:

Hepatitis A

Methodology:

The aHAVM assay is a 2-step antibody-capture chemiluminescent immunoassay (CMIA).
In step 1, patient IgM is captured from a 1:10 diluted sample using a biotinylated anti-human IgM antibody bound to strepatavidin-coated magnetic particles.

In Step 2, captured anti-HAV IgM is detected using HAV antigen plus an acridinium-ester-labeled anti- HAV aantibody.

The resulting light signal (RLU) is concerted to a signal-to-cutoff (S/CO) ratio via a master
curve.

Specimen Requirements:

Primary Tube:

SST

Primary Substance:

Serum

Temperature

Period

Stable Fridge:

2 -8 C Stability 7 days

Clinical Info:

The Atellica® IM Hepatitis A IgM (aHAVM) assay is for in vitro diagnostic use in the qualitative determination of IgM response to the hepatitis A virus (HAV) in human pediatric (aged 2–21 years) and adult serum and plasma (EDTA, lithium heparin, and sodium heparin) using the Atellica® IM Analyzer. This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age.

Test Limitations:

- The Atellica IM aHAVM assay is limited to the detection of IgM 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 negative test result does not exclude the possibility of exposure to hepatitis A virus.
- The Atellica IM aHAVM assay can be used to determine if a patient has or recently had an acute or asymptomatic hepatitis A infection. This test does not measure anti-HAV IgG and therefore cannot be used to determine a patient’s immune status to hepatitis A.
- The calculated values for hepatitis A in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay used. Values obtained with different assay methods cannot be
used interchangeably.
- Assay performance characteristics have not been established for
immunocompromised or immunosuppressed patients.
- The performance of the assay has not been established with cord blood, neonatal specimens, cadaver specimens, heat-inactivated specimens, or body fluids other than serum or plasma, such as saliva, urine, amniotic fluid, or pleural fluid. Atellica CI Analyzer aHAVM 11204873_EN Rev. 06, 2026-02 9 / 20
- 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.12,13 Additional information may be required for diagnosis.
- A reactive HAV IgM result does not exclude co-infection by another hepatitis virus

Test Information:

Components: