Accuracy of HemoCue301 portable hemoglobin analyzer for anemia screening in capillary blood from women of reproductive age in a deprived region of Northern Peru: An on-field study

Abstract

Objective We aim to assess the accuracy and effectiveness of the HemoCue 301, a point-of-care (POC) device for measuring hemoglobin levels, and detecting anemia among individuals living in Tumbes, a rural, underserved area in Northern Peru. Methods Baseline analysis of a clinical trial aimed at assessing the effect of multi-fortified bread (NCT05103709). Adult women with capillary blood HemoCue 301 readings below 12 g/dL were recruited in coastal city of Tumbes, Peru. A total of 306 women took part of the study, venous blood samples were taken and analyzed with an automated hematology analyzer. Serum samples were used to measure ferritin, serum iron and C reactive protein. Results Capillary blood measured by the Hemocue 301 has a bias of 0.36 ± 0.93 g/dL respect to the automated Hb. More than 50% of women with normal ferritin values were classified as anemics according to the HemoCue 301. Automated Hb cut-off of 10.8 g/dL [AUC 0.82 (0.77–0.88)] had a specificity of 0.817 and a sensitivity 0.711 while with the HemoCue 301 cut-off of 11.1 g/dL [AUC 0.71 (0.62–0.79)] had a specificity of 0.697 and a sensitivity 0.688. The performance of the automated Hb cut-off was significantly better than the HemoCue (p<0.001). Conclusion Caution must be taken when using POC devices, especially with values around the threshold. Cut-off values found in our study could be used as surrogate means when no confirmatory tests are available. Clinical outcomes should be prioritized when diagnosing iron deficiency anemia in women of reproductive age to ensure proper diagnosis.