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ACB-CLIN-CHEM-GEN  August 2016

ACB-CLIN-CHEM-GEN August 2016

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Subject:

Re: TnI-Ultra

From:

"Robeson, Bryan E" <[log in to unmask]>

Reply-To:

Robeson, Bryan E

Date:

Thu, 11 Aug 2016 14:24:14 +0000

Content-Type:

text/plain

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We just finished verification study on lot 112 vs lot 106.  Our results are very similar.

			Slope		ave % bias patients	ave %bias qc

Centaur XP-1	 	1.19		+15%			+9%

Centaur XP-2		1.26		+21%			+9%



Apparently there is a much more significant change than Siemens suggested in their product notification.



This is the first lot we have tried with their new polyclonal antibody.



Our lab will be contacting Siemens with this concern.



Bryan E. Robeson | Technical Manager

Chemistry-Immunoassay-RUA

24 Hour Services – Clinical Automated Lab

Marshfield Labs/ Marshfield Clinic

Marshfield, WI 54449

[log in to unmask]

Ph 715-221-6334

Fx 715-221-6339





Dear All,



On verification of new lot (110) of TnI-Ultra reagent on our Centaur XP, we found a 20% positive bias (slope 1.21) compared to previous reagent lot (106).  This is also now reflected in diminished performance on EQA (RIQAS).   I have verified our precision satisfies <10% CV at the 99th percentile. However, the observed bias is a concern.  Have any other Siemens users found similar issues on moving to lot 110? Is EQA performance on other schemes impacted? 



Thanks

Phil



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