PDF(Pubmed)
Abstract：
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.
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.
摘要：
目的：我们旨在评估用于测量血红蛋白水平的即时护理（POC）设备HemoCue301的准确性和有效性，并检测生活在Tumbes的个体的贫血，一个农村,秘鲁北部服务不足的地区。
方法：一项旨在评估多重强化面包效果的临床试验的基线分析（NCT05103709）。在沿海城市Tumbes招募了毛细血管血HemoCue301读数低于12g/dL的成年女性，秘鲁。共有306名女性参加了这项研究，采集静脉血样本,并用自动血液学分析仪进行分析.血清样本用于测量铁蛋白，血清铁和C反应蛋白。
结果:由Hemocue301测量的毛细管血液相对于自动化Hb具有0.36±0.93g/dL的偏差。根据HemoCue301，超过50％的铁蛋白值正常的女性被归类为狂潮。10.8g/dL[AUC0.82(0.77-0.88)]的自动化Hb截止具有0.817的特异性和0.711的灵敏度,而HemoCue301截止为11.1g/dL[AUC0.71(0.62-0.79)]具有0.697的特异性和0.688的灵敏度。自动化Hb截止的性能显著优于HemoCue(p<0.001)。
结论：使用POC设备时必须谨慎，尤其是阈值附近的值。当没有验证性测试时，我们研究中发现的截止值可以用作替代手段。在诊断育龄妇女缺铁性贫血时，应优先考虑临床结果，以确保正确诊断。
方法：一项旨在评估多重强化面包效果的临床试验的基线分析（NCT05103709）。在沿海城市Tumbes招募了毛细血管血HemoCue301读数低于12g/dL的成年女性，秘鲁。共有306名女性参加了这项研究，采集静脉血样本,并用自动血液学分析仪进行分析.血清样本用于测量铁蛋白，血清铁和C反应蛋白。
结果:由Hemocue301测量的毛细管血液相对于自动化Hb具有0.36±0.93g/dL的偏差。根据HemoCue301，超过50％的铁蛋白值正常的女性被归类为狂潮。10.8g/dL[AUC0.82(0.77-0.88)]的自动化Hb截止具有0.817的特异性和0.711的灵敏度,而HemoCue301截止为11.1g/dL[AUC0.71(0.62-0.79)]具有0.697的特异性和0.688的灵敏度。自动化Hb截止的性能显著优于HemoCue(p<0.001)。
结论：使用POC设备时必须谨慎，尤其是阈值附近的值。当没有验证性测试时，我们研究中发现的截止值可以用作替代手段。在诊断育龄妇女缺铁性贫血时，应优先考虑临床结果，以确保正确诊断。
