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

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

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.

结论/意义

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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