Systematic Review: Professional-Use Glucometers Meet ISO 15197 Accuracy Standards, but Home-Use Devices Fall Short
A meta-analysis of 30 studies covering 56 point-of-care glucose devices and 4,918 participants found that professional-use glucometers met ISO 15197 accuracy criteria with pooled results above 98% within acceptable limits, while home-use devices achieved only 87-89%. Professional devices also showed superior analytical linearity (correlation 0.988 vs 0.930), underscoring the performance gap that affects diabetic management decisions.
The original study
Assessment of accuracy, clinical validity, and analytical linearity in point-of-care glucose monitoring devices for diabetes mellitus: A systematic review and meta-analysis.
- Authors
- Ukpe MP, Ezeanuka AC
- Journal
- Clinical biochemistry
- Type
- Journal Article, Systematic Review, Meta-Analysis
- PMID
- 40086777
Original abstract
Point-of-care technology (POCT) is utilized in diabetes management due to its fast turnaround time. However, the accuracy and reliability of its results are of concern. This review aims to evaluate the (i) accuracy, (ii) clinical validity and (iii) linearity of POCT for blood glucose concentration following ISO 15197. The study was conducted following the PRISMA framework. Searches with the search term "point of care test" OR "POCT" AND "Accuracy" AND "glucose" were made on Scopus, PubMed, DOAJ, and Cochrane Library. Quality assessments were performed using the QUADAS-2 tool. Proportion and Coefficient meta-analyses were used. Recent studies (2019-2023) evaluating the accuracy of POC devices in blood glucose estimation were included. 4918 participants and 56 POC brands were identified from the 30 included studies. The pooled percentage of POCT results within ±15 mg/dL (±0.83 mmol/L) for glucose concentrations <100 mg/dL (<5.6 mmol/L) was 98.83 % (95 % CI: 96.52-99.92) for professional use and 87.70 % (95 % CI: 62.65-99.65) for home-use glucometers. For glucose concentrations ≥100 mg/dL (≥5.6 mmol/L), the pooled percentages were 98.59 % (95 % CI: 95.90-99.88) and 88.79 % (95 % CI: 67.35-99.44), respectively. Measurements in zones A and B of the consensus error grid analysis were 98.06 % (95 % CI: 94.59-99.80) for professional-use and 98.70 % (95 % CI: 95.85-99.95) for home-use glucometers. The pooled correlation coefficient for professional-use glucometers was 0.988 (95 % CI: 0.980-0.993) while home-use was 0.930 (95 % CI: 0.869-0.963). While professional-use glucometers met ISO 15197 accuracy criteria but not clinical validity standards, home-use devices failed to meet both accuracy and clinical validity criteria. Professional-use glucometers demonstrated superior accuracy compared to home-use glucometers. Based on the variability in analytical performance of POC devices, it is recommended that proper care be taken when selecting POCT devices for optimal use in diabetic management.