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Hepatitis immunoassays

Hepatitis immunoassays banner image
Hepatitis immunoassays banner image
Hepatitis immunoassays banner image

Viral hepatitis is a global health burden and leading cause of chronic hepatitis, cirrhosis, or hepatocellular carcinoma.1,5  Five different viruses are linked to hepatitis, most common of which are Hepatitis A (HAV), Hepatitis B (HBV) and Hepatitis C (HCV).  In 2019, 296 million people were living with HBV and 58 million people with chronic HCV infection,2 and many were unaware they are infected. Hepatitis can be prevented, effectively treated and in the case of HCV, is curable. When HCV patients are treated with the new and highly effective pan-genotypic direct-acting antiviral (DAA)3 therapies, it is estimated that 95% of persons with HCV can be cured.4,5 The high rate of asymptomatic infections makes timely Hepatitis diagnosis challenging and diagnostic testing remains the first critical step.  

Abbott supports laboratories with a harmonized family of innovative systems, including Alinity and ARCHITECT. These systems provide scalable and flexible testing options needed to support HAV, HBV and HCV patient management. Together with the AlinIQ Digital Health Solutions from Abbott, these solutions help streamline your laboratory operations to support hepatitis elimination efforts.

For over 50 years, Abbott has been committed to delivering the highest quality products to serve the hepatitis diagnostics community.

In 1972, Abbott launched its first hepatitis test and scientists and market experts are continuously working together to solve today’s challenges, understand future needs and eliminate gaps in the diagnosis of hepatitis infected patients and in our overall health care community.

Assays designed to overcome the hepatitis diagnostic challenges

Every laboratory requires a high-quality test menu to help meet requirements for reliable, accurate and precise immunoassay testing results. Our HAV, HBV and HCV assays are designed to overcome the hepatitis diagnostic challenges and help streamline laboratory operations to support hepatitis elimination goals.

In addition, our assay design is not susceptible to biotin interference.6

Learn more about our hepatitis assays By selecting the tabs below.  

Background

Since symptomatic hepatitis A virus (HAV) infections can be clinically indistinguishable from infection with hepatitis B or C virus, serological testing is an important tool to achieve proper diagnosis.  During the acute phase of HAV infection, anti-HAV IgM appears in the patient’s serum and is nearly always detectable at the onset of symptoms.7-10

In most cases, anti-HAV IgM response usually peaks within the first month of illness and can persist for up to six months.11,12  The presence of anti-HAV IgG, with a nonreactive anti-HAV IgM test result, implies past infection with hepatitis A virus (HAV) or vaccination against HAV.13

Hepatitis a virus infection64, 65

HAVAb IgG

Intended use

The Alinity i and ARCHITECT HAVAb IgG assays are a chemiluminescent microparticle immunoassays (CMIA) used for the qualitative detection of IgG antibody to hepatitis A virus (IgG anti-HAV) in human serum and plasma on the Alinity i and ARCHITECT systems. The Alinity i and ARCHITECT HAVAb IgG assay is to be used as an aid in the diagnosis of hepatitis A viral infection or detection of IgG anti-HAV.14, 15

HAVAb IgM

Intended use

The Alinity i and ARCHITECT HAVAb IgM assays are a chemiluminescent microparticle immunoassays (CMIA) used for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human serum and plasma on the Alinity i and ARCHITECT systems. The Alinity i and ARCHITECT HAVAb IgM assay is to be used as an aid in the diagnosis of acute or recent hepatitis A viral infection. 16, 17

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HBsAg Assays
Background

During infection, Hepatitis B Virus (HBV) produces an excess of Hepatitis B surface antigen (HBsAg), which can be detected in the blood of infected individuals. It is responsible for binding the virus to the liver cells and is the target structure of neutralizing antibodies.18,19 HBsAg assays are routinely used to aid in the diagnosis of suspected hepatitis B viral (HBV) infection and to monitor the status of infected individuals, i.e., to determine whether the patient’s infection has resolved or if the patient has developed a chronic HBV infection.20

For the diagnosis of acute or chronic hepatitis, HBsAg reactivity should be correlated with patient history and the presence of other hepatitis B serological markers. A sample which is found to be repeatedly reactive should be confirmed by a neutralizing confirmatory test utilizing human anti-HBs.

