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On 15/06/2016 at 9:42 PM, A little lab lost said:

I am considering using a NIBSC anti-D for a comparison study between the automation and manual testing.  I'm unsure how often this should be done to comply with ISO 15189.

We also got NC for not using NIBSC for comparison in our recent UKAS inspection.  As far as I know they recommend  twice a year.

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I am going to have a rant here!! I think using this type of reagent for routine blood banking (as opposed to quantification techniques) is WAY over the top.  Metrologicals are all very relevant in chemistry where you are looking for a number but totally meaningless in most areas of immunohaematology.  With the exception mentioned by Malcolm, IH is NOT a quantitative technique.  So just what are you trying to prove with this expensive and precious material ?  You want to compare that your instrument is getting the same results as your manual technique?  So use a series of weak antibodies.  The actual strength does not really matter, does it?  What you want to know is - for the same cells and the same technique, did my instrument detect the same antibodies, and was the reaction strength the same?

Rant over!

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On 09/07/2016 at 10:42 AM, gagpinks said:

We also got NC for not using NIBSC for comparison in our recent UKAS inspection.  As far as I know they recommend  twice a year.

Rant totally justified Anna - and gagpinks, I should have suggested to you well before now to challenge your UKAS Inspector to show where (anywhere) NIBCS reagents are mentioned in ISO15189.  I presume that you are aware that the weak anti-D reagent produced by NHSBT has a specific concentration of anti-D (although I am at home at the moment, and cannot, for the life of me, remember what is this concentration, but I know that it is very low, as it was lowered a few years back, to reflect the fact that everyone was getting "too good" at detecting the the slightly higher concentration of anti-D, as a result of using more sensitive techniques, such as column agglutination technology, and, not to be forgotten, a general increase in the ability of Biomedical Scientists to actually detect antibodies!).

As I said above, we do NOT routinely use NIBSC reagents in RCI in NHSBT, except for quantification, where we are looking at a concentration of antibody, and all of our eight RCI laboratories have just been inspected by UKAS.  We did not get an NC for this.  I would suggest that your particular UKAS inspector was, shall we say, a little over-enthusiastic!  Were they actually a Blood Transfusion person themselves (either now or retired)?

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