Wrong biochemistry results

BMJ 2002; 324 doi: https://doi.org/10.1136/bmj.324.7334.422/a (Published 16 February 2002) Cite this as: BMJ 2002;324:422

Companies and Medical Devices Agency must act to prevent wrong results

  1. Ian D Watson (ian.watson@aht.nwest.nhs.uk), consultant biochemist,
  2. K Lawton, principal biochemist
  1. University Hospital Aintree, Liverpool L9 7AL
  2. Sahlgren Academy at Göteborg University, Sahlgren University Hospital, SE-413 45 Gothenburg, Sweden
  3. Sahlgren Academy at Göteborg University, Sahlgren University Hospital/Mölndal, SE-431 80 Mölndal, Sweden
  4. Clinical Chemistry Laboratory, Västerås Hospital, SE-721 89 Västerås, Sweden
  5. Department of Clinical Chemistry, Lund University Hospital, SE-221 85 Lund, Sweden
  6. Department of Clinical Chemistry and Pharmacology, Centre for Laboratory Medicine, University Hospital, SE-751 85 Uppsala, Sweden
  7. EQUALIS AB, Box 977, SE-751 09 Uppsala, Sweden
  8. Department of Laboratory Medicine, University Hospital of Padua, 35128 Padua, Italy
  9. Department of Laboratory Medicine, Università Vita-Salute San Raffaele, 20132 Milan, Italy

    EDITOR—In their editorial Ismail and Barth discuss the possibility of getting wrong biochemistry results, particularly when immunoassays are done.1 Laboratories try to detect these problems and provide an accurate, clinically relevant result. But the large number of assays done has resulted in widespread reliance on automation, particularly for hormones, and the “one size fits all” approach inherent in this makes the likelihood of inaccurate results quite high.

    What is needed is fit-for-purpose assays on these automated platforms. We are aware, though, of the problems that this may present: we have experienced difficulty in persuading a company that the female testosterone values that its machine produces are analytically incorrect and may lead to inappropriate clinical action if preceded by an oestradiol assay (table). The fact that we elicited similar findings from other centres through a computer mailbase and added this weight of evidence to ours did not matter to the company or, worryingly, to the Medical Devices Agency.

    View this table:

    Readings showing that female testosterone values may be analytically incorrect if preceded by oestradiol assay

    Until companies recognise that, in a clinical governance setting, no-blame reporting is constructive criticism requiring positive action, then inappropriate interventions will continue to affect patients. More critical oversight of analysis and its clinical implications by the Medical …

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