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

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.

Difference in Hemoglobin Value Between Prick Test and Venous Puncture: Implication of Iron Supplementation in Pregnant Women in Primary Health Care, Bengkulu, Indonesia

“…The use of hemoglobin meters in resource limited settings might offer enormous advantages compared to a reference analyser. But extreme caution and clinical judgment are imperative to complement their use (Choukem et al, 2020). HB meter is a digital multicheck medical device that is used to measure hemoglobin where its use is accurate, does not hurt, anytime and anywhere can be done.…”

Use of point‐of‐care haemoglobin tests to diagnose childhood anaemia in low‐ and middle‐income countries: A systematic review

“…No POC(Hb) T showed excellent diagnostic accuracy across all measurements and therefore may not meet all ASSURED criteria [12]. Five studies reported overestimation of Hb concentration in eight POC(Hb)Ts (Table 2) [15,29,32,49,58]. This is vital since it could result in misclassification of severity of anaemia and therefore prevent truly eligible children from receiving a lifesaving transfusion or appropriate treatment.…”

“…Thirteen studies (32%) reported challenges to POC(Hb)T use [13,15,19,29,31,32,47,49,50,54,55,58,60]. Overestimation of Hb concentration (n = 5) and errors in sampling and environmental factors (n = 5) were the most frequently reported challenges.…”

“…Diagnostic accuracy data were available for 10 POC(Hb) Ts in 11 of 14 diagnostic studies (Table 3) [15,19,29,31,47,49,54,55,58,60,63]. Accuracy data were not extracted in three studies due to pooled data with adults and children (n = 2) and use of a non Hb-measuring tool (n = 1) [32,50,62]. Five studies reported accuracy results were clinically unacceptable (Table 2) [15,29,31,32,49].…”

“…Age ranged from 0 to 20 years. Only six studies included older children (>15 years) (15%)[32,35,50,51,54,60]. One study did not report specific age of included children[47].…”