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Comparative Study
. 2020 Jun:127:104383.
doi: 10.1016/j.jcv.2020.104383. Epub 2020 Apr 24.

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

Catherine A Hogan  1 , Malaya K Sahoo  2 , ChunHong Huang  2 , Natasha Garamani  2 , Bryan Stevens  1 , James Zehnder  2 , Benjamin A Pinsky  3
Affiliations
Comparative Study

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

Catherine A Hogan et al. J Clin Virol. 2020 Jun.

Abstract

Background: Numerous nucleic acid amplification assays have recently received emergency use authorization (EUA) for the diagnosis of SARS-CoV-2 infection, and there is a need to assess their test performance relative to one another.

Objectives: The aim of this study was to compare the test performance of the Hologic Panther Fusion SARS-CoV-2 assay targeting two regions of open reading frame 1ab (ORF1ab) to a high complexity molecular-based, laboratory-developed EUA from Stanford Health Care (SHC) targeting the SARS-CoV-2 envelope (E) gene.

Study design: We performed a diagnostic comparison study by testing nasopharyngeal samples on the two assays. Assay agreement was assessed by overall percent agreement and Cohen's kappa coefficient.

Results: A total of 184 nasopharyngeal samples were tested using the two assays, of which 180 showed valid results and were included for the comparative analysis. Overall percent agreement between the assays was 98.3 % (95 % confidence interval (CI) 95.2-99.7) and kappa coefficient was 0.97 (95 % CI 0.93-1.0). One sample was detected on the SHC laboratory developed test (LDT) and not on the Panther Fusion, and had a Ct of 35.9. Conversely, 2 samples were detected on the Panther Fusion and not on the LDT, and had Ct values of 37.2 and 36.6.

Conclusion: The Panther Fusion SARS-CoV-2 assay and the SHC LDT perform similarly on clinical nasopharyngeal swab specimens. Other considerations, including reagent availability, turnaround time, labor requirements, cost and instrument throughput should guide the decision of which assay to perform.

Keywords: Laboratory-developed test; Panther fusion; QIAsymphony; SARS-CoV-2.

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Conflict of interest statement

Declaration of Competing Interest The authors declare no conflicts of interest.

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References

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