Abstract
A comprehensive and effective screening programme is essential to support the banking of tissues from deceased donors. However, the overall quality of the samples obtained from deceased donors, quantity and condition, is often not ideal, and this may lead to problems in achieving accurate and reliable results. Additionally a significant percentage of referrals are still rejected upon receipt as unsuitable for screening. We are actively involved in improving the overall quality of deceased donor screening outcomes, and have specifically evaluated and validated both serological and molecular assays for this purpose, as well as developing a specific screening strategy to minimise the specificity issues associated with serological screening. Here we review the nature and effectiveness of the deceased donor screening programme implemented by National Health Service Blood and Transplant (NHSBT), the organisation with overall responsibility for the supply of tissue products within England. Deceased donor screening data, serological and molecular, from August 2007 until May 2012 have been collated and analysed. Of 10,225 samples referred for serology screening, 5.5 % were reported as reactive; of 2,862 samples referred for molecular screening, 0.1 % were reported as reactive/inhibitory. Overall 20 % of the serological and 100 % of the molecular screen reactivity was confirmed as reflecting true infection. The use of a sequential serology screening algorithm has resulted in a marked reduction of tissues lost unnecessarily due to non-specific screen reactivity. The approach taken by NHSBT has resulted in the development of an effective and specific approach to the screening of deceased tissue donors.
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References
Advisory Committee on the Safety of Blood Tissues and Organs (SaBTO) (2011) Guidance on the microbiological safety of human organs, tissues and cells used in transplantation. Feb 2011. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_121497?ssSourceSiteId=ab
Baleriola C, Johal H, Robertson P, Jacka B, Whybin R, Taylor P, Rawlinson WD (2012) Infectious disease screening of blood specimens collected from post-mortem provides comparable results to pre-mortem specimens. Cell Tissue Bank 13:251–258
Bensoussan D, Jeulin H, Decot V, Agrinier N, Venard V (2010) Analysis of the effects of collection and processing time on the results of serology testing of cadaveric cornea donors. Dign Microbiol Infect Dis 68:40–45
Cahane M, Barak A, Goller O, Avni I (2000) The incidence of hepatitis C virus positive serological test results among cornea donors. Cell Tissue Banking 1:81–85
Challine D, Roudot-Thoraval F, Sabatier P, Dubernet F, Larderie P, Rigot P, Pawlotsky JM (2006) Serological viral testing of cadaveric cornea donors. Transplantation 82:788–793
Cleland A, Davis C, Adams N, Lycett C, Jarvis LM, Holmes H, Simmonds P (2001) Development of multiplexed nucleic acid testing for human immunodeficiency virus type 1 and hepatitis C virus. Vox Sang 81:93–101
Eastland T (2000) Hemodilution due to blood loss and transfusion and the reliability of cadaver tissue donor infectious disease testing. Cell Tissue Banking 1:121–127
General Directions 003/2010 implementing the Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment (2010) Human Tissue Authority. http://www.hta.gov.uk/_db/_documents/Annex_-_Guide_to_Quality_and_Safety_Assurance_for_Tissues_and_Cells_for_Patient_Treatment.pdf
Humar A, Morris M, Blumberg E et al (2010) Nucleic acid testing (NAT) of organ donors: is the ‘best’ test the right test? A consensus conference report. Am J Transplant 10:889–899
Kalus U, Wilemeyer I, Caspari G, Schroeter J, Pruss A (2011) Validation of the serological testing for anti-HIV-1/2, anti-HCV, HBsAg and anti-HBc from post-mortem blood on the Siemens BEP-III automatic system. Transfus Med Hemother 38:365–372
Kitchen AD, Gillan HL (2009) The serological screening of deceased tissue donors within the English Blood Service for infectious agents—a review of current outcomes and a more effective strategy for the future. Vox Sang. doi:10.1111/j.1423-0410.2009.01284.x
Kitchen AD, Newham JA (2011) Qualification of serological infectious disease assays for the screening of samples from deceased tissue donors. Cell Tissue Banking. doi:10.1007/s10561-010-9175-7
Liu Y, Hussain M, Wong S, Fung SK, Yim HJ, Lok AS (2007) A genotype-independent real-time PCR assay for quantification of hepatitis B virus DNA. J Clin Microbiol 45:553–558
Miedouge M, Chatelut M, Mansuy JM, Rostaing L, Malecaze F, Sandres-Saune K, Boudet F, Puel J, Abbal M, Izopet J (2002) Screening of blood from potential organ and cornea donors for viruses. J Med Virol 66:571–575
Nett RJ, Kuehnert MJ, Ison MG, Orlowski JP, Fischer M, Staples JE (2012) Current practices and evaluation of screening solid organ donors for West Nile virus. Transpl Infect Dis 14:268–277
Padley D, Ferguson M, Warwick RM, Womack C, Lucas SB, Saldanha J (2005) Challenges in the testing of non-heart-beating cadavers for viral markers: implications for the safety of tissue donors. Cell Tissue Banking 6:171–179
Pruss A, Caspari G, Kruger DH, Blumel J, Nubling CM, Gurtler L, Gerlich WH (2010) Tissue donation and virus safety: more nucleic acid amplification testing is needed. Transpl Infect Dis 12:375–386
Strong DM, Nelson K, Pierce M, Stramer SL (2005) Preventing disease transmission by deceased tissue donors by testing blood for viral nucleic acid. Cell Tissue Bank 6(4):255–262
Thomas S, Klapper PE, Mutton KJ, Turner AJ, Tullo AB, Zambrano I, Carley F, Taylor A (2007) Lack of vision, loss of sight: consequences of mandatory HTLV screening in corneal transplantation. Transpl Infect Dis 9:171–172
Wilkemeyer I, Pruss A, Kalaus U, Schroeter J (2012) Comparative infectious serology testing of pre-and post-mortem blood samples from cornea donors. Cell Tissue Bank (epub ahead)
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Kitchen, A.D., Newham, J.A. & Gillan, H.L. Effective serological and molecular screening of deceased tissue donors. Cell Tissue Bank 14, 633–644 (2013). https://doi.org/10.1007/s10561-012-9358-5
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DOI: https://doi.org/10.1007/s10561-012-9358-5