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ACB-CLIN-CHEM-GEN  October 2008

ACB-CLIN-CHEM-GEN October 2008

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Subject:

Re: Modernising Scientific Careers

From:

Roger Ekins <[log in to unmask]>

Reply-To:

Roger Ekins <[log in to unmask]>

Date:

Sat, 18 Oct 2008 10:48:36 +0100

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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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