Comparison of the performance of the Panther Fusion respiratory virus panel to R-Gene and laboratory developed tests for diagnostic and hygiene screening specimens from the upper and lower respiratory tract

Ganzenmueller, Tina; Kaiser, Rolf; Baier, Claas; Wehrhane, M.; Hilfrich, Brigitta; Witthuhn, Jenny; Flucht, Sandra; Heim, Albert

doi:10.1099/jmm.0.001133

Cited by 10 publications

(13 citation statements)

References 39 publications

(49 reference statements)

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“…Hologic Panther Fusion (PF) is an algorithmic method which emphasis on random accessing rather than batch-wise testing [90,91]. Two PCR protocols were adapted and then processed for PF program.…”

Section: Algorithm Based Coronavirus Detectionmentioning

confidence: 99%

Diagnostic approaches in COVID-19: clinical updates

Asrani

Eapen

Chia

et al. 2020

Expert Review of Respiratory Medicine

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Introduction: COVID-19 is a recent emerging pandemic whose prognosis is still unclear. Diagnostic tools are the main players that not only indicate a possible infection but can further restrict the transmission and can determine the extent to which disease progression would occur. Areas covered: In this paper, we have performed a narrative and critical review on different technology-based diagnostic strategies such as molecular approaches including real-time reverse transcriptase PCR, serological testing through enzyme-linked immunosorbent assay, laboratory and point of care devices, radiology-based detection through computed tomography and chest X-ray, and viral cell cultures on Vero E6 cell lines are discussed in detail to address COVID-19. This review further provides an overview of emergency use authorized immunodiagnostic and molecular diagnostic kits and POC devices by FDA for timely and efficient conduction of diagnostic tests. The majority of the literature cited in this paper is collected from guidelines on protocols and other considerations on diagnostic strategies of COVID-19 issued by WHO, CDC, and FDA under emergency authorization. Expert opinion: Such information holds importance to the health professionals in conducting error-free diagnostic tests and researches in producing better clinical strategies by addressing the limitations associated with the available methods.

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Section: Algorithm Based Coronavirus Detectionmentioning

confidence: 99%

Diagnostic approaches in COVID-19: clinical updates

Asrani

Eapen

Chia

et al. 2020

Expert Review of Respiratory Medicine

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“…For comparison, the Hologic Panther Fusion (PF) system provides a panel of three CE marked and FDA cleared multiplex real-time PCRs that cover influenza virus A/B (Flu A/B), respiratory syncytial virus (RSV), parainfluenza virus 1-4 (ParaFlu), human metapneumovirus (hMPV), adenovirus (AdV) and rhinovirus (RhV) and can be performed according to the individual diagnostic request. These assays were validated for samples from the lower respiratory tract in a previous study (22).…”

Section: Introductionmentioning

confidence: 99%

Fully automated detection and differentiation of pandemic and endemic coronaviruses (NL63, 229E, HKU1, OC43 and SARS-CoV-2) on the Hologic Panther Fusion

Cordes

Rehrauer²,

Accola

et al. 2020

Preprint

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The Hologic Panther Fusion (PF) platform provides fully automated CE marked diagnostics for respiratory viruses, including recently SARS-coronavirus 2 by a transcription mediated amplification (TMA) assay, but not for the endemic human coronaviruses (hCoV). Therefore, a laboratory developed multiplexed RT-PCR protocol (LDT) that detects and differentiates the four hCoV NL63, 229E, HKU1 and OC43 was adapted on the PF. The novel CE marked Aptima SARS-CoV-2 TMA and the LDT for hCoV were validated with 321 diagnostic specimens from the upper and lower respiratory tract in comparison to two SARS-CoV-2 RT-PCRs (PF E-gene LDT and genesig RT-PCR, 157 specimens) or the R-GENE hCoV / hParaFlu RT-PCR (164 specimens), respectively. For the endemic hCoV, results were 96.3% concordant with two specimens discordantly positive in the PF and four specimens discordantly positive in the R-GENE assay. All discordantly positive samples had Ct values between 33 and 39. The PF hCoV LDT identified 23 hCoV positive specimens as NL63, 15 as 229E, 15 as HKU1 and 25 as OC43. The Aptima SARS-CoV-2 TMA gave 99.4 % concordant results compared to the consensus results with a single specimen discordantly positive. Moreover, 36 samples from proficiency testing panels were detected and typed correctly by both novel methods. In conclusion, the SARS-CoV-2 TMA and the LDT for hCoV enhanced the diagnostic spectrum of the PF for all coronaviruses circulating globally for a multitude of diagnostic materials from the upper and lower respiratory tract.

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“…The emerging SARS-coronavirus-2 (SARS-CoV-2, previously 2019-nCoV) can cause severe lower respiratory tract infections and was declared a global emergency by the WHO [1,2]. Diagnosis of respiratory infections can be achieved more rapidly with a random access approach than with batch-wise testing [3,4]. The Hologic Panther Fusion (PF) system permits immediate, fully automated processing of diagnostic specimens including RNA extraction, amplification of target sequences and real time detection of PCR amplicons in about 3.5 h. Rapid diagnosis of SARS-CoV-2 is essential in order to implement therapeutic and infection prevention measures.…”

mentioning

confidence: 99%

“…Previously, it had been demonstrated that the respiratory virus assays available for the PF System (e.g. Influenza/RSV) were capable to process a multitude of respiratory specimen types from the upper and lower respiratory tract (LRT) including bronchoalveolar lavages [3,7]. SARS-CoV-2 virus loads were reported to be higher in LRT specimens [8].…”

mentioning

confidence: 99%

“…Although LRT specimens originating from SARS-CoV-2 infected patients were not yet available to us, we assume that the novel SARS-CoV-2 PCR protocols for the PF will also be appropriate for LRT specimens, because identical reagents for RNA extraction are used as in the commercially available diagnostic assays for other respiratory viruses (e.g. the PF influenza/RSV assay) [3,7]. Therefore, a sensitive diagnosis of SARS-CoV-2 from upper and lower respiratory tract specimens seems to be feasible.…”

mentioning

confidence: 99%

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