Unidad de Conocimiento y Evidencia (CONEVID), Universidad Peruana Cayetano Heredia, Lima, Perú.
Centro de Salud Global, Tumbes, Peru.
PLoS One. 2023 Nov 14;18(11):e0293984. doi: 10.1371/journal.pone.0293984. eCollection 2023.
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.
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.
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).
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.
我们旨在评估 HemoCue 301 作为一种即时检测(POC)设备用于测量血红蛋白水平和检测秘鲁北部通贝斯(Tumbes)农村欠发达地区个体贫血症的准确性和有效性。
对一项评估多强化面包效果的临床试验进行基线分析(NCT05103709)。从秘鲁沿海城市通贝斯招募毛细血管 HemoCue 301 读数低于 12 g/dL 的成年女性。共有 306 名女性参与了该研究,采集静脉血样本并使用自动血液分析仪进行分析。采集血清样本用于测量铁蛋白、血清铁和 C 反应蛋白。
HemoCue 301 测量的毛细血管血与自动 Hb 相比有 0.36 ± 0.93 g/dL 的偏差。根据 HemoCue 301,超过 50%铁蛋白正常的女性被归类为贫血。自动 Hb 截断值为 10.8 g/dL [AUC 0.82(0.77-0.88)],特异性为 0.817,敏感性为 0.711,而 HemoCue 301 截断值为 11.1 g/dL [AUC 0.71(0.62-0.79)],特异性为 0.697,敏感性为 0.688。自动 Hb 截断值的性能明显优于 HemoCue(p<0.001)。
在使用 POCT 设备时需谨慎,特别是在接近阈值的情况下。在我们的研究中发现的截断值可作为没有确认性检测时的替代手段。在诊断育龄期妇女缺铁性贫血时,应优先考虑临床结果,以确保正确诊断。