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| Obligatory | Must not donate. | | Additional Information |
Hepatitis B is a serious viral infection that can lead to chronic liver disease and liver cancer (hepatoma).
Individuals who are chronically infected are sometimes referred to as 'carriers'. They often have no, or minimal, symptoms associated with their infection.
Cases are often linked to place of birth, or mother’s place of birth. The condition is very common in many parts of the world and vertical spread from mother to baby is often a major route of transmission. Hepatitis B may also be acquired by injecting drug use, sexual transmission and more rarely tattoos and piercings
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| Obligatory | Must not donate:
if less than 12 months since diagnosis | | Discretionary | If more than 12 months since diagnosis of HBV infection, and if they have successfully cleared the infection, accept.
Refer to the designated medical officer if advice on interpretation of test results is required.
| | See if Relevant | Tissue Safety Entry | | Additional Information |
Leaving 12 months from diagnosis before testing allows sufficient time for a donor to clear any acute infection or develop markers of a chronic infection which will be detected on screening.
If less than 12 months from diagnosis the donor may be accepted if the risk of delaying transplant outweighs the risk of transmission of hepatitis B subject to documented individual risk assessment.
Anti-HBc is required as a mandatory test under the EU Cell and Tissue Directive for cell and tissue donations, and is therefore a regulatory requirement. If the donor is HBsAg negative and HBV DNA negative anti-HBs testing is not required. Anti-HBc must be carried out to comply with regulation and there is no requirement for anti-HBs levels. However some international stem cell registries require anti-HBs status to determine donor suitability.
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| Obligatory | Obtain history (including time since last sexual contact, and the dates that HBV immunisation given).
Must not donate if:
Less than 3 months from last sexual contact
| | Discretionary | If more than 3 months since last sexual contact, accept.
If less than 3 months since last sexual contact, and the donor is shown to be naturally immune, accept. | | Additional Information | A donor with a period of less than 3 months since the last sexual contact with an infected individual may be accepted following individual risk assessment if risk of delaying transplant outweighs the risk of transmission of hepatitis B. A shortened time between last sexual contact and testing increases the risk of not detecting a recently acquired infection on screening.
The current partner of an individual with hepatitis B infection should have been offered immunisation. If the relationship started after the diagnosis of hepatitis B, immunisation may not have been carried out. | | Reason for Change | This entry has been modified in line with the recommendations of the SaBTO Donor Selection Criteria Review Report published on 23rd July (2017). |
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| Obligatory | Obtain history (including time since last contact, date that the partner was diagnosed with HBV infection and the date that HBV immunisation of the donor commenced).
Must not donate if:
Less than 3 months from last sexual contact with the a partner who has been diagnosed with HBV infection less than 12 months ago | | Discretionary | a) If more than 3 months since last sexual contact, regardless of when the partner was diagnosed with the HBV infection, accept
or
b) If partner was diagnosed with HBV infection more than 12 months ago and has cleared the infection at the time of last sexual contact, accept. | | Additional Information | A donor who had sexual contact less than 3 months ago with a partner who had been diagnosed with the HBV infection less than 12 months ago at the time of sexual contact, may be accepted following individual risk assessment if risk of delaying transplant outweighs the risk of transmission of hepatitis B.
The current partner of an individual with hepatitis B infection should have been offered immunisation. If the relationship started after the diagnosis of hepatitis B, immunisation may not have been carried out. | | Reason for Change | This entry has been modified in line with the recommendations of the SaBTO Donor Selection Criteria Review Report published on 23rd July 2017. |
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| Obligatory | Obtain history to determine if they are still sharing a home, and if not, the time since sharing ceased
Must not donate:
If less than 3 months since sharing ceased. | | Discretionary | If more than 3 months since sharing ceased, accept.
If less than 3 months since sharing ceased, and the donor is shown to be naturally immune, accept | | See if Relevant | 6. Hepatitis B Immunization, below. | | Additional Information | A person sharing a home with a person infected with hepatitis B within the past 3 months may be accepted following individual risk assessment if the risk of delaying transplant outweighs the risk of transmission of hepatitis B. | | Reason for Change | This entry has been modified in line with the recommendations of the SaBTO Donor Selection Criteria Review Report published on 23rd July 2017. |
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| Obligatory |
a) If Immunised Following Known Exposure:
Must not donate
b) If Immunised With No Known Exposure:
Must not donate if:
Less than 7 days after the last immunization was given.
| | Discretionary | a) If Immunised Following Known Exposure:
If more than 3 months from immunization, accept
b) If Immunised With No Known Exposure:
If more than 7 days after the last immunization was given, accept. | | See if Relevant | Hepatitis A - 4. Immunization | | Additional Information |
Immunization post exposure may be with specific anti-HB immunoglobulin as well as with HBsAg. Generally immunoglobulin would only be given after a known exposure to hepatitis B.
There is no requirement to monitor the anti-HBs level.
May be combined with hepatitis A immunization.
Sensitive assays for HBsAg may be positive following recent immunization. This is why a 7 day deferral is required.
| | Reason for Change | The immunisation section has been incorporated into the main Hepatitis B entry. |
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