Validation of Spiked Postmortem Blood Samples from Cornea Donors on the Abbott ARCHITECT and m2000 Systems for Viral Infections

Schmack, Ingo; Ballikaya, Seda; Erber, B; Voehringer, Irina; Burkhardt, Ulrich; Schnitzler, Paul

doi:10.1159/000502866

Cited by 3 publications

(8 citation statements)

References 28 publications

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“…One strength of our study is that paired spiked and unspiked pre- and post-mortem blood specimens were tested. This also applies to a study by Schmack et al [ 7 ] where similar results were generated when this platform was used and screened for HBsAg, anti-HBc, anti-HCV, anti-HIV-1/2, and HIV p24 Ag. They tested 20 related spiked and unspiked pre- and post-mortem blood on the Architect, and no false-positive or false-negative results were generated.…”

Section: Discussionsupporting

confidence: 56%

“…In the study by Schmack et al [7], also no significant deviations could be observed when performing HCV-PCR on an Abbott m2000rt cycler using 20 related spiked and unspiked pre-and post-mortem cornea donor blood samples, the latter taken up to 24 h after death. In a study by Ribeiro et al [6], the Roche CAP/CTM HIV-1 Test, v2.0, demonstrated a sensitivity and specificity of 100%, whereas in contrast to our study, the CAP/CTM HCV Test, v2.0, only demonstrated a sensitivity of 80% and specificity of 60% when testing 20 spiked and 5 unspiked post-mortem blood samples with a timeframe between death and blood sampling <24 h. Post-mortem samples may be used up to a maximum of 24 h after the occurrence of death, because they are often of inferior quality.…”

Section: Discussionmentioning

confidence: 87%

“…The assays demonstrated a sensitivity and specificity of 100% when unrelated spiked and unspiked pre- and post-mortem blood samples ( n = 72) taken up to 24 h after the occurrence of death were tested [5]. In the study by Schmack et al [7], also no significant deviations could be observed when performing HCV-PCR on an Abbott m2000rt cycler using 20 related spiked and unspiked pre- and post-mortem cornea donor blood samples, the latter taken up to 24 h after death. In a study by Ribeiro et al [6], the Roche CAP/CTM HIV-1 Test, v2.0, demonstrated a sensitivity and specificity of 100%, whereas in contrast to our study, the CAP/CTM HCV Test, v2.0, only demonstrated a sensitivity of 80% and specificity of 60% when testing 20 spiked and 5 unspiked post-mortem blood samples with a timeframe between death and blood sampling <24 h.…”

Section: Discussionmentioning

confidence: 99%

“…However, haemolysis, autolysis, and other factors may interfere with assay sensitivity and specificity with the risk of generating false-negative or false-positive test results [ 4 ]. To ensure routinely used tests meet the specified quality requirements when testing post-mortem blood samples, they need to be validated [ 5 , 6 , 7 ]. But the majority of commercially available screening assays are not or only validated for the use of cadaveric blood samples in a limited manner [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

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Suitability of Different Diagnostic Platforms for Virological Testing of Blood Samples from Cornea Donors

Kohmer

Kortenbusch

Berger

et al. 2022

Transfus Med Hemother

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Background: To minimize the risk of disease transmission in cornea transplantation, donor screening for blood-derived viral infections is mandatory. Ideally, pre-mortem blood samples are used, but based on availability, cadaveric blood samples of cornea donors may also be used. However, serological and nucleic acid amplification tests (NATs) need to be validated for the use of cadaveric specimens. Methods: Hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV) 1/2, and Treponema pallidum (syphilis)-specific serological and/or NAT assays were validated on different platforms (Abbott Alinity i, Alinity m, Roche Cobas 6800, and Roche Cobas AmpliPrep/Cobas TaqMan (CAP/CTM)) using (un)spiked paired pre- and post-mortem cornea donor blood samples from the same individual (up to 23.83 h after death) of 28 individuals in accordance with the specifications of the German Federal Institute for Vaccines and Biomedicines (Paul-Ehrlich-Institut [PEI]). In addition, routinely HBV-, HCV- and HIV-PCR-negative tested post-mortem blood samples of 24 individuals were used to assess NAT specificity. Results: For the majority of serological parameters on the Abbott Alinity i (HBsAg, anti-HBc, anti-HBs, anti-HCV, anti-HIV, anti-HTLV 1/2, and anti-Treponema pallidum), ratios of generated test results of (un)spiked paired pre- and post-mortem blood samples differed ≤25%, with an agreement of qualitative pre- and post-mortem test results ranging from 91.2 to 100%. For NAT parameters (HBV, HCV, and HIV) on the Cobas 6800, Alinity m, and CAP/CTM, no significant deviation in virus concentrations (factor >5) of spiked pre- and post-mortem blood samples could be observed. Ct-values of corresponding internal controls did also not differ significantly (>1.5 Ct-values). In addition, no false-positive test results were generated when specificity was assessed. Conclusion: Overall, fluctuations of test results for serological and NAT parameters in pre- and post-mortem blood samples examined in this study, were only limited and within the range of what is also observed when routinely testing fresh patient specimens. We conclude that all examined assays are eligible for the screening of blood samples taken up to about 24 h after the occurrence of death.

