Johnathan,
In response to your central question, at least some of the functions
of healthcare scientists that you list below used to be performed by
the original Supraregional (Hormone) Assay Service Labs originally
established by the DHSS in 1973 (all in university research
departments) of which my own lab was one. Out of the funding we
received, my colleagues and I not only provided a range of assays
available throughout the UK, but developed some of the methods and
reagents in widespread use today - for example, free (thyroid)
hormone assays, PTH and vitamin D assays; also monoclonal antibodies
(which we distributed to other SAS and NHS labs on request). We also
provided the first (I think) external QC scheme established in the
UK (for thyroid hormones).
Another role that we subsequently performed - when RIA assay kits
later became commercially available - was to evaluate the clinical
utility and reliability of certain kits produced by different
manufacturers (for which task we were separately funded by the
DHSS); for example FT4 and FT3 kits, some of which were based on
false physicochemical principles and were demonstrably clinically
misleading. Interestingly about a year ago - at a meeting at the
Houses of Parliament (to which ACB members were invited, but few
attended) - attention was drawn to the fact that no organization in
the UK is responsible for evaluating the clinical usefulness of the
many new commercial diagnostic methods that are appearing on the
market. In principle this is something that the ACB could undertake
(in the case of diagnostic assay methods) because of the wide range
of patients that pass through its collective hands, albeit the
magnitude, complexity and cost of such a task should not be
underestimated.
Some of the problems in such an enterprise are alluded to in an
article published in Clin Chem in 2001 by Ulf Stenman (see Stenman
U-H. 'Immunoassay standardization: is it possible, who is
responsible, who is capable?' Clin Chem: 2001; 47; 815-820.) in
which he refers to an article in which I assert that standardization
of immunoassays of heterogeneous analytes (such as FSH) is
impossible. Since the majority of analytes assayed by ACB members are
of this nature (implying that numerical results are 'method
dependant' and are likely to differ in - at least - pathological
samples), this is potentially a major problem (which Ulf Stenman does
not not resolve in his paper ). Hence my own view is that the most
that can be done in regard to such analytes is to establish the
clinical utility of the different commercially-available methods ,
this requiring, inter alia, access to a wide range of clinical
samples.
So I think you're entirely right to raise the fundamental questions
you raise below - and I hope that the ACB will address them.
Certainly most of them cannot be addressed by NHS hospital
laboratories working in isolation.
Roger
>Hi
>
>I have a slide which introduces most of my lectures to clinical
>scientists and BMS trainees.
>
>It is entitled "What healthcare scientists (should) be doing"
>
>It has the following elements:
>
>1. Identify biochemical entities which help diagnose, screen and
>monitor treatment
>
>2. Create analytically valid and traceable routine assays,
>underpinned by reference materials and methods, in order to measure
>these entities properly
>
>3. Create a (Bayesian) evidence base which enables clinicians to use
>these measurements appropriately for the benefit of patients
>
>4. Research and develop the field of analysis both analytically and clinically
>
>5. Continuously improve analytical quality to meet goals based on
>within and between-individual variability
>
>6. Audit clinical use, generate guidelines and promulgate best practice
>
>Could someone knowledgeable about Modernising Scientific Careeers
>tell me please who will be undertaking each of these elements and
>where the work will be done?
>
>Thank you!
>
>Jonathan
>
>
--
Prof Roger Ekins, PhD DSc FRS
Windeyer Institute
University College London
London W1T 4JF
Phone +44 20 7679 9410
Fax +44 20 7679 9407
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