Afinion™ 2 Analyzer – HbA1c

SKUP has published a report, SKUP/2021/126, describing the testing of the Afinion™ 2 Analyzer from Abbott Diagnostics Technologies AS.

The Afinion™ 2 Test System is an in vitro diagnostic device for quantitative measurement of Haemoglobin A1c (HbA1c), C-reactive protein (CRP), albumin/creatinine ratio (ACR) and Lipid Panel.
The product is intended for professional use.

The report provides a vendor-independent evaluation of the analytical quality and user-friendliness of the Afinion™ 2 Analyzer for measurement of HbA1c, both when used under optimal conditions by experienced laboratory personnel and under real-life conditions by intended users in primary health care centres.

The HbA1c evaluation was performed in the spring of 2021 at the request of Abbott Rapid Diagnostics GmbH in Germany.

The analytical results and user-friendliness were assessed according to pre-set quality goals.
• The quality goal for precision was fulfilled.
• The quality goal for accuracy was fulfilled.
• The quality goal for user-friendliness was fulfilled

On SKUP’s website you can find the evaluation report.

Here you will also find an overview of ongoing evaluations and published SKUP reports.

SKUP would like to thank Morten Toftagers praksis in Kerteminde, Glamsbjerglægerne in Glamsbjergand Clinical Biochemistry Department at Odense University Hospital and the department of Clinical Biochemistry and Pharmacology, Odense University Hospital in Odense for their great affort in carrying out the practical work of the evaluation.