NHS PASA's Centre for Evidence-based Purchasing (CEP) - previously
MHRA/MDA's Device Evaluation Service, have received a project proposal
for HPLC/mass spec. We've been asked to write a buyer's guide to help
people understand the market, what features are most important and where
there is added value in terms of manufacturer support etc. We would also
try to capture any benefits in using this technology in terms of
reducing retesting, benefits to patients, economic considerations.
Perhaps an example business case for trusts to use if the economic
evidence is available? We may also be able to include some work on
comparative specifications which could act as a lever for manufacturer's
to improve their products.
This project hasn't been formally agreed yet. We should have a decision
after our prioritisation board meeting in November.
Katie Garner
Pathology Cluster Manager
Centre for Evidence-based Purchasing
[log in to unmask]
Tel: 020 7972 5388
Business mobile: 0774 7816958, fax: 020 7972 5795
152C Skipton House
80 London Road, London, SE1 6LH
-----Original Message-----
From: Clinical biochemistry discussion list
[mailto:[log in to unmask]] On Behalf Of Sandra Rainbow
Sent: 20 September 2007 13:59
To: [log in to unmask]
Subject: Re: Summary of Testosterone levels in pregnancy[Scanned]
In support of Jonathans summary about the poor performance of
immunoassays for steroids and in particular testosterone in females and
children, I have just returned today from the Asilomar Mass Spectrometry
meeting organised by the American Society of Mass Spectrometry on the
relevant topic of Clinical Applications of Mass Spectrometry.
Testosterone analysis was discussed in detail by Dr William Rosner, MD,
St. Luke's-Roosevelt Hospital Center & College of Physicians and
Surgeons, Columbia University who has chaired a committee for the
American Endocrine Society on the measurement of testosterone and its
lack of value and transferability of results by modern immunoassay
methods. The summary of the position statement can be viewed at the
following
http://jcem.endojournals.org/cgi/content/abstract/92/2/405
In the US there are a large number of reference labs producing their
results by LC Tandem Mass Spectrometry and the text books will have to
be rewritten with the correct results. Reports to NEQAS indicate that
there are at least 4 labs in the UK that have seen the light. The
biggest challenge is getting universal standardisation so that we are
all able to report against an accepted standard
I wonder when the European Endocrine societies will focus on this topic
and appreciate the poor quality of the results being produced by
immunoassays
regards
Sandra
Dr Sandra Rainbow
Consultant Clinical Scientist
Department of Clinical Biochemistry
NWLH
020 8869 2120
-----Original Message-----
From: Clinical biochemistry discussion list
[mailto:[log in to unmask]]On Behalf Of Jonathan G. Middle
Sent: 20 September 2007 12:17
To: [log in to unmask]
Subject: Re: Summary of Testosterone levels in pregnancy[Scanned]
Thanks Helen
I think that as soon as we have reliable routine mass spectrometry
methods with analytical parameters and calibration underpinned by a
network of ID-GCMS reference laboratories, we will have to
systematically re-examine what 'true' values are for hormones in health
and disease - steroids in particular. We are already starting to see
that 'true' testosterone levels in women may be half that which we
currently think of as 'normal'. This doesn't mean that the testosterone
that is there is half what we thought, but that the methods that gave us
these values are 100% 'out' - you know what I mean!
We cannot rely on or easily compare studies where non-extraction
immunoassay has been used, because of poor analytical sensitivity,
non-specificity, uncertain calibration, and manufacturer
're-formulations' which occur from time to time.
A concerted effort is needed to establish 'best practice' protocols for
tandem mass spectrometry methods for steroids, so that we can build this
knowledge base. There will be some sessions at Focus 2008 on this
subject.
I am already seeing a growing group of labs amongst UK NEQAS
participants using Tandem Mass Spec. Interestingly, some of these labs
have very poor consistency of bias performance scores against the ALTM,
because they get high negative bias for endogenous samples and high
positive bias for spiked samples. This is because they are probably
getting the right answer and also have quantitative recovery (see
below).
For UK NEQAS participants I have recently uploaded to the participants
website some reports on three recent distributions of oestradiol,
progesterone and cortisol samples with ID-GCMS target values. (Some of
my 2006 data on Testosterone in females were included within John Kane's
paper in the Annals this year.) These exercises reveal that some
methods are 'spot on' but others are 'miles out'.
I have also just reported and uploaded to the participants website,
results of my annual classical recovery exercises. These do not make
very comfortable reading if you share with me the belief that recovery
is an important indicator of analytical validity.
I have also performed an exercise on recovery of the SHBG IS (not yet
uploaded to the website but coming soon), which showed method
differences (range 80 - 120%) which correlated quite well with median UK
NEQAS method bias. By serendipity the median recovery of the 40 labs
surveyed was 100%, so for this analyte, the ALTM may very well be
'right'.
The presence of large differences between testosterone and SHBG methods
renders the reliability of indices derived from combining these
parameters somewhat suspect, and comparison between publications using
different combinations of methods but maybe using the same reference
ranges for these indices, pretty nearly impossible.
Cheers
Jonathan
Dr Jonathan Middle
Deputy Director, UK NEQAS Birmingham
0121 414 7300, fax 0121 414 1179
-----Original Message-----
From: Clinical biochemistry discussion list on behalf of Grimes, Helen,
UCHG
Sent: Wed 19/09/2007 18:41
To: [log in to unmask]
Subject: Summary of Testosterone levels in pregnancy
I posted the following "What is acceptable testosterone level in
pregnancy since SHBG increases. It specifically arises when we were
asked to do a testosterone level on a hirsute 16/40 pregnant lady. Her
testosterone is 5.5 nmol/L (Ref 0.5-2.6) with a SHBG of 310 nmol/L (Ref
26-110 - non pregnant)."
Several replies, and in general it was considered "Normal" for pregnancy
and if one calculated a FAI (though its applicability was queried) then
the FAI was normal. Some had seen higher in normal pregnancies.
Apparently Sophie Barnes has some data generated when she worked with
Mike Wheeler, but it is unpublished, which is a pity.
Of interest in the replies was the fact that hairiness is common in
pregnancy. It was queried and rightly so, as to whether it was a true
testosterone, we use Centaur, and so far agreement with Mass Spec with
Leeds for high levels but not for moderately elevated levels).
The fact that PCOS women are know to have higher androgen levels during
pregnancy See Human Reproduction Vol 17, No 10, pp2573-2579, 2002,
T.Sir-Petermann et al Maternal serum androgens in pregnant women with
PCOS; possible implication in prenatal androgenization. Method here
stated to be DPC Radioimmunoassay.
Finally the referring Consultant was anxious regarding a publication
that elevated Testosterone in pregnancy could affect offspring size, and
someone gave me the reference. Maternal testosterone levels during
pregnancy are associated<?xml:namespace prefix = o ns =
"urn:schemas-microsoft-com:office:office" />
with offspring size at birth. S M Carlsen et al. European Journal of
Endocrinology (2006) 155 365-370 ISSN 0804-4643
Online version via <http://www.eje-online.org> www.eje-online.org.
Immulite method for SHBG and Orion Diagnostics for Testosterone.
I have not read the latter paper in detail, but if an increase in
Testosterone and SHBG are "normal", was the last paper based on a chance
finding, and what was being measured anyway?? So more questions??
All the best
Helen.
------------------------------------------------------------------------
------------------
Dr Helen Grimes, Dept Clinical Biochemistry, University College
Hospital, Galway, Ireland
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