SEROLOGY 

 

** This course meets the 1 hr. Serology requirement for Florida license renewal. ** 

 

     

HEPATITIS B: IMMUNITY AND PREVENTION  STRATEGIES THROUGH VACCINATION  AUTHORED BY:   Centers for Disease Control  COURSE CODE:           S020 CONTACT HOURS:     4  COURSE LEVEL:          Intermediate 

            

 

   

Continuing Education Unlimited 6231 PGA Blvd / Suite 104, #306 / Palm Beach Gardens, FL 33418 888-423-8462 / General Fax: 561-775-4933 / Answer  Sheet ONLY Fax: 561-775-4948 / www.4CEUINC.com PROVIDER #s: Florida: 50-2256 | California: 0001 | ASCLS P.A.C.E.: 511

 

 

 

COURSE OBJECTIVES 

  1. Discuss the background, clinical features, and complications of Hepatitis B Virus.   2. Identify appropriate laboratory tests for both pre and post‐vaccine testing.     3. Discuss the epidemiology of Hepatitis B virus.   4. Recall the secular trends for Hepatitis B virus that exist in the United States.     5. List general characteristics of the Hepatitis B vaccines.   6. Discuss the immunogenicity and vaccine effectiveness among the different age groups.  1.)   7. Recall the vaccine schedule and effectiveness among the different age groups.    8. Discuss post‐vaccination blood testing and its appropriateness in different scenarios.  9. Discuss treatment options for post‐exposure management.    10. List contraindications and adverse reactions as they relate to the Hepatitis B vaccine series.   

 

 

COPYRIGHT INFO:  RIGHTSHOLDER 

CEUINC LICENSE INFO:  LABORATORY   

Author:  Centers for Disease Control ‐ General Disease Info Copyright:   September 28,  2012  Publication:   N/A

CA Department of Health:  Florida Board of Clinical Lab:  ASCLS P.A.C.E.® 

 

0001  50‐2256  511 

 

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http://www.cdc.gov/vaccines/pubs/pinkbook/hepb.html#trends  

 

       

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** CEUINC is approved as a provider of continuing education programs in the clinical laboratory sciences by the  ®

ASCLS P.A.C.E.  Program. ** 

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Last Revised 11/09/12

Continuing Education Unlimited 6231 PGA Blvd , Ste 104 / #306 Palm Beach Gardens, FL 33418 General Fax: 561-775-4933 / Answer Sheet Only Fax: 561-775-4933

Phone: 561-775-4944 / Web: www.4CEUINC.com

                                                                                                                                           

    

Thanks for choosing CEUINC for your continuing education needs!  We strive to offer you current course material at the most cost  effective price.  If you have comments or suggestions, be sure to add them to your evaluation – we appreciate them.  If you like our  courses pass them on to a coworker or friend.    

READ BEFORE COMPLETING MATERIAL  GENERAL: 1.) Check your reading material to make sure that it contains the correct course(s) you ordered. 2.) Carefully read the material before completing your quiz packet. All answers are within the reading material. With few exceptions, quiz questions typically follow in order of the reading. 3.) Courses must be completed within 1 year of purchase date, unless otherwise specified. 4.) All of your records are available to you on our website for 4 years. If you don’t have a login to access your records, please contact our office and we will give you that information. Please do not create a 2nd profile! 5.) When sharing your materials with a coworker, be sure to pass on both the reading material and the quiz.

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ALERT:   iii

 

Please make a copy of your answer sheets before mailing them!

When faxing your answer sheets, make a note of the date and time you sent them! This safeguards you in the event that your answer sheet does not reach its destination.  www.4CEUINC.com 

Continuing Education Unlimited 6231 PGA Blvd , Ste 104 / #306 Palm Beach Gardens, FL 33418

Last Revised 11/09/12

General Fax: 561-775-4933 / Answer Sheet Only Fax: 561-775-4933

Phone: 561-775-4944 / Web: www.4CEUINC.com

                                      

                              

                                                

 

  

                              

               

FREQUENTLY  ASKED  QUESTIONS  Q. Your phones are often busy, how can I reach you? A. Because we have a small staff, the most efficient way would be to Schedule a Call Back by clicking the button on the Home Page of our website. You will then be able to select a convenient time for our staff to call you back.

