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

Abstract

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.

Reviewing methods of deep learning for diagnosing COVID-19, its variants and synergistic medicine combinations

“…It uses retroviral reverse transcriptase and T7 RNA polymerase to differentiate nucleic acids from various microbes. Per this criterion, the Panther Fusion stage from Hologic may perform both RT-PCR and TMA [ 112 ]. The Panther combination stage stands apart for its high test effectiveness (up to 1,000 tests in 24 h) and its capacity to control other regular respiratory infections whose manifestations cover COVID-19 utilizing a similar example and a similar patient assortment bottle [ 113 ].…”