Clinical validation of MESI mTABLET BP according to ISO 81060-2:2018 + A1 + A2.

OBJECTIVE: The objective of this study was to clinically validate the MESI mTABLET BP device in accordance with the protocol outlined in ISO 81060-2:2018 + A1 + A2. METHODS: A total of 127 adult participants were enrolled, of whom 36 were excluded. The final study sample consisted of 91 participants with upper arm circumferences ranging from 22 to 50 cm. Blood pressure measurements obtained with the MESI mTABLET BP were compared with reference auscultatory measurements performed simultaneously by two trained observers. A same-arm sequential method was used, in which each MESI mTABLET BP measurement was compared against the average of the preceding and subsequent reference measurements. The study was approved by the National Medical Ethics Committee of the Republic of Slovenia. RESULTS: The mean blood pressure difference between MESI mTABLET BP and the reference auscultatory method was 1.6 ± 4.3 mmHg for SBP and 1.9 ± 5.1 mmHg for DBP; hence, criterion 1 from the standard was fulfilled (required |mean| ≤5.00, SD ≤8.00 mmHg). Criterion 2 was also met, as the SD of average paired determinations per participant was ±3.56 mmHg for SBP and ±4.66 mmHg for DBP (required ≤6.76 and ≤6.68 mmHg, respectively). CONCLUSION: The MESI mTABLET BP demonstrated clinical accuracy and reliability, and can hence be recommended for use in clinical and primary care settings in adult populations with upper arm circumferences between 22 and 50 cm, as validated in the present study.