Hepatitis A Antibody, IgG & IgM

Label Mnemonic:	HAVAB
Epic code:	LAB620
Downtime form:	A-1a Doctor/Provider Orders - Pathology Core and Specialty Care Nursery

Chemistry
6240 RCP
356-3527

Specimen(s):

Plasma

Collection Medium:

Plasma Separator Tube 4.5 mL

Alternate Collection Media:

Call laboratory for additional acceptable specimen collection containers.

Minimum:

3 mL whole blood from light green top tube or TWO Microtainer^® devices for pediatric patients.

Testing Schedule:

24 hrs/day, 7 days a week, including holidays.

Turn Around Time:

1 hour (upon receipt in laboratory)

Reference Range:

Negative Result:
This assay measures both IgG and IgM antibodies to hepatitis A virus (HAV), but does not differentiate between them. A negative result indicates the absence of HAV-specific antibodies, implying no past exposure or immunity to HAV infection. The best test to diagnose acute HAV infection is HEPATITIS A ANTIBODY-IgM (LAB621).

Positive Result [no flagging for abnormal]:
This assay measures both IgG and IgM antibodies to hepatitis A virus (HAV), but does not differentiate between them. A positive result indicates the presence of HAV-specific antibodies from either vaccination or past exposure to HAV. The best test to diagnose acute HAV infection is HEPATITIS A ANTIBODY-IgM (LAB621).

Interpretive Data:

Results obtained with the Elecsys Anti-HAV assay are resulted as follows:

Negative          >1.0 COI
Positive          ≤1.0 COI

The cutoff of 1.0 COI corresponds to 25.4 IU/L.  Per the assay 
manufacturer, the cutoff was established with internal studies and 
validated by external clinical studies.  This assay is traceable to 
the WHO 2nd international standard for anti-HAV.  To define a 
protective antibody response, clinical vaccine studies typically use
anti-HAV levels of >20 IU/L.

Comments:

This assay may be significantly impacted by high-dose biotin (>5 mg dose) taken within previous 12 hours. High concentrations of biotin may lead to falsely increased results. These concentrations may be found in patients taking over-the-counter supplements with biotin content much higher than nutritional requirements for biotin. Specimens should not be collected until at least 12 hours after the last dose.

Test Limitations:

The assay is unaffected by icterus (bilirubin < 66 mg/dL), hemolysis (< 1000 mg/dL), lipemia (Intralipid < 2000 mg/dL), and biotin < 205 nmol/L or < 50 ng/mL.

As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes. In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur. These effects are minimized by suitable test design.

Methodology:

Electrochemiluminescence Immunoassay

Updated to Roche Elecsys Anti-HAV Generation II assay on 06/30/2020

CPT Code:

86708

See Additional Information:
Biotin Interference with Immunoassays