Editing Plasmapheresis (section)

== Plasma donation ==
[[File:Plasmapheresis line full.jpg|thumb|alt=See caption |Plasma donation uses two lines – a single needle connects to one line that splits into an outgoing line and a return line. A spur can also be seen that is used for collecting test samples of the whole blood.]]
[[File:Plasmapheresis line detail 1.jpg|thumb|Detail shows the process as the return line is filling for the first time]]
[[File:Plasmapheresis line detail 2.jpg|thumb|Detail shows the process when the return line is full]]
Donating plasma is similar in many ways to [[Blood donation|whole blood donation]], though the end product is used for different purposes.  Most plasmapheresis is for [[plasma fractionation|fractionation]] into other products; other blood donations are transfused with relatively minor modifications.  Plasma that is collected solely for further manufacturing is called Source Plasma.<ref name="fransenetal2023">{{cite journal |last1=Fransen |first1=Michelle |last2=Becker |first2=Mark |last3=Hershman |first3=Janet |last4=Lenart |first4=James |last5=Simon |first5=Toby L. |title=Why do US source plasma donors stop donating? |journal=Transfusion |date=October 2023 |volume=63 |issue=10 |pages=1904–1915 |doi=10.1111/trf.17522 |url=https://onlinelibrary.wiley.com/doi/full/10.1111/trf.17522 |access-date=5 January 2025|doi-access=free }}</ref>

Plasma donors undergo a screening process to ensure both the donor's safety and the safety of the collected product.  Factors monitored include [[blood pressure]], [[pulse]], temperature, total protein, [[protein electrophoresis]], health history screening similar to that for whole blood, as well as an annual physical exam with a licensed physician or an approved physician substitute under the supervision of the physician. Donors are screened at each donation for viral diseases that can be transmitted by blood, sometimes by multiple methods.  For example, donations are tested for [[HIV]] by [[ELISA]], which shows if they have been exposed to the disease, as well as by nucleic acid methods ([[Polymerase chain reaction|PCR]] or similar) to rule out recent infections that the ELISA test might miss and are also screened for [[hepatitis B]] and [[hepatitis C]]. Industry standards require at least two sets of negative test results before the collected plasma is used for injectable products.  The plasma is also treated in processing multiple times to inactivate any virus that was undetected during the screening process.<ref name="Burnouf2007">{{cite journal |last1=Burnouf |first1=Thierry |title=Modern Plasma Fractionation |journal=Transfusion Medicine Reviews |date=April 2007 |volume=21 |issue=2 |pages=101–117 |doi=10.1016/j.tmrv.2006.11.001 |url=https://www.sciencedirect.com/science/article/pii/S0887796306000940 |access-date=5 January 2025|pmc=7125842 }}</ref>

In a few countries, plasma (like blood) is donated by unpaid volunteers. In others, including the United States, Austria, Germany and some Canadian facilities plasma donors are paid for their donations.<ref>{{Cite web|url=https://think.kera.org/2015/09/01/one-day-two-dollars/|title=One Day, Two Dollars|date=September 1, 2015}}</ref> Standards for donating plasma are set by national regulatory agencies such as the [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA),<ref>{{Cite web|url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=640&showFR=1&subpartNode=21:7.0.1.1.7.7|title=CFR - Code of Federal Regulations Title 21|website=www.accessdata.fda.gov}}</ref> the [[European Union]], and by a professional organization, the Plasma Protein Therapeutics Association (or PPTA),<ref>Plasma Protein Therapeutics Association. [https://www.pptaglobal.org/ PPTA [Online&#93;].</ref> which audits and accredits collection facilities. A [[National Donor Deferral Registry]] (NDDR) is also maintained by the PPTA for use in keeping donors with prior positive [[virus|viral]] [[antibody]] test results from donating at any facility.

Almost all plasmapheresis in the US is performed by automated methods.<ref>{{Cite journal|last1=Ahmed|first1=Sadiq|last2=Kaplan|first2=Andre|date=2020-04-20|title=Therapeutic Plasma Exchange Using Membrane Plasma Separation|url=https://cjasn.asnjournals.org/content/early/2020/04/18/CJN.12501019|journal=Clinical Journal of the American Society of Nephrology|volume=15|issue=9|pages=1364–1370|language=en|doi=10.2215/CJN.12501019|issn=1555-9041|pmid=32312791|pmc=7480555}}</ref> In some cases, automated plasmapheresis is used to collect plasma products like [[fresh frozen plasma]] for direct transfusion purposes, often at the same time as [[plateletpheresis]]. These procedures are performed at facilities such as [[List of blood donation agencies in the United States|community blood centers]].<ref>{{Cite web|title=Therapeutic Apheresis Services {{!}} New York Blood Center|url=https://nybloodcenter.org/products-and-services/clinical-services/apheresis-services/|access-date=2020-07-04|website=nybloodcenter.org|archive-date=2020-07-17|archive-url=https://web.archive.org/web/20200717202156/https://nybloodcenter.org/products-and-services/clinical-services/apheresis-services/|url-status=dead}}</ref>

