Hepatitis A Acute Ab (IgM)

The Qualitative detection of Hepatitis A virus IgM antibody (anti-HAV IgM) in human sera using the FDA approved Abbott ARCHITECT HAVAB-M test two-step chemiluminescent immunoassay.

In the first step, sample, assay diluent, and hepatitis A virus (human) coated paramagnetic microparticles are combined. IgM anti-HAV present in the sample binds to the hepatitis A virus (human) coated microparticles. In the second step, anti-human IgM acridinium-labeled conjugate is added, which binds to IgM anti-HAV. Then pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs).

The presence or absence of IgM anti-HAV in the sample is determined by comparing the chemiluminescent signal in the reaction to the cutoff signal determined from an ARCHITECT HAVAB-M calibration. Specimens with signal to cutoff (S/CO) values ≥ 1.21 are considered reactive for IgM anti-HAV. Specimens with S/CO values of 0.80 to < 1.21 are considered indeterminate and specimens with S/CO values < 0.80 are considered nonreactive.

Blood: 5 mL blood in GOLD TOP serum separator tube (SST).

Also acceptable: 5 mL blood in ORANGE TOP rapid serum tube (RST) or RED TOP tube

Blood: Specimens may be stored on or off the clot, red blood cells, or separator gel for up to 3 days at room temperature (15-30°C) or up to 7 days at 2-8°C. If testing will be delayed more than 3 days for specimens stored at room temperature or more than 7 days for specimens stored at 2-8°C, remove serum from the clot, red blood cells, or separator gel and store at -20°C or colder. Avoid more than three freeze/thaw cycles.

Outside Laboratories: Specimens may be stored on or off the clot, red blood cells, or separator gel for up to 3 days at room temperature (15-30°C) or up to 7 days at 2-8°C. If testing will be delayed more than 3 days for specimens stored at room temperature or more than 7 days for specimens stored at 2-8°C, remove serum from the clot, red blood cells, or separator gel and store at -20°C or colder. Avoid more than three freeze/thaw cycles.

Unacceptable samples: Cord blood, neonatal specimens, cadaver specimens, heat-inactivated specimens, or body fluids such as saliva, urine, amniotic fluid, or pleural fluid. Specimens with obvious microbial contamination or are grossly hemolyzed.