Title:In search of a home-based HbA1c point-of-care testing device that is fit-for-purpose: a non-systematic review

Author:Samarina MA Musaad, Geoffrey CE Herd and Frances Mouat

Abstract:Aims: Lockdown conditions and the potential for misreporting of self-monitored blood glucose levels posed challenges for monitoring outpatient diabetic children. The primary objective was to investigate clinical, analytical and technical performance of handheld point-of-care testing devices for glycated haemoglobin. A secondary objective was to report on a proof-of-concept comparison of HbA1c results for the A1CNow+ (PTS Diagnostics, Indianapolis, USA) and the DCA Vantage bench-top point-of-care testing analyzer (Siemens Healthcare Diagnostics, Germany) used in paediatric outpatient clinics.
Methods: Four databases were interrogated in a non-systematic review of English language literature, and 14 pairs of finger-prick HbA1c results were compared in-house.
Results: Sixteen evaluation studies were reviewed. Most studies omitted important elements of a comprehensive evaluation. Findings were heterogeneous and conflicting. HbA1c results from the A1CNow+ were approximately 80% lower than those from the DCA Vantage in the in-house comparison.
Conclusions: Evidence on the performance of A1CNow+ did not support its use in our paediatric population. Evidence on the performance of a second device, the A1c EZ 2.0 (BioHermes, Wuxi, China), was limited. No studies on other devices were found. Paediatricians need to be aware of the limitations of home-based point of care HbA1c testing for monitoring and decision making. Standardization of reporting of evaluation studies for point-of-care testing and improvement in statistical analyses is needed.
Key Words: Point-of-care testing (POCT), HbA1c, glycated haemoglobin, handheld, home-based, A1CNow+, A1c EZ, telemedicine
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