tetano
Editor, Senior Moderator
J Clin Virol. 2017 Jul 26;94:86-90. doi: 10.1016/j.jcv.2017.07.012. [Epub ahead of print]
[h=1]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.[/h] Young S[SUP]1[/SUP], Illescas P[SUP]2[/SUP], Nicasio J[SUP]2[/SUP], Sickler JJ[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]OBJECTIVE:[/h] To compare the performances of the cobas[SUP]?[/SUP] Liat[SUP]?[/SUP] 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[SUP]?[/SUP] Respiratory Viral Panel as the reference method, a FDA cleared IVD PCR test.
[h=4]STUDY DESIGN:[/h] 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).
[h=4]RESULTS:[/h] 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).
[h=4]CONCLUSION:[/h] The cobas Influenza A/B assay demonstrated performance equivalent to laboratory-based PCR, and could replace rapid antigen tests.
Copyright ? 2017 Elsevier B.V. All rights reserved.
[h=4]KEYWORDS:[/h] Alere i Influenza A&B assay; Influenza virus infection; Point-of-care; Real-time polymerase chain reaction; cobas(?) Liat(?) Influenza A/B assay
PMID: 28772170 DOI: 10.1016/j.jcv.2017.07.012
[h=1]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.[/h] Young S[SUP]1[/SUP], Illescas P[SUP]2[/SUP], Nicasio J[SUP]2[/SUP], Sickler JJ[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] 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.
[h=4]OBJECTIVE:[/h] To compare the performances of the cobas[SUP]?[/SUP] Liat[SUP]?[/SUP] 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[SUP]?[/SUP] Respiratory Viral Panel as the reference method, a FDA cleared IVD PCR test.
[h=4]STUDY DESIGN:[/h] 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).
[h=4]RESULTS:[/h] 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).
[h=4]CONCLUSION:[/h] The cobas Influenza A/B assay demonstrated performance equivalent to laboratory-based PCR, and could replace rapid antigen tests.
Copyright ? 2017 Elsevier B.V. All rights reserved.
[h=4]KEYWORDS:[/h] Alere i Influenza A&B assay; Influenza virus infection; Point-of-care; Real-time polymerase chain reaction; cobas(?) Liat(?) Influenza A/B assay
PMID: 28772170 DOI: 10.1016/j.jcv.2017.07.012