Preventing disease transmission by deceased tissue donors by testing blood for viral nucleic acid

Strong, Douglas M.; Nelson, Karen; Pierce, M I; Stramer, Susan L.

doi:10.1007/s10561-005-2834-4

Cited by 27 publications

(24 citation statements)

References 24 publications

(21 reference statements)

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“…No appropriate and/or relevant published data covering degradation of serological targets could be found. There are papers that investigate assay interference, but these either relate to the specificity, rather than sensitivity, of serology assays or inhibition of molecular assays (Heim et al 1999;Cahane et al 2000;Challine et al 2006;Thomas et al 2007;Pepose et al 1993;Strong et al 2005). Similarly Serological Data are available on the screening of post-mortem samples for a range of discrete quantifiable and generally stable large molecular weight bio-molecules such as poisons, drugs etc.…”

Section: Discussionmentioning

confidence: 99%

Qualification of serological infectious disease assays for the screening of samples from deceased tissue donors

Kitchen

Newham

2010

Cell Tissue Bank

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Whilst some of the assays used for serological screening of post-mortem blood samples from deceased tissue donors in some countries have been specifically validated by the manufacturer for this purpose, a significant number of those currently in use globally have not. Although specificity has previously been considered a problem in the screening of such samples, we believe that ensuring sensitivity is more important. The aim of this study was to validate a broader range of assays for the screening of post-mortem blood samples from deceased tissue donors. Six microplate immunoassays currently in use within National Health Service Blood and Transplant (NHSBT) for the screening of blood, tissue and stem cell donations were included. Representative samples from confirmed positive donors were titrated in screen negative post-mortem samples in parallel with normal pooled negative serum to determine if there was any inhibition with the post-mortem samples. There were no significant differences seen (P < 0.005) between the dilution curves obtained for the positive samples diluted in post-mortem samples and normal pooled sera. Although small numbers of samples were studied, it can be surmised that the post-mortem blood samples from deceased tissue donors, collected according to United Kingdom guidelines, are a suitable substrate for the assays evaluated. No diminution of reactivity was seen when dilution with sera from deceased donors was compared to dilution using pooled serum from live donors. In the absence of genuine low titre positive post-mortem samples, the use of samples spiked with various levels of target material provides a means of qualifying serological screening assays used by NHSBT for the screening of post-mortem blood samples from deceased tissue donors.

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Section: Discussionmentioning

confidence: 99%

Qualification of serological infectious disease assays for the screening of samples from deceased tissue donors

Kitchen

Newham

2010

Cell Tissue Bank

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“…Some cases of donor-derived infection in organ transplantation occurred after failures in serologic testing (e.g., window-period cases before seroconversion) ( 9 , 19 – 21 ). NAT is useful for detecting infection only in blood samples of viremic donors and is not available for every potential organism ( 22 ). …”

Section: Challenges In Evaluating Donorsmentioning

confidence: 99%

Infectious Disease Transmission during Organ and Tissue Transplantation

Greenwald

Kuehnert²,

Fishman³

2012

Emerg. Infect. Dis.

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Transplantation of organs and tissues (bone, tendon, skin, cornea) will always be associated with some risk for transmission of infectious diseases from donor to recipient. Understanding and minimizing this risk is difficult for many reasons: donor screening processes vary, screening for every infectious organism is not possible, and assessment of recipient health after transplantation to determine possibility of disease transmission is often not adequate. In May 2010, the US Food and Drug Administration held a meeting to address these challenges and establish a research agenda for minimizing these transplant transmission risks. Attendees agreed that the focus should be on standardizing donor screening, compiling disease transmissibility data, monitoring of transplant recipients’ health, and assessing effectiveness of measures to minimize disease transmission. Collaboration and sharing of perspectives, experiences, and resources of all stakeholders in the transplantation process (government, private industry, and health care providers) can improve the safety of organ and tissue transplantation.

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“…However, there are data showing that HBV DNA is not detectable in a subset of HBs Ag positive donations, raising concern about the safety impact of replacing HBs Ag with HBV NAT, particularly in the absence of anti-HBc screening (Kuhns 2004;Roth 2002). In addition to this donors samples obtained post-morten have the potential to produce an invalid NAT result due to inhibition of amplification reactions by hemolysis and other factors (Strong 2005).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of tissue discards after implementation of anti-HBc test in a tissue bank in Spain

Villalba

Fornés

Eisman

et al. 2007

Cell Tissue Banking

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The recent introduction as a minimum test required in The Guide to Safety and Quality Assurance for Organs, Tissues and Cells (Council Europe) and the Directive 2004/23/EC applied to donation, procurement, testing, processing, preservation, storage and distribution of human cells and tissues make necessary the implementation of these markers in all European Tissue Establishments. In this study we have analyzed the impact in tissues discard by introducing anti-HBc in a European Tissue Establishment in a country with a high prevalence of HBV infection. The adoption of this exclusion criteria in this region results in acceptably rejection rates among tissue donors, although some studies are needed on basis a risk assessment to determine the eligibility for clinical use.

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Preventing disease transmission by deceased tissue donors by testing blood for viral nucleic acid

Cited by 27 publications

References 24 publications

Qualification of serological infectious disease assays for the screening of samples from deceased tissue donors

Qualification of serological infectious disease assays for the screening of samples from deceased tissue donors

Infectious Disease Transmission during Organ and Tissue Transplantation

Evaluation of tissue discards after implementation of anti-HBc test in a tissue bank in Spain

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