BLOOD PRODUCTS ADVISORY COMMITTEE

April 1-2, 2009

REFERENCES

                       

Topic IA:  Blood Donor Screening for Hepatitis B Virus Infection by Nucleic Acid Testing

 

  1. Assal A et al. Sensitivity of two hepatitis B virus, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) nucleic acid test systems relative to hepatitis B surface antigen, anti-HCV, anti-HIV, and p24/anti-HIV combination assays in seroconversion panels.  Transfusion 2009; 49:301-310.
  2. Biswas R et al.  Comparative sensitivity of HBV NATs and HBsAg assays for detection of acute HBV infection.  Transfusion 2003; 43: 788-789. 
  3. Ganem D and Prince AM.  Hepatitis B Virus Infection – Natural History and Clinical Consequences.  N Engl J Med 2004; 350:1118-29.
  4. FDA.  Frequently Asked Questions Regarding Implementation of the Roche Molecular Systems COBAS Ampliscreen HBV Test.  April 21, 2005.
  5. Komiya Y et al.  Minimum infectious does of hepatitis B virus in chimpanzees and difference in the dynamics of viremia between genotype A and genotype C.  Transfusion 2008; 48: 286-294.   
  6. Linauts S et al.  PRISM Hepatitis B Surface Antigen Detection of Hepatitis B Virus Minipool Nucleic Acid Testing Yield Samples. Transfusion 2008; 48: 1376-1382.
  7. McMahon BJ et al.  Antibody Levels and Protection after Hepatitis B Vaccination:  Results of a 15-year Follow-up.  Annals of Internal Medicine 2005; 142: 333-341.
  8. Phikulsod S et al.  One Year Experience of NAT Testing for HIV-1, HCV and HBV in Thai Blood Donors.  Transfusion 2009; Accepted, in press. 
  9. Tabuchi A.  Titration of Hepatitis B Virus Infectivity in the Sera of Pre-Acute and Late Acute Phases of HBV Infection:  Transmission Experiments to Chimeric Mice with Human Liver Repopulated Hepatocytes.  Journal of Medical Virology 2008; 80:  2064-2068.     
  10. Zou, S et al.  Current Incidence and Residual Risk of Hepatitis B Infection among Blood Donations in the United States.  Transfusion 2009. Accepted, in press.

 

Topic IB:  Testing Donors of Human Cells, Tissues and Cellular and Tissue-based Products (HCT/Ps) for Hepatitis B Virus Infection by Nucleic Acid Testing

 

  1. Linauts S et al.  PRISM Hepatitis B Surface Antigen Detection of Hepatitis B Virus Minipool Nucleic Acid Testing Yield Samples.  Transfusion 2008; 48: 1376-1382.

2.      Zou S et al.  Probability of Viremia with HBV, HCV, HIV and HTLV among Tissue Donors in the United States.  N Engl J Med 2004; 351:751-9.

3.      FDA.  Testing HCT/P Donors:  Specific Requirements.  February 26, 2008.

4.      FDA Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases. August, 19, 2008.

 

Topic II:   Potential Testing Strategies for T. cruzi Infection in Blood Donors

 

  1. AABB.  Association Bulletin #06-08.  Information Concerning Implementation of a Licensed Test for Antibodies to Trypanosoma cruzi.  December 14, 2006.
  2. Bern C et al.  Chagas Disease and the US Blood Supply.  Curr Opin Infect Dis 2008; 21: 476-482.
  3. FDA Blood Products Advisory Committee Meeting. April 2007.  Transcript: http://www.fda.gov/ohrms/dockets/ac/07/transcripts/2007-4300t1-01.pdf

 

Topic III:  Current Considerations on Plasma Obtained from Whole Blood Donors for Further Manufacturing Use

 

  1. Akerblom O et al. Freezing technique and quality of fresh frozen plasma. Infusionstherapie 1992; 19: 283-287.
  2. Blomback M et al.  Activation of blood coagulation, fibrinolytic and kallikrein systems during storage of plasma. Vox Sang 1984; 47: 335-342.
  3. Burnouf T.  Modern Plasma Fractionation.  Transfusion Medicine Reviews 2007; 21: 101-117.
  4. Carlebjörk G et al.  Improvement of plasma quality as raw material for factor VIII: C concentrates.  Vox Sang 1983; 45: 233-242.
  5. Carlebjörk G et al.  Freezing of plasma and recovery of factor VIII.  Transfusion 1986; 26: 159-162.
  6. Downes K et al.  Serial measurement of clotting factors in thawed plasma stored for 5 days.  Transfusion 2001; 41: 570.
  7. International Forum.  What are the critical factors in the production and quality control of frozen plasma intended for direct transfusion or for fractionation to provide medically needed labile coagulation factors. Vox Sang 1983; 44: 246-259.
  8. Kotitschke R et al.  Stability of fresh frozen plasma: results of 36-month storage at –20 °C, –30 °C, and – 40 °C. Infus Ther Transfus Med 2000; 27: 174-180.
  9. Pepper M et al.  Plasma factor VIII, Variables affecting stability under standard blood bank conditions and correlation with recovery in concentrates. Transfusion 1978; 18: 756-760.
  10. Runkel, S et al.  The quality of plasma collected by automated apheresis and of recovered plasma from leukodepleted whole blood.  Transfusion 2005; 45: 427-432.
  11. Skjonsberg, OH et al.  Thrombin generation during collection and storage of blood. Vox Sang 1986; 50; 33-37.
  12. Wallvik J et al.  Proteolytic activity during storage of platelets in plasma.  Transfusion Medicine 1992; 2: 135-142.
  13. Woodhams B et al.  Stability of coagulation proteins in frozen plasma. Blood Coagulation and Fibrinolysis 2001; 12: 229-236.
  14. Yazer M et al.  Coagulation factor levels in plasma frozen within 24 hours of

            phlebotomy over 5 days of storage at 1 to 6°C.  Transfusion 2008; 48: 2525-2530.

      15. FDA Public Workshop on Plasma Standards. August 31-September 1, 2004.          Transcript: http://www.fda.gov/cber/minutes/workshop-min.htm

      16. FDA Blood Products Advisory Committee.  Discussion on Recovered Plasma,        

            June 20, 2003.  Transcript:      http://www.fda.gov/ohrms/dockets/ac/cber03.html#BloodProducts