Yoshida Atsushi, Saito Keiko, Ishii Kenji, Azuma Isao, Sasa Hidenori, Furuya Kenichi
Department of Obstetrics and Gynecology, National Defense Medical College, Tokorozawa, Japan.
Department of Obstetrics and Gynecology, Nishisaitama-Chuo National Hospital, Tokorozawa, Japan.
Med Devices (Auckl). 2014 Jan 15;7:11-6. doi: 10.2147/MDER.S54696. eCollection 2014.
Using the Pronto-7® analyzer, we measured percutaneous hemoglobin (SpHb) noninvasively in pregnant and early postpartum women, and assessed the accuracy of the measurements by comparing them with laboratory measurements of hemoglobin.
We obtained SpHb measurements from 193 pregnant women, 269 early postpartum women, and 76 nonpregnant women. A laboratory total hemoglobin (tHb) measurement, from venous blood sampling, was obtained immediately prior to the SpHb measurement. The total number of measurements obtained from the nonpregnant, pregnant, and postpartum women was 76, 438, and 347, respectively.
The mean biases (SpHb - tHb) among the nonpregnant, first trimester, second trimester, third trimester, and early postpartum women were -0.20, 0.19, 1.01, 1.32, and 1.10 g/dL, respectively. The Bland-Altman comparison showed neither the tendency of a fixed bias nor proportional biases among the measurements in the category of nonpregnant and first trimester women. But in the second and third trimester and postpartum category, a significant fixed bias was noted, without any tendencies of proportional bias.
In this study, we found higher hemoglobin values with the Pronto-7 analyzer than were measured in the laboratory. We consider that the device has certain limitations in obstetrical utility and requires further modifications for use in the perinatal period.
我们使用Pronto-7®分析仪对孕妇和产后早期女性进行了无创经皮血红蛋白(SpHb)测量,并通过与实验室血红蛋白测量结果进行比较来评估测量的准确性。
我们获取了193名孕妇、269名产后早期女性和76名非孕妇的SpHb测量值。在进行SpHb测量前,立即从静脉血样本中获取实验室总血红蛋白(tHb)测量值。从非孕妇、孕妇和产后女性获得的测量总数分别为76、438和347。
非孕妇、孕早期、孕中期、孕晚期和产后早期女性的平均偏差(SpHb - tHb)分别为-0.20、0.19、1.01、1.32和1.10 g/dL。Bland-Altman比较显示,在非孕妇和孕早期女性类别中,测量值之间既没有固定偏差的趋势,也没有比例偏差的趋势。但在孕中期、孕晚期和产后类别中,发现了显著的固定偏差,没有任何比例偏差的趋势。
在本研究中,我们发现使用Pronto-7分析仪测得的血红蛋白值高于实验室测量值。我们认为该设备在产科应用中有一定局限性,需要进一步改进以用于围产期。