BioFire FilmArray respiratory panel RP2.1 for SARS-CoV-2 detection: The pitfalls

Chang, Yu‐Chang; Hsiao, Chiung-Tzu; Chen, Wan-Li; Su, Yang-Di; Hsueh, Po-Ren

doi:10.1016/j.jinf.2022.07.030

Cited by 8 publications

(6 citation statements)

References 5 publications

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“…Indeed, our study showed that rhinovirus/enterovirus was in persistent circulation during the study period ( Figure 2 ). Moreover, a recent study also showed that rhinovirus/enterovirus (32.7%) is the most common detected virus in Taiwanese population using BioFire FilmArray respiratory PCR panel 2.1 [ 53 ].…”

Section: Discussionmentioning

confidence: 99%

“…The authors concluded that the BioFire RP2.1 showed excellent performance in the detection of SARS-CoV-2. However, Chang YC et al [ 53 ] reported that 42.6% of SARS-CoV-2 positive results obtained from FilmArray TM RP 2.1 assay were inconsistent with other PCR systems (cobas Liat or cobas 6800 systems). They concluded that if the SARS-CoV-2 positive results by FilmArray TM RP 2.1 assay should be reconfirmed by other quantitative RT-PCR assays.…”

Section: Discussionmentioning

confidence: 99%

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Distribution of Viral Respiratory Infections during the COVID-19 Pandemic Using the FilmArray Respiratory Panel

Chen

2022

Biomedicines

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This study was conducted to evaluate the distribution of respiratory viral pathogens in the emergency department during the coronavirus disease 2019 (COVID-19) pandemic. Between May 2020 and September 2022, patients aged between 0.1 and 98 years arrived at the emergency department of Asia University Hospital, and samples from nasopharyngeal swabs were tested by the FilmArrayTM Respiratory Panel (RP). SARS-CoV-2 positivity was subsequently retested by the cobas Liat system. There were 804 patients for whom the FilmArrayTM RP was tested, and 225 (27.9%) of them had positive results for respiratory viruses. Rhinovirus/enterovirus was the most commonly detected pathogen, with 170 (61.8%) cases, followed by adenovirus with 38 (13.8%), SARS-CoV-2 with 16 (5.8%) cases, and coronavirus 229E, with 16 (5.8%) cases. SARS-CoV-2 PCR results were positive in 16 (5.8%) cases, and there were two coinfections of SARS-CoV-2 with adenovirus and rhinovirus/enterovirus. A total of 43 (5.3%) patients were coinfected; the most coinfection was adenovirus plus rhinovirus/enterovirus, which was detectable in 18 (41.9%) cases. No atypical pathogens were found in this study. Intriguingly, our results showed that there was prefect agreement between the detection of SARS-CoV-2 conducted with the cobas Liat SARS-CoV-2 and influenza A/B nucleic acid test and the FilmArrayTM RP. Therefore, the FilmArrayTM RP assay is a reliable and feasible method for the detection of SARS-CoV-2. In summary, FilmArrayTM RP significantly broadens our capability to detect multiple respiratory infections due to viruses and atypical bacteria. It provides a prompt evaluation of pathogens to enhance patient care and clinical selection strategies in emergency departments during the COVID-19 pandemic.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Distribution of Viral Respiratory Infections during the COVID-19 Pandemic Using the FilmArray Respiratory Panel

Chen

2022

Biomedicines

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“…For example the Biofire FilmArray ™ respiratory panel 2.1 is one of a number of multiplex panels directed at respiratory pathogens [1]. It detects 19 viruses [21, 23]. We have trialled using this in Bristol to investigate co-infection of respiratorypathogens.…”

Section: Discussionmentioning

confidence: 99%

Combined multiplex panel test results are a poor estimate of disease prevalence without adjustment for test error

