Hepatitis B Virus Core (HBc) Total Antibody EIA
A special account is required to order pre-transplant testing. Contact Client Services or your account executive to set up a pre-transplant account to order this assay. Specimens should not be collected until after an account has been created.
The Alinity s Anti-HBc assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibody to hepatitis B core antigen (anti-HBc) in human serum and plasma specimens on the Alinity s System.
The Alinity s Anti-HBc assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HBc. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing serum specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens.
About HEPATITIS B CORE Virus
Hepatitis B virus (HBV) is the causative agent of hepatitis B. An estimated 257 million individuals are living with hepatitis B virus infection. More than 887 000 people die annually of HBV-related liver disease. Globally, chronic hepatitis B is a major cause of liver cirrhosis and hepatocellular carcinoma.1, 2 HBV belongs to the hepadnavirus family and is a partially double stranded DNA virus. It consists of a central core nucleocapsid containing viral DNA, DNA polymerase, and a surrounding envelope consisting of hepatitis B surface antigen (HBsAg), which is expressed during HBV infection. Additionally, HBV-infected cells produce spherical or long filamentous particles that consist of excess HBsAg.3 The virus is divided into multiple major serotypes (e.g., adr, adw, ayr, ayw) based on antigenic determinants present on the envelope proteins, and into at least 8 genotypes (A–H) according to overall nucleotide sequence variation of the genome. Differences among genotypes can affect the disease severity, course and likelihood of complications, response to treatment, and possibly vaccine protection.2-5
HBV is transmitted through sexual, parenteral, and perinatal routes. Transmission may also occur through transfusion of HBV contaminated blood and blood products. After infection with HBV, antibody to the hepatitis B core antigen (anti-HBc) appears in the serum one to two weeks after the appearance of HBsAg. Because it generally remains detectable for the remainder of a patient’s life, anti-HBc is an indicator of current infection (acute or chronic) or of past infection.3, 6 Anti-HBc assays are used to screen blood and blood products for the presence of anti-HBc to prevent transmission of HBV infection to recipients of blood or blood products. Anti-HBc assays are also used to screen organ and tissue donors. In addition, anti-HBc assays are used in the diagnosis of HBV infection in combination with other hepatitis B serological markers.3, 7-10
ProcedureThis assay is a two-step immunoassay for the qualitative detection of anti-HBc in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology. Sample, recombinant hepatitis B core antigen (rHBcAg) coated paramagnetic microparticles, assay diluent, and specimen diluent are combined and incubated. The anti-HBc present in the sample binds to the rHBcAg coated microparticles. The mixture is washed.
Anti-human IgG and IgM acridinium-labeled conjugate is added to create a reaction mixture and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added. The resulting chemiluminescent reaction is measured as relative light units (RLU). There is a direct relationship between the amount of anti-HBc in the sample and the RLU detected by the system optics. The presence or absence of anti-HBc in the sample is determined by comparing the chemiluminescent RLU in the reaction to the cutoff RLU was determined from active calibration.
Test performed by Eurofins DPT, 6933 S. Revere Parkway, Centennial, CO 80112.
This test has been cleared or approved for diagnostic use by the U.S. Food and Drug Administration. See package insert for more information.
Within 24 hours from receipt of specimen.
| Specimen Type | Test Code | CPT Code | NY Approved | Volume | Assay Range | Special Instructions |
|---|---|---|---|---|---|---|
| Plasma (1) | 30821 | 86704 | Yes | 100 µL (min 50 µL) |
Qualitative |
Living
To ensure sample volume for all testing performed for donor screening, it is recommended to submit (2) Red Top Tubes and (1) EDTA Tube and ensure the tubes are filled completely. |
| Serum (1) | 30821 | 86704 | Yes | 100 µL (min 50 µL) |
Qualitative |
Living
Postmortem - Serum only
To ensure sample volume for all testing performed for donor screening, it is recommended to submit (2) Red Top Tubes and (1) EDTA Tube and ensure the tubes are filled completely. |
All specimens must be labeled with patient's name and collection date. Please contact Client Services or your Account Executive for detailed shipping instructions.
Causes for RejectionWhole blood frozen, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.
All Alinity's Platform individual assays have been FDA approved for Living and Cadaveric donor samples. All Alinity s Platform individual assays are CE marked. For more information, please use the FDA HCT/P Approved Testing link here.
Specimens are approved for testing in New York only when indicated in the Specimen Information field above.
The CPT codes provided are based on Eurofins DPT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins DPT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.
References- World Health Organization. Hepatitis B. https://www.who.int/en/newsroom/fact-sheets/detail/hepatitis-b. Updated July 2018. Accessed June 16, 2019.
- Chan HL, Wong VW. Hepatitis B. In: Boyer TD, Manns MP, Sanyal AJ editors. Zakim and Boyer’s Hepatology. 6th ed. Philadelphia: Elsevier Saunders; 2012:540-563.
- Dienstag JL. Acute viral hepatitis. In: Longo DL and Fauci AS editors. Harrison's Gastroenterology and Hepatology. McGraw-Hill; 2010:349–377.
- Stramer SL, Wend U, Candotti D, et al. Nucleic acid testing to detect HBV infection in blood donors. N Engl J Med. 2011;364:236–247.
- Seed CR, Jones NT, Pickworth AM, et al. Two cases of asymptomatic HBV “vaccine breakthrough” infection detected in blood donors screened for HBV DNA. MJA. 2012;196:651–652.
- Lok ASF and Conjeevaram HS. Hepatitis B. In: Schiff ER, Sorrel MF, and Maddrey WC, editors. Schiff’s Diseases of the Liver. 9th ed. Philadelphia: Lippincott Williams & Wilkins, 2003:763-806.
- Niederhauser, C. Reducing the risk of hepatitis B virus transfusiontransmitted infection. J Blood Med. 2011;2:91-102.
- Perkins HA, Busch MP. Transfusion-associated infections: 50 years of relentless challenges and remarkable progress. Transfusion. 2010;50:2080–2099.
- Seem DL, Lee I, Umscheid CA, et al. PHS guideline for reducing human immunodeficiency virus, hepatitis B virus, and hepatitis C virus transmission through organ transplantation. Public Health Reports. 2013;128:247-343
- U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research. Guidance for industry: eligibility determination for donors of human cells, tissues, and cellular and tissue-based products. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm091345.pdf. Published August 2007. Accessed June 16, 2019.