Dear Prof Ekins
Thank you for again raising these problems.
Maybe I should regret that I responded to the initial remark that the
CPA requested measurement uncertainty. But since this is a - or even
the - accepted concept since 1993 I thought it might be worth while to
point out some pertinent publications on the subject also to the UK
colleages. Unfortunately, the Mailbase participants seem only
moderately interested and ponders along with the total error concept
as if it were new, when in fact it has been abandoned by most
analytical chemists, clinical chemists and accreditation bodies using
the international standard EN/ISO 15189.
I can assure you that the heterogenity of certain molecules has never
been forgotten and I would give credit at this time to Dr Rudi Lequin
who has been involved in writing many ISO standards and always
reminded the working parties of the problem. I do not think it has
been resolved in generic terms yet - or ever will be - but it is
stated in all flowcharts and descriptions referred to in the field
that the first thing to do is to identify the quantity. That may
result in mentioning, in the name of the quantity, the calibrator, the
antibody and the manufacturer and whatever specifications necessary.
The IFCC/IUPAC nomenclature, as described by the IUPAC C-NPU
(www.iupac.org), offers a complete description of the nomenclature and
a list of some 25000 quantities that have been defined with unique
descriptors. In reviewing this you should also consider the modern
definition of bias, developed and changed since the previous edition
of VIM (www.BIPM.org).
The imprecision, or uncertainty, profile is extremely important and
should be part of the verification process. We usually advice a
profile based on both standard uncertainty and relative uncertainty
with the same arguments as providing difference plots (e.g. according
to Bland-Altman) in both absolute and relative differences. To be
feasible for the laboratories that perhaps do not afford, or want, to
set up special experiments this prompts for user-friendly software
that allows partitioning of results of measurements of patient samples
and estimating the uncertainty in appropriate concentration intervals.
The alternative, of course, is to make repeated measurements at
intelligently chosen concentrations. I think the latter is preferred
since the former may require assuming a homoscedactic uncertainty
distribution in the particular partion.
With my best regarsds,
Anders Kallner
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