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Accuracy validation of the Microlife 3AS1-2 blood pressure device in a pregnant population with low blood pressure

Nathan, Hannah L.; de Greeff, Annemarie; Hezelgrave, Natasha L.; Chappell, Lucy C.; Shennan, Andrew H.

doi: 10.1097/MBP.0000000000000134
Devices and Technology

Objective To assess the accuracy of the Microlife 3AS1-2 blood pressure (BP) device in pregnant women with low BP to investigate suitability for hypotensive detection in low-income and middle-income countries.

Methods A prospective observational study was carried out evaluating the Microlife 3AS1-2, a hand-held, upper-arm, semiautomated BP device, according to British Hypertension Society (BHS) protocol methods. Thirty (stable) pregnant women with a clinical systolic BP less than 100 mmHg and/or diastolic BP less than 60 mmHg were recruited from antenatal wards and clinics and their BP was measured by three trained observers at a district-level hospital in South Africa. Accuracy was assessed according to the BHS grading criteria (A/B=pass) and the ANSI/AAMI/ISO standard for mean difference and SD (≤5±8 mmHg).

Results The device achieved an A/A grade according to the BHS grading criteria. The mean difference±SD between the observer and the test device was 0.5±6.2 and 1.3±5.4 mmHg for systolic and diastolic BP, respectively, fulfilling the standard required by the ANSI/AAMI/ISO protocol. All observer differences were within 4 mmHg.

Conclusion According to the BHS protocol, the Microlife 3AS1-2 BP device is accurate in pregnant women with low BP. The device has been validated previously in pregnancy and pre-eclampsia and also fulfils the criteria of the WHO for use in a low-resource setting. Although unstable women were not included in this validation (for safety and pragmatic reasons), this device could potentially improve the detection of shock secondary to obstetric haemorrhage or sepsis, as well as being used in pre-eclampsia, particularly in low-income and middle-income countries.

Supplemental Digital Content is available in the text.

Women’s Health Academic Centre, King’s College London, St Thomas’ Hospital, London, UK

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's website (www.bpmonitoring.com).

Correspondence to Andrew H. Shennan, MBBS, FRCOG, MD, Women’s Health Academic Centre, King’s College London, 10th Floor, North Wing, St Thomas’ Hospital, London SE1 7EH, UK Tel: +44 020 718 84138; fax: +44 020 762 01227; e-mail: andrew.shennan@kcl.ac.uk

Received August 19, 2014

Received in revised form April 15, 2015

Accepted April 18, 2015

Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.