My Dear Martin,
I could not disagree more strongly with your primary remarks.
Do you want the profession to descend into a bunch of deskilled automatons,
relying on commercial companies whose main aim is to satisfy their
shareholders, and who, on so many occasions, that everyone in the
profession can attest to,has been found wanting? Just take a critical look
at what is written in the name of science in some kit package inserts!AND
THEY GET FDA APPROVAL!!!
One of our laboratory's best assays, by any measure you wish to test it, is
17 alpha-hydroxyprogesterone. This is a fully 'in-house' extraction manual
method, carried out by experienced,well-trained, highly skilled MLSOs, the
results interpreted by experienced biochemists and accepted by grateful
clinicians who have faith and confidence in the results produced by the
laboratory. Lord, Allah, or whoever else you wish to invoke, help us if we
used one particular commercial company's assay for the above-mentioned
analyte!
Yours
Michael Diver.
--On 15 November 2001 10:31 +0000 "Myers, Martin"
<[log in to unmask]> wrote:
> It is interesting how this debate has evolved.
>
> The days of altering reagents in an in-house assay are long gone. Rules
> and regulations are such that in-house assays have to be used with extreme
> medico-legal caution. I support the principal of this- we must have
> regulation and traceability for all methods. However most assays depend
> on third parties to formulate and manage the assays. I agree with the
> assertion that Clinical Chemists have a duty of care to ensure that the
> assays are fit for purpose and the Clinical Chemist has many tools to
> ensure that this is the case. However, there is a risk that Clinical
> Chemists may be unclear about some of the limitations of assays,
> especially when the formulation is changed.
>
> Traditional modes for clarification, such as discussion with companies,
> MDA, NEQAS, colleagues etc. may not be effective. In addition there is a
> risk that the bigger picture may be missed. The relationship between the
> in-vitro diagnostics companies and the professional bodies have always
> been very good. Diagnostic companies and Clinical Chemists both put a
> lot of effort in ensuring the quality of assays. However I agree, in
> part, with Roger Ekins when he says that " it is perhaps worth
> considering whether an independent body should undertake the detailed
> monitoring of kit performance, to which, inter alia, representations and
> complaints might be made by users." Laboratory testing, POCT and OTC
> POCT, advanced POCT in primary care, who do not require accreditation
> for the provision of diagnostic testing, are all issues where tighter
> regulation is now required.
>
>
> I suggest an independent body looking at in-vitro diagnostics, wherever
> they are used, is set up and that this forms part of the modernisation of
> pathology process. The independent body should not result in beaurocratic
> stagnation inhibiting progress and change, but at least be the repository
> of methods and alterations, with power to investigate and veto. As
> Jonathan states, the MDA and NEQAS are, in part, already involved in
> this, but do they do what we want?
>
> Martin Myers
> Consultant Clinical Biochemist
> Preston and Chorley Hospitals
> UK
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