The National Donor Deferral Registry, also known as the (NDDR) is a database of individuals who have tested "reactive" for viral agents like human immunodeficiency viruses (HIV), Hepatitis B virus (HBV), and hepatitis C virus (HCV) and are permanently prohibited from donating plasma. [1] NDDR is a registered trademark of the Plasma Protein Therapeutics Association. U.S. regulations require organizations that collect plasma screens for viruses and flag donors and keep a list. The NDDR was established in 1993. This is to help plasma donation centers notify other centers of a donor who has tested positive for one of the listed viruses.
The NDDR is a confidential database that is used in North America and the United States to help provide the collection of safe plasma donation through plasmapheresis. When identifying information is matched in the registry, the donation center should not accept a person donation. The U.S. Food and Drug Administration lists the requirements for donor federal in 21 CFR § 610.41
In November 2020, the U.S. Food and Drug Administration reviewed a Section 510(k) premarket notification of a cloud-based version of the NDDR by Headspring Healthcare, Inc. [2] The new web-based systems would allow
Each donation center is responsible for checking the NDDR prior to donation and uploading any positive or reactive tests for each donor. An International Quality Plasma Program (IQPP) facility is a lab that has agreed to the voluntary standards program of the PPTA. [3]
The personally identifiable information (PII) that is collected is "individual's donor ID, first and last name, middle initial birthdate and gender. The donor's social security number or INDS number."
The FDA has established rules under how a previously deferred donor may be able to requalify. There are two methods which the FDA has adopted.
or
It was not until May 2010 when the FDA published a way for individuals to be requalified due to repeatedly reactive test for anti-HBC. The FDA admitted that up to 21,500 people in the late 1980s and 1990s because of "false positive" tests results. The FDA estimated that almost 200,000 donors could be eligible for reentry. [4]
There is no central agency responsible for reviewing or correcting errors. Each company that inputs data into the NDDR must have a written procedure to correct errors.
A Woman in Des Moines, Iowa, was listed on the NDDR after having a 'reactive' test for HIV however, after additional testing was found to be negative for HIV. [5]
HIV tests are used to detect the presence of the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), in serum, saliva, or urine. Such tests may detect antibodies, antigens, or RNA.
A blood donation occurs when a person voluntarily has blood drawn and used for transfusions and/or made into biopharmaceutical medications by a process called fractionation. Donation may be of whole blood, or of specific components directly (apheresis). Blood banks often participate in the collection process as well as the procedures that follow it.
Plasmapheresis is the removal, treatment, and return or exchange of blood plasma or components thereof from and to the blood circulation. It is thus an extracorporeal therapy, a medical procedure performed outside the body.
Tenofovir disoproxil, sold under the trade name Viread among others, is a medication used to treat chronic hepatitis B and to prevent and treat HIV/AIDS. It is generally recommended for use with other antiretrovirals. It may be used for prevention of HIV/AIDS among those at high risk before exposure, and after a needlestick injury or other potential exposure. It is sold both by itself and together in combinations such as emtricitabine/tenofovir, efavirenz/emtricitabine/tenofovir, and elvitegravir/cobicistat/emtricitabine/tenofovir. It does not cure HIV/AIDS or hepatitis B. It is available by mouth as a tablet or powder.
Canadian Blood Services is a non-profit charitable organization that is independent from the Canadian government. The Canadian Blood Services was established as Canada's blood authority in all provinces and territories except for Quebec in 1998. The federal, provincial and territorial governments created the Canadian Blood Services through a memorandum of understanding. Canadian Blood Services is funded mainly through the provincial and territorial governments.
In England, blood and other tissues are collected by NHS Blood and Transplant (NHSBT). NHSBT Blood Donation was previously known as the National Blood Service until it merged with UK Transplant in 2005 to form a NHS special health authority. Other official blood services in the United Kingdom include the Northern Ireland Blood Transfusion Service, the Scottish National Blood Transfusion Service and the Welsh Blood Service.
Lamivudine/zidovudine, sold under the brand name Combivir among others, is a fixed-dose combination antiretroviral medication used to treat HIV/AIDS. It contains two antiretroviral medications, lamivudine and zidovudine. It is used together with other antiretrovirals. It is taken by mouth twice a day.
