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A review of the relationship between quality control and donor sample results obtained from serological assays used for screening blood donations for anti-HIV and hepatitis B surface antigen

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Abstract

Quality control principles, initially designed for manufacturing, have been applied to clinical chemistry and later to serological testing for infectious diseases. Methods for setting control limits have been included using the effects of assay performance on clinical outcomes. However, this approach assumes that the reactivity of patient samples change proportionally with the results of quality control samples tested in the same assay. Although this may be the case for clinical chemistry, this assumption has never been tested for serological assays. During a 9-month period, 177910 and 185684 donor test results for HBsAg and anti-HIV, respectively, were analysed and compared with 712 HBsAg and 710 anti-HIV results obtained from a single batch of a multimarker quality control sample obtained from the same assays. Results of the analysis showed that the negative donor results did not change in proportion with the changes experienced by the quality control sample results as determined by regression coefficients, particularly when results obtained from different reagent batches were compared. There were insufficient results obtained from positive samples for a similar analysis. However, investigations show that, even if the reactivity of positive donor samples changed in proportion with the change in reactivity of the quality control sample, few false-negative donor test results would have occurred.

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Acknowledgments

Australian governments fully fund the Australian Red Cross Blood Service for the provision of blood products and services to the Australian community.

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Authors and Affiliations

  1. NRL, 4th Floor, Healy Building, 41 Victoria Parade, Fitzroy, VIC, 3065, Australia

    Wayne Dimech & Kathy Smeh

  2. Australian Red Cross Blood Service, 44 Musk Ave, Kelvin Grove, Brisbane, QLD, 4059, Australia

    Robert Freame

  3. The Kirby Institute, University of New South Wales, 45 Beach Street, Coogee, Sydney, 2034, Australia

    Handan Wand

Authors
  1. Wayne Dimech
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  2. Robert Freame
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  3. Kathy Smeh
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  4. Handan Wand
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Correspondence to Wayne Dimech.

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Dimech, W., Freame, R., Smeh, K. et al. A review of the relationship between quality control and donor sample results obtained from serological assays used for screening blood donations for anti-HIV and hepatitis B surface antigen. Accred Qual Assur 18, 11–18 (2013). https://doi.org/10.1007/s00769-012-0950-y

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  • DOI: https://doi.org/10.1007/s00769-012-0950-y

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