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Nano accuracy

P

PFletch

Newbie
Messages
4
Hi all

What sort of level of accuracy should I expect from an Accu-Chek Aviva Nano (about 6 weeks old)?

I did a test this morning, which seemed a bit high at 8.2 so I did another test within one minute - this time, 7.7.

This evening, another two tests - 7.3 and 6.9; this time, I even used the same finger puncture, and the second reading was within a few seconds of the first.

I always wash my hands before testing, so I don't think there is any contamination involved. The strips are brand new, with a years' shelf-life left, and bought from a pharmacy. So I hope, not dodgy strips.

Is this the level of accuracy to be expected ?

Perhaps its a case of you get what you pay for- it was only a tenner on special offer at the local chemist.

Paul Fletcher
 
Hi Paul.

Meter accuracy. We have been here so many times before ? Do a search for meters top right ?

First of all it is good that you wash your hands pre test. You also have to be sure that they are perfectly dry as well. Any moisture will contaminate the results.

All meters are built to a set standard even the cheap ones. Providing when you test the meter with a control solution you get the correct readings you can rely on the meter.

You will never get the same readings twice no matter how soon you test, too many variables such as moisture, heat, blood degradation etc.
Even under Laboratory conditions the meters will often give slightly different figures.

Just stick with one meter and stick with it's results. You won't go far wrong.

Hope that helps.
Ken.
 
Just searched on forums, and as said there are lots of posts - must remember to do that in future !

So, accuracy of +/- 20% is "acceptable" - ie a true value of 8 could give a reading of between 6.4 and 9.6 !!

What's the point of the manufacturers making the display show the result to the nearest 0.1 if they can't even guarantee the whole numbers ? - it just misleads everyone.

That's just blown my test results for the last month if a mouthfull of lettuce can jack the reading up by 3.2.


Mr angry from Slough
Paul Fletcher
 
Accu-Chek Aviva Nano.
This product fulfi lls the requirements of Directive 98/79/EC on in vitro diagnostic medical devices.

This is the link to the EC Directive.
http://www.mhra.gov.uk/Howweregulate/De ... /index.htm
Take it from me it is not easy reading. Page after page after page !

Here is an extract relating to meters etc which shows that any CE marked devices are manufactured to the same standards to be EC Approved.

COMMON TECHNICAL SPECIFICATIONS
For products currently in List A of Annex II conformity assessment may involve the use of “Common Technical Specifications” (CTS) (Commission Decision of 7 May 2002 on common technical specifications for in-vitro diagnostic medical devices (notified under document C (2002) 1344) to establish performance evaluation and re-evaluation criteria, batch release criteria, reference methods and reference materials. CTS are drawn up by an Expert Group convened by the Commission rather than by the Standards Bodies. Manufacturers are expected to comply with the CTS. If they have justified reasons for not doing so they must adopt solutions that they can prove are at least equivalent to the CTS in terms of the above criteria.
As with harmonised standards, Member States must presume compliance with the essential requirements in respect of devices designed and manufactured in conformity with common technical specifications.

Are the Accu-Chek Aviva Nano systems approved for use in clinical settings?
Yes. The Accu-Chek Aviva Nano systems are cleared to test capillary, venous, arterial, and neonatal blood samples.

So they use them in Hospitals and they are all built to the same standards and specific tolerances.

Ken.
 
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