Evaluations, validations and verifications of diagnostic tests – except ISO accreditation


 

“Where two kits have equivalent performance characteristics, the one which is easier to use, cheaper, faster or requires a more easily obtainable sample might be preferred.”   UK Standards for Microbiology Investigations Q 1: Evaluations, validations and verifications of diagnostic tests, p9.

This guidance document describes the work necessary for the evaluation, validation and verification of laboratory tests.  It’s all good stuff, heavy and demanding.  Such thinking pre-existed the ISO management standards and UKAS.  But before accreditation, all of it wasn’t applied in every lab, all the time.

Maybe all previous testing must be suspect.  Maybe it was quite sufficient for specialist labs to do this work and for other labs to rely on their assurances.  Maybe great science doesn’t need it.  Who knows?

Now UKAS has to inspect every lab’s validation and verification of every variation in every test method.

It’s not putting labs out of service, so we may assume this extra work is making little difference to test results.  Internal quality control and external quality assurance would give labs an idea about that.

You’ll have to search elsewhere if you want to know how much difference this approach makes to the usefulness of laboratory testing.

Searching, you will find almost none of this laborious and necessary work applied to the inspection of ISO laboratory standards.

Here is a useful document.  Figure out how to apply it to UKAS inspections themselves.  Publish the results.

For all we know, millons are being wasted on screening labs for “quality” that actually makes no difference.  You’ll find a little evidence for that, but nobody cares.

It’s an equality issue – laboratory tests must always be validated.  Inspections of the ISO standards themselves must never be validated.

“Where two kits have equivalent performance characteristics, the one which is easier to use, cheaper, faster or requires a more easily obtainable sample might be preferred.”p9.

 

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