Indonesia is a developing country with the seventh largest population of diabetic patients in the world. HbA1c examination is the key to establishing a diagnosis as well as managing diabetes mellitus. There are obstacles in this examination, such as not all places have these facilities and the relatively high examination costs. Examination Hba1c Point of Care Testing (POCT) is one alternative to address this problem. A study is needed to measure the accuracy of this examination with a standard examination
Cross-sectional observational study involving three Primary Health Care Centres (PHC). Subjects were taken by consecutive sampling method from participants in the Chronic Disease Management Program (PROLANIS) who came to PHC, both patients with type 2 diabetes mellitus (DMT2) and those without DMT2. Subjects were subjected to capillary blood examination for HbA1c POCT examination using the Tri-stat HbA1c as well as venous blood for HbA1c examination according to the standards of the National Glycohemoglobin Standardization Program (NGSP) using Premier Hb9210 equipment. The results of the examination were grouped into groups that were HbA1c <5.7%, groups that were HbA1c ≥ 6.5% and groups with HbA1c levels ≤ 7
Three hundred thirty-eight subjects participated in this study. Five subjects were excluded because of anemia, so there were 333 subjects consisting of 133 men (39.7%) and 200 women (60.3%). The average age of subjects was 63 years (25-75). The mean HbA1c POCT was 7.24% ± 2.15, while the mean HbA1C with the standard method was 7.78% ± 2.34 (P<0.001). Correlation tests showed a very strong positive correlation (r = 0.916) between the two tested devices. The accuracy of HbA1c POCT for HbA1c levels <5.7% was 82.5% with sensitivity of 83.1% and specificity of 75%. The accuracy of HbA1c POCT for HbA1c levels ≥ 6.5% was 87.1% with a sensitivity of 83.1% and a specificity of 75%. The accuracy of HbA1c POCT for HbA1c level ≤ 7% was 88.8% with sensitivity of 79.1% and specificity of 98.8%.
Results of this study indicate that the use of POCT HbA1c examination has a fairly good accuracy (> 80%) with a correlation coefficient (R) 0.916. This is similar to a study conducted by Sujaytha et al and a study conducted by Wiwanitkit et al., And a study conducted by Sicard et al and Knaebell et al.
Conclusion : The results of this study show good accuracy of the use of HbA1c POCT for HbA1c <5.7%, ≥ 6.5% and ≤ 7%. This can be the basis for considering its use in PHC as part of the management of T2DM. However, it is always necessary to understand the limitations in using all diagnostic tools to avoid misinterpretation of results.
Rulli Rosandi– Staff Endocrine Metabolic and Diabetes Division, Dr Saiful Anwar - Fakultas Kedokteran Universitas Brawijaya Malang Indonesia, Malang, Indonesia
Achmad Rudijanto– Staff of Endocrine Metabolic and Diabetes Division, Fakultas Kedokteran Universitas Brawijaya Malang Indonesia
Staff Endocrine Metabolic and Diabetes Division
Dr Saiful Anwar - Fakultas Kedokteran Universitas Brawijaya Malang Indonesia
I was born in Banda Aceh, 12 September 1977. Graduated from Medical degree at Brawijaya University in 2002, Internal Medicine in 2009 and as an Endocrinologist since 2018. Currently, I works as an Endocrine metabolic and diabetes division staff in internal Medicine Departement Saiful Anwar Hospital – Fakultas Kedokteran Universitas Brawijaya Malang. Some training and workshop that he participated in included Osteoporosis workshop, Good Clinical Practice workshop, Radiology Master Class for thyroid disease, Head and Neck Ultrasound course. I am also actives in some various organization such as PERKENI (Perkumpulan Endokrinologi Indonesia), PERSADIA (Persatuan Diabetes Indonesia) and also AACE (American Association of Clinical Endocrinology).
Staff of Endocrine Metabolic and Diabetes Division
Fakultas Kedokteran Universitas Brawijaya Malang Indonesia
I am a professor of endocrine-metabolic and diabetes from Fakultas Kedokteran Universitas Brawijaya. I previously served as chairman of Indonesia Society of Endocrinology (2012-2018).