数字血红蛋白仪作为血红蛋白估测的即时检测设备:来自印度的一项验证研究
Digital Hemoglobinometers as Point-of-Care Testing Devices for Hemoglobin Estimation: A Validation Study from India.
作者信息
Yadav Kapil, Kant Shashi, Ramaswamy Gomathi, Ahamed Farhad, Vohra Kashish
机构信息
National Centre of Excellence and Advanced Research on Anemia Control, Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India.
Centre for Community and Family Medicine, All India Institute of Medical Sciences, Kalyani, West Bengal, India.
出版信息
Indian J Community Med. 2020 Oct-Dec;45(4):506-510. doi: 10.4103/ijcm.IJCM_558_19. Epub 2020 Oct 28.
INTRODUCTION
India has launched Anemia Mukt Bharat (AMB) strategy in 2018, to deal with the high burden of anemia in the country. Point-of-care testing (POCT) of anemia using digital hemoglobinometers and treatment is one of the primary interventions under AMB. This study aimed to determine the diagnostic validity of digital hemoglobinometers (TrueHb and HemoCue 301) for screening of anemia compared to hematology analyzer.
METHODOLOGY
A hospital-based, cross-sectional study was conducted among pregnant women attending antenatal clinics of a selected primary health center and subdivisional hospital of Haryana, India, during January 2019. Hemoglobin (Hb) levels of the pregnant women were estimated in digital hemoglobinometers using capillary blood samples and hematology analyzer using venous blood samples. Bias, limits of agreement (LOA), and validity of digital hemoglobinometers were assessed against a hematology analyzer.
RESULTS
A total of 110 pregnant women were included. Bias (LOA) in Hb values estimated using digital hemoglobinometers was -0.09 g/dL (-1.97 to 1.80 ) for HemoCue301 and -0.04 g/dL (-1.69 to 1.60) for TrueHb compared to the hematology analyzer. HemoCue 301 (sensitivity: 86% and specificity: 83%) had relatively higher sensitivity and specificity compared to TrueHb (sensitivity: 78.9% and specificity: 81%).
CONCLUSIONS
Digital hemoglobinometers have high sensitivity and specificity. Thus, these can be a potential POCTs for screening of anemia in peripheral health facilities. Further studies are required to establish the validity of the digital hemoglobinometers at community settings.
引言
印度于2018年推出了“无贫血印度”(AMB)战略,以应对该国贫血症的高负担问题。使用数字血红蛋白仪进行贫血的即时检测(POCT)和治疗是AMB的主要干预措施之一。本研究旨在确定与血液分析仪相比,数字血红蛋白仪(TrueHb和HemoCue 301)用于贫血筛查的诊断有效性。
方法
2019年1月,在印度哈里亚纳邦选定的初级卫生中心和分区医院的产前诊所就诊的孕妇中进行了一项基于医院的横断面研究。使用毛细血管血样在数字血红蛋白仪中估计孕妇的血红蛋白(Hb)水平,并使用静脉血样在血液分析仪中进行检测。以血液分析仪为对照,评估数字血红蛋白仪的偏差、一致性界限(LOA)和有效性。
结果
共纳入110名孕妇。与血液分析仪相比,使用HemoCue301数字血红蛋白仪估计的Hb值偏差(LOA)为-0.09 g/dL(-1.97至1.80),TrueHb为-0.04 g/dL(-1.69至1.60)。与TrueHb(灵敏度:78.9%,特异性:81%)相比,HemoCue 301(灵敏度:86%,特异性:83%)具有相对较高的灵敏度和特异性。
结论
数字血红蛋白仪具有较高的灵敏度和特异性。因此,这些可以成为外周卫生设施中贫血筛查的潜在即时检测工具。需要进一步研究以确定数字血红蛋白仪在社区环境中的有效性。
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