Department of Emergency Medicine, College of Medicine, Korea University Guro Hospital, Seoul, Republic of Korea.
Department of Laboratory Medicine, College of Medicine, Korea University Guro Hospital, Seoul, Republic of Korea.
PLoS One. 2019 Mar 13;14(3):e0213451. doi: 10.1371/journal.pone.0213451. eCollection 2019.
Dengue is an increasing public health concern worldwide and requires efficient laboratory diagnostics. We evaluated three commercially available dengue rapid diagnostic tests-the Humasis Dengue Combo NS1 & IgG/IgM (Humasis, Korea), SD Bioline Dengue Duo NS1 Ag & IgG/IgM (SD Bioline, Korea), and CareUS Dengue Combo NS1 and IgM/IgG kits (WellsBio, Korea)-and compared them to reference immunoglobulin M (IgM) or immunoglobulin G (IgG) ELISAs and quantitative reverse transcription polymerase chain reaction (qRT-PCR) assays. In total, 109 dengue-positive samples from children with acute symptomatic dengue and 63 dengue-negative samples from febrile and asymptomatic individuals were collected. For the nonstructural 1 protein (NS1) Ag test, the sensitivity and specificity were in the following order: CareUS (79.82 and 100%), Humasis (63.30 and 100%), and SD Bioline (48.62 and 100%). For IgM and IgG, CareUS had the highest sensitivities and specificities (89.91 and 100%; 82.57 and 100%, respectively), followed by SD Bioline (60.55 and 100%, 77.98 and 100%, respectively), and Humasis (51.38 and 98.21%, 72.48 and 95.24%, respectively). The IgM kits were more sensitive than the NS1 Ag or IgG kits; however, combining NS1 Ag and IgM reduced the number of missed cases. Therefore, the NS1 Ag plus IgM dengue kits increase the accuracy of the results. In our study, the CareUS Dengue Combo NS1 and IgM/IgG kit showed higher accuracy in performance with reference to qRT-PCR and ELISA results.
登革热是一个日益严重的全球公共卫生问题，需要高效的实验室诊断。我们评估了三种市售的登革热快速诊断试剂盒——Humasis Dengue Combo NS1 & IgG/IgM（韩国 Humasis）、SD Bioline Dengue Duo NS1 Ag & IgG/IgM（韩国 SD Bioline）和 CareUS Dengue Combo NS1 和 IgM/IgG 试剂盒（韩国 WellsBio）——并将其与参考免疫球蛋白 M（IgM）或免疫球蛋白 G（IgG）酶联免疫吸附测定（ELISA）和实时荧光定量聚合酶链反应（qRT-PCR）检测进行比较。共收集了 109 份来自患有急性有症状登革热的儿童的登革热阳性样本和 63 份来自发热和无症状个体的登革热阴性样本。对于非结构蛋白 1（NS1）Ag 检测，灵敏度和特异性依次为：CareUS（79.82%和 100%）、Humasis（63.30%和 100%）和 SD Bioline（48.62%和 100%）。对于 IgM 和 IgG，CareUS 的灵敏度和特异性最高（89.91%和 100%；82.57%和 100%），其次是 SD Bioline（60.55%和 100%，77.98%和 100%）和 Humasis（51.38%和 98.21%，72.48%和 95.24%）。IgM 试剂盒比 NS1 Ag 或 IgG 试剂盒更敏感；然而，结合 NS1 Ag 和 IgM 减少了漏诊病例的数量。因此，NS1 Ag 和 IgM 登革热试剂盒提高了结果的准确性。在我们的研究中，CareUS Dengue Combo NS1 和 IgM/IgG 试剂盒在参考 qRT-PCR 和 ELISA 结果时表现出更高的准确性。
