评估两种在撒哈拉以南非洲人群中使用的即时血红蛋白计的准确性：一项横断面研究。

Evaluation of the accuracy of two point-of-care haemoglobin meters used in sub-Saharan African population: a cross-sectional study.

机构信息

Department of Internal Medicine and Paediatrics, Faculty of Health Sciences, University of Buea, Buea, Cameroon.

Health and Human Development (2HD) Research Network, Douala, Cameroon.

出版信息

BMC Cardiovasc Disord. 2020 Mar 5;20(1):111. doi: 10.1186/s12872-020-01371-x.

DOI:10.1186/s12872-020-01371-x

PMID:32138653

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7057498/

Abstract

BACKGROUND

Point-of-care haemoglobin meters are attractive solutions to improve timely diagnosis of anaemia in resource-limited settings. However, concerns regarding the accuracy of these meters may affect their adoption. The accuracy of two hand-held point-of-care haemoglobin meters was evaluated against reference full blood count analyser.

METHODS

This was a hospital-based cross-sectional study conducted at the Douala General hospital, Cameroon. Two handheld haemoglobin meters were assessed: Urit12® (URIT Medical Electronics Co.,Ltd. Guangxi, China) and MissionHb®(ACON Laboratories, Inc., San Diego, USA); against a reference standard CELL-DYN RUBY® (ABBOTT DIAGNOSTICS, Illinois, USA). The Pearson's correlation and Bland-Altman agreement were used to assess the technical accuracy of the meters. Clinical accuracy was evaluated using total error allowable and area under the Receiver Operating Curve. Finally, their agreement with the reference in diagnosing anaemia was assessed using the kappa statistic.

RESULTS

A total of 228 participants were included in the study. The mean haemoglobin values of both haemoglobin meters (MissionHb®: 11.6 ± 2.5 g/dl; Urit12®: 10.9 ± 2.7 g/dl) were significantly higher than the reference value (10.5 ± 2.5 g/dl), p < 0.001 for both meters. Both haemoglobin meters had good correlation with the reference analyser (r = 0.89 and r = 0.90 for Urit12® and MissionHb® respectively) and good agreement on the Bland-Altman plots. However, the MissionHb® meter did not meet the clinical accuracy requirements (p < 0.001). Even though both meters were excellent at identifying the presence of anemia (MissionHb® - AUC = 0.9161, Urit 12® - AUC = 0.9009), they, however, both had weak agreement with the reference analyser in diagnosing the severity of anaemia (K = 0.39 for MissionHb®, p < 0.001 and K = 0.54 for Urit12®, p < 0.001).

CONCLUSION

Although both devices showed technical accuracy with a positive correlation with the reference analyser and were able to accurately diagnose the presence of anemia, both meters however, had sub-optimal agreement with the reference analyser in diagnosing the degree of severity of anaemia among our participants.

摘要

背景

即时检测血红蛋白仪在资源有限的环境中提高贫血即时诊断的吸引力解决方案。然而，对这些仪表准确性的担忧可能会影响它们的采用。评估了两种手持式即时检测血红蛋白仪与参考全血细胞分析仪的准确性。

方法

这是一项在喀麦隆杜阿拉总医院进行的基于医院的横断面研究。评估了两种手持式血红蛋白仪：Urit12®（URIT Medical Electronics Co.，Ltd.，广西，中国）和 MissionHb®（ACON Laboratories，Inc.，圣地亚哥，美国）；与参考标准 CELL-DYN RUBY®（ABBOTT DIAGNOSTICS，伊利诺伊州，美国）进行比较。使用 Pearson 相关和 Bland-Altman 一致性来评估仪表的技术准确性。使用总允许误差和接收器操作曲线下面积评估临床准确性。最后，使用kappa 统计评估它们在诊断贫血方面与参考值的一致性。

结果

共有 228 名参与者纳入研究。两种血红蛋白仪的平均血红蛋白值（MissionHb®：11.6±2.5g/dl；Urit12®：10.9±2.7g/dl）均显著高于参考值（10.5±2.5g/dl），p 值均<0.001。两种血红蛋白仪与参考分析仪均具有良好的相关性（Urit12®和 MissionHb®的 r 值分别为 0.89 和 0.90），Bland-Altman 图上也具有良好的一致性。然而，MissionHb®仪不符合临床准确性要求（p<0.001）。尽管两种仪表在识别贫血的存在方面都非常出色（MissionHb®-AUC=0.9161，Urit12®-AUC=0.9009），但它们在诊断贫血严重程度方面与参考分析仪的一致性均较弱（MissionHb®-K=0.39，p<0.001，Urit12®-K=0.54，p<0.001）。