Department of Biochemistry, Division of Life Science, Chungbuk National University, Cheongju, Chungbuk 361-763, Republic of Korea.
Virol J. 2010 Sep 20;7:244. doi: 10.1186/1743-422X-7-244.
This study evaluated the clinical accuracy and analytical sensitivity of the NanoSign® Influenza A/B antigen kit in detecting 2009 pandemic influenza A/H1N1 viruses. The kit is one of the most popular rapid diagnostic tests for detecting influenza in Republic of Korea.
The NanoSign® Influenza A/B kit resulted in 79.4% sensitivity and 97.2% specificity compared to RT-PCR in the detection of the viruses from 1,023 specimens. In addition, the kit was able to detect two strains of novel influenza viruses, Influenza A/California/12/2009(H1N1) and clinically isolated wild-type novel influenza A/H1N1, both of which are spreading epidemically throughout the world. In addition, the correlation between NanoSign® Influenza A/B test and conventional RT-PCR was approximately 94%, indicating a high concordance rate. Analytical sensitivity of the kit was approximately 73 ± 3.65 ng/mL of the purified viral proteins and 1.13 ± 0.11 hemagglutination units for the cultured virus.
As the NanoSign® Influenza A/B kit showed relatively high sensitivity and specificity and the good correlation with RT-PCR, it will be very useful in the early control of influenza infection and in helping physicians in making early treatment decisions.
本研究评估了 NanoSign® 流感 A/B 抗原试剂盒在检测 2009 年甲型 H1N1 流感病毒方面的临床准确性和分析灵敏度。该试剂盒是韩国最受欢迎的用于检测流感的快速诊断检测试剂盒之一。
与 RT-PCR 相比，NanoSign® 流感 A/B 试剂盒在检测来自 1023 份标本的病毒时，灵敏度为 79.4%，特异性为 97.2%。此外，该试剂盒能够检测到两种新型流感病毒，即甲型流感病毒/加利福尼亚/12/2009（H1N1）和临床分离的野生型新型甲型 H1N1，这两种病毒在全球范围内都在流行。此外，NanoSign® 流感 A/B 检测与常规 RT-PCR 的相关性约为 94%，表明具有较高的一致性。该试剂盒的分析灵敏度约为 73±3.65ng/ml 的纯化病毒蛋白和 1.13±0.11 血凝单位的培养病毒。
由于 NanoSign® 流感 A/B 试剂盒显示出相对较高的灵敏度和特异性，以及与 RT-PCR 的良好相关性，它将非常有助于流感感染的早期控制，并帮助医生做出早期治疗决策。