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ALERT:

Please make a copy of your answer sheets before mailing them!

When faxing your answer sheets, make a note of the date and time you sent them! This safeguards you in the event that your answer sheet does not reach its destination.

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HEPATITIS B: IMMUNITY AND PREVENTION STRATEGIES THROUGH VACCINATION Category: Serology | Contact Hours: 4 | Course Code: S020 

1.) Hepatitis B Virus (HBV) has been shown to remain infectious on environmental surfaces for more than ________ at room temperature. A. 60 minutes B. 7 days C. 2 weeks 2.)

The incubation period for HBV ranges from _______________________. A. 6 to 12 days B. 15 to 35 days (average 25 days) C. 45 to 160 days (average 120 days)

3.) Most acute HBV infections in adults result in complete recovery with elimination of HBsAg from the blood and the production of anti-HBs, creating immunity to future infection. A. True B. False 4.) As many as 90% of infants who acquire HBV infection from their mothers at birth become chronically infected. A. 20% B. 40% C. 90% 5.)

Chronic active hepatitis develops in more than ______ of carriers and often results in cirrhosis. A. 25% B. 45% C. 75%

6.) Anti-HBc generally persists for life and is not a serologic marker for acute infection. A. True B. False 7.) A patient with the following test results would be considered _____________: (Positive), IgM anti-HBc (Positive), anti-HBs (Negative). A. Immune due to natural infection B. Chronically infected C. Acutely infected

HBsAG (Positive), anti-HBc

8.) A patient with the following test results would be considered _____________: HBc (Negative), anti-HBs (Positive with ≥ 10mIU/mL). A. Suseptible B. Chronically infected C. Immune due to vaccination

HBsAG (Negative), anti-

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  HEPATITIS B: IMMUNITY AND PREVENTION STRATEGIES THROUGH VACCINATION - QUIZ PAGE 2 - 

 

9.)  Interferon is the most effective treatment for chronic HBV infection and is successful in 25% to 50% of cases. A. True B. False 10.)

HBV infection affects only humans, as no animal hosts, insect hosts, or vectors are known to exist. A. True B. False

11.) The virus is transmitted by parenteral or mucosal exposure to HBsAg-positive body fluids from persons who have acute or chronic HBV infection. A. True B. False 12.) If a mother is positive for both HBsAg and HBeAg, _________ of infants will become infected in the absence of postexposure prophylaxis. A. 20%-30% B. 40%-50% C. 70%–90% 13.)

The incidence of reported hepatitis B peaked in the mid-_____. A. 1970s B. 1980s C. 1990s

14.) According to the CDC, it’s estimated that _____________ persons become chronically infected each year.. A. 5,000-8,000 B. 10,000-12,000 C. 18,000-20,000 15.)

3-10% of _________________are positive for HBsAg. A. prisoners B. patients of hemodialysis units C. heterosexuals with multiple partners

16.) A plasma-derived vaccine was licensed in the United States in ______. A. 1979 B. 1981 C. 1986 17.) Recombinant vaccine is produced by inserting a plasmid containing the gene for HBsAg into __________. A. attenuated Staph epidermidis bacteria B. common baker’s yeast C. a stem cell 18.) All of the formulations of Recombivax HB contain thimerosal and other preservatives. A. True B. False vi

 

