The MDA has just published an evaluation of 3 POCT HbA1c measurement
devices (MDA 02098) and a further evaluation (of HbA1c measurement on the
Bayer DCA 2000+) in currently in draft. The evaluations cover both
analytical performance and subjective assessment including ease of use.
The 3 devices were:
Glycosal HbA1c from Provalis Diagnostics Ltd.
Nycocard HbA1c Test from Axis-Shield Diagnostics Ltd
A1cNow (formerly DRx, mentioned in Jan’s e-mail) from Chirus Ltd.
Metrika Inc, the manufacturers of the A1cNow, state that they have further
developed their product so that its total imprecision now meets the NGSP
requirements of less than 5% but the product we tested pre-dates these
improvements.
We were unable to assess the Primus PDQ because the company were unable to
provide us with an instrument within the timescale of our evaluations (1
year).
The report is available free to the NHS from the MDA Orders dept on 020
7972 8181,fax: 020 7972 8105, e-mail: dep@medical –devices.gov.uk or check
out the website: www.medical-devices.gov.uk
Wendy Bennitt,
Principal Evaluator,
MDA Evaluation Unit, CCSM,
School of Biomedical & Life Sciences,
University of Surrey
Guildford,
Surrey.
GU2 7XH
Tel: 01483 689207
Fax: 01483 689979
E-Mail : [log in to unmask]
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