The epidemiology of virus transmission by plasma derivatives: clinical studies verifying the lack of transmission of hepatitis B and C viruses and HIV type 1

The epidemiology of virus transmission by plasma derivatives: clinical studies verifying the lack... Therapeutic products made from human plasma provide life‐saving relief to hundreds of thousands of patients each year. The efficient production of these derivatives requires that they be made from large pools of human plasma, often comprising as many as 60,000 donations each. This review will examine the viruses that can be transmitted by plasma and for which sensitive detection systems and virus‐removal and ‐inactivation methods are available. The exclusion of plasma units that test positive for certain viral markers ensures that almost all units entering the pool are free of viruses. Each plasma donation is screened by using sensitive immunoassays to detect the presence of hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV types 1 and 2 (HIV‐1/2). Manufacturing steps for plasma products have been shown to remove or inactivate these viruses. Nevertheless, plasma units containing these viruses can enter the pool when a donor is in the window period of the disease, which is the short period during which the virus is present in the blood before the screening tests have become positive. At present, the screening of small pools of plasma (“minipools”) by using nucleic acid amplification assays such as polymerase chain reaction (PCR) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Transfusion Wiley

The epidemiology of virus transmission by plasma derivatives: clinical studies verifying the lack of transmission of hepatitis B and C viruses and HIV type 1

Transfusion, Volume 39 (11-12) – Jan 12, 1999

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Publisher
Wiley
Copyright
Copyright © 1999 Wiley Subscription Services
ISSN
0041-1132
eISSN
1537-2995
D.O.I.
10.1046/j.1537-2995.1999.39111160.x
Publisher site
See Article on Publisher Site

Abstract

Therapeutic products made from human plasma provide life‐saving relief to hundreds of thousands of patients each year. The efficient production of these derivatives requires that they be made from large pools of human plasma, often comprising as many as 60,000 donations each. This review will examine the viruses that can be transmitted by plasma and for which sensitive detection systems and virus‐removal and ‐inactivation methods are available. The exclusion of plasma units that test positive for certain viral markers ensures that almost all units entering the pool are free of viruses. Each plasma donation is screened by using sensitive immunoassays to detect the presence of hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV types 1 and 2 (HIV‐1/2). Manufacturing steps for plasma products have been shown to remove or inactivate these viruses. Nevertheless, plasma units containing these viruses can enter the pool when a donor is in the window period of the disease, which is the short period during which the virus is present in the blood before the screening tests have become positive. At present, the screening of small pools of plasma (“minipools”) by using nucleic acid amplification assays such as polymerase chain reaction (PCR)

Journal

TransfusionWiley

Published: Jan 12, 1999

Keywords: ; ; ; ; ; ; ; ; ; ;

References

  • Incomplete inactivation of hepatitis B virus after heat treatment at 60C for 10 hours.
    Shikata, T; Karasawa, T; Abe, K
  • On the epidemiology, clinic, immunology and morphology of non‐A/non‐B hepatitis.
    Renger, F; Porst, H; Frank, KH
  • Hepatitis C infection in patients with primary hypogammaglobulinemia after treatment with contaminated immune globulin.
    Bjøro, K; Frøland, SS; Yun, Z
  • Hepatitis C virus infection associated with administration of intravenous immune globulin. A cohort study.
    Bresee, JS; Mast, EE; Coleman, PJ
  • Safety of therapeutic immune globulin preparations with respect to transmission of human T‐lymphotropic virus type III/lymphadenopathy‐associated virus infection.
  • Inactivation and partition of human T‐cell lymphotrophic virus, type III, during ethanol fractionation of plasma.
    Wells, MA; Wittek, AE; Epstein, JS
  • Factor VIII concentrate, hepatitis‐safe: progress in the treatment of hemophilia A.
    Heimburger, N; Schwinn, H; Mauler, R

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