Acute hepatitis b diagnostic profile66-68

HBsAg Next Qualitative

Intended use

The Alinity i and ARCHITECT HBsAg Next Qualitative assays are a chemiluminescent microparticle immunoassays (CMIA) used for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma, including specimens collected post-mortem (non-heart-beating), on the Alinity i and ARCHITECT systems. The HBsAg Next Qualitative assay is intended to be used as an aid in the diagnosis of Hepatitis B virus (HBV) infection and as a screening test to prevent transmission of HBV to recipients of blood, blood components, cells, tissue, and organs. 21, 22

HBsAg Next Confirmatory

Intended use

The Alinity i and ARCHITECT HBsAg Next Confirmatory assays are a chemiluminescent microparticle immunoassays (CMIA) used for the confirmation of the presence of Hepatitis B surface antigen (HBsAg) in human serum and plasma, including specimens collected post-mortem (non-heart-beating), by means of specific antibody neutralization on the Alinity i and ARCHITECT systems. The HBsAg Next Confirmatory assay is intended to be used for the confirmation of samples found to be repeatedly reactive by the HBsAg Next Qualitative assay. 23, 24

 

HBsAg Quantitative

Intended use

The Alinity i and ARCHITECT HBsAg assays are a chemiluminescent microparticle immunoassays (CMIA) used for the quantitative determination of hepatitis B surface antigen (HBsAg) in human serum and plasma on the Alinity i and ARCHITECT systems.25, 26

HBsAg Quantitative Confirmatory

Intended use

The Alinity i and ARCHITECT HBsAg Confirmatory V.1 assays are a chemiluminescent microparticle immunoassays (CMIA) used for the confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma by means of specific antibody neutralization on the Alinity i and ARCHITECT systems.27, 28

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HBeAg
Background

Hepatitis B e-antigen (HBeAg) determinations can be used to monitor the progress of hepatitis B viral infection. HBeAg is first detectable in the early phase of hepatitis B viral infection, after the appearance of hepatitis B surface antigen (HBsAg).29 The titers of both antigens rise rapidly during the period of viral replication in acute infection. The presence of HBeAg correlates with increased numbers of infectious virus (Dane particles), the occurrence of core particles in the nucleus of the hepatocyte, and the presence of hepatitis B virus specific DNA and DNA polymerase in serum.29

Intended use

The Alinity i and ARCHITECT HBeAg assays are a chemiluminescent microparticle immunoassays (CMIA) for the qualitative detection of hepatitis B e antigen (HBeAg) in human serum and plasma and is indicated for use as an aid in the diagnosis and monitoring of hepatitis B viral infection. The Alinity i and ARCHITECT HBeAg assays can also be used for the quantitative determination of HBeAg. Refer to Alinity i and ARCHITECT HBeAg Quantitative Calibrators package inserts (09P1001 and 7P24-01 respectively) for instructions and further information. 30, 31

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Anti-HBc IgM
Background

Viral specific IgM antibody has been detected in most acute HBV viral infections and is a reliable marker of acute disease. The concentrations of anti-HBc IgM rise rapidly in patients with acute infection; high levels of anti-HBc IgM have been detected in patients with acute hepatitis B viral infection while low levels may be detected during the course of a chronic infection.32-37

Intended use

The Alinity i and ARCHITECT Anti-HBc IgM assays are a chemiluminescent microparticle immunoassays (CMIA) used for the qualitative detection of IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human serum and plasma on the Alinity i and ARCHITECT systems, The Alinity i and ARCHITECT Anti-HBc IgM assays are indicated for use as an aid in the diagnosis of acute or recent hepatitis B viral infection. 38, 39

Anti-HBc II
Background

Anti-HBc determinations can be used as an indicator of current or past HBV infection. Anti-HBc is found in serum after the appearance of hepatitis B surface antigen (HBsAg) in acute HBV infections. It will persist after the disappearance of HBsAg and before the appearance of detectable antibody to HBsAg (anti-HBs).40-46 In the absence of information about any other HBV markers, it must be considered that an individual with detectable levels of anti-HBc may be actively infected with HBV or that the infection may have resolved.47

