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

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 glyc...

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Publicado en:New Zealand Journal of Medical Laboratory Science Vol. 77; no. 2; pp. 59 - 65
Autores principales: Musaad, Samarina M. A., Herd, Geoffrey C. E., Mouat, Frances
Formato: review tables/charts Journal Article
Publicado: New Zealand Institute of Medical Laboratory Science Jul2023
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Jul2023
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      pub: New Zealand Institute of Medical Laboratory Science
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        atl: In search of a home-based HbA1c point-of-care testing device that is fit-for-purpose: a non-systematic review.
      aug:
        au:
          Musaad, Samarina M. A.
          Herd, Geoffrey C. E.
          Mouat, Frances
        affil: Te Whatu Ora Waitemata, New Zealand
      sug:
        subj:
          Glycated Hemoglobin
          Home Diagnostic Tests
          Point-of-Care Testing Equipment and Supplies
          Blood Glucose Self-Monitoring Equipment and Supplies
          Autoanalyzers
          Diabetes Mellitus In Infancy and Childhood
          Equipment Reliability
          Outpatient Service
          Telemedicine
          New Zealand
          Child
          Child: 6-12 years
      ab: 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. HbA1 c results from the A1 CNow+ 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.
      pubtype: Academic Journal
      doctype:
        review
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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