Hi all,

We are getting a new vesmatic ESR analyzer, for the verification of the trueness (accurate)  in accordance to CLSI standard, must we compare results with the standard westergren method? or are we allowed to compare results with a verified vesmatic analyzer from other hospital , or to use EQAP materials?

Thanks!!

Yolanda

Edited November 29, 20177 yr by Yolandalau

Hi,

I work at the lab of a public sector teaching hospital. Recently we shifted from manual to automated ESR analyzer by Vesmatic, and discussed our case with our QA team as well as people from ISO 15189. We were advised to validate the analyzer from another vesmatic validated analyzer as we cannot compare apples with oranges (oranges in this case is the manual method). 

 

Regards

I am not familiar with ISO 15189 standards--at a minimum you obviously have to follow them, along with manufacturer's requirements--but it seems to me...

...like you are being advised to validate a particular analyzer by comparing it to another exactly the same, which presumably was compared to another exactly the same, which was...

With any new method, you must show correlation with a previous method, in this case, your manual method.  Comparing it to an analyzer at another facility seems rather pointless.  (The exception being if the other facility is part of your system, and you use the same procedures and reference ranges).

You should also be doing a reference range study to validate your reference range, especially if there is significant variance in the correlation.  It has been our experience that automated methods correlate pretty well with the old manual ESRs.

Scott