Intended use

The Alinity i and ARCHITECT Anti-HBc II assays are a chemiluminescent microparticle immunoassays (CMIA) used for the qualitative detection of antibody to hepatitis B core antigen (anti-HBc) in human serum and plasma, including specimens collected post-mortem (non-heart beating) on the Alinity i and ARCHITECT systems. The Alinity i and ARCHITECT Anti-HBc II assays are intended to be used as an aid in the diagnosis of hepatitis B infection and as a screening test to prevent transmission of hepatitis B virus (HBV) to recipients of blood, blood components, cells, tissue and organs. 48, 49

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Anti-HBe
Background

Hepatitis B e antigen (HBeAg) and its antibody (anti-HBe) are found in association with hepatitis B viral infection.50 HBeAg is first detectable in the early phase of hepatitis B viral infection, shortly after the appearance of hepatitis B surface antigen (HBsAg).29

Seroconversion from HBeAg to anti-HBe during acute hepatitis B infection is usually indicative of resolution of infection and a reduced level of infectivity. A negative HBeAg result may indicate (1) early acute infection before the peak of viral replication or (2) early convalescence when HBeAg has declined below detectable levels. The presence of anti-HBe serves to distinguish between these two phases.51 Patients with chronic hepatitis B may often be positive for anti-HBe.37

Intended use

The Alinity i and ARCHITECT Anti-HBe assays are a chemiluminescent microparticle immunoassays (CMIA) used for the qualitative detection of antibody to hepatitis B e antigen (anti-HBe) in human serum and plasma on the Alinity i and ARCHITECT systems. The Alinity i and ARCHITECT Anti-HBe assay is to be used as an aid in the diagnosis and monitoring of hepatitis B viral infection. 52, 53

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Anti-HBs
Background

The Anti-HBs assay determines the concentration of antibody to Hepatitis B surface antigen (anti-HBs) present in human serum and plasma. Anti-HBs assays are often used to monitor the success of Hepatitis B vaccination. The presence of anti-HBs has been shown to be important in protection against Hepatitis B virus (HBV) infection. 54

Intended use

The Alinity i and ARCHITECT Anti-HBs assays are a Chemiluminescent Microparticle Immunoassays (CMIA) for the quantitative determination of antibody to Hepatitis B surface antigen (anti-HBs) in human serum and plasma on the Alinity i and ARCHITECT systems. 55, 56

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Background

HCV Serological testing involves detection of antibodies to the HCV (anti-HCV) and HCV antigen (Ag). In general, antibodies to HCV are absent in the early weeks of infection and are not detected until approximately 6-10 weeks after infection. The presence of anti-HCV indicates that an individual may have been infected with HCV, may harbor infectious HCV, and/or may be capable of transmitting HCV infection.57

An HCV Ag assay can detect acute HCV infection in newly infected individuals who are seronegative for antibodies to HCV due to the delayed response of HCV specific antibodies. In anti-HCV positive individuals, HCV Ag is a marker for active viral replication.58-60 HCV Ag assays are used as an aid in the diagnosis of suspected HCV infection and to monitor the status of infected individuals, i.e., whether the patient’s infection has resolved, or the patient has developed a chronic HCV infection.

Visit HCV Diagnostics to learn more.

Serologic pattern of acute hcv infection with progression to chronic infection69, 70

Anti-HCV

Intended use

The Alinity i and ARCHITECT Anti-HCV assays are a chemiluminescent microparticle immunoassays (CMIA) used for the qualitative detection of antibody to Hepatitis C virus (anti-HCV) in human serum and plasma, including  specimens collected post mortem (non-heart beating) on the Alinity i and ARCHITECT systems.

The Alinity i and ARCHITECT Anti-HCV assays are intended to be used as an aid in the diagnosis of Hepatitis C infection and as a screening test to prevent transmission of Hepatitis C virus (HCV) to recipients of blood, blood components, cells, tissue, and organs.61, 62

HCV Ag

Intended use

The ARCHITECT HCV Ag assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of Hepatitis C virus core antigen in human serum and plasma.63

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Alinity immunoassay systems

Alinity is your total laboratory solution, a unified, holistic family of systems designed to deliver unprecedented integration across your laboratory. The HAV, HBV and HCV assays are available on the Alinity i, a compact, immunoassay system that maximizes throughput and processes more tests per square meter than most systems, making it one of the most efficient on the market today.

