Challenges in Hb A1c Point-of-Care Testing: Only 5 of 19 Hb A1c Point-of-Care Devices Meet IFCC and NGSP Certification Criteria on Independent Evaluation

This study shows the importance of independent evaluations for assessing the performance of Hb A1c POC devices. The analytical performance of the devices was very poor overall, with 74% not meeting both IFCC and NGSP criteria. These evaluations were performed under ideal conditions; performance may worsen further when used in a clinical setting.

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Publication Details

Journal
Clinical Chemistry
Published
2025-05-26
DOI
https://doi.org/10.1093/clinchem/hvaf059
Primary Topic
Diabetes Management and Research
Type
article
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0.00
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article

Challenges in Hb A1c Point-of-Care Testing: Only 5 of 19 Hb A1c Point-of-Care Devices Meet IFCC and NGSP Certification Criteria on Independent Evaluation

Beatrice Vetter, Emma English, Erna Lenters‐Westra, Priyanka Singh
Clinical Chemistry
Diabetes Management and Research
article

Challenges in Hb A1c Point-of-Care Testing: Only 5 of 19 Hb A1c Point-of-Care Devices Meet IFCC and NGSP Certification Criteria on Independent Evaluation

Beatrice Vetter, Emma English, Erna Lenters‐Westra, Priyanka Singh
article en

Abstract

This study shows the importance of independent evaluations for assessing the performance of Hb A1c POC devices. The analytical performance of the devices was very poor overall, with 74% not meeting both IFCC and NGSP criteria. These evaluations were performed under ideal conditions; performance may worsen further when used in a clinical setting.

Clinical ChemistryVol. 71(7)
FIND (CH), University of Cambridge (GB), Isala (NL)
No poverty
Openalex Percentile: Top 83%
Diabetes Management and Research
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