Accuracy of PoCT devices for glycated hemoglobin in outpatient settings: a scoping review

Abstract Background Early screening for type 2 diabetes mellitus is a global public health priority. Point-of-care testing (PoCT) technologies offer a promising alternative to diagnosis and monitoring of metabolic risk. However, it is essential to assess the accuracy of these devices compared to golden standart methods. Objectives To map the diagnostic accuracy of PoCT devices for HbA1c used in outpatient settings. Methods Scoping review conducted according to JBI and PRISMA-ScR guidelines. Searches were performed in PubMed, Scopus, Embase, Web of Science, Lilacs, and CINAHL. We included studies published until April 2025. Eligible studies involved adults (≥18 years) and evaluated PoCT devices for HbA1c using capillary blood for diabetes screening or diagnosis, conducted in outpatient clinical settings, with no restrictions on language or publication year. Excluded studies were those using only venous blood, those evaluating capillary glucose, glucometers, or continuous glucose monitoring systems. Results We analysed 17 studies measuring accuracy of PoCT devices for HbA1c. Devices from 10 different brands and one prototype were identified. Sensitivity ranged from 50% to 100%, with a median of 87.5%; specificity median was 84.4% (43.5% - 97.3%). Observed advantages included fast result time (5-9 minutes), ease of use, portability, low cost, and good correlation with laboratory methods. Limitations included lower precision at HbA1c extremes and reduced sensitivity in low-income populations. Conclusions PoCT devices for HbA1c are practical, specific, and sensitive tools for rapid screening of glycemic risk, especially useful in settings with limited access to laboratory services. When used strategically, these devices may support early detection and help reduce inequalities in diabetes monitoring and diagnosis. More studies conducted in low-income countries are essential, given their potential to positively impact healthcare delivery for vulnerable populations. Key messages • Using PoCT technologies for diabetes screening may offer an effective and accessible alternative to expand early diagnosis. • Adopting PoCT technologies can help overcome structural barriers in healthcare and reduce disparities in diabetes diagnosis, especially in vulnerable populations.