Lab Guide
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Test ID: Hepatitis A Antibody IgM
Hepatitis A Antibody IgM
Detection of Hepatitis A IgM Antibody in Blood
Useful For

For differential diagnosis of acute hepatitis A.

Method name and description

μ-Capture test principle

Measurement of antigen or antibody based on the change in electrochemiluminescence (ECL) signal before and after immunoreaction. Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration.

Reporting name

Hep A IgM

Clinical information

The hepatitis A virus (HAV) is a non-enveloped single stranded RNA-virus that is one of the most common causes of infectious jaundice and is transmitted by the fecal-oral route. HAV causes acute hepatitis and is not associated with chronic liver disease, nor does the virus persist in the organism. Serologic testing for detection of immunoglobulin M (IgM) antibodies to HAV is required for differential diagnosis of acute hepatitis A. Anti‑HAV IgM antibodies can always be detected at the onset of the disease, and usually disappear within 3‑6 months but can be detected in some patients for a longer period of time. Development of HAV IgM antibodies after vaccination is rare.

Aliases

Hep A IgM

Specimen type / Specimen volume / Specimen container

Specimen type: Serum, Plasma

Minimum volume of sample: 1 mL

Serum: Plain tube (red or yellow top)

Plasma: Li‑heparin

Collection instructions / Special Precautions / Timing of collection

Collect blood by standard venipuncture techniques as per specimen requirements. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Storage and transport instructions

Storage: 7 days at 15 – 25°C

              14 days at 2 – 8°C;

               3 months at ‑20 °C (± 5 °C)

Transport: 2-25°C 

Specimen Rejection Criteria

Grossly hemolyzed, icteric and lipemic samples, wrong collection container, insufficient sample and heat‑inactivated samples.

Biological reference intervals and clinical decision values

Analyte/Unit

Result message

Result message

Interpretation/

further steps

 COI* 

COI < 1.0

Non-reactive

Negative for HAV IgM specific

Antibodies

COI*

COI ≥ 1.0

 Reactive

Positive for HAV IgM specific Antibodies

*COI = cutoff index

Factors affecting test performance and result interpretation

As with many μ‑capture assays, an interference with unspecific IgM is observed, increasing amounts of unspecific IgM may lead to a decrease in the recovery of positive samples with the Elecsys Anti‑HAV IgM assay

In rare cases, interference due to high titers of antibodies to immunological components, streptavidin or ruthenium can occur.

Turnaround time / Days and times test performed / Specimen retention time

Daily (24/7)

Turn-around time:

Routine: One working day

Specimen Retention: 4 days