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PETS, PATIENTS, AND ZOONOSES - QUIZ PAGE 3 -  19.) Hepatitis B vaccine administered by any route or site other than intramuscularly in the anterolateral thigh or deltoid muscle should not be counted as valid and should be repeated unless serologic testing indicates that an adequate response has been achieved.  A. True   B. False 20.) Although antibody levels decline with time, immune memory remains intact for more than _______ following immunization. A. 15 years B. 20 years C. 30 years 21.) For adults and children with normal immune status, booster doses of vaccine are not recommended. A. True B. False 22.) Preterm infants born to HBsAg-positive women and women with unknown HBsAg status must receive immunoprophylaxis with hepatitis B vaccine and hepatitis B immune globulin (HBIG) within _________ of birth. A. 30 minutes B. 12 hours C. 48 hours 23.) For Hepatitis B vaccine purposes, children through ___ years are considered adolescents. A. 12 years B. 15 years C. 18 years 24.) Twinrix is a combination vaccine for ________________ that is approved for adults. A. Hepatitis B and HPV B. Hepatitis A and Hepatitis B C. Hepatitis B and Hepatitis C 25.) Although prevaccination serologic testing is typically not recommended, it would be for injection drug users. A. True B. False 26.) Healthcare personnel who have ongoing contact with patients or blood and who are at risk for sharps injuries should be routinely tested for antibodies ______ after completion of the 3-dose series. A. 2 to 4 weeks B. 1 to 2 months C. 4 to 6 months

  27.) Fewer than ____ of persons receiving six doses of hepatitis B vaccine administered by the appropriate schedule in the deltoid muscle fail to develop detectable anti-HBs antibody. A. 5% B. 10% C. 15% 28.) For newborns that receive post-exposure preventative treatment, the Hepatitis B vaccine and the HBIG should be given at the same time, _________________________. A. within the same syringe B. at the same site C. at different sites vii

 

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PETS, PATIENTS, AND ZOONOSES - QUIZ PAGE 4 - 

29.) After a percutaneous (needle stick, laceration, bite) or permucosal exposure that contains or might contain HBV, blood should be obtained from the person who was the source of the exposure to determine their HBsAg status. A. True B. False 30.) As a precaution, Hepatitis B vaccine does contain live virus, so it is not suitable for those with immunodeficiency. A. True B. False 31.) The most common adverse reaction to the Hepatitis B vaccine is/are _________________. A. a low grade temperature B. mild systemic complaints C. injection site pain

*****LAST QUESTION ****

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Table of Contents Background .................................................................................................... 1 Hepatitis B Virus ............................................................................................. 1 Clinical Features ............................................................................................. 3 Complications ................................................................................................. 3 Chronic HBV Infection ...................................................................................... 4 Laboratory Diagnosis ...................................................................................... 5 Medical Management ...................................................................................... 6 Epidemiology .................................................................................................. Reservoir ....................................................................................................... Transmission .................................................................................................. Communicability .............................................................................................

7 7 7 9

Secular Trends in the United States ................................................................ 9 Hepatitis B Prevention Strategies .................................................................. 11 Hepatitis B Vaccine ........................................................................................ 12 Characteristics ............................................................................................... 12 Immunogenicity and Vaccine Efficacy ............................................................ 14 Vaccination Schedule and Use........................................................................ 16 Infants and Children ....................................................................................... 16 Comvax ........................................................................................................ 17 Pediarix ........................................................................................................ 18 Adolescents................................................................................................... 19 Adults (20 Years of Age and Older) ................................................................... 20 Twinrix ......................................................................................................... 22 Serologic Testing of Vaccine Recipients ......................................................... 23 Prevaccination Serologic Testing ...................................................................... 23 Postvaccination Serologic Testing ..................................................................... 24 Vaccine Non-Response .................................................................................... 25 ix

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Postexposure Management ............................................................................ 26 Non-Occupational Exposure to an HBsAg-Positive Source ..................................... 29 Non-Occupational Exposure to a Source with Unknown HBsAg Status .......................... 30 Contraindications and Precautions to Vaccination .......................................... 30 Adverse Reactions Following Vaccination ...................................................... 31 Vaccine Storage and Handling ....................................................................... 31 References .................................................................................................... 32