Alinity is transforming labs around the world with clinical chemistry, immunoassay, and integrated systems. To discover more visit the Alinity ci-series page.

Architect immunoassay systems

Abbott’s HAV, HBV and HCV assays are also available on the high-throughput ARCHITECT i2000SR system, which can produce over 4,000 results in 24 hours, with a 29 minute time to first result.

The ARCHITECT i2000SR and i1000SR meet your laboratory’s high standards. For additional test menu, system specifications and resources visit the ARCHITECT Immunoassay Systems page.

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Hepatitis learning guide

In addition to finding the hepatitis learing guide explore additional Abbott learning guides that help to build key laboratory competencies.

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References
  1. Hepatitis. World Health Organization, https://www.who.int/health-topics/hepatitis#tab=tab_1 Accessed February 5, 2022.
  2. World Health Organization, Global progress report on HIV, viral hepatitis and sexually transmitted infections, 2021, p 8; https://www.who.int/publications/i/item
    /9789240027077, Accessed July 7 2021.
  3. Zoratti M.J., Siddiqua A., Morassut R.E., et al. Pangenotypic direct acting antivirals for the treatment of chronic hepatitis C virus infection: A systematic literature review and meta-analysis; Elsevier. Clinical Medicine. 2020;18, 100237.
  4. Collins L.F., Chan A., Zheng J., et al. Direct-Acting Antivirals Improve Access to Care and Cure for Patients With HIV and Chronic HCV Infection OFID. 2017; https://www.ncbi.nlm.nih.gov/pmc/articles
    /PMC5753271/pdf/ofx264.pdf, accessed March 9, 2022.
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  8. Bradley DW, Maynard JE, Hindman SH, et al. Serodiagnosis of viral hepatitis A: detection of acute-phase immunoglobulin M anti-hepatitis A virus by radioimmunoassay. J Clin Microbiol 1977; 5:521-530.
  9. Bradley DW, Fields HA, McCaustland KA, et al. Serodiagnosis of viral hepatitis A by a modified competitive binding radioimmunoassay for immunoglobulin M anti-hepatitis A virus. J. Clin. Microbiol 1979;9(1):120-127.
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  14.  Alinity i HAVAb IgG Reagent Kit Package insert G71335R04, Abbott Laboratories; April 2020.
  15. ARCHITECT HAVAb IgG Reagent Kit Package insert G67567R03, Abbott Laboratories; February 2020.
  16. Alinity i HAVAb IgM Reagent Kit Package insert G71344R03, Abbott Laboratories; May 2018.
  17. ARCHITECT HAVAb IgM Reagent Kit Package insert G80448R02, Abbott Laboratories; February 2020.
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  20.  Perrillo RP, Aach RD. The clinical course and chronic sequelae of hepatitis B virus infection. Seminars in Liver Disease 1981; 1:15-25.
  21.  Alinity i HBsAg Next Qualitative Reagent Kit Package insert G94551R03, Abbott Laboratories; March 2020.
  22.  ARCHITECT HBsAg Next Qualitative Reagent Kit Package insert G94410R02, Abbott Laboratories; June 2019.
  23.  Alinity i HBsAg Next Confirmatory Reagent Kit Package insert G94552R02, Abbott Laboratories; March 2020.
  24.  ARCHITECT HBsAg Next Confirmatory Reagent Kit Package insert G94409R02, Abbott Laboratories; June 2019.
  25. Alinity i HBsAg Reagent Kit (Quant) Package insert G71222R03, Abbott Laboratories; June 2019.
  26. ARCHITECT HBsAg Reagent Kit (Quant) Package insert G59166R02, Abbott Laboratories; May 2019.
  1. Alinity i HBsAg Confirmatory V.1 Reagent Kit Package insert G71228R03; June 2019.
