tetano
Editor, Senior Moderator
J Clin Virol. 2017 Aug 8;95:5-9. doi: 10.1016/j.jcv.2017.08.004. [Epub ahead of print]
[h=1]Multi-center evaluation of the cobas? Liat? Influenza A/B & RSV assay for rapid point of care diagnosis.[/h] Gibson J[SUP]1[/SUP], Schechter-Perkins EM[SUP]2[/SUP], Mitchell P[SUP]2[/SUP], Mace S[SUP]3[/SUP], Tian Y[SUP]4[/SUP], Williams K[SUP]4[/SUP], Luo R[SUP]4[/SUP], Yen-Lieberman B[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] Point of Care Testing (POCT) provides the capability for rapid laboratory test results in patient care environments where a traditional clinical laboratory is not available. POCTs have shorter turn-around times (TATs), they may be performed by non-laboratory personnel, and the need for transport time is eliminated. The Food and Drug Administration (FDA) recently granted Clinical Laboratory Improvements Amendment (CLIA) waiver status to the cobas[SUP]?[/SUP] Influenza A/B & RSV assay, a rapid, accurate point-of-care test for Influenza and respiratory syncytial virus (RSV) performed on the Liat[SUP]?[/SUP] System. The performance characteristics of this test were determined though a multi-site study consisting of different point of care testing environments. Prospectively collected Nasopharyngeal (NP) swabs from 1361 patients seen at 8 primary care clinics and 4 emergency departments (EDs) and 295 retrospectively identified specimens were tested for Influenza A/B and RSV on the cobas[SUP]?[/SUP] Liat[SUP]?[/SUP] platform. Performance characteristics were determined through comparison to ProFlu+, a laboratory-based PCR test for Influenza A/B and RSV (reference test). Discordant specimens were adjudicated following bi-directional sequencing. The cobas[SUP]?[/SUP] Influenza A/B and RSV assay showed sensitivities of 99.6%, 99.3%, and 96.8% for Influenza A, Influenza B, and RSV, respectively as determined from percent positive agreement (PPA) following comparison to the reference test. Sequencing confirmed cobas[SUP]?[/SUP] Influenza A/B and RSV results in 49.2% of reference test discordant specimens, while crossing threshold data suggest increased sensitivity compared to the reference test. The cobas[SUP]?[/SUP] Influenza A/B and RSV assay was found to be a rapid, sensitive POCT for the detection of these viruses, and provides laboratory-quality PCR-based diagnostic results in point of care settings.
Copyright ? 2017 Elsevier B.V. All rights reserved.
[h=4]KEYWORDS:[/h] Influenza A; Influenza B; Point of care testing; RSV
PMID: 28818691 DOI: 10.1016/j.jcv.2017.08.004
[h=1]Multi-center evaluation of the cobas? Liat? Influenza A/B & RSV assay for rapid point of care diagnosis.[/h] Gibson J[SUP]1[/SUP], Schechter-Perkins EM[SUP]2[/SUP], Mitchell P[SUP]2[/SUP], Mace S[SUP]3[/SUP], Tian Y[SUP]4[/SUP], Williams K[SUP]4[/SUP], Luo R[SUP]4[/SUP], Yen-Lieberman B[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] Point of Care Testing (POCT) provides the capability for rapid laboratory test results in patient care environments where a traditional clinical laboratory is not available. POCTs have shorter turn-around times (TATs), they may be performed by non-laboratory personnel, and the need for transport time is eliminated. The Food and Drug Administration (FDA) recently granted Clinical Laboratory Improvements Amendment (CLIA) waiver status to the cobas[SUP]?[/SUP] Influenza A/B & RSV assay, a rapid, accurate point-of-care test for Influenza and respiratory syncytial virus (RSV) performed on the Liat[SUP]?[/SUP] System. The performance characteristics of this test were determined though a multi-site study consisting of different point of care testing environments. Prospectively collected Nasopharyngeal (NP) swabs from 1361 patients seen at 8 primary care clinics and 4 emergency departments (EDs) and 295 retrospectively identified specimens were tested for Influenza A/B and RSV on the cobas[SUP]?[/SUP] Liat[SUP]?[/SUP] platform. Performance characteristics were determined through comparison to ProFlu+, a laboratory-based PCR test for Influenza A/B and RSV (reference test). Discordant specimens were adjudicated following bi-directional sequencing. The cobas[SUP]?[/SUP] Influenza A/B and RSV assay showed sensitivities of 99.6%, 99.3%, and 96.8% for Influenza A, Influenza B, and RSV, respectively as determined from percent positive agreement (PPA) following comparison to the reference test. Sequencing confirmed cobas[SUP]?[/SUP] Influenza A/B and RSV results in 49.2% of reference test discordant specimens, while crossing threshold data suggest increased sensitivity compared to the reference test. The cobas[SUP]?[/SUP] Influenza A/B and RSV assay was found to be a rapid, sensitive POCT for the detection of these viruses, and provides laboratory-quality PCR-based diagnostic results in point of care settings.
Copyright ? 2017 Elsevier B.V. All rights reserved.
[h=4]KEYWORDS:[/h] Influenza A; Influenza B; Point of care testing; RSV
PMID: 28818691 DOI: 10.1016/j.jcv.2017.08.004