The use of Clinitest tablets for faecal reducing substances is a widely used test and the question to ask is why is this not approved by the FDA?
Is it because the test does not work? - if so then we should know what the limitations of te test are.
Or is it because the maunufactures have not submitted the required paper work to the FDA!
In our local experience the test is used widely but the application of the method is not standardised.
For example
*one lab takes a pea sized piece of faeces and emulsifies with an equal volume of water - then applies the clinitest test to 20 drops of the mixture
*another lab may do the same but use 15 drops.
*yet anothe lab takes a pea size piece and emulsifies in 5mL of water etc
It is time this simple test was evaluated, external QC set up, test details published with the tablets and approval given by the relevent regulatory bodies - or the test should be superceeded and abandoned into history.
What is the correct aspplication of the tablets to faeces?
cheers
Trevor Walmsley
"If you need to use statistics then you have done the wrong experiment"
Trevor Walmsley, Canterbury Health Labs, Christchurch, New Zealand.
Phone: (0064 3) 364 0326 Fax:Phone: (0064 3) 364 0320
eMail: [log in to unmask]
Internet: http://www.cdhb.govt.nz/chlabs/staff/trevorw.htm
>>> "Bertholf, Roger" <[log in to unmask]> 13/2/03 4:34 am >>>
Dear Colleagues:
My apologies to subscribers to more than one of these lists (like me), but I
wanted to reach the widest audience possible.
We have recently discovered that our neonatologists frequently use the
CliniTest tablets (Benedict's copper reduction reaction) to detect reducing
substances in stool, for purposes of evaluating malabsorption syndromes in
newborns. This is not an FDA approved use of the CliniTest tablets, and I
have told them that the off-label application could not be performed under
their waived testing CLIA license. They insist that this is a critically
important test for them (and that ALL neonatal units use it), so I am
obligated to find an alternative. I have been unable to find any helpful
literature references to the measurement of stool reducing substances in
neonates.
Is anyone performing this test in their lab or at the bedside, or can you
recommend other tests that may be helpful.
Roger
Roger L. Bertholf, Ph.D.
Associate Professor of Pathology
Director of Clinical Chemistry & Toxicology
University of Florida Health Science Center/Jacksonville
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