  2.  ARCHITECT HBsAg Confirmatory V.1 Reagent Kit Package insert G47750R16; July 2019.
  3.  Koff RS. Viral Hepatitis. In: Schiff L, Schiff ER, editors. Diseases of the Liver. 7th ed. Philadelphia: JB Lippincott, 1993:492-577.
  4.  Alinity i HBeAg Reagent Kit Package insert G71188R04, Abbott Laboratories; February 2020.
  5.  ARCHITECT HBeAg Reagent Kit Package insert G65476R04, Abbott Laboratories; February 2020.
  6.  Lindsay KL, Nizze JA, Koretz R, et al. Diagnostic usefulness of testing for anti-HBc IgM in acute hepatitis B. Hepatol 1986;6:1325- 1328.
  7.  Chau KH, Hargie MP, Decker RH, et al. Serodiagnosis of recent hepatitis B infection by IgM class anti-HBc. Hepatology 1983;3(2):142-149.
  8.  Wang A-X, Coulepis AG, Hui Z, et al. Immunoglobulin M antibodies against hepatitis B core antigen in patients with chronic hepatitis B infection. Pathol. 1984; 16:83-85.
  9. Eble K, Clemens J, Krenc C, et al. Differential diagnosis of acute viral hepatitis using rapid, fully automated immunoassays. J. Med. Virol. 1991; 33:139-150.
  10.  Gerlich WH, Uy A, Lambrecht F, et al. Cutoff levels of immunoglobulin M antibody against viral core antigen for differentiation of acute, chronic, and past hepatitis B virus infections. J. Clin. Microbiol 1986; 24:288-293
  11.  Gerlich WH. Medical Virology of Hepatitis B how it began and where we are now Virol.J.2013; 10:239.
  12.  Alinity i Anti-HBc IgM Reagent Kit Package insert G71211R05, Abbott Laboratories; January 2020.
  13.  ARCHITECT Anti-HBc IgM Reagent Kit Package insert G60417R05, Abbott Laboratories; January 2020.
  14.  Hoofnagle JH, Gerety RJ, Barker LF. Antibody to hepatitis-B-virus core in man. Lancet 1973; II:869-873.
  15.  Szmuness W, Hoofnagle JH, Stevens CE, et al. Antibody against the hepatitis type B core antigen. A new tool for epidemiologic studies. Am J Epidemiol 1976;104(3):256-262.
  16.  Hoofnagle JH, Seeff LB, Buskell-Bales Z, et al. Serologic responses in HB. In: Vyas GN, Cohen SN, Schmid R, editors. Viral Hepatitis. Philadelphia, PA: Franklin Institute Press; 1978:219-242.
  17.  Krugman S, Overby LR, Mushahwar IK, et al. Viral hepatitis, type B studies on natural history and prevention re-examined. N. Engl. J. Med 1979; 300:101-106.
  18.  Zito DR, Gurdak RG, Tucker FL, et al. Hepatitis B virus serology: Loss of antibody to surface antigen. Am. J. Clin. Pathol 1987;88(2):229-231.
  19.  Gitlin N. Hepatitis B; Diagnosis, Prevention, and Treatment. Clin. Chem 1997;43(8B);1500-1506.
  20.  Koff RS. Viral Hepatitis. In: Schiff L, Schiff ER, editors. Diseases of the Liver. 7th ed. Philadelphia: JB Lippincott, 1993:492-577.
  21.  Dodd RY, Popovsky MA, Members of the Scientific Section Coordinating Committee. Antibodies to hepatitis B core antigen and the infectivity of the blood supply. Transfusion 1991;31(5):443-449.
  22. Alinity i Anti-HBc II Reagent Kit Package insert G71214R04, Abbott Laboratories; January 2020.
  23.  ARCHITECT Anti-HBc II Reagent Kit Package insert G47715R10, Abbott Laboratories; February 2020.
  24.   Magnius LO, Lindholm A, Lundin P, et al. A new antigen-antibody system. Clinical significance in long-term carriers of hepatitis B surface antigen. JAMA 1975;231(4):356-359.
  1.  Ling C-M, Mushahwar IK, Overby LR, et al. Hepatitis B e-antigen and its correlation with other serological markers in chimpanzees. Infect. Immun. 1979;24(2):352-356.
  2. Alinity i Anti-HBe Reagent Kit Package insert G71185R04, Abbott Laboratories; January 2020.
