Validation of the Measurement Accuracy of the CONTEC ABPM50 Ambulatory Blood Pressure Monitor according to the International Protocol of the European Society of Hypertension ESH-IP 2010 protocol in a resource-limited healthcare setting

Objective : The aim of the present study was to validate the ambulatory blood pressure monitoring device CONTEC ABPM50 according to the International Protocol revision 2010 of the European Society of Hypertension (ESH-IP 2010) in a Venezuelan adult population. Patients and Methods: In 39 adult participants aged 25-82 years, blood pressure measurements were performed alternately via the CONTEC ABPM50 and a reference mercury sphygmomanometer according to the ESH-IP 2010 guidelines. A total of 117 paired comparisons were included for analysis. The measurements covered all required blood pressure ranges and were performed by two blinded observers. Results : The absolute differences between the test device and the reference were within 5 mmHg in 114 of 117 comparisons (97.4%) for systolic blood pressure (SBP) and 116 of 117 (99.1%) for diastolic blood pressure (DBP). The mean ± SD difference between CONTEC ABPM50 and the mercury sphygmomanometer was 0.24 ±3.54 mmHg for SBP and −0.85 ±3.32 mmHg for DBP. Bland–Altman analysis showed a mean bias of −0.18 mmHg for systolic blood pressure (SBP) with 95% limits of agreement from −5.96 to +4.60 mmHg, and a mean bias of +1.17 mmHg for diastolic blood pressure (DBP) with 95% limits of agreement from −3.69 to +6.04 mmHg. The device met all the criteria specified in parts 1 and 2 of the ESH-IP 2010 protocol. Conclusion : The CONTEC ABPM50 met the static accuracy requirements of the ESH-IP 2010. While this study validates the device’s measurement module under controlled conditions, further research is needed to evaluate its performance during dynamic ambulatory activities and nocturnal periods.