Field Evaluation and Impact on Clinical Management of a Rapid Diagnostic Kit That Detects Dengue NS1, IgM and IgG
Field Evaluation and Impact on Clinical Management of a Rapid Diagnostic Kit That Detects Dengue NS1, IgM and IgG
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DOI：
10.1371/journal.pntd.0001993
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发表时间：
2012-12-01
影响因子：
3.8
通讯作者：
Buchy, Philippe
中科院分区：
文献类型：
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作者：
Andries, Anne-Claire;Duong, Veasna;Buchy, Philippe
背景：登革热诊断是复杂的，直到最近，只有专门的实验室才能明确确认登革热感染。快速检测现已商业化，使现场生物诊断成为可能。本研究的目的是评价登革热联合快速检测NS1和IgM/Ig G抗体的方法。这项评估是在现场条件下前瞻性进行的，包括将其用作病例管理的护理点测试的影响的研究，以及对参考实验室中一组特征良好的样本的回顾研究。方法/主要研究结果：在前瞻性研究中，纳入了157名因怀疑登革热而住院的患者。在医院实验室中，NS1/IgM/Ig G联合检测的总体敏感性、特异性、PPV和NPV分别为85.7%、83.9%、95.6%和59.1%，而在柬埔寨巴斯德研究所国家参考实验室中，其敏感性、特异性、PPV和NPV分别为94.4%、90.0%、97.5%和77.1%。这些结果表明，最佳表现需要充分的培训和质量保证。回顾性研究表明，组合试剂盒的敏感性在不同的血清型之间没有显著差异，也不受免疫状况或发烧到采集样本之间的时间间隔的影响。对病历的分析表明，医生没有考虑到快速检测的结果，包括护理管理和抗生素治疗的使用。结论：在我们的前瞻性现场研究背景下，我们论证了如果正确使用SD Bioline Dengue Duo试剂盒，阳性结果高度提示登革热病例，但阴性结果不排除登革热感染。然而，柬埔寨儿科医生在日常工作中依赖于他们的临床诊断，因此获得的假阴性结果不会直接影响临床管理。
Background: Dengue diagnosis is complex and until recently only specialized laboratories were able to definitively confirm dengue infection. Rapid tests are now available commercially making biological diagnosis possible in the field. The aim of this study was to evaluate a combined dengue rapid test for the detection of NS1 and IgM/IgG antibodies. The evaluation was made prospectively in the field conditions and included the study of the impact of its use as a point-of-care test for case management as well as retrospectively against a panel of well-characterized samples in a reference laboratory.Methodology/Principal Findings: During the prospective study, 157 patients hospitalized for a suspicion of dengue were enrolled. In the hospital laboratories, the overall sensitivity, specificity, PPV and NPV of the NS1/IgM/IgG combination tests were 85.7%, 83.9%, 95.6% and 59.1% respectively, whereas they were 94,4%, 90.0%, 97.5% and 77.1% respectively in the national reference laboratory at Institut Pasteur in Cambodia. These results demonstrate that optimal performances require adequate training and quality assurance. The retrospective study showed that the sensitivity of the combined kit did not vary significantly between the serotypes and was not affected by the immune status or by the interval of time between onset of fever and sample collection. The analysis of the medical records indicates that the physicians did not take into consideration the results obtained with the rapid test including for care management and use of antibiotic therapy.Conclusions: In the context of our prospective field study, we demonstrated that if the SD Bioline Dengue Duo kit is correctly used, a positive result highly suggests a dengue case but a negative result doesn't rule out a dengue infection. Nevertheless, Cambodian pediatricians in their daily practice relied on their clinical diagnosis and thus the false negative results obtained did not directly impact on the clinical management.