Efficacy And Safety Of Hepatitis B Virus Vaccines
Completion of HBV vaccination produces adequate lifelong antibody response in over 90% of healthy adults. Similar efficacy has been reported among the different three-dose formulations. The newer two-dose vaccine demonstrated comparable efficacy to traditional vaccines . However, PWID are one distinct population in whom HBV vaccine response may be attenuated. Reported seroprotection rates among PWID have ranged between 55% and 97% . Nonstandardized timing of anti-HBs measurement may impact estimates, with highest rates seen when testing for anti-HBs is performed 2 months following the third dose . Older age, active drug use, and coinfection, including HIV infection, have been linked with lower responses in individual studies. Safety concerns regarding the HBV vaccine are minimal. Anaphylaxis is extremely rare, estimated at 1 per 1.1 million doses . Although various conditions have been reported , no causal link between these conditions and the vaccine has been established.
PIERRE VANDEPAPELIÈRE, in, 2000
Questions For Your Doctor About Test Results
Patients may find it helpful to ask questions about their hepatitis B test results. Questions that may be helpful include:
- What was my test result?
- Do I have an acute or chronic hepatitis B infection?
- Does the test result suggest that I have immunity for hepatitis B?
- Would I benefit from hepatitis B vaccination?
- Do I need any follow-up tests based on my hepatitis B test results?
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Additional Specimen Collection Information
Collect blood in a lithium heparin, green-top, EDTA purple-topor red-top tube. PST and SST are acceptable. Serum orplasma should be separated from contact with the cells within 2hours of collection. Specimens not centrifuged within 4 hours ofcollection may be rejected. Refrigerate the specimen if unable toassay within 8 hours of collection. Samples with > 1+ lipemiamust be cleared prior to analysis.
Question 7 Is Hepatitis B Surface Antibody Antibody Always Acquired After A Completed Vaccination Protocol
No. After 3 intramuscular doses of vaccine, > 90% of healthy adults and > 95% of those < 19 years of age develop immunity .1 However, there is an age-specific decline in development of immunity. After age 40 years, about 90% of people become immune, but by age 60 years, only 75% of people become immune.1 Larger vaccine doses or an increased number of doses are required to induce immunity in many hemodialysis patients and in other immunocompromised people.1
This FAQ is provided for informational purposes only and is not intended as medical advice. A clinicians test selection and interpretation, diagnosis, and patient management decisions should be based on his/her education, clinical expertise, and assessment of the patient.Document FAQS.105 Revision: 0
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Provides Information To Assist In Interpretation Of The Test Results
A positive result indicates recovery from acute or chronic hepatitis B virus infection or acquired immunity from HBV vaccination. This assay does not differentiate between a vaccine-induced immune response and an immune response induced by infection with HBV. A positive total antihepatitis B core result would indicate that the hepatitis B surface antibody response is due to past HBV infection.
Per assay manufacturer’s instructions for use, positive results, defined as anti-HBs levels of 12.0 mIU/mL or greater, indicate adequate immunity to hepatitis B from past hepatitis B or HBV vaccination. However, per current CDC guidance, individuals with anti-HBs levels greater than 10 mIU/mL after completing an HBV vaccination series are considered protected from hepatitis B.
Negative results, defined as anti-HBs levels of less than 5.0 mIU/mL, indicate a lack of recovery from acute or chronic hepatitis B or inadequate immune response to HBV vaccination. The US Advisory Committee on Immunization Practices does not recommend more than 2 HBV vaccine series in nonresponders.
Indeterminate results, defined as anti-HBs levels in the range from 5 to 11.9 mIU/mL, indicate inability to determine if anti-HBs is present at levels consistent with recovery or immunity. Repeat testing is recommended in 1 to 3 months.
Understanding Your Test Results
Understanding your hepatitis B blood tests can be confusing. It is important to talk to your health care provider so you understand your test results and your hepatitis B status. Are you infected? Protected? Or at risk? The Hepatitis B Panel of blood tests includes 3 tests and all three results must be known in order to confirm your status.
Below is a chart with the most common explanation of the test results, but unusual test results can occur. Please note that this chart is not intended as medical advice, so be sure to talk to your health care provider for a full explanation and obtain a printed copy of your test results. In some cases, a person could be referred to a liver specialist for further evaluation.
More Detailed Information About Hepatitis B Blood Tests
An acute hepatitis B infection follows a relatively long incubation period – from 60 to 150 days with an average of 90 days. It can take up to six months, however, for a person to get rid of the hepatitis B virus. And it can take up to six months for a hepatitis B blood test to show whether as person has recovered from an acute infection or has become chronically infected .
The following graphic from the U.S. Centers for Disease Control and Prevention represents the typical course of an acute hepatitis B infection from first exposure to recovery.