Australian Red Cross Lifeblood, simply known as Lifeblood, is a branch of the Australian Red Cross responsible for the collection and distribution of blood and biological products in Australia. Lifeblood employs around 3,700 employees across scientific, clinical and support services, processing over one and a half a million blood donations each year. Lifeblood is primarily funded by the Australian Government and state and territory governments.
The Irish Blood Transfusion Service (IBTS), or Seirbhís Fuilaistriúcháin na hÉireann in Irish, was established in Ireland as the Blood Transfusion Service Board (BTSB) by the Blood Transfusion Service Board (Establishment) Order, 1965. It took its current name in April 2000 by Statutory Instrument issued by the Minister for Health and Children to whom it is responsible. The Service provides blood and blood products for humans.
Contaminated hemophilia blood products were a serious public health problem in the late 1970s up to 1985.
The New York Blood Center (NYBC) is a community, nonprofit blood bank based in New York City. Established in 1964 by Dr. Aaron Kellner, NYBC supplies blood to approximately 200 hospitals in the Northeast United States. NYBC and its operating divisions also provide transfusion-related medical services to over 500 hospitals nationally.
Many countries have laws, regulations, or recommendations that effectively prohibit donations of blood or tissue for organ and corneal transplants from men who have sex with men (MSM), a classification irrespective of their sexual activities with same-sex partners and of whether they identify themselves as bisexual or gay. Temporary restrictions are sometimes called "deferrals", since blood donors who are found ineligible may be found eligible at a later date. However, many deferrals are indefinite meaning that donations are not accepted at any point in the future, constituting a de facto ban. Even men who have monogamous relations with their same-sex partners are found ineligible.
A transfusion transmitted infection (TTI) is a virus, parasite, or other potential pathogen that can be transmitted in donated blood through a transfusion to a recipient. The term is usually limited to known pathogens, but also sometimes includes agents such as simian foamy virus which are not known to cause disease.
Hepatitis B immunoglobulin (HBIG) is a human immunoglobulin that is used to prevent the development of hepatitis B and is used for the treatment of acute exposure to HBsAg.
Discrimination against people with HIV/AIDS or serophobia is the prejudice, fear, rejection, and stigmatization of people with HIV/AIDS. Marginalized, at-risk groups such as members of the LGBTQ+ community, intravenous drug users, and sex workers are most vulnerable to facing HIV/AIDS discrimination. The consequences of societal stigma against PLHIV are quite severe, as HIV/AIDS discrimination actively hinders access to HIV/AIDS screening and care around the world. Moreover, these negative stigmas become used against members of the LGBTQ+ community in the form of stereotypes held by physicians.
Simeprevir, sold under the brand name Olysio among others, is a medication used in combination with other medications for the treatment of hepatitis C. It is specifically used for hepatitis C genotype 1 and 4. Medications it is used with include sofosbuvir or ribavirin and peginterferon-alfa. Cure rates are in 80s to 90s percent. It may be used in those who also have HIV/AIDS. It is taken by mouth once daily for typically 12 weeks.
In sperm banks, screening of potential sperm donors typically includes screening for genetic diseases, chromosomal abnormalities and sexually transmitted infections (STDs) that may be transmitted through the donor's sperm. The screening process generally also includes a quarantine period, during which samples are frozen and stored for at least six months after which the donor will be re-tested for STIs. This is to ensure no new infections have been acquired or have developed during since the donation. If the result is negative, the sperm samples can be released from quarantine and used in treatments.
Elbasvir/grazoprevir, sold under the brand name Zepatier, is a fixed-dose combination for the treatment of hepatitis C, containing elbasvir and grazoprevir. It is used to treat chronic hepatitis C virus (HCV) genotypes 1 or 4 infection in both treatment-naïve and treatment-experienced patients.
Velpatasvir is an NS5A inhibitor which is used together with sofosbuvir in the treatment of hepatitis C infection of all six major genotypes.
Shuping Wang was a Chinese-American medical researcher and public health whistleblower. She exposed the poor practices that led to the spread of hepatitis C and HIV in central China in the 1990s, potentially saving tens of thousands of lives. In 2001, following harassment by Chinese officials, she moved to the United States, where she worked until her death.