Challen,

Chatzilena,

Qian

et al. 2023

Preprint

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Multiplex panel tests identify many individual pathogens at once, using a set of component tests. In some panels the number of components can be large. If the panel is detecting causative pathogens for a single syndrome or disease then we might estimate the burden of that disease by combining the results of the panel, for example determining the prevalence of pneumococcal pneumonia as caused by many individual pneumococcal serotypes. When we are dealing with multiplex test panels with many components, test error in the individual components of a panel, even when present at very low levels, can cause significant overall error. Uncertainty in the sensitivity and specificity of the individual tests, and statistical fluctuations in the numbers of false positives and false negatives, will cause large uncertainty in the combined estimates of disease prevalence. In many cases this can be a source of significant bias. In this paper we develop a mathematical framework to characterise this issue, present novel statistical methods that adjust for this bias and quantify uncertainty, and use simulation to test these methods. As multiplex testing becomes more commonly used for screening in routine clinical practice, accumulation of test error due to the combination of large numbers of test results needs to be identified and corrected for.Author summaryDuring analysis of pneumococcal incidence data obtained from serotype specific multiplex urine antigen testing, we identified that despite excellent test sensitivity and specificity, the small error rate in each individual serotype test has the potential to compound and cause large uncertainty in the resulting estimates of pneumococcal prevalence, obtained by combining individual results. This limits the accuracy of estimates of the burden of disease caused by vaccine preventable pneumococcal serotypes, and in certain situations can produce marked bias.

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“…In addition, this rapid and high-throughput method for the simultaneous detection of multiple respiratory viruses based on the MPA platform was compared with other multiplex PCR methods to explore the possibility and practicability limitations. In terms of pathogen coverage, some commercial kits, such as QIA stat-SARS (QIAGEN Diagnostics GmbH) [ 25 , 26 ], Fire RP2.1(Bio Fire Diagnostics) [ 27 , 28 ], can detect more than 20 respiratory pathogens, and they share a similar pathogen spectrum with the MPA assay. However, these commercial kits are much more expensive for each reaction than the MPA assay.…”

Section: Discussionmentioning

confidence: 99%

Clinical Evaluation of a Multiplex PCR Assay for Simultaneous Detection of 18 Respiratory Pathogens in Patients with Acute Respiratory Infections

Wang

Liu

et al. 2022

Pathogens

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Reliable diagnostics are necessary to identify influenza infections, and coronavirus disease 2019 (COVID-19) highlights the need to develop highly specific and sensitive viral detection methods to distinguish severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and other respiratory pathogens to prevent their further spread. In this prospective study, 1070 clinical respiratory samples were collected from patients with acute respiratory infections from January 2019 to February 2021 to evaluate the diagnostic performance of a multiplex probe amplification (MPA) assay, designed to screen 18 pathogens, mainly those causing acute respiratory infections. Ninety-six positive samples and twenty negative samples for the 18 respiratory pathogens defined by the MPA assay and reverse transcription polymerase chain reaction (RT–PCR) were further confirmed by reference next-generation sequencing (NGS). The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the MPA assay were 95.00%, 93.75%, 98.96% and 75.00%, respectively. Additionally, the co-infection rate for these positive samples were 25% (24/95). The MPA assay demonstrated a highly concordant diagnostic performance with NGS in the diagnosis of 18 respiratory pathogens and might play an important role in clinical respiratory pathogen diagnosis.

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BioFire FilmArray respiratory panel RP2.1 for SARS-CoV-2 detection: The pitfalls

Cited by 8 publications

References 5 publications

Distribution of Viral Respiratory Infections during the COVID-19 Pandemic Using the FilmArray Respiratory Panel

Distribution of Viral Respiratory Infections during the COVID-19 Pandemic Using the FilmArray Respiratory Panel

Combined multiplex panel test results are a poor estimate of disease prevalence without adjustment for test error

Clinical Evaluation of a Multiplex PCR Assay for Simultaneous Detection of 18 Respiratory Pathogens in Patients with Acute Respiratory Infections

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