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