The Scientific and Regulatory Affairs Committee (SRAC) of the Australasian Association of Clinical Biochemists (AACB) is charged with coordinating two Scientific Education Seminars each year. In 2007, the theme of one of the seminars was “Analytical Quality – A Technical Checklist”, the idea being to present material useful for anyone wishing to introduce a new assay into their laboratory, to manage and troubleshoot an existing assay, or simply as background to these operations. Jill Tate, chair of SRAC, was largely responsible for putting the seminar programme together and cajoled a number of her committee members to speak. The seminar was well received, so much so that the initial offering in Sydney was repeated later in the year in Brisbane with largely the same cast of speakers.
Following on from the seminar it was decided to produce a written version with an expanded list of topics that would give a more complete coverage than was possible in a one day seminar. This would then be a handy guide for general laboratory use and available to anyone, not just those who had attended the seminar. This publication represents the product of the labours of several of the speakers and other authors and we are grateful to all contributors for their efforts.
The guide is intended for the laboratory scientist who deals on a daily basis with the technical laboratory issues. In line with the terms of reference of the International Federation of Clinical Chemistry and Laboratory Medicine Committee on Analytical Quality (IFCC C-AQ), chaired by Dr Ken Sikaris, the material deals with everyday matters of what to look for in a suitable test, selecting the right specimen, characterising tests in terms of their analytical performance, monitoring their performance, and reporting the results. The fundamental characteristics of imprecision, bias and interference lead naturally to traceability and the derived limits of detection and uncertainty of measurement. The section on monitoring performance includes the familiar internal and external QC and perhaps the less familiar situation of handling multiple analysers both in the laboratory and at point-of-care. Reporting includes advice on application of reference intervals, significant figures, and the use of comments, both manual and automated. A section on diagnostic validation introduces likelihood ratios as a way of expressing results to clinicians in a more intelligible form.
Where possible, we have tried to make the material accessible to the generalist laboratory worker by including examples of aspects discussed. These examples are included either within the text or as more extensive numerical treatments in spreadsheet format on the AACB website (http://www.aacb.asn.au/web/Resources/Tools/).
Aside from the writers, many people have contributed to the production of this issue as reviewers and publications staff. They work behind the scenes largely unnoticed. We thank them for their efforts and in particular want to acknowledge the support of Dr Sam Vasikaran, and also Dr David Bullock, a member of the IFCC C-AQ for critical review and editing of all papers.