Panther Fusion® Respiratory Virus Assays for the detection of influenza and other respiratory viruses

Stellrecht, Kathleen A.; Cimino, Jesse L.; Wilson, Lisa I; Maceira, Vincente P.; Butt, Shafiq A.

doi:10.1016/j.jcv.2019.104204

Cited by 17 publications

(12 citation statements)

References 20 publications

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“…The results showed that the detection rate of each positive QC was 100%. As has been demonstrated that 103 copies• mL −1 is a reliable threshold for determining a respiratory infection [40][41][42][43], the Onestart assay can meet clinical diagnosis requirements.…”

Section: Limit-of-detectionmentioning

confidence: 99%

A fully automated microfluidic PCR-array system for rapid detection of multiple respiratory tract infection pathogens

et al. 2021

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Rapid and accurate identification of respiratory tract infection pathogens is of utmost importance for clinical diagnosis and treatment, as well as prevention of pathogen transmission. To meet this demand, a microfluidic chip-based PCR-array system, Onestart, was developed. The Onestart system uses a microfluidic chip packaged with all the reagents required, and the waste liquid is also collected and stored on the chip. This ready-to-use system can complete the detection of 21 pathogens in a fully integrated manner, with sample lysis, nucleic acid extraction/purification, and real-time PCR sequentially implemented on the same chip. The entire analysis process is completed within 1.5 h, and the system automatically generates a test report. The lower limit-of-detection (LOD) of the Onestart assay was determined to be 1.0 × 10 3 copies•mL −1 . The inter-batch variation of cycle threshold (Ct) values ranged from 0.08% to 0.69%, and the intra-batch variation ranged from 0.9% to 2.66%. Analytical results of the reference sample mix showed a 100% specificity of the Onestart assay. The analysis of batched clinical samples showed consistency of the Onestart assay with real-time PCR. With its ability to provide rapid, sensitive, and specific detection of respiratory tract infection pathogens, application of the Onestart system will facilitate timely clinical management of respiratory tract infections and effective prevention of pathogen transmission.

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Section: Limit-of-detectionmentioning

confidence: 99%

A fully automated microfluidic PCR-array system for rapid detection of multiple respiratory tract infection pathogens

et al. 2021

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“…The in-house SARS-CoV-2 RTf-qPCR assay was adapted to use the Open Access function on the Panther Fusion ® System (Hologic, Inc, Marlborough, MA, USA), a randomaccess platform that combines extraction of genetic material and real-time RT-PCR [19]. For that, 500 µL of a patient-derived or laboratory-generated sample was transferred into a specimen lysis tube containing 710 µL of lysis buffer (Hologic ® ), then loaded onto the Panther Fusion ® System.…”

Section: Adapting the Sars-cov-2 Rt-qpcr Assay To The Hologic Panther Fusion ® Systemmentioning

confidence: 99%

Rapid Response to SARS-CoV-2 in Aotearoa New Zealand: Implementation of a Diagnostic Test and Characterization of the First COVID-19 Cases in the South Island

Lawley

Grant

Harfoot

et al. 2021

Viruses

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It has been 20 months since we first heard of SARS-CoV-2, the novel coronavirus detected in the Hubei province, China, in December 2019, responsible for the ongoing COVID-19 pandemic. Since then, a myriad of studies aimed at understanding and controlling SARS-CoV-2 have been published at a pace that has outshined the original effort to combat HIV during the beginning of the AIDS epidemic. This massive response started by developing strategies to not only diagnose individual SARS-CoV-2 infections but to monitor the transmission, evolution, and global spread of this new virus. We currently have hundreds of commercial diagnostic tests; however, that was not the case in early 2020, when just a handful of protocols were available, and few whole-genome SARS-CoV-2 sequences had been described. It was mid-January 2020 when several District Health Boards across New Zealand started planning the implementation of diagnostic testing for this emerging virus. Here, we describe our experience implementing a molecular test to detect SARS-CoV-2 infection, adapting the RT-qPCR assay to be used in a random-access platform (Hologic Panther Fusion® System) in a clinical laboratory, and characterizing the first whole-genome SARS-CoV-2 sequences obtained in the South Island, right at the beginning of the SARS-CoV-2 outbreak in New Zealand. We expect that this work will help us and others prepare for the unequivocal risk of similar viral outbreaks in the future.

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“…The Fusion RA and ePlex RPP are currently widely used in clinical laboratories, though these tests had not previously been directly compared. In other diagnostic comparison studies, the Fusion RA demonstrated PPAs >96% and NPAs > 98% when compared with other respiratory virus tests, including the BioFire FilmArray Respiratory Panel (v. 1.7 and 2.0), XT-8 RVP, and Seegene Allplex Respiratory Panels [ [8] , [9] , [10] , [11] ]. The GenMark ePlex also exhibited similar performance when compared to a laboratory-developed RT-PCR panel and BioFire Film Array (v. 1.7), respectively [ 12 , 13 ].…”

Section: Discussionmentioning

confidence: 92%

Combined SARS-CoV-2 nucleic acid amplification testing and respiratory virus panel RT-PCR on the Hologic Panther Fusion system

Stevens

Hogan

Mfuh

et al. 2021

Journal of Clinical Virology

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Background Significant overlap exists between the symptoms of SARS-CoV-2 and other respiratory viruses. This poses a serious challenge to clinical diagnosis, laboratory testing, and infection control programs. Objectives To evaluate the performance of the Hologic Panther Fusion Respiratory Assays (RA) compared to the GenMark ePlex Respiratory Pathogen Panel (RPP) and to assess the ability of the Panther Fusion to perform parallel testing of SARS-CoV-2 and other respiratory viruses from a single sample. Study design A diagnostic comparison study was carried out using 375 clinical nasopharyngeal specimens. Assay performance was assessed by overall, positive, and negative percent agreement and Cohen’s kappa coefficient. Results Overall agreement between the Fusion RA and ePlex RPP was 97.3% (95% CI 96.3-98.0), positive percent agreement was 97.2% (95% CI 93.0-99.2), negative percent agreement was 97.3% (95% CI 96.3-98.0), and the kappa coefficient was 0.85 (95% CI 0.81-0.89). Forty additional viruses in 30 specimens were detected by Fusion that were not detected by ePlex. The maximum specimen throughput for parallel testing of the Fusion Respiratory Assays with SARS-CoV-2 was 275 samples in 20.7 hours for Fusion SARS-CoV-2 and 350 samples in 20.0 hours for Aptima Transcription Mediated Amplification SARS-CoV-2. Conclusion Fusion RA demonstrated substantial agreement compared to the ePlex RPP. However, the Fusion detected respiratory viruses not identified by ePlex, consistent with higher clinical sensitivity. Workflows for parallel testing of respiratory pathogens and SARS-CoV-2 demonstrate that the Panther Fusion instrument provides a flexible, moderate to high throughput testing option for pandemic and seasonal respiratory viruses.

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Panther Fusion® Respiratory Virus Assays for the detection of influenza and other respiratory viruses

Cited by 17 publications

References 20 publications

A fully automated microfluidic PCR-array system for rapid detection of multiple respiratory tract infection pathogens

A fully automated microfluidic PCR-array system for rapid detection of multiple respiratory tract infection pathogens

Rapid Response to SARS-CoV-2 in Aotearoa New Zealand: Implementation of a Diagnostic Test and Characterization of the First COVID-19 Cases in the South Island

Combined SARS-CoV-2 nucleic acid amplification testing and respiratory virus panel RT-PCR on the Hologic Panther Fusion system

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