NDLI: 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

Content Provider	Springer Nature Link
Author	Dimech, Wayne Freame, Robert Smeh, Kathy Wand, Handan
Copyright Year	2013
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.
Starting Page	11
Ending Page	18
Page Count	8
File Format	PDF
ISSN	09491775
Journal	Accreditation and Quality Assurance
Volume Number	18
Issue Number	1
e-ISSN	14320517
Language	English
Publisher	Springer-Verlag
Publisher Date	2013-01-08
Publisher Place	Berlin, Heidelberg
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Quality control Serology Infectious disease Commutability Analytical Chemistry Food Science Biochemistry Commercial Law Ecotoxicology Marketing
Content Type	Text
Resource Type	Article
Subject	Chemistry Instrumentation Chemical Engineering Safety, Risk, Reliability and Quality

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