Since returning [[red cells]] causes the body to replace plasma more rapidly, a donor can provide up to a liter of plasma at a time and can donate with only a few days between donations, unlike the 56-day deferral for blood donation. The amount allowed in a donation varies vastly from country to country, but generally does not exceed two donations, each as much as a liter (one-third of the total plasma volume), per seven-day period. If a significant amount of red blood cells cannot be returned, the donor may not donate for 56 days, just as if they had donated a unit of blood.  Depending on the collection system and the operation, the removed plasma may be replaced by [[Saline (medicine)|saline]].  The body typically replaces the collected volume within 24 hours, and donors typically donate up to twice a week, though this varies by country.<ref name="D'aesetal2024">{{cite journal |last1=D'aes |first1=Tine |last2=van den Hurk |first2=Katja |last3=Schroyens |first3=Natalie |last4=Mikkelsen |first4=Susan |last5=Severijns |first5=Pieter |last6=De Buck |first6=Emmy |last7=O'Leary |first7=Peter |last8=Tiberghien |first8=Pierre |last9=Compernolle |first9=Veerle |last10=Erikstrup |first10=Christian |last11=Van Remoortel |first11=Hans |title=Balancing Donor Health and Plasma Collection: A Systematic Review of the Impact of Plasmapheresis Frequency |journal=Transfusion Medicine Reviews |date=October 2024 |volume=38 |issue=4 |pages=150851 |doi=10.1016/j.tmrv.2024.150851 |url=https://www.sciencedirect.com/science/article/pii/S0887796324000415?via%3Dihub#tbl0001 |access-date=5 January 2025|doi-access=free }}</ref>

The collected plasma is promptly frozen at lower than -20&nbsp;°C (-4&nbsp;°F) and is typically shipped to a processing facility for fractionation. This process separates the collected plasma into specific components, such as [[albumin]] and [[immunoglobulins]], most of which are made into medications for human use. Sometimes the plasma is thawed and transfused as Fresh Frozen Plasma (FFP), much like the plasma from a normal blood donation.<ref name="stanworthetal2004">{{cite journal |last1=Stanworth |first1=S. J. |last2=Brunskill |first2=S. J. |last3=Hyde |first3=C. J. |last4=McClelland |first4=D. B. L. |last5=Murphy |first5=M. F. |title=Is fresh frozen plasma clinically effective? A systematic review of randomized controlled trials |journal=British Journal of Haematology |date=July 2004 |volume=126 |issue=1 |pages=139–152 |doi=10.1111/j.1365-2141.2004.04973.x |url=https://onlinelibrary.wiley.com/doi/full/10.1111/j.1365-2141.2004.04973.x |access-date=5 January 2025}}</ref>

; Manual method
: For the manual method, approximately the same as a [[blood donation|whole blood donation]] is collected from the donor. The collected blood is then separated by centrifuge machines in separate rooms, the plasma is pressed out of the collection set into a satellite container, and the red blood cells are returned to the donor.
: The danger with this method was that if the wrong red blood cells were returned to the donor, a serious and potentially fatal [[transfusion reaction]] could occur. Requiring donors to recite their names and ID numbers on returned bags of red cells minimized this risk. This procedure has largely become obsolete in favor of the automated method.
; Automated method
[[File:Fenwal Erythropheresis machine for plasmapheresis.jpg|thumb|An [[Erythropheresis]] machine being used for plasmapheresis]]
: The automated method uses a very similar process. The difference is that the collection, separation, and return are all performed inside a machine connected to the donor through a needle in the arm, typically the [[Cephalic vein|antecubital vein]]. There is no risk of receiving the wrong red cells.<ref>{{Cite web|url=https://www.biolifeplasma.com/|archiveurl=https://web.archive.org/web/20070822150455/https://www.biolifeplasma.com/en/donating-plasma/donation-process.html|url-status=dead|title=BioLife Plasma Services|archivedate=August 22, 2007|website=www.biolifeplasma.com}}</ref> The devices used are very similar to the devices used for therapeutic plasmapheresis, and the potential for citrate toxicity is similar. The potential risks are explained to prospective donors at the first donation, and most donors tolerate the procedure well.<ref>{{Cite web|url=https://octapharmaplasma.com/|title=Donate Plasma. Make Money. Save Lives. &#124; Octapharma Plasma|website=octapharmaplasma.com}}</ref> In the UK in 2020, plasma donation is sought from volunteers who have recovered from [[COVID-19]]. 

; Antibodies
: Donors are sometimes immunized against agents such as [[tetanus]] or [[hepatitis B]] so that their plasma contains the antibodies against the toxin or disease.  In other donors, an intentionally incompatible unit of blood is transfused to produce antibodies to the antigens on the red cells.  The collected plasma then contains these components, which are used in manufacturing of medications. Donors who are already ill may have their plasma collected for use as a positive control for laboratory testing.<ref name="tedderetal2018">{{cite journal |last1=Tedder |first1=Richard S. |last2=Samuel |first2=Dhan |last3=Dicks |first3=Steve |last4=Scott |first4=Janet T. |last5=Ijaz |first5=Samreen |last6=Smith |first6=Catherine C. |last7=Adaken |first7=Charlene |last8=Cole |first8=Christine |last9=Baker |first9=Samuel |last10=Edwards |first10=Tansy |last11=Kamara |first11=Philip |last12=Kargbo |first12=Osman |last13=Niazi |first13=Saidia |last14=Nwakanma |first14=Davis |last15=d'Alessandro |first15=Umberto |last16=Burch |first16=Graham |last17=Doughty |first17=Heidi |last18=Brown |first18=Colin S. |last19=Andrews |first19=Nick |last20=Glynn |first20=Judith R. |last21=van Griensven |first21=Johan |last22=Investigators |first22=Ebola_CP Consortium |last23=Pollakis |first23=Georgios |last24=Paxton |first24=William A. |last25=Semple |first25=Malcolm G. |title=Detection, characterization, and enrollment of donors of Ebola convalescent plasma in Sierra Leone |journal=Transfusion |date=2018 |volume=58 |issue=5 |pages=1289–1298 |doi=10.1111/trf.14580 |url=https://onlinelibrary.wiley.com/doi/full/10.1111/trf.14580 |access-date=5 January 2025|hdl=10044/1/81489 |hdl-access=free }}</ref>