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HEPATITIS B: IMMUNITY AND PREVENTION STRATEGIES THROUGH VACCINATION

COURSE # - S020

BACKGROUND Viral hepatitis is a term commonly used for HEPATITIS B several clinically similar yet etiologically and  Epidemic jaundice described by epidemiologically distinct diseases. Hepatitis Hippocrates in 5th century A (formerly called infectious hepatitis) and  Jaundice reported among recipients of hepatitis B (formerly called serum hepatitis) human serum and yellow fever vaccines in 1930s and 1940s have been recognized as separate entities  Australian antigen described in 1965 since the early 1940s and can be diagnosed  Serologlogic tests developed in 1970s with specific serologic tests. Delta hepatitis is an infection dependent on the hepatitis B virus (HBV). It may occur as a coinfection with acute HBV infection or as superinfection of an HBV carrier. Epidemic jaundice was described by Hippocrates in the 5th century. The first recorded cases of "serum hepatitis," or hepatitis B, are thought to be those that followed the administration of smallpox vaccine containing human lymph to shipyard workers in Germany in l883. In the early and middle parts of the 20th century, serum hepatitis was repeatedly observed following the use of contaminated needles and syringes. The role of blood as a vehicle for virus transmission was further emphasized in 1943, when Beeson described jaundice that had occurred in seven recipients of blood transfusions. Australia antigen, later called hepatitis B surface antigen (HBsAg), was first described in 1965, and the Dane particle (complete hepatitis B virion) was identified in 1970. Identification of serologic markers for HBV infection followed, which helped clarify the natural history of the disease. Ultimately, HBsAg was prepared in quantity and now comprises the immunogen in highly effective vaccines for prevention of HBV infection.

HEPATITIS B VIRUS HBV is a small, double-shelled virus in the family Hepadnaviridae. Other Hepadnaviridae include duck hepatitis virus, ground squirrel hepatitis virus, and woodchuck hepatitis virus. The virus has a small circular DNA genome that is partially double-stranded. HBV contains numerous antigenic components, including HBsAg, hepatitis B core antigen (HBcAg), and hepatitis B e antigen (HBeAg). Humans are the only known host for HBV, although some nonhuman primates have been infected in laboratory conditions. HBV is relatively resilient 1

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HEPATITIS B: IMMUNITY AND PREVENTION STRATEGIES THROUGH VACCINATION

HEPATITIS B VIRUS 

Hepadnaviridae family (DNA)



Numerous antigenic components



Humans are only known host



May retain infectivity for more than 7 days at room temperature

COURSE # - S020

and, in some instances, has been shown to remain infectious on environmental surfaces for more than 7 days at room temperature.

An estimated 2 billion persons worldwide have been infected with HBV, and more than 350 million persons have chronic, lifelong infections. HBV infection is an established cause of acute and chronic hepatitis and cirrhosis. It is the cause of up to 80% of hepatocellular carcinomas. The World Health Organization estimated that more than 600,000 persons died worldwide in 2002 of hepatitis B-associated acute and chronic HEPATITIS B VIRUS INFECTION  More than 350 million chronically liver disease. infected worldwide 

Established

cause

of

chronic

Several well-defined antigen–antibody hepatitis and cirrhosis systems are associated with HBV infection.  Human carcinogen – cause of up to HBsAg, formerly called Australia antigen or 80% of hepatocellular carcinomas hepatitis-associated antigen, is an antigenic determinant found on the surface of the virus. It also makes up subviral 22-nm spherical and tubular particles. HBsAg can be identified in serum 30 to 60 days after exposure to HBV and persists for variable periods. HBsAg is not infectious. Only the complete virus (Dane particle) is infectious. However, when HBsAg is present in the blood, complete virus is also present, and the person may transmit the virus. During replication, HBV produces HBsAg in excess of that needed for production of Dane particles. HBcAg is the nucleocapsid protein core of HBV. HBcAg is not detectable in serum by conventional techniques, but it can be detected in liver tissue of persons with acute or chronic HBV infection. HBeAg, a soluble protein, is also contained in the core of HBV. HBeAg is detected in the serum of persons with high virus titers and indicates high infectivity. Antibody to HBsAg (antiHBs) develops during convalescence after acute HBV infection or following hepatitis B vaccination. The presence of anti-HBs indicates immunity to HBV. (Anti-HBs is sometimes referred to as HBsAb, but use of this term is discouraged because of 2

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HEPATITIS B: IMMUNITY AND PREVENTION STRATEGIES THROUGH VACCINATION

COURSE # - S020

potential confusion with HBsAg.) Antibody to HBcAg (anti-HBc) indicates infection with HBV at an undefined time in the past. IgM class antibody to HBcAg (IgM anti-HBc) indicates recent infection with HBV. Antibody to HBeAg (anti-HBe) becomes detectable when HBeAg is lost and is associated with low infectivity of serum.

