Beckmann Christiane, Hirsch Hans H
Division of Infection Diagnostics, Department Biomedicine (Haus Petersplatz), University of Basel, Switzerland.
Division of Infection Diagnostics, Department Biomedicine (Haus Petersplatz), University of Basel, Switzerland; Transplantation & Clinical Virology, Department Biomedicine (Haus Petersplatz), University of Basel, Switzerland; Infectious Disease & Hospital Epidemiology, University Hospital Basel, Basel, Switzerland.
J Clin Virol. 2015 Jun;67:43-6. doi: 10.1016/j.jcv.2015.03.024. Epub 2015 Mar 31.
Rapid diagnosis of influenza is important for controlling outbreaks and starting antiviral therapy. Direct antigen detection (DAD) is rapid, but lacks sensitivity, whereas nucleic acid amplification testing (NAT) is more sensitive, but also more time-consuming.
To evaluate the performance of a rapid isothermal NAT and two DADs.
During February-May 2014, we tested 211 consecutive patients with influenza-like illness using a commercial isothermal NAT (Alere™ Influenza A&B) as well as the DAD Sofia(®) Influenza A+B and BinaxNOW(®) Influenza A&B for detection of influenza-A and -B virus. RespiFinder-22(®) a commercial multiplex NAT served as reference test. Serial 10-fold dilutions of influenza-A and -B cell culture supernatants were examined. Another 225 patient samples were tested during December 2014-February 2015.
Compared to RespiFinder-22(®), the isothermal NAT Alere™ Influenza A&B, and the DAD Sofia(®) Influenza A+B and BinaxNOW(®) Influenza A&B had sensitivities of 77.8%, 59.3% and 29.6%, and specificities of 99.5%, 98.9% and 100%, respectively, for the first 211 patient samples. Alere™ Influenza A&B showed 85.7% sensitivity and 100% specificity in the second cohort. Isothermal NAT was 10-100-fold more sensitive compared to DAD for influenza virus culture supernatants with a lower limit of detection of 5000-50,000 copies/mL. The average turn-around time (TAT) of isothermal NAT and DADs was 15min, but increased to 110min for Alere™ Influenza A&B, 30min for BinaxNOW(®) Influenza A&B, and 45min for Sofia(®) Influenza A+B, when analyzing batches of 6 samples.
Simple sample processing and a TAT of 15min render isothermal NAT Alere™ Influenza A&B suitable for sequential near-patient testing, but the TAT advantage is lost when testing of larger series.
流感的快速诊断对于控制疫情爆发和启动抗病毒治疗至关重要。直接抗原检测（DAD）速度快，但缺乏敏感性，而核酸扩增检测（NAT）更敏感，但耗时也更长。
评估一种快速等温核酸扩增检测和两种直接抗原检测的性能。
在2014年2月至5月期间，我们使用一种商用等温核酸扩增检测（Alere™甲型和乙型流感检测试剂）以及DAD Sofia(®)甲型和乙型流感快速诊断试剂和BinaxNOW(®)甲型和乙型流感快速诊断试剂，对211例连续的流感样疾病患者进行检测，以检测甲型和乙型流感病毒。RespiFinder-22(®)一种商用多重核酸扩增检测作为参考检测。对甲型和乙型流感细胞培养上清液进行10倍系列稀释检测。在2014年12月至2015年2月期间对另外225份患者样本进行了检测。
对于前211例患者样本，与RespiFinder-22(®)相比，等温核酸扩增检测Alere™甲型和乙型流感检测试剂、DAD Sofia(®)甲型和乙型流感快速诊断试剂以及BinaxNOW(®)甲型和乙型流感快速诊断试剂的敏感性分别为77.8%、59.3%和29.6%，特异性分别为99.5%、98.9%和100%。在第二个队列中，Alere™甲型和乙型流感检测试剂显示出85.7%的敏感性和100%的特异性。对于检测下限为5000 - 50000拷贝/毫升的流感病毒培养上清液，等温核酸扩增检测的敏感性比直接抗原检测高10 - 100倍。等温核酸扩增检测和直接抗原检测的平均周转时间（TAT）为15分钟，但在分析6份样本批次时，Alere™甲型和乙型流感检测试剂的周转时间增加到110分钟，BinaxNOW(®)甲型和乙型流感快速诊断试剂为30分钟，Sofia(®)甲型和乙型流感快速诊断试剂为45分钟。
简单的样本处理和15分钟的周转时间使等温核酸扩增检测Alere™甲型和乙型流感检测试剂适用于床边连续检测，但在检测大量样本时周转时间优势丧失。
