Dear all,
The following link issued by FDA titled "Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use" may answer most of the questions raised on the systematic approach on POCT glucose meters comparison studies.
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm380325.pdf
Thanks
Mansour
-----Original Message-----
From: ACB Point-of-Care Testing [mailto:[log in to unmask]] On Behalf Of Cambridge Anthony (PLYMOUTH HOSPITALS NHS TRUST)
Sent: 25 September 2015 14:55
To: [log in to unmask]
Subject: Re: Evaluating glucose meters
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Hi Darren
I wouldn't expect that to be the case but I will be looking into it. I would expect to be validating the POCT method against the lab method for the analyte. That would mean establishing the differences between capillary and serum/plasma with regard to each' method in use. What's the use of knowing a capillary blood result for glucose using the lab method when you are never going to be generating patient data in this way? If ISO 15189 states this is required, it will be another case of the standards not adding any worth at all to the service that we provide our patients. Just a time consuming waste of laboratory and POCT personnel time plus the cost.
I would expect to producing a validation report so that clinicians know the statistical differences between the POCT method and the lab method to help management of the patient using both.
Regards
Tony Cambridge
Lead Biomedical Scientist
and POCT Coordinator
T: 01752 792294
E: [log in to unmask]
________________________________________
From: ACB Point-of-Care Testing [[log in to unmask]] On Behalf Of Darren Browne [[log in to unmask]]
Sent: 25 September 2015 11:25
To: [log in to unmask]
Subject: Evaluating glucose meters
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This message was sent from an email address external to NHSmail but gives the appearance of being from an NHSmail (@nhs.net) address. The recipient should verify the sender and content before acting upon information contained within.
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Hi all,
I wondered if any body can share their experiences of evaluating their POCT glucose meters against the laboratory that will satisfy the ISO 15198 or 22870 standard. I am having difficulty with this as there are issues:
1. Sample type - the evaluation should be done on a like for like basis e.g capillary sample (POCT) vs capillary sample (lab). This is difficult to determine on the lab analyser (small sample size).
2. Sample stability issues - only got a short time to analyse sample particularly if it is a capillary sample.
3. Collecting samples across the measuring range of POCT glucose meters e.g <4 mmol/L 4. Ethical approval
Any thoughts or ideas most welcomed.
Regards,
Darren Browne
Point Of Care Manager
Darent Valley Hospital
Pathology department (Level 3)
Darenth Wood Road, Dartford
Kent DA2 8DA
Tel: 01322 428100 x4876
Email: [log in to unmask]
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