CLINICAL FEATURES The clinical course of acute hepatitis B is indistinguishable from that of other types of acute viral hepatitis. The incubation period ranges from 45 to 160 days (average, 120 days). Clinical signs and symptoms occur more often in adults than in infants or children, who usually have an asymptomatic acute course. However, approximately 50% of adults who have acute infections are asymptomatic.

HEP B VIRUS CLINICAL FEATURES 

Incubation period 45-160 days (avg. 120 days)



Nonspecific prodrome of fever, headache, myalgia



Illness not specific for hepatitis B



At

lease

50%

of

malaise,

infections

asymptomatic

The pre-icteric, or prodromal phase from initial symptoms to onset of jaundice usually lasts from 3 to l0 days. It is nonspecific and is characterized by insidious onset of malaise, anorexia, nausea, vomiting, right upper quadrant abdominal pain, fever, headache, myalgia, skin rashes, arthralgia and arthritis, and dark urine, beginning 1 to 2 days before the onset of jaundice. The icteric phase is variable but usually lasts from l to 3 weeks and is characterized by jaundice, light or gray stools, hepatic tenderness and hepatomegaly (splenomegaly is less common). During convalescence, malaise and fatigue may persist for weeks or months, while jaundice, anorexia, and other symptoms disappear. Most acute HBV infections in adults result in complete recovery with elimination of HBsAg from the blood and the production of anti-HBs, creating immunity to future infection.

COMPLICATIONS While most acute HBV infections in adults result in complete recovery, fulminant hepatitis occurs in about 1% to 2% of acutely infected persons. About 200 to 300 3

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HEPATITIS B: IMMUNITY AND PREVENTION STRATEGIES THROUGH VACCINATION

HEPATITIS B COMPLICATIONS

COURSE # - S020

HEPATITIS B VIRUS INFECTION



Fulminant hepatitis



Chronic viremia



Hospitalization



Responsible for most mortality



Cirrhosis



Overall risk 5%



Hepatocellular carcinoma



Higher risk with early infection



Death

Americans die of fulminant disease each year (case-fatality rate 63% to 93%). Although the consequences of acute HBV infection can be severe, most of the serious complications associated with HBV infection are due to chronic infection.

CHRONIC HBV INFECTION Approximately 5% of all acute HBV infections progress to chronic infection, with the risk of chronic HBV infection RISK OF CHRONIC HBV CARRIAGE BY AGE decreasing with age. As many as OF INFECTION 90% of infants who acquire HBV infection from their mothers at birth become chronically infected. Of children who become infected with HBV between 1 year and 5 years of age, 30% to 50% become chronically infected. By adulthood, the risk of acquiring chronic HBV infection is approximately 5%. Persons with chronic infection are often asymptomatic and may not be aware that they are infected; however, they are capable of infecting others and have been referred to as carriers. Chronic infection is responsible for most HBV-related morbidity and mortality, including chronic hepatitis, cirrhosis, liver failure, and hepatocellular carcinoma. Approximately 25% of persons with chronic HBV infection die prematurely from cirrhosis or liver cancer. Chronic active hepatitis develops in more than 25% of carriers and often results in cirrhosis. An estimated 3,000 to 4,000 persons die of hepatitis B-related cirrhosis each year in the United States. Persons with chronic 4

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HEPATITIS B: IMMUNITY AND PREVENTION STRATEGIES THROUGH VACCINATION

COURSE # - S020

HBV infection are at 12 to 300 times higher risk of hepatocellular carcinoma than noncarriers. An estimated 1,000 to 1,500 persons die each year in the United States of hepatitis B-related liver cancer. Anti-HBc (core antibody) develops in all HBV infections, appears shortly after HBsAg in acute disease, and indicates HBV infection at some undefined time in the past. Anti-HBc only occurs after HBV infection and does not develop in persons whose immunity to HBV is from vaccine. Anti-HBc generally persists for life and is not a serologic marker for acute infection. IgM anti-HBc appears in persons with acute disease about the time of illness onset and indicates recent infection with HBV. IgM anti-HBc is generally detectable 4 to 6 months after onset of illness and is the best serologic marker of acute HBV infection. A negative test for IgM-anti-HBc together with a positive test for HBsAg in a single blood sample identifies a chronic HBV infection

