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Serological testing for infectious diseases markers of donor specimens from 24 h after death show no significant change in outcomes from other specimens

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Abstract

There is increasing demand for organ and tissue donations to cater for a growing waiting list of recipients. Serological screening of donors remains the initial assessment upon which many decisions are made, particularly if donors are found to be seropositive. Multiple different platforms are now available, although the Abbott ARCHITECT platform assays are currently licensed globally for testing of blood collected at less than 15 h post-mortem. Compliance with the specified maximum collection times drastically decreases the number of eligible deceased donors, with ~ 70% more donations available if screened at up to 24 h post mortem. A large scale study on deceased donors was performed where blood was collected between 12 and 25 h post-mortem. A total of 194 cadaveric serological specimens were tested using the Abbott ARCHITECT analyser for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human T Lymphotropic Virus type I/II, and syphilis infection. The specificity, sensitivity, accuracy, reproducibility and influence of storage conditions were assessed for testing with Abbott ARCHITECT platform for HIV antigen/antibody Combo, HCV antibody, HBV surface antigen (HBsAg), HBV core antibody (HBcAb), HTLVI/II antibody (rHTLV-I/II), and Syphilis TP assays. There was no significant difference between testing of sera from living and cadaveric individuals in terms of assay specificity, sensitivity and accuracy. The findings show testing of human serum and plasma specimens collected up to 24 h post-mortem with these assays is acceptable and reflects host status accurately.

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Acknowledgements

We thank Abbott Diagnostics Australia for reagents and kits. We thank Volker Keller (Abbott GmbH & Co. KG, Max-Planck-Ring 2, 65205 Wiesbaden, Germany) and Sonu Bhatnagar (Abbott Laboratories Singapore Pte Ltd., 3 Fraser St Level 22, Duo Tower, Singapore 189352) for their valuable support in data analysis and advice during the course of the project. We thank the New South Wales Tissue Banks incorporating the Lions NSW Eye Bank and NSW Bone Bank; Lions Eye Donation Service, Victoria; Queensland Tissue Bank and Lions Eye Institute, Western Australia for the provision of samples used in the study.

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Correspondence to William D. Rawlinson.

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The authors have no funding sources or conflicts of interest to declare.

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This article does not contain any studies with animals performed by any of the authors.

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Ethical approval for this project was assessed by the LNR Committee in accordance with the “New South Wales Health Guideline GL2007_020 Human Research Ethics Committees—Quality Improvement and Ethics Review: A Practice Guide for New South Wales” and was recommended to be a quality improvement or quality assurance (QA/QI) activity not requiring independent ethics review.

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Kok, C.C., Ramachandran, V., Egilmezer, E. et al. Serological testing for infectious diseases markers of donor specimens from 24 h after death show no significant change in outcomes from other specimens. Cell Tissue Bank (2020). https://doi.org/10.1007/s10561-020-09810-x

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Keywords

  • Validation
  • Serology
  • Tissue donor
  • Post-mortem