Lower Respiratory Multiplex Panels for the Detection of Bacterial and Viral Infections

Abstract

Development of commercial multiplex panels for the detection and diagnosis of lower respiratory tract infections is rapidly progressing, and FDA-cleared assays are currently available. This review provides a comprehensive overview of the current or soon-to-be available commercial assays, focusing on their analytical performance, advantages, and challenges and the potential impact on patient outcomes when laboratories deploy the assays. CMN 132 Clinical Microbiology Newsletter 40:16,

Laboratory evaluation of the BioFire FilmArray Pneumonia plus panel compared to conventional methods for the identification of bacteria in lower respiratory tract specimens: a prospective cross-sectional study from South Africa

“…Although the use of the FAPP panel has obvious benefits for the diagnosis and management of patients with suspected pneumonia, its implementation is not without challenges. ( Alby and Mitchell, 2018 ) Firstly, the sensitivity of detection of each target may be compromised due to the diverse number of targets included in the panel. ( Alby and Mitchell, 2018 ) This was demonstrated in the study by Kerr et al (2018) that reported lower sensitivities for the detection of a number of targets in the FAPP panel.…”

“…( Alby and Mitchell, 2018 ) Firstly, the sensitivity of detection of each target may be compromised due to the diverse number of targets included in the panel. ( Alby and Mitchell, 2018 ) This was demonstrated in the study by Kerr et al (2018) that reported lower sensitivities for the detection of a number of targets in the FAPP panel. ( Kerr et al, 2018 ) In our analysis we also found low sensitivity for some targets.…”

“…( BioMérieux Diagnostics ) Although data are limited, the FAPP panel has demonstrated good overall performance. ( Alby and Mitchell, 2018 , Yoo et al, 2020 , Lee et al, 2019 , Faron et al, 2018 , Kerr et al, 2018 , Furukawa et al, 2019 , Huang et al, 2018 )…”

“…( Sullivan and Bard, 2019 ) Consequently, rapid multiplex polymerase chain reaction (PCR) assays are fast becoming valuable diagnostic tools. ( Alby and Mitchell, 2018 ) A number of commercially available PCR assays have recently been approved for the diagnosis of pneumonia by the US Food and Drug Administration (US FDA, Washington, DC, USA). ( Alby and Mitchell, 2018 , Ramanan et al, 2018 ) One such assay, the BioFire FilmArray Pneumonia plus (FAPP) panel (BioFire Diagnostics LLC, Salt Lake City, UT, USA) uses a nested PCR technique with melting curve analysis to detect 15 common bacteria, three atypical bacteria, and nine viruses that cause both community- and hospital-acquired LRTI, as well as seven antibiotic resistance markers, in approximately one hour.…”

“…( Alby and Mitchell, 2018 ) A number of commercially available PCR assays have recently been approved for the diagnosis of pneumonia by the US Food and Drug Administration (US FDA, Washington, DC, USA). ( Alby and Mitchell, 2018 , Ramanan et al, 2018 ) One such assay, the BioFire FilmArray Pneumonia plus (FAPP) panel (BioFire Diagnostics LLC, Salt Lake City, UT, USA) uses a nested PCR technique with melting curve analysis to detect 15 common bacteria, three atypical bacteria, and nine viruses that cause both community- and hospital-acquired LRTI, as well as seven antibiotic resistance markers, in approximately one hour. ( BioMérieux Diagnostics ) To facilitate clinical decision making, genomic material of certain bacteria that are detected in the assay are then also reported semi-quantitatively with bins representing 10 4 -, 10 5 -, 10 6 - and ≥10 7 copies per millilitre (copies/mL).…”