Dear DCA users.
Before I ask the MHRA to intervene, can anyone show recent acceptable comparability between their Lab Method and Siemens DCA 2000 HbA1c using patient samples.
Siemens make no claim as to comparability with any other method. We see a 15 to 20 % neg bias at the target threshold levels vs Lab, so either the DCA or the Lab (Menarini) is wrong.
EQA (as previously stated) doesn’t reveal the difference.
Kind Regards
John
Mr John Shepherd FRCPath | Consultant in Clinical Biochemistry
Blood Sciences, Pathology Dept, Hull and East Yorkshire Hospitals, Anlaby Road, HULL, HU13 2JZ
B 00 44 (0)1482 607707 (direct)
-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of ACB-POCT automatic digest system
Sent: 22 February 2018 11:26
To: [log in to unmask]
Subject: [[SPAM]] - ACB-POCT Digest - 20 Feb 2018 to 22 Feb 2018 - Special issue (#2018-26)
There are 2 messages totaling 10420 lines in this issue.
Topics in this special issue:
1. DCA 2000 HbA1c
2. POCT and Pathology Events
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Date: Thu, 22 Feb 2018 08:40:38 +0000
From: "BAULCH, David (FRIMLEY HEALTH NHS FOUNDATION TRUST)"
<[log in to unmask]>
Subject: Re: DCA 2000 HbA1c
Hi John,
Would it possible to swap the data you have on this?
My email is [log in to unmask]<mailto:[log in to unmask]>
Cheers,
Dave
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of BAULCH, David (FRIMLEY HEALTH NHS FOUNDATION TRUST)
Sent: 16 February 2018 16:38
To: [log in to unmask]
Subject: Re: DCA 2000 HbA1c
We're also seeing this with a routine lot verification, quite a significant negative bias (roughly 10%).
Not sure what the matrix of NEQAS samples are but a positive bias was picked up by Qpoint EQAS too - the matrix here is fresh whole blood.
We will attempt to re-verify the lot (Mon or Tues) but it can't be a coincidence others have picked this up too.
Dave
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of Shepherd, John
Sent: 16 February 2018 16:26
To: [log in to unmask]<mailto:[log in to unmask]>
Subject: DCA 2000 HbA1c
Historically our DCA results are negatively biased when comparing patients with Lab (Menarini). EQA however shows a slight pos bias(NEQAS) Siemens have recalibrated the DCA due to the pos EQA bias and there is now an unacceptable negative bias with patients(Minus 6-8 mmol/mol) - Has anyone else seen this?
Looks like the EQA matrix isn't behaving like patient blood!
Has anyone else re-evaluated following the notice from Siemens?
Many Thanks
John
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Date: Thu, 22 Feb 2018 11:15:18 +0000
From: Nichola Cadwallader <[log in to unmask]>
Subject: POCT and Pathology Events
Hello,
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End of ACB-POCT Digest - 20 Feb 2018 to 22 Feb 2018 - Special issue (#2018-26)
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