Clinical evaluation of the BioFire® Respiratory Panel 2.1 and detection of SARS-CoV-2

Creager, Hannah M.; Cabrera, Barbara J; Schnaubelt, Andy; Cox, Jesse L.; Cushman‐Vokoun, Allison M.; Shakir, Salika M.; Tardif, Keith D.; Huang, Meei Li; Jerome, Keith R.; Greninger, Alexander L.; Drobysheva, Daria; Spaulding, Usha; Rogatcheva, Margarita B.; Bourzac, Kevin M.; Hinrichs, Steven H.; Broadhurst, M. Jana; Fey, Paul D.

doi:10.1016/j.jcv.2020.104538

Cited by 75 publications

(69 citation statements)

References 13 publications

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“…To date, only three studies have reported the use of multiplex PCR for the detection of SARS-CoV-2 and other common pathogens [ 29–31 ]. These two commercial kits, BioFire RP2.1 (BioFire Diagnostics) and QIAstat-SARS (QIAGEN Diagnostics GmbH), have been demonstrated to provide more than 20 detection results, including SARS-CoV-2.…”

Section: Discussionmentioning

confidence: 99%

Novel dual multiplex real-time RT-PCR assays for the rapid detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus using the BD MAX open system

Chung

Jian

Chang

et al. 2021

Emerging Microbes & Infections

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Severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has spread rapidly, causing deaths worldwide. In this study, we evaluated the performance of the BD MAX Open System module for identifying viral pathogens, including SARS-CoV-2, in nasopharyngeal specimens from individuals with symptoms of upper respiratory tract infection. We developed and validated a rapid total nucleic acid extraction method based on real-time reverse transcription-polymerase chain reaction (RT-PCR) for the reliable, high-throughput simultaneous detection of common cold viral pathogens using the BD MAX Platform. The system was evaluated using 205 nasopharyngeal swab clinical samples. For assessment of the limit of detection (LoD), we used SARS-CoV-2, influenza A/B, and respiratory syncytial virus (RSV) RNA standards. The BD MAX dual multiplex real-time RT-PCR panel demonstrated a sensitivity comparable to that of the World Health Organization-recommended SARS-CoV-2 assay with an LoD of 50 copies/PCR. The LoD of influenza A/B and RSV was 100-200 copies/PCR. The overall percent agreement between the BD MAX panel and laboratory-developed RT-PCR test on 55 SARS-CoV-2-positive clinical samples was 100%; no cross-reactions were encountered. Among the 55 positive cases of COVID-19 analysed, no coinfection was detected. The BD MAX rapid multiplex PCR provides a highly sensitive, robust, and accurate assay for the rapid detection of SARS-CoV-2, influenza A/B, and RSV. Our assay could accurately identify SARS-CoV-2 and other common respiratory viral infections, shortening the turnaround time, and could thus increase the effectiveness of control and prevention measures for this emerging infectious disease.

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Section: Discussionmentioning

confidence: 99%

Novel dual multiplex real-time RT-PCR assays for the rapid detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus using the BD MAX open system

Chung

Jian

Chang

et al. 2021

Emerging Microbes & Infections

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“…These locations may not have access to central laboratory equipment or personnel and have a need to triage or counsel the patient according to the results obtained, thus making a point-of-care test the optimal solution. The evaluations of several rapid or point-of-care test solutions for molecular detection of SARS-CoV-2 have been recently published ( Zhen et al, 2020 , Basu et al, 2020 , Wolters et al, 2020 , Creager et al, 2020 , Hogan et al, 2020 ), however these studies have used mostly residual samples submitted for central laboratory testing and the testing was performed by in a controlled laboratory environment.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Cue Health point-of-care COVID-19 (SARS-CoV-2 nucleic acid amplification) test at a community drive through collection center

Donato

Trivedi

Stransky

et al. 2021

Diagnostic Microbiology and Infectious Disease

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“…However, practical considerations are still lacking (including the best target populations). Meanwhile, several manufacturers have developed molecular point-of-care tests, most of which additionally target influenza and/or RSV (14,15) while others offer wider respiratory syndromic panel (16).…”

Section: Introductionmentioning

confidence: 99%

SARS-CoV-2 Diagnostic Tests: Algorithm and Field Evaluation From the Near Patient Testing to the Automated Diagnostic Platform

Yin

Debuysschere

Decroly³

et al. 2021

Front. Med.

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Introduction: Since the first wave of COVID-19 in Europe, new diagnostic tools using antigen detection and rapid molecular techniques have been developed. Our objective was to elaborate a diagnostic algorithm combining antigen rapid diagnostic tests, automated antigen dosing and rapid molecular tests and to assess its performance under routine conditions.Methods: An analytical performance evaluation of four antigen rapid tests, one automated antigen dosing and one molecular point-of-care test was performed on samples sent to our laboratory for a SARS-CoV-2 reverse transcription PCR. We then established a diagnostic algorithm by approaching median viral loads in target populations and evaluated the limit of detection of each test using the PCR cycle threshold values. A field performance evaluation including a clinical validation and a user-friendliness assessment was then conducted on the antigen rapid tests in point-of-care settings (general practitioners and emergency rooms) for outpatients who were symptomatic for <7 days. Automated antigen dosing was trialed for the screening of asymptomatic inpatients.Results: Our diagnostic algorithm proposed to test recently symptomatic patients using rapid antigen tests, asymptomatic patients using automated tests, and patients requiring immediate admission using molecular point-of-care tests. Accordingly, the conventional reverse transcription PCR was kept as a second line tool. In this setting, antigen rapid tests yielded an overall sensitivity of 83.3% (not significantly different between the four assays) while the use of automated antigen dosing would have spared 93.5% of asymptomatic inpatient screening PCRs.Conclusion: Using tests not considered the “gold standard” for COVID-19 diagnosis on well-defined target populations allowed for the optimization of their intrinsic performances, widening the scale of our testing arsenal while sparing molecular resources for more seriously ill patients.

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Clinical evaluation of the BioFire® Respiratory Panel 2.1 and detection of SARS-CoV-2

Cited by 75 publications

References 13 publications

Novel dual multiplex real-time RT-PCR assays for the rapid detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus using the BD MAX open system

Novel dual multiplex real-time RT-PCR assays for the rapid detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus using the BD MAX open system

Evaluation of the Cue Health point-of-care COVID-19 (SARS-CoV-2 nucleic acid amplification) test at a community drive through collection center

SARS-CoV-2 Diagnostic Tests: Algorithm and Field Evaluation From the Near Patient Testing to the Automated Diagnostic Platform

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