  3. ARCHITECT Anti-HBe Reagent Kit Package insert G60570R08, Abbott Laboratories; February 2020.
  4. Wainwright RB, McMahon BJ, Bulkow LR, et al. Duration of immunogenicity and efficacy of hepatitis B vaccine in a Yupik Eskimo population-preliminary results of an 8-year study. In: Hollinger FB, Lemon SM, Margolis HS, editors. Viral Hepatitis and Liver Disease. Baltimore: Williams & Wilkins, 1991:762-766.        
  5.  Alinity i Anti-HBs Reagent Kit Package insert G72481R04, Abbott Laboratories; July 2019.
  6.  ARCHITECT Anti-HBs Reagent Kit Package insert G80543R03, Abbott Laboratories; May 2019.
  7.  Choo QL, Weiner AJ, Overby LR, et al. Hepatitis C virus: the major causative agent of viral non-A, non-B hepatitis. Br. Med. J. 1990; 46:423-441.
  8.  Mederacke I, Wedermeyer H, Ciesek S, et al. Performance and Clinical Utility of a Novel Fully Automated HCV-Core Antigen Assay. Journal of Clinical Virology 2009; 46:210-215.
  9.  Ottiger, C.; Gygli, N.; Huber, A.R., Detection limit of architect hepatitis C core antigen assay in correlation with HCV RNA, and renewed confirmation algorithm for reactive anti-HCV samples. Journal of Clinical Virology 58:535-540. 2013.
  10.  Cloherty G, Cheng K, Chevaliez S et al., Clinical utility of the Abbott ARCHITECT Hepatitis C core antigen testing in the staging and monitoring of treatment naive non-cirrhotic patients receiving an all-oral, interferon-free regimen. Journal of Hepatology Volume 62, Supplement 2, Page S617.
  11.  Alinity i Anti-HCV Reagent Kit Package Insert H07801R03. Abbott Laboratories; November 2020.
  12.  ARCHITECT Anti-HCV Reagent Kit Package Insert G94395R02. Abbott Laboratories; January 2020.
  13.  ARCHITECT HCV Ag Reagent Kit Package Insert F5-Y406-2/R13. Abbott Laboratories; August 2020.
  14.  Hepatitis A Questions and Answers for Health Professionals. Available at the CDC website, https://www.cdc.gov/hepatitis/hav/ havfaq.htm. Updated July 28, 2020. Accessed Oct. 19, 2020.
  15.  Epidemiology and Prevention of Vaccine-Preventable Diseases. The Pink Book: Course Textbook – 13th   Edition (2015), Chapter 9: Hepatitis A. Available at the CDC website, https://www.cdc.gov/vaccines/pubs/pinkbook/hepa.html. Updated April 15, 2019. Accessed Feb. 14, 2020.
  16.    Hepatitis B Questions and Answers for Health Professionals. Available at the CDC website, https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm. Updated July 28, 2020. Accessed Oct. 19, 2020.
  17.  Epidemiology and Prevention of Vaccine-Preventable Diseases. The Pink Book: Course Textbook – 13th Edition (2015), Chapter 10: Hepatitis B. Available at the CDC website,https://www.cdc.gov/vaccines/pubs/pinkbook/hepb.html. Updated April 15, 2019. Accessed Feb. 14, 2020.
  18.  Harris AM. Health Information for International Travel. CDC Yellow Book 2020, Chapter 4: Travel-Related Infectious Diseases – Hepatitis B. Available at the CDC website,https://wwwnc.cdc.gov/travel/yellowbook/2020/travel-related-infectious-diseases/hepatitis-b. Updated July 1, 2019.  Accessed Oct. 16, 2020.
  19.  Hepatitis C Questions and Answers for Health Professionals. Available at the CDC website, https://www.cdc.gov/hepatitis/hcv/hcvfaq.htm. Updated Aug. 7, 2020. Accessed Oct. 19, 2020.
  20.  World Health Organization Hepatitis C Fact Sheet. Available at the WHO website, https://www.who.int/news-room/fact-sheets/detail/hepatitis-c. Updated July 27, 2020. Accessed Oct. 16, 2020.
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