Journal Watch: The Quality of Estradiol Assays

Posted by Sten Westgard, MS

"In many cases the answer to the question 'Are oestradiol assays fit for purpose?' is 'No',  yet we have the apparent paradox that very many laboratories offer this test and many thousands of tests are regularly requested of them annually." [ed. emphasis added]

"Diagnostic companies should cease the undesirable practice of 'calibrating' assays to produce the same results as other systems, EQA schemes or 'expected values', especially where the origin of the latter may be uncertain. The established reference measurement system must be used to calibrate according to the scientific principle of metrological traceability....If all manufacturers use the same trueness benchmark, this should improve comparability."

Just two choice quotes from a recent paper:

Jonathan G. Middle and John W Kane, Oestradiol assays: fitness for purpose? Ann Clin Biochem 2009; 46: 441-456.

The entire paper is well worth a read, but the meat of the article is found in a table that lists the uses of the estradiol /oestradiol test - and notes whether or not current testing methods can actually provide the quality required by that use.

It's a very sobering reminded that quality is not a given, even with today's New! Improved! Faster! Better-than-ever! methods.