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Comparison of the Panther Fusion and a laboratory-developed test targeting the envelope gene for detection of SARS-CoV-2.
J Clin Virol. 2020 06; 127:104383.JC

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.

Authors+Show Affiliations

Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA; Clinical Virology Laboratory, Stanford Health Care, Stanford, CA, USA.Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA; Clinical Virology Laboratory, Stanford Health Care, Stanford, CA, USA.Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA; Clinical Virology Laboratory, Stanford Health Care, Stanford, CA, USA; Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA. Electronic address: bpinsky@stanford.edu.

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

32353760

Citation

Hogan, Catherine A., et al. "Comparison of the Panther Fusion and a Laboratory-developed Test Targeting the Envelope Gene for Detection of SARS-CoV-2." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 127, 2020, p. 104383.
Hogan CA, Sahoo MK, Huang C, et al. Comparison of the Panther Fusion and a laboratory-developed test targeting the envelope gene for detection of SARS-CoV-2. J Clin Virol. 2020;127:104383.
Hogan, C. A., Sahoo, M. K., Huang, C., Garamani, N., Stevens, B., Zehnder, J., & Pinsky, B. A. (2020). Comparison of the Panther Fusion and a laboratory-developed test targeting the envelope gene for detection of SARS-CoV-2. Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 127, 104383. https://doi.org/10.1016/j.jcv.2020.104383
Hogan CA, et al. Comparison of the Panther Fusion and a Laboratory-developed Test Targeting the Envelope Gene for Detection of SARS-CoV-2. J Clin Virol. 2020;127:104383. PubMed PMID: 32353760.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of the Panther Fusion and a laboratory-developed test targeting the envelope gene for detection of SARS-CoV-2. AU - Hogan,Catherine A, AU - Sahoo,Malaya K, AU - Huang,ChunHong, AU - Garamani,Natasha, AU - Stevens,Bryan, AU - Zehnder,James, AU - Pinsky,Benjamin A, Y1 - 2020/04/24/ PY - 2020/04/13/received PY - 2020/04/18/revised PY - 2020/04/21/accepted PY - 2020/5/1/pubmed PY - 2020/6/17/medline PY - 2020/5/1/entrez KW - Laboratory-developed test KW - Panther fusion KW - QIAsymphony KW - SARS-CoV-2 SP - 104383 EP - 104383 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J Clin Virol VL - 127 N2 - 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. SN - 1873-5967 UR - https://www.unboundmedicine.com/medline/citation/32353760/Comparison_of_the_Panther_Fusion_and_a_laboratory_developed_test_targeting_the_envelope_gene_for_detection_of_SARS_CoV_2_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(20)30125-6 DB - PRIME DP - Unbound Medicine ER -