Nguyen-Khoa Thao, Mine Louis, Allaf Bichr, Ribeil Jean-Antoine, Remus Christelle, Stanislas Aurélie, Gauthereau Valérie, Enouz Sarah, Kim Jason S, Yang Xiaoxi, Gluckman Eliane, Beaudeux Jean-Louis, Munnich Arnold, Girot Robert, Cavazzana Marina
Service de biochimie générale, Hôpital universitaire Necker-Enfants malades, AP-HP, Paris, France.
Unité de dépistage néonatal de la drépanocytose et des hémoglobinopathies, Laboratoire de biochimie hormonologie, Hôpital Robert Debré, AP-HP, Paris, France.
Ann Biol Clin (Paris). 2018 Aug 1;76(4):416-420. doi: 10.1684/abc.2018.1354.
Sickle SCAN™ is a rapid, qualitative, point-of-care lateral flow immunoassay for the identification of AS, AC, SS/Sβthal, SC and CC/Cβthal phenotype. We evaluated this test under the conditions encountered in the French newborn screening (NBS) program for sickle cell disease: a total of 104 dried blood spots (DBSs) were tested with an HPLC reference method and then with the Sickle SCAN™ device. Sickle SCAN™ identified the hemoglobin (Hb) phenotype correctly on 96% of cases. In the four non-concordant cases, the antibody anti-HbS cross-reacted with HbE (n=2), HbD (n=1) or HbX (n=1). There were no false negative. In order to test Sickle SCAN™'s sensitivity to low levels of HbA and HbS in the presence of high HbF levels, we selected another 21 DBS cards with low percentages of HbA (0.6-4.2%) and HbS (2.0-6.9%). HbA and HbS were always detected when present at levels of more than 1% and 2%, respectively. Sickle SCAN™ appears to be an accurate point-of-care method for the identification of newborns with SCD trait. The device meets the criteria for sickle cell disease NBS programs in endemic countries with poor access to laboratory equipment.
镰状细胞检测扫描™（Sickle SCAN™）是一种快速、定性的即时检测侧向流动免疫分析法，用于鉴定AS、AC、SS/Sβ地中海贫血、SC和CC/Cβ地中海贫血表型。我们在法国镰状细胞病新生儿筛查（NBS）项目所遇到的条件下对该检测方法进行了评估：总共104份干血斑（DBS）先用高效液相色谱（HPLC）参考方法进行检测，然后再用镰状细胞检测扫描™设备进行检测。镰状细胞检测扫描™在96%的病例中正确鉴定出了血红蛋白（Hb）表型。在4例不一致的病例中，抗-HbS抗体与HbE（n = 2）、HbD（n = 1）或HbX（n = 1）发生了交叉反应。没有假阴性结果。为了测试镰状细胞检测扫描™在高HbF水平存在时对低水平HbA和HbS的敏感性，我们又选择了另外21张HbA百分比低（0.6 - 4.2%）和HbS百分比低（2.0 - 6.9%）的DBS卡片。当HbA和HbS水平分别超过1%和2%时，总能检测到它们。镰状细胞检测扫描™似乎是一种用于鉴定患有镰状细胞病特征新生儿的准确即时检测方法。该设备符合在难以获得实验室设备的流行国家开展镰状细胞病NBS项目的标准。
