登革热诊疗指南(2014年版)

  目的  本研究旨在评估登革热NS1抗原、病毒RNA和IgM抗体检测在登革热病毒感染早期实验室诊断中的应用。  方法  2014年6 — 11月，连续采集广东省疑似登革热患者432份血清样本，所有样本同时进行了4项商用诊断试验，包括NS1 快速诊断试验（RDT）、NS1 酶联免疫吸附试验（ELISA）、实时定量RT-PCR（qRT-PCR）试验和IgM/IgG ELISA试验。  结果  361例（83.6 %）样本被检出登革病毒NS1抗原或病毒RNA或IgM抗体阳性，其中317例（87.8 %）和43例（11.9 %）为原发性和继发性登革热病例。NS1抗原总阳性率最高（358份，82.9 %），其次是病毒RNA（268份，74.3 %）和IgM抗体（179份，49.5 %）。在采集标本时，本研究观察到疾病早期NS1抗原和病毒RNA呈阳性、而IgM抗体是逐渐出现阳性的时间变化。NS1 RDT（97.0 %）和NS1 ELISA试验（98.6 %）对急性期和急性后期标本的敏感性均显著高于qRT-PCR（88.9 %）和IgM-ELISA（59.3 %）试验（P < 0.01）。NS1 RDT和NS1 ELISA的检测结果相似，具有较好的一致性（κ = 0.363，P < 0.001），qRT-PCR对急性期标本的敏感性高于IgM-ELISA（P < 0.01）。  结论  在以原发性感染为主的非登革热疫区国家，应重视高灵敏度的NS1抗原检测。病毒RNA检测对登革热早期诊断仍有价值，而IgM抗体检测最适合作为第5天或第5天以上患者的辅助诊断方法。为了从诊断角度及时做出适当的疫情反应，迫切需要这些信息和进一步的调查。

Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG

  Objectives  To evaluate potential application of serum detections of dengue virus (DENV) nonstructural 1 antigen (NS1), viral RNA, and immunoglobulin M (IgM) antibody in early laboratory diagnosis of dengue virus infection.  Methods  Totally 432 serum specimens were collected consecutively from June to November 2014 from patients clinically suspected with dengue fever in Guangdong province, China. All the specimens were simultaneously detected for NS1 with flow immune chromatographic rapid diagnosis test (RDT) and enzyme-linked immunosorbent assay with (ELISA), viral RNA with real time quantitative polymerase chain reaction (qRT-PCR), and DENV IgM/IgG antibody with ELISA.  Results  Of all the specimens, 361 (83.6%) were positive for one of or more of the three indicators and the indicator with the highest positive rate was DENV NS1 (358, 82.9%), followed by viral RNA (268, 74.3%) and IgM antibody (179, 49.5%). For the all positive specimens, 87.8% (317) and 11.9% (43) were collected from primary and secondary dengue fever patients. For the specimens collected from dengue fever patients in acute or late acute phase, the positive rate of DENV NS1 RDT (97.0%) and ELIZA (98.6%) were significantly higher than that of viral RNA qRT-PCR (88.9%) and IgM antibody ELISA (59.3%) (both P < 0.01). The results of DENV NS1 detection with RDT and ELISA were significantly consistent (κ = 0.363, P < 0.001). For the specimens collected from acute phase patients, the positive rate of viral RNA detection with qRT-PCR was significantly higher than that of IgM antibody detection with ELISA (P < 0.01).  Conclusion  The study results suggest that DENV NS1 antigen detection is highly sensitive in diagnosis of primary dengue fever patients in non-endemic regions; DENV RNA test is of significance in early diagnosis of dengue fever; while, DENV IgM antibody detection is a suitable test for auxiliary diagnosis of dengue fever at or after the 5th day of the incidence.