According to the CDC, a hepatitis B blood test result varies depending on whether the infection is a new acute infection or a chronic infection.
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What Is The Purpose Of A Hepatitis B Test
Hepatitis B test is performed to detect, classify, and treat hepatitis B virus infection.
Hepatitis B blood tests involve the measurement of several HBV-specific antigens and antibodies. In addition, HBV blood tests also include liver enzymes and liver function tests to assess and monitor the condition of the liver and provide appropriate treatment.
The HBV specific tests include the following:
- HBsAg: HBsAg is an antigen found on the surface of hepatitis B virus. HBsAg may be detected in the blood any time after 1 week post-exposure to HB virus, but usually appears after 4 weeks.
- Anti-HBs: Anti-HBs are antibodies produced by the bodys immune system to fight HBsAg. Anti-HBs from a prior infection or vaccination provides immunity against further infection.
- Hepatitis B core antigen : HBcAg is an antigen found in the core layer which covers the hepatitis B viral DNA.
- Hepatitis B core antibody : Anti-HBc is the antibody that fights HBcAg. Anti-HBc is the first detectable antibody after HBV infection. There are two kinds of Anti-HBc:
- Immunoglobulin M hepatitis B core antibody : IgM anti-HBc indicates acute or reactivated recent infection within the previous 6 months.
- Immunoglobulin G hepatitis B core antibody : IgG anti-HBc may indicate previous or chronic infection. Once present, IgG anti-HBc persists for a lifetime.
What Is Hepatitis B Surface Antibody
When you are exposed to hepatitis B, your body mounts an immune reaction against it as an invader. This happens whether you are exposed due to blood or sexual contact or if you are vaccinated with the hepatitis B vaccine.
The hepatitis B virus has proteins on its surface that cause your immune system to produce antibodies. With the vaccine, the sample contains the protein only and not the virus itself.
The first response your body will make when exposed to hepatitis B is to manufacture hepatitis B IgM antibodies. These early antibodies are produced to fight against several parts of the virus including its core. These antibodies are seen in the initial response, but they eventually fade away.
Your immune system then begins to produce IgG antibodies. It continues to produce these antibodies for the rest of your life. In this way, your immune system is always ready to attack hepatitis B virus when it is exposed to it.
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When Should I Get Hepatitis B Testing
Using hepatitis B tests to screen for HBV is recommended for certain groups that are at an increased risk of infection. Groups that may benefit from hepatitis B screening include:
- Pregnant people
- People born in parts of the world where hepatitis B is more common, including Africa, Asia, Eastern Europe, South America, and parts of the Middle East
- People who didnt receive a hepatitis B vaccine
- HIV-positive people
- Pain in the joints or abdomen
- Loss of appetite, nausea, or vomiting
- Yellowish skin and eyes
Using hepatitis B testing to assess immunity to HBV may be used before or after vaccination. Pre-vaccination testing is not always needed but may be performed if there is a chance that a patient has previously been infected with HBV or has already been vaccinated. Post-vaccination testing is used in certain groups of people who are at an especially elevated risk for HBV infection, including infants born to mothers with a hepatitis B infection.
Can I Take The Test At Home
Samples for hepatitis B testing can be collected at home. At-home hepatitis B testing requires a patient to collect a blood sample, typically from a fingerstick using a very small needle provided in the test kit. Once a blood sample is collected, it is prepared according to the instructions contained in the test kit and mailed to a laboratory for testing.
Because there are numerous types of tests for HBV, it is important to look closely at the specific components of any at-home test kit. Many at-home test kits only look for hepatitis B surface antigen .
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Hbv Dna Hbv Genotype And Hbv Drug Resistance Assays
Specimen: Serum or plasma
Container: Red-top tube, yellow-top tube , gel-barrier tube, plasma preparation tube, or lavender tube
Collection method: Routine venipuncture
The specimen should be transfused to separate plasma/serum from cells within 6 hours and kept frozen when testing cannot be done promptly.
The tests use PCR amplification, DNA probe hybridization, and sequencing method.
How Much Does The Test Cost
The cost of hepatitis B testing depends on the tests that are performed, where the test is conducted, and a patients health insurance coverage. When testing is ordered by a doctor, patients with health insurance may find it helpful to discuss the cost of testing with their health insurance company as they may be responsible for testing costs as well as other out-of-pocket costs such as copays and deductibles.
For patients without health insurance or for whom insurance doesnt cover the cost of testing, it may be helpful to discuss the cost of hepatitis B testing with a doctor or hospital administrator.
The cost of at-home hepatitis B testing starts around $45. At-home test kits may also test for additional types of viral hepatitis in the same sample. The cost of test panels that look for more than one type of viral hepatitis start around $80.
