Comparison of the Panther Fusion and a laboratory-developed test targeting the envelope gene for detection of SARS-CoV-2

Abstract

Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre-including this research content-immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

Comparison of the analytical sensitivity of seven commonly used commercial SARS-CoV-2 automated molecular assays

“…As a step forward for optimizing the validations and collecting comparable assays’ performance data, the FDA currently offers reference panels for EUA applications which should also assist in different assays’ calibrations and on-going monitoring of the performance [ 26 ]. Although several papers have been published comparing the characteristics and sensitivities between a few SARS-CoV-2 molecular tests ( Table 2 ) and [ 10 , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] ], our study provides a direct comparison between 7 of the most commonly used commercially available assays using the same quantified clinical specimen.…”

Pushing beyond specifications: Evaluation of linearity and clinical performance of the cobas 6800/8800 SARS-CoV-2 RT-PCR assay for reliable quantification in blood and other materials outside recommendations

“…The benefits of automation for molecular diagnostics have been discussed extensively in previous studies [ 11 , 16 ]. While various sample-to-result systems were already used for SARS-CoV-2 diagnostics utilizing open modes during the early weeks of the pandemic [ 10 , 17 , 18 ], commercial test kits have since been released under emergency use authorization (EUA) for most automated PCR-platforms [ 12 , 19 , 20 ].…”

Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens

“…The reference assay for this study was the Stanford Health Care Clinical Virology Laboratory real-time reverse transcriptase PCR LDT (SHC-LDT) targeting the E gene ( 11 – 13 ). The Accula SARS-CoV-2 POCT (Mesa Biotech, Inc., San Diego, CA) is a sample-to-answer nucleic acid amplification test that can yield a diagnostic result within 30 min of specimen collection.…”