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Serological testing on the ADVIA Centaur system for human immunodeficiency virus, hepatitis B virus, and hepatitis C virus in specimens from deceased and living individuals demonstrates equivalent results ƚ
Author(s) -
Wright Theodore B.,
Patibandla Sai,
Walsh Renee,
Fonstad Rachel,
Gee Matthew,
Bitcon Vera,
Hopper Julie,
Braniff Susie J.,
Best Susan,
Read Scott
Publication year - 2022
Publication title -
transplant infectious disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.69
H-Index - 67
eISSN - 1399-3062
pISSN - 1398-2273
DOI - 10.1111/tid.13802
Subject(s) - medicine , serology , hepatitis c virus , virology , immunology , virus , antibody
To determine the suitability of human tissues and cells for transplantation, guidelines mandate infectious disease testing of serum or plasma obtained from deceased donors, which are often collected after cessation of the heartbeat. Tests used for this purpose are required to show equivalent performance when compared to pre‐mortem specimens. This study evaluated whether serology assays for HIV Ag/Ab Combo, hepatitis B virus (HBc Total; HBsAgII), and HCV on the ADVIA Centaur system, were fit for testing post‐mortem sera. Performance evaluation studies included precision, specificity, and sensitivity. Methods Blood specimens were collected within 24 h after death from 82 deceased and 83 healthy living individuals. Studies followed standard guidelines. The 20‐day precision study was performed on five levels of post‐mortem specimens (non‐spiked and spiked). The specificity study compared 81–83 pre‐mortem and 74–82 post‐mortem specimens. The sensitivity study compared 50 pre‐mortem and 50 post‐mortem specimens spiked with positive sera for each analyte at two levels to achieve a low (near cutoff) positive result and a second higher positive result. Results Precision, specificity, and sensitivity study results met acceptance criteria for all assays and lots; post‐mortem and pre‐mortem results were equivalent. Conclusion Based on this study, the ADVIA Centaur CHIV, HBcT, HBsAgII, and HCV assays are acceptable for use in routine testing of deceased donor sera collected after cessation of the heartbeat.