使用成人鼻咽拭子样本检测流感时，实时荧光定量PCR cobas Liat甲型/乙型流感检测法及Alere i甲型/乙型流感NEAR等温核酸扩增检测法的诊断准确性。
Diagnostic accuracy of the real-time PCR cobas Liat Influenza A/B assay and the Alere i Influenza A&B NEAR isothermal nucleic acid amplification assay for the detection of influenza using adult nasopharyngeal specimens.
作者信息
Young Stephen, Illescas Patrick, Nicasio Joclin, Sickler Joanna Jackson
机构信息
TriCore Reference Laboratories, Albuquerque, NM, USA.
TriCore Reference Laboratories, Albuquerque, NM, USA.
出版信息
J Clin Virol. 2017 Sep;94:86-90. doi: 10.1016/j.jcv.2017.07.012. Epub 2017 Jul 26.
BACKGROUND
Accurate detection of influenza requires diagnostic testing; however, methods such as RADTs and central laboratory-based tests are limited by low sensitivity and time constraints, respectively.
OBJECTIVE
To compare the performances of the cobas Liat Influenza A/B and Alere™ i Influenza A&B point-of-care (POC) assays for detecting influenza A and B viruses using fresh nasopharyngeal specimens with the GenMark Dx Respiratory Viral Panel as the reference method, a FDA cleared IVD PCR test.
STUDY DESIGN
A total of 87 samples collected in viral transport medium from adults ≥18 years of age were re-tested on both POC assays (based on the reference PCR method, 29 were influenza A and 18 were influenza B virus positive).
RESULTS
The overall sensitivity and specificity of the cobas Influenza A/B for the detection of influenza A and B relative to reference PCR was 97.9% (95% confidence interval [CI] 88.9%, 99.6%) and 97.5% (95% CI: 87.1%, 99.6%), respectively, while the sensitivity of the Alere i Influenza A&B assay relative to the reference PCR method was 63.8% (95% CI: 49.5%, 76.0%) and the specificity was 97.5% (95% CI: 87.1%, 99.6%). The individual sensitivities and specificities of the cobas Influenza A/B assay for influenza A alone and influenza B alone were comparable to those of the reference PCR method (influenza A: sensitivity of 100% [95% CI: 88.3%, 100.0%] and specificity of 98.3% [95% CI: 90.9%, 99.7%]; influenza B: sensitivity of 94.4% [95% CI: 74.2%, 99.0%] and specificity of 100% [95% CI: 94.7%, 100.0%]). For the Alere i Influenza A&B assay, the individual specificities for influenza A and B were comparable to those of the reference PCR method (98.3% [95% CI: 90.9%, 99.7%] and 97.1% [95% CI: 90.0%, 99.2%], respectively), while the individual sensitivities were low relative to reference PCR (55.2% [95% CI: 37.5%, 71.6%] and 72.2% [95% CI: 49.1%, 87.5%], respectively).
CONCLUSION
The cobas Influenza A/B assay demonstrated performance equivalent to laboratory-based PCR, and could replace rapid antigen tests.
背景
准确检测流感需要进行诊断测试；然而，快速抗原检测（RADTs）和基于中心实验室的检测等方法分别受到灵敏度低和时间限制的制约。
目的
以FDA批准的体外诊断（IVD）聚合酶链反应（PCR）检测方法GenMark Dx呼吸道病毒检测板作为参考方法，比较cobas Liat甲型/乙型流感检测和Alere™ i甲型/乙型流感即时检测（POC）检测在使用新鲜鼻咽拭子标本检测甲型和乙型流感病毒方面的性能。
研究设计
对87份从18岁及以上成年人采集于病毒运输培养基中的样本，在两种即时检测方法上重新进行检测（基于参考PCR方法，29份为甲型流感阳性，18份为乙型流感病毒阳性）。
结果
相对于参考PCR，cobas甲型/乙型流感检测对甲型和乙型流感检测的总体灵敏度和特异性分别为97.9%（95%置信区间[CI]88.9%，99.6%）和97.5%（95%CI：87.1%，99.6%），而Alere i甲型/乙型流感检测相对于参考PCR方法的灵敏度为63.8%（95%CI：49.5%，76.0%），特异性为97.5%（95%CI：87.1%，99.6%）。cobas甲型/乙型流感检测单独对甲型流感和单独对乙型流感的个体灵敏度和特异性与参考PCR方法相当（甲型流感：灵敏度为100%[95%CI：88.3%，100.0%]，特异性为98.3%[95%CI：90.9%，99.7%]；乙型流感：灵敏度为94.4%[95%CI：74.2%，99.0%]，特异性为100%[95%CI：94.7%，100.0%]）。对于Alere i甲型/乙型流感检测，甲型和乙型流感的个体特异性与参考PCR方法相当（分别为98.3%[95%CI：90.9%，99.7%]和97.1%[95%CI：90.0%，99.2%]），而个体灵敏度相对于参考PCR较低（分别为55.2%[95%CI：37.5%，71.6%]和72.2%[95%CI：49.1%，87.5%]）。
结论
cobas甲型/乙型流感检测显示出与基于实验室的PCR相当的性能，并且可以替代快速抗原检测。
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