It may well be that hydroxybutyrate is a non-standardised measurand and that there is no calibrator or reference material with an international endorsement.

 

JCTLM doesn’t list a higher order reference material or measurement procedure so far as I can see, and I also can’t see anything obvious in the catalogues of IRMM, NIST or NIBSC. 

 

I don’t think that the use of SI units implies anything definite about traceability.

 

I do think that Randox should be able to provide additional information about how they assign values in there assay, but it is quite possible that this will not address the need identified by UKAS and that some in-house calibration may be required.

 

Overall an unsatisfactory situation!  I would also be interested in how other manufacturers evidence traceability for hydroxybutyrate.

 

Best wishes

 

Ian

 

 

IS Young
Professor of Medicine, Queen's University Belfast
Associate Medical Director (Research and Development), Belfast Health and Social Care Trust

 

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