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Section: Discussionsupporting

confidence: 56%

Section: Discussionmentioning

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Suitability of Different Diagnostic Platforms for Virological Testing of Blood Samples from Cornea Donors

Kohmer

Kortenbusch

Berger

et al. 2022

Transfus Med Hemother

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show abstract

“…Newer-generation tests (e.g., 4th generation) generally lead to a shortened serological window period [20, 21]. Where CE-marked assays and systems are not available for testing of postmortem blood specimens, laboratories performing this work must validate the assays for this purpose [22, 23].…”

Section: General Requirementsmentioning

confidence: 99%

Algorithms for the Testing of Tissue Donors for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus

Chandrasekar

Ibáñez

Lucas-Samuel

et al. 2020

Transfus Med Hemother

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Background: Although transmission of pathogenic viruses through human tissue grafts is rare, it is still one of the most serious dreaded risks of transplantation. Therefore, in addition to the detailed medical and social history, a comprehensive serologic and molecular screening of the tissue donors for relevant viral markers for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) is necessary. In the case of reactive results in particular, clear decisions regarding follow-up testing and the criteria for tissue release must be made. Methods: Based on the clinical relevance of the specific virus markers, the sensitivity of the serological and molecular biological methods used and the application of inactivation methods, algorithms for tissue release are suggested. Results: Compliance with the preanalytical requirements and assessment of a possible hemodilution are mandatory requirements before testing the blood samples. While HIV testing follows defined algorithms, the procedures for HBV and HCV diagnostics are under discussion. Screening and decisions for HBV are often not as simple, e.g., due to cases of occult HBV infection, false-positive anti-HBc results, or early window period positive HBV NAT results. In the case of HCV diagnostics, modern therapies with direct-acting antivirals, which are often associated with successful treatment of the infection, should be included in the decision. Conclusion: In HBV and HCV testing, a high-sensitivity virus genome test should play a central role in diagnostics, especially in the case of equivocal serology, and it should be the basis for the decision to release the tissue. The proposed test algorithms and decisions are also based on current European recommendations and standards for safety and quality assurance in tissue and cell banking.

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Preanalytical variables influencing the interpretation and reporting of biological tests on blood samples of living and deceased donors for human body materials

Padalko,

Colenbie,

Delforge

et al. 2023

Cell Tissue Bank

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With the present paper, the Working Group on Cells, Tissues and Organs and other experts of the Superior Health Council of Belgium aimed to provide stakeholders in material of human origin with advice on critical aspects of serological and nucleic acid test (NAT) testing, to improve virological safety of cell- and tissue and organ donation. The current paper focusses on a number of preanalytical variables which can be critical for any medical biology examination: (1) sampling related variables (type of samples, collection of the samples, volume of the sample, choice of specific tubes, identification of tubes), (2) variables related to transport, storage and processing of blood samples (transport, centrifugation and haemolysis, storage before and after centrifugation, use of serum versus plasma), (3) variables related to dilution (haemodilution, pooling of samples), and (4) test dependent variables (available tests and validation). Depending on the type of donor (deceased donor (heart-beating or non-heart beating) versus living donor (allogeneic, related, autologous), and the type of donated human material (cells, tissue or organs) additional factors can play a role: pre- and post-mortem sampling, conditions of sampling (e.g. morgue), haemodilution, possibility of retesting.

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Validation of Spiked Postmortem Blood Samples from Cornea Donors on the Abbott ARCHITECT and m2000 Systems for Viral Infections

Cited by 3 publications

References 28 publications

Suitability of Different Diagnostic Platforms for Virological Testing of Blood Samples from Cornea Donors

Suitability of Different Diagnostic Platforms for Virological Testing of Blood Samples from Cornea Donors

Algorithms for the Testing of Tissue Donors for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus

Preanalytical variables influencing the interpretation and reporting of biological tests on blood samples of living and deceased donors for human body materials

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