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  1. Article ; Online: International Society for Blood Transfusion Guidelines for Traceability of Medical Products of Human Origin.

    Ashford, Paul / Butch, Suzanne / Barhoush, Amjad Omar / Bolton, Wayne / Cusmai, Michele / Espensen, Lone / Geary, Josh / Moniz, Karen

    Vox sanguinis

    2023  Volume 118, Issue 7, Page(s) 587–597

    MeSH term(s) Humans ; Blood Transfusion ; Transfusion Reaction ; Blood Safety
    Language English
    Publishing date 2023-05-25
    Publishing country England
    Document type Journal Article
    ZDB-ID 80313-3
    ISSN 1423-0410 ; 0042-9007
    ISSN (online) 1423-0410
    ISSN 0042-9007
    DOI 10.1111/vox.13473
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Improved efficiency of national HIV, HCV, and HTLV antibody testing algorithms based on sequential screening immunoassays.

    Seed, Clive R / Margaritis, Angelo R / Bolton, Wayne V / Kiely, Philip / Parker, Susan / Piscitelli, Lisa

    Transfusion

    2003  Volume 43, Issue 2, Page(s) 226–234

    Abstract: Background: Traditional strategies for clarifying the antibody status of donors giving repeatedly reactive (RR) results on primary screening immunoassays (IA1) have usually involved direct testing by immunoblot. However, such strategies can generate ... ...

    Abstract Background: Traditional strategies for clarifying the antibody status of donors giving repeatedly reactive (RR) results on primary screening immunoassays (IA1) have usually involved direct testing by immunoblot. However, such strategies can generate nonspecific in determinate results. The aim of this report is to present the results of an alternative strategy based on the use of sequential immunoassays (SI) before immunoblot testing.
    Study design and methods: The efficiency of traditional and SI strategies was compared in terms of the number of IA1 RR samples requiring immunoblot testing and the percentage of immunoblot tests giving indeterminate results. In addition, the biologic false- reactive overlap between the PRISM assays selected as IA1 and candidate secondary screening immuno- assays (IA2) was calculated to determine the most efficient IA1/IA2 combinations.
    Results: There was a significant decrease in the proportion of IA1 RR samples requiring immunoblot testing under the SI strategy when compared with existing site-specific strategies for HIV (0.49 vs. 0.08, p < 0.05), HCV (0.85 vs. 0.42, p < 0.05), and HTLV (0.69 vs. 0.05, p < 0.05) algorithms. In addition, there was a significant decrease in the percentage of immunoblot tests giving indeterminate results for HIV and HTLV under the SI strategy. However, there was no significant difference in the proportion of confirmed positive results for HIV, HCV, or HTLV before and after national SI algorithm implementation. For the anti-HIV IA2s, there was considerable variation of biologic false-reactive overlap with the PRISM HIV O plus chemiluminescent immunoassay (range, 1.6-15.6%).
    Conclusions: The results presented in this report demonstrate that the sequential use of screening immunoassays before immunoblot testing can significantly reduce both the number of immunoblot tests and proportion of indeterminate results, without impacting sensitivity, thereby improving algorithm efficiency and simplifying donor management.
    MeSH term(s) Algorithms ; Antibodies, Viral/blood ; Australia ; Blood Donors ; Deltaretrovirus Antibodies/blood ; HIV Antibodies/blood ; Hepatitis C Antibodies/blood ; Humans ; Immunoassay/standards ; Immunoblotting ; Mass Screening/methods ; Predictive Value of Tests ; Sensitivity and Specificity
    Chemical Substances Antibodies, Viral ; Deltaretrovirus Antibodies ; HIV Antibodies ; Hepatitis C Antibodies
    Language English
    Publishing date 2003-02
    Publishing country United States
    Document type Evaluation Studies ; Journal Article
    ZDB-ID 208417-x
    ISSN 1537-2995 ; 0041-1132
    ISSN (online) 1537-2995
    ISSN 0041-1132
    DOI 10.1046/j.1537-2995.2003.00304.x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Assessing the accuracy of three viral risk models in predicting the outcome of implementing HIV and HCV NAT donor screening in Australia and the implications for future HBV NAT.

    Seed, Clive R / Cheng, Anthea / Ismay, Susan L / Bolton, Wayne V / Kiely, Philip / Cobain, Trevor J / Keller, Anthony J

    Transfusion

    2002  Volume 42, Issue 10, Page(s) 1365–1372

    Abstract: Background: Risk modeling is now the most practical method of estimating the residual risk of viral transmission in developed countries. One method of assessing the accuracy of a risk model is to measure the observed against the predicted outcome after ... ...

    Abstract Background: Risk modeling is now the most practical method of estimating the residual risk of viral transmission in developed countries. One method of assessing the accuracy of a risk model is to measure the observed against the predicted outcome after implementing a new screening method. The primary objective of this paper is to assess the accuracy of three published models in predicting the impact of implementing HIV and HCV NAT in Australia.
    Study design and methods: Viral screening data on Australian donors for 2000 and 2001 were retrospectively analyzed. The data were applied to the three models to estimate the risk of transmission and predicted NAT yield for HIV, HCV, and HBV.
    Results: The median risk estimates for the three models were 1 in 3,415,000 for HIV NAT, 1 in 911,000 for HCV NAT, and 1 in 483,000 for HBsAg. The predicted NAT yield for the three models ranged from 0.17 to 0.30 per million donations for HIV, 1.20 to 5.55 for HCV, and 0.47 to 1.01 for HBV. The observed NAT yield was not significantly different from the expected yield with any of the three models for either HIV or HCV.
    Conclusions: First, the residual risk in Australian donors is small in comparison with other transfusion complications and comparable to or lower than the risk in US and European nonremunerated donors. Second, mathematical risk modeling has sufficient precision to be used as a predictive tool for risk-benefit assessments of novel screening procedures. Finally, in relation to the case for implementing HBV NAT and/or anti-HBc in Australia, we conclude that at present, there is inadequate information about our donor population to perform an evidence-based risk-benefit analysis.
    MeSH term(s) Adult ; Australia/epidemiology ; Blood Donors ; HIV/isolation & purification ; HIV Infections/blood ; HIV Infections/epidemiology ; HIV Infections/prevention & control ; HIV Infections/transmission ; HIV Infections/virology ; HIV Seropositivity/epidemiology ; Hepacivirus/isolation & purification ; Hepatitis B/blood ; Hepatitis B/epidemiology ; Hepatitis B/prevention & control ; Hepatitis B/transmission ; Hepatitis B/virology ; Hepatitis B virus/isolation & purification ; Hepatitis C/blood ; Hepatitis C/epidemiology ; Hepatitis C/prevention & control ; Hepatitis C/transmission ; Hepatitis C/virology ; Humans ; Immunoassay ; Mass Screening ; Models, Theoretical ; Outcome and Process Assessment (Health Care) ; Prevalence ; Probability ; RNA, Viral/blood ; Retrospective Studies ; Risk Assessment ; Transfusion Reaction ; Viremia/virology
    Chemical Substances RNA, Viral
    Language English
    Publishing date 2002-10
    Publishing country United States
    Document type Comparative Study ; Journal Article
    ZDB-ID 208417-x
    ISSN 1537-2995 ; 0041-1132
    ISSN (online) 1537-2995
    ISSN 0041-1132
    DOI 10.1046/j.1537-2995.2002.00204.x
    Database MEDical Literature Analysis and Retrieval System OnLINE

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