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Hep B Titer Test Required By Most Schools And Employers
This assay is used to determine immune status for Hepatitis B.
Hepatitis B Surface Antibody : The surface antibody is formed in response to the hepatitis B virus. Your body can make this antibody if you have been vaccinated, or if you have recovered from a hepatitis B infection. If this test is positive, then your immune system has successfully developed a protective antibody against the hepatitis B virus. This will provide long-term protection against future hepatitis B infection. Someone who is surface antibody positive is not infected, and cannot pass the virus on to others.
This is a Quantitative test required by many schools and medical programs. Levels of anti-HBs will be provided.
Question 3 How Is The Quantitative Hepatitis B Surface Antibody Test Performed
An immunometric technique is used. The anti-HBs binds to HBsAg ad and ay subtypes, which are coated on the test wells. Binding of a horseradish peroxidase-labeled HBsAg conjugate to the anti-HBs completes the sandwich formation. Unbound materials are then washed away. In the next step, the horseradish peroxidase catalyzes oxidation of a luminogenic substrate, producing light. Light signals are detected and quantified. Intensity of the light is proportional to the amount of anti-HBs present in the patient sample. The result is standardized to an international unit system and reported as milliinternational units per milliliter .
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Taking A Hepatitis B Test
Testing for hepatitis B is performed on a sample of blood. A doctor, nurse, or other health care provider can obtain a blood sample using a small needle to draw blood from a vein.
At-home hepatitis B testing requires that users carefully follow instructions provided in the test kit to collect a small sample of blood, package the sample, and mail it to a lab for testing.
What Do Hepatitis B Test Results Mean
Hepatitis B test results help determine if HBV infection is negative or positive, and if positive, whether the infection is acute or chronic, or if recovery is complete. A combination of results are considered to identify and classify HBV infection status.
The following are some interpretations of hepatitis B test results:
Table: Hepatitis B test results and interpretations
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What Does The Test Measure
Hepatitis B testing looks for antigens, antibodies, or the genetic material of the hepatitis B virus. HBV antigens are substances from the virus that cause a patients body to produce an immune response. Antibodies are substances made by the immune system in response to the hepatitis B virus.
Initial tests for hepatitis B measure antibodies and antigens related to HBV including:
If a patient is diagnosed with hepatitis B based on these initial tests, additional hepatitis B testing may be used to monitor the disease, guide treatment, and determine if a person can spread hepatitis B to others. These additional tests may include:
- Hepatitis B e antigen : Hepatitis B e antigen is a protein from the hepatitis B virus found in some patients who are positive for hepatitis B surface antigen. Measuring this antigen can help doctors understand infectivity, which describes a persons ability to spread HBV to others.
What Is The Normal Range For Hepatitis B Surface Antibody
- Anti-HBs greater than 10-12 mIU/mL: Protected against hepatitis B virus infection, either from vaccination or successful recovery from a previous HBV infection.
- Anti-HBs less than 5 mIU/mL: Negative for HBV infection, but susceptible and hence requires vaccination.
- Anti-HBs from 5-12 mIU/mL: Inconclusive results and the test should be repeated.
However, there is no standardization of these values so it is advisable to check the manufacturers values it is the reason values are mainly reported as positive or negative.
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Understanding Of Lab Tests Results
Please visit the site associated with The American Association for Clinical Chemistry for better understanding of tests. There you will find the most detailed and full information regarding lab tests. In “common questions” tab you will find answers on the most common questions.
In addition, you can use a special form to ask the question. It is useful, if there is no answer on your question on the web site. A laboratory scientist will answer your question. It is a part of voluntary service provided by the American Society for Clinical Laboratory Science.
Discusses Physiology Pathophysiology And General Clinical Aspects As They Relate To A Laboratory Test
Hepatitis B virus infection, also known as serum hepatitis, is endemic throughout the world. The infection is spread primarily through blood transfusion or percutaneous contact with infected blood products, such as sharing of needles among injection drug users. The virus is also found in virtually every type of human body fluid and has been known to be spread through oral and genital contact. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions, but it is not commonly transmitted via the transplacental route.
The incubation period for HBV infection averages 60 to 90 days . Common symptoms include malaise, fever, gastroenteritis, and jaundice . After acute infection, HBV infection becomes chronic in 30% to 90% of infected children younger than 5 years of age and in 5% to 10% of infected individuals age 5 or older. Some of these chronic carriers are asymptomatic, while others progress to chronic liver disease, including cirrhosis and hepatocellular carcinoma.
Hepatitis B surface antigen is the first serologic marker, appearing in the serum 6 to 16 weeks following HBV infection. In acute cases, HBsAg usually disappears 1 to 2 months after the onset of symptoms with the appearance of hepatitis B surface antibody . Anti-HBs also appears as the immune response following hepatitis B vaccination.
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