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HelpTest Code SOFT: Z1000 Hepatitis E Virus IgM Antibody Screen with Reflex to Confirmation, Serum
Additional Codes
| Ordering Mnemonic | Mayo Test ID |
| EPIC NAME: MISC. LAB TEST | HEVM |
| EPIC CODE: LAB000 |
Reporting Name
HEV IgM Ab Screen, SUseful For
Diagnosis of acute or recent (<6 months) hepatitis E infection
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HEVML | HEV IgM Ab Confirmation, S | Yes | No |
Testing Algorithm
If hepatitis E virus (HEV) IgM antibody screen is reactive or borderline, HEV IgM antibody confirmation will be performed at an additional charge.
For more information see Hepatitis E: Testing Algorithm for Diagnosis and Management.
Method Name
Enzyme Immunoassay (EIA)
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
Serum SSTNecessary Information
Date of collection is required.
Specimen Required
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Collection Instructions:
1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into plastic vial.
Specimen Minimum Volume
See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Frozen (preferred) | ||
| Refrigerated | 24 hours | ||
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
Special Instructions
Reference Values
Negative
Day(s) Performed
Tuesday, Thursday
CPT Code Information
86790
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HEVM | HEV IgM Ab Screen, S | 14212-5 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 86212 | HEV IgM Ab Screen, S | 14212-5 |
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.Clinical Information
Hepatitis E virus (HEV) causes an acute, usually self-limited infection. This small, nonenveloped RNA virus is transmitted from animal reservoir (eg, hogs) to humans via the fecal-oral route. HEV is endemic in Southeast and Central Asia, with several outbreaks observed in the Middle East, northern and western parts of Africa, and Mexico. In developed countries, HEV infection occurs mainly in persons who have traveled to disease-endemic areas. Transmission of HEV may also occur parenterally, and direct person-to-person transmission is rare. Clinically severe cases occur in young to middle-aged adults. Unusually high mortality (approximately 20%) occurs in patients infected during the third trimester of pregnancy. Although there is no carrier state associated with HEV, immunocompromised patients may have prolonged periods (eg, months) of viremia and virus shedding in the feces.
In immunocompetent patients, viremia and virus shedding in the feces occur in the pre-icteric phase, lasting up to 10 days into the clinical phase. After an incubation period ranging from 15 to 60 days, HEV-infected patients develop symptoms of hepatitis with appearance of anti-HEV IgM antibody in serum, followed by detectable anti-HEV IgG within a few days. Anti-HEV IgM may remain detectable up to 6 months after onset of symptoms, while anti-HEV IgG usually persists for many years after infection. Anti-HEV IgM is the serologic marker of choice for diagnosis of acute HEV infection.
Interpretation
Positive results suggest the presence of acute or recent (in the preceding 6 months) hepatitis E infection.
Negative results indicate absence of acute or recent hepatitis E infection. If clinical suspicion persists, submit new specimen for retesting in 1 to 2 weeks.
Borderline results may be seen in acute hepatitis E infection with rising level of anti-hepatitis E virus (HEV) IgM, recent hepatitis E infection with declining level of anti-HEV IgM, or cross-reactivity with nonspecific antibodies (ie, false-positive results).
Cautions
Despite having a high specificity rate, the positive predictive value of the hepatitis E virus (HEV) IgM antibody screening test may be low (ie, relatively high frequency of false-positive test results) due to low prevalence of acute hepatitis E in the patient population being screened. HEV IgM antibody confirmatory test is helpful and necessary to determine the true infection status of patients with reactive HEV IgM antibody screening test results.
A negative test result does not exclude the presence of recent hepatitis E infection, especially in immunocompromised patients. Repeat testing of serum for anti-HEV IgM in 2 to 4 weeks may be necessary for diagnosis of acute in such patients.
Performance characteristics of this assay have not been established for serum specimens that are heat-inactivated, icteric, lipemic, hemolyzed, or contain particulate matter.
Clinical Reference
1. Aggarwal R, Jameel S: Hepatitis E. Hepatology. 2011 Dec;54(6):2218-2226
2. Hoofnagle JH, Nelson KE, Purcell RH: Hepatitis E. New Engl J Med. 2012 Sep;367(13):1237-1244
3. Aggarwal R: Diagnosis of hepatitis E. Nat Rev Gastroenterol Hepatol. 2013 Jan;10(1):24-33
Method Description
This is a qualitative, in vitro test for the detection and identification of IgM antibodies specifically against hepatitis E virus (HEV) in human serum. This assay is a screening test based on the principle of an indirect sandwich enzyme-linked immunosorbent assay.
Highly purified recombinant HEV-ORF2 viral antigens (specific for HEV genotypes 1 and 3) are fixed to microplate wells. Diluted patient serum specimens are incubated in the wells, in which antibodies bind specifically to the HEV recombinant antigens coating the surface of the wells. Unbound antibodies are then washed away. Anti-human immunoglobulin antibodies (IgM), which are coupled to horseradish peroxidase, are then added to the wells and incubated. Unbound conjugate antibodies are then washed away. Specifically, bound antibodies are detected by a peroxidase-catalyzed color reaction. Intensity of the color, as measured with a photometric analyzer, is proportionate to the quantity of bound HEV IgM antibodies present in the serum specimen.(Unpublished Mayo method)
Report Available
1 to 7 daysSpecimen Retention Time
14 daysForms
If not ordering electronically, complete, print, and send 1 of the following:
-Gastroenterology and Hepatology Test Request (T728)
-Infectious Disease Serology Test Request (T916)
-Microbiology Test Request (T244)