Validation of the Microlife BPA100 Plus device for self-home blood pressure measurement according to the International Protocol

Abstract

Current guidelines recommend that only validated devices for blood pressure measurement should be used. This study presents the validation results of the Microlife BPA100 Plus monitor for self-home blood pressure measurement, according to the European Society of Hypertension International Protocol. Fifteen study participants were included in phase 1 and an additional 18 in phase 2 (total 33). Simultaneous blood pressure measurements were taken by two trained observers (Y tube connected mercury sphygmomanometers) four times, sequentially with three measurements taken using the tested device. Absolute differences between observer and device blood pressure were classified into three zones (within 5, 10 and 15 mmHg). The number of readings with a difference within 5 mmHg was calculated for each individual. In phase 1, the device produced 32, 42 and 43 measurements within 5, 10 and 15 mmHg, respectively, for systolic blood pressure and 31, 45 and 45 for diastolic blood pressure. In phase 2.1, the device produced 71, 87 and 96 measurements within 5, 10 and 15 mmHg, respectively, for systolic blood pressure, and 71, 98 and 99 measurements for diastolic blood pressure. In phase 2.2, 26 participants had at least two of their differences within 5 mmHg and three participants had no differences within 5 mmHg for systolic blood pressure, whereas for diastolic blood pressure 24 and three participants, respectively. Mean systolic blood pressure differences were -2.0+/-6.0 mmHg and diastolic blood pressure differences were -3.1+/-4.1 mmHg. The Microlife BPA100 Plus device for self-home blood pressure measurement comfortably passes the validation requirements of the International Protocol and therefore can be recommended for clinical use in the adult population.