LABORATORY DIAGNOSIS Diagnosis is based on clinical, laboratory, and epidemiologic findings. HBV infection cannot be differentiated on the basis of clinical symptoms alone, and definitive diagnosis depends on the results of serologic testing. Serologic markers of HBV infection vary depending on whether the infection is acute or chronic. HBsAg is the most commonly used test for diagnosing acute HBV infections or detecting carriers. HBsAg can be detected as early as 1 or 2 weeks and as late as 11 or 12 weeks after exposure to HBV when sensitive assays are used. The presence of HBsAg indicates that a person is infectious, regardless of whether the infection is acute or chronic. Anti-HBc (core antibody) develops in all HBV infections, appears shortly after HBsAg in acute disease, and indicates HBV infection at some undefined time in the past. Anti-HBc only occurs after HBV infection and does not develop in persons whose immunity to HBV is from vaccine. Anti-HBc generally persists for life and is not a serologic marker for acute infection. IgM anti-HBc appears in persons with acute disease about the time of illness onset and indicates recent infection with HBV. IgM anti-HBc is generally detectable 4 to 6 months after onset of illness and is the best serologic marker of acute HBV infection. A negative test for IgM-anti-HBc together with a positive test for HBsAg in a single blood sample identifies a chronic HBV infection. 5

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HEPATITIS B: IMMUNITY AND PREVENTION STRATEGIES THROUGH VACCINATION

COURSE # - S020

INTERPRETATION OF HEPATITIS B SEROLOGIC TESTS

*Postvaccination testing, when it is recommended, should be performed 1-2 months following dose #3. † 1. May be recovering from acute HBV infection. 2. May be distantly immune and the test is not sensitive enough to detect a very low level of anti-HBs in serum. 3. May be susceptible with a false positive anti-HBc. 4. May be chronically infected and have an undetectable level of HBsAg present in the serum.

MEDICAL MANAGEMENT There is no specific therapy for acute HBV infection. Treatment is supportive. Interferon is the most effective treatment for chronic HBV infection and is successful in 25% to 50% of cases. Persons with acute or chronic HBV infections should prevent their blood and other potentially infective body fluids from contacting other persons. They should not 6

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HEPATITIS B: IMMUNITY AND PREVENTION STRATEGIES THROUGH VACCINATION

COURSE # - S020

donate blood or share toothbrushes or razors with household members. In the hospital setting, patients with HBV infection should be managed with standard precautions.

EPIDEMIOLOGY RESERVOIR Although other primates have been infected in laboratory conditions, HBV infection affects only humans. No animal or insect hosts or vectors are known to exist.

TRANSMISSION The virus is transmitted by parenteral or HEPATITIS B EPIDEMIOLOGY mucosal exposure to HBsAg-positive body  Reservoir - Human fluids from persons who have acute or  Transmission – Bloodborne & chronic HBV infection. The highest Subclinical cases transmit concentrations of virus are in blood and  Communicability – 1 to 2 months before and after onset of symptoms serous fluids; lower titers are found in other Chronic carriers fluids, such as saliva and semen. Saliva can be a vehicle of transmission through bites; however, other types of exposure to saliva, including kissing, are unlikely modes of transmission. There appears to be no HEPATITIS B PERINATAL TRANSMISSION 

If a mother positive for HBsAG and HBeAG o o





70-90% of infants infected 90% of infected infants become chronically infected

10% of infants infected 90% of infected infants become chronically infected

High (> or =8%): 45% of global population o o

Lifetime risk of infection >60% Early childhood infections common

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Intermediate (2%-7%): 43% of global population o Lifetime risk of infection 20-60% o Infections occur in all age groups

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Low (