• Open Access

Taking a new biomarker into routine use – A perspective from the routine clinical biochemistry laboratory

Authors

  • Catharine Sturgeon,

    Corresponding author
    1. Clinical Biochemistry, Royal Infirmary of Edinburgh, Edinburgh, UK
    • Department of Clinical Biochemistry, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, UK Fax: +44-131-242-6882
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  • Robert Hill,

    1. Clinical Biochemistry, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
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    • Robert Hill attended the Hinxton meeting on behalf of the Scientific Committee of the UK Association for Clinical Biochemistry (ACB) and Glen Hortin attended on behalf of the American Association for Clinical Chemistry (AACC).

  • Glen L. Hortin,

    1. Quest Diagnastics, Inc., Cincinnati, OH, USA
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    • Robert Hill attended the Hinxton meeting on behalf of the Scientific Committee of the UK Association for Clinical Biochemistry (ACB) and Glen Hortin attended on behalf of the American Association for Clinical Chemistry (AACC).

  • Douglas Thompson

    1. Clinical Biochemistry, St. James' Hospital, Leeds, UK
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Abstract

There is increasing pressure to provide cost-effective healthcare based on “best practice.” Consequently, new biomarkers are only likely to be introduced into routine clinical biochemistry departments if they are supported by a strong evidence base and if the results will improve patient management and outcome. This requires convincing evidence of the benefits of introducing the new test, ideally reflected in fewer hospital admissions, fewer additional investigations and/or fewer clinic visits. Carefully designed audit and cost-benefit studies in relevant patient groups must demonstrate that introducing the biomarker delivers an improved and more effective clinical pathway. From the laboratory perspective, pre-analytical requirements must be thoroughly investigated at an early stage. Good stability of the biomarker in relevant physiological matrices is essential to avoid the need for special processing. Absence of specific timing requirements for sampling and knowledge of the effect of medications that might be used to treat the patients in whom the biomarker will be measured is also highly desirable. Analytically, automation is essential in modern high-throughput clinical laboratories. Assays must therefore be robust, fulfilling standard requirements for linearity on dilution, precision and reproducibility, both within- and between-run. Provision of measurements by a limited number of specialized reference laboratories may be most appropriate, especially when a new biomarker is first introduced into routine practice.

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