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Test Code HAVAB Hepatitis A IgM Antibody

Infectious

Additional Codes

EPIC LAB4117

Clinical Significance

Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection. 

 

The hepatitis A virus is an RNA‑containing virus that lacks an envelope. It belongs to the family of picornaviruses. To date, just one human serotype and 7 genotypes have been described. The viral capsid consists of 3 proteins (VP1‑VP3) that form an immunodominant structure on the surface of the viral particle that is highly conserved between all genotypes. After vaccination or natural infection, the immune response is directed against this structure. 

 

Hepatitis A is the most common form of acute viral hepatitis. It is transmitted by the fecal-oral route. The disease has not been known to take a chronic course, nor does the virus persist in the organism. An acute or recently acquired hepatitis A infection can be assumed if anti‑HAV IgM antibodies are detected. Anti‑HAV IgM antibodies can always be detected at the onset of the disease, and usually disappear 3 to 4 months later. Anti‑HAV IgM can also be detected in some patients for a longer period, however. HAV IgM antibodies develop only very rarely after vaccination.

 

Source: Roche Cobas Elecsys Anti-HAV IgM Method Sheet V5.0 11-2022 

Methodology

μ-Capture test principle (Roche Cobas e801)

Sample Type

Preferred Sample Type
Yellow top - Serum

 

Acceptable Sample Type(s)
Red top - Serum
Light green top - Plasma
Dark green top - Plasma

Centrifuge: Yes

Specimen Minimum Volume

55 uL with insert cup

Specimen Stability

Temperature Time
Ambient (15-25°C) 7 days
Refrigerated (2-8°C) (store) 14 days
Frozen (<-20°C) 3 months*

Separate serum or plasma from cells ASAP.

*Samples may be frozen up to 5 times.

Reference Ranges

Initial Testing
Cut-off Index (COI) Result Retest Procedure
<0.90 Non-reactive (negative) Retesting not required
≥0.90 to <1.10 Borderline Retest in duplicate
≥1.10 Reactive (positive) Retesting not required

 

Repeat Testing
COI after retest Final Result Interpretation
2 of the 3 results are <1.0 Non-reactive Negative for HAV IgM antibodies.
2 of the 3 results are ≥1.0 Reactive Positive for HAV IgM antibodies.
2 of the 3 results are between ≥0.90 to <1.10 Borderline It is recommended that a specimen be drawn in two weeks and retested.

 

 

Rejection Criteria

Hemolysis Index >1,000
Icterus Index >50
Lipemia Index >2,000, ultracentrifuge

Availability

Performed STAT
24/7 Yes

 

Performing Laboratory

MultiCare Yakima Memorial Hospital Laboratory

Lab Department

Chemistry

CPT Code

86709

LOINC

13950-1 HAV IgM IA QI

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