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登革热NS1抗原检测方法对急性登革热病毒感染诊断的敏感性和特异性的评估

Currently, no dengue NS1 detection kit has regulatory approval for the diagnosis of acute dengue fever. Here we report the sensitivity and specificity of the InBios DEN Detect NS1 ELISA using a panel of well characterized human acute fever serum specimens.

当前，没有登革热NS1检测试剂盒具有诊断急性登革热的法规批准。在这里，我们使用一组特征明确的人急性发热血清标本报告了InBios DEN Detect NS1 ELISA的敏感性和特异性。

The InBios DENV Detect NS1 ELISA was tested using a panel composed of 334 serum specimens collected from acute febrile patients seeking care in a Bangkok hospital in 2010 and 2011. Of these patients, 314 were found to have acute dengue by either RT-PCR and/or anti-dengue IgM/IgG ELISA. Alongside the InBios NS1 ELISA kit, we compared the performance characteristics of the BioRad Platelia NS1 antigen kit. The InBios NS1 ELISA Ag kit had a higher overall sensitivity (86% vs 72.8%) but equal specificity (100%) compared to the BioRad Platelia kit. The serological status of the patient significantly influenced the outcome. In primary infections, the InBios NS1 kit demonstrated a higher sensitivity (98.8%) than in secondary infections (83.5%). We found significant variation in the sensitivity of the InBios NS1 ELISA kit depending on the serotype of the dengue virus and also found decreasing sensitivity the longer after the onset of illness, showing 100% sensitivity early during illness, but dropping below 50% by Day 7.

InBios DENV Detect NS1 ELISA使用一组由334份血清样本组成的小组进行了测试，这些样本于2010年和2011年在曼谷一家医院的急症患者中进行了护理。在这些患者中，有314例通过RT-PCR和/或发现患有登革热或抗登革热IgM / IgG ELISA。除了InBios NS1 ELISA试剂盒，我们还比较了BioRad Platelia NS1抗原试剂盒的性能特征。与BioRad Platelia试剂盒相比，InBios NS1 ELISA Ag试剂盒具有更高的总体灵敏度（86％比72.8％），但特异性相同（100％）。患者的血清状况显着影响结果。在原发感染中，InBios NS1试剂盒的敏感性（98.8％）比继发感染（83.5％）更高。我们发现，根据登革热病毒的血清型，InBios NS1 ELISA试剂盒的敏感性存在显着差异，并且还发现发病后时间越长，敏感性降低的程度越小，发病初期显示100％的敏感性，但到第7天降至50％以下。

结论/意义

The InBios NS1 ELISA kit demonstrated high accuracy when compared to the initial clinical diagnosis with greater than 85% agreement when patients were clinically diagnosed with dengue illness. Results presented here suggest the accurate detection of circulating dengue NS1 by the InBios DENV Detect NS1 ELISA can provide clinicians with a useful tool for diagnosis of early dengue infections.

与最初的临床诊断相比，InBios NS1 ELISA试剂盒具有很高的准确性，当临床诊断出患有登革热疾病时，一致性超过85％。此处显示的结果表明，通过InBios DENV Detect NS1 ELISA可以准确检测循环登革热NS1，可以为临床医生提供诊断早期登革热感染的有用工具。

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