Browne Sara H, Bernstein Mike, Bickler Philip E
Division of Infectious Diseases and Global Public Health, University of California San Diego, La Jolla, CA, USA.
Specialists in Global Health, Encinitas, CA, USA.
medRxiv. 2021 Feb 18:2021.02.17.21249755. doi: 10.1101/2021.02.17.21249755.
Pulse oximetry is used as an assessment tool to gauge the severity of COVID-19 infection and identify patients at risk of poor outcomes. The pandemic highlights the need for accurate pulse oximetry, particularly at home, as infection rates increase in multiple global regions including the UK, USA and South Africa. Over 100 million Samsung smartphones containing dedicated biosensors (Maxim Integrated Inc, San Jose, CA) and preloaded Apps to perform pulse oximetry, are in use globally. We performed detailed in human hypoxia testing on the Samsung S9 smartphone to determine if this integrated hardware meets full FDA/ISO requirements for clinical pulse oximetry.
The accuracy of integrated pulse oximetry in the Samsung 9 smartphone during stable arterial oxygen saturations (SaO) between 70% and 100% was evaluated in 12 healthy subjects. Inspired oxygen, nitrogen, and carbon dioxide partial pressures were monitored and adjusted via a partial rebreathing circuit to achieve stable target SaO plateaus between 70% and 100%. Arterial blood samples were taken at each plateau and saturation measured on each blood sample using ABL-90FLEX blood gas analyzer. Bias, calculated from smartphone readings minus the corresponding arterial blood sample, was reported as root mean square deviation (RMSD).
The RMSD of the over 257 data points based on blood sample analysis obtained from 12 human volunteers tested was 2.6%.
Evaluation of the smartphone pulse oximeter performance is within requirements of <3.5% RMSD blood oxygen saturation (SpO) value for FDA/ISO clearance for clinical pulse oximetry. This is the first report of smartphone derived pulse oximetry measurements that meet full FDA/ISO accuracy certification requirements. Both Samsung S9 and S10 contain the same integrated pulse oximeter, thus over 100 million smartphones in current global circulation could be used to obtain clinically accurate spot SpO measurements to support at home assessment of COVID-19 patients.
脉搏血氧饱和度测定法用作评估工具，以衡量新型冠状病毒肺炎（COVID-19）感染的严重程度，并识别预后不良风险的患者。这场大流行凸显了对准确脉搏血氧饱和度测定的需求，尤其是在家中，因为在包括英国、美国和南非在内的多个全球地区感染率都在上升。全球有超过1亿部配备专用生物传感器（美信集成产品公司，加利福尼亚州圣何塞）和预加载用于进行脉搏血氧饱和度测定应用程序的三星智能手机在使用。我们对三星S9智能手机进行了详细的人体低氧测试，以确定这种集成硬件是否符合美国食品药品监督管理局（FDA）/国际标准化组织（ISO）对临床脉搏血氧饱和度测定的全部要求。
在12名健康受试者中评估了三星9智能手机在70%至100%的稳定动脉血氧饱和度（SaO）期间集成脉搏血氧饱和度测定的准确性。通过部分再呼吸回路监测和调整吸入氧气、氮气和二氧化碳分压，以在70%至100%之间实现稳定的目标SaO平台期。在每个平台期采集动脉血样，并使用ABL-90FLEX血气分析仪测量每个血样的饱和度。从智能手机读数减去相应动脉血样计算得出的偏差报告为均方根偏差（RMSD）。
基于对12名接受测试的人类志愿者的血样分析获得的超过257个数据点的RMSD为2.6%。
智能手机脉搏血氧仪性能评估在FDA/ISO批准临床脉搏血氧饱和度测定的RMSD血氧饱和度（SpO）值＜3.5%的要求范围内。这是首次关于符合FDA/ISO全部准确性认证要求的智能手机衍生脉搏血氧饱和度测量的报告。三星S9和S10都包含相同的集成脉搏血氧仪，因此目前全球流通的超过1亿部智能手机可用于获得临床准确的即时SpO测量值，以支持对COVID-19患者的家庭评估。
