Abstract
BackgroundPoint-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.MethodsThis 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.ResultsA 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).ConclusionAlthough 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.
Highlights
Point-of-care haemoglobin meters are attractive solutions to improve timely diagnosis of anaemia in resource-limited settings
We aimed to evaluate the technical and clinical accuracy of two POC haemoglobin meters and their agreement with a reference analyser in diagnosing anaemia in the African setting
In our study we noticed a positive and significant correlation between each haemoglobin meter and the reference analyser (r = 0.90 for MissionHb® and r = 0.89 for Urit12®). Both devices did not meet clinical accuracy requirements using total error allowable. Both meters significantly overestimated haemoglobin values and both had a weak agreement with the reference analyser in diagnosing the presence and severity of anaemia among our participants
Summary
Point-of-care haemoglobin meters are attractive solutions to improve timely diagnosis of anaemia in resource-limited settings. Anaemia constitutes a major global public health problem. It currently affects two billion people (32.9% of the world’s population) [1]. It is disproportionately concentrated in developing nations where it is four times more prevalent than in developed world [2]. Anaemia is associated with major health consequences including decreased wellbeing, fatigue, lethargy, impaired physical activity and work performance [4]. In children it is associated with increased mortality and decreased cognitive and physical development [5, 6]. In pregnant women it is associated with low-birth weights, increased risk of maternal and perinatal mortality [7]
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