Wrong biochemistry results : Companies and Medical Devices Agency must act to prevent wrong results

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. 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 Devices Agency is vital. We need confidence that any problem will be addressed either cooperatively or by effective monitoring.