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Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA.
J Appl Lab Med. 2020 11 01; 5(6):1307-1312.JA

Abstract

BACKGROUND

Numerous nucleic acid amplification assays utilizing different target genes of the SARS-CoV-2 genome have received emergency use authorization (EUA) by the United States Food and Drug Administration (FDA). Limited data are available comparing the test performance characteristics of these assays.

METHODS

A diagnostic comparison study was performed to evaluate the performance of the Cepheid Xpert Xpress SARS-CoV-2 assay compared to the Hologic Panther Fusion SARS-CoV-2 assay using clinical nasopharyngeal specimens. Agreement between the two assays was assessed by overall, positive, and negative percent agreement and Cohen's kappa coefficient.

RESULTS

A total of 104 (54 positive and 50 negative) clinical nasopharyngeal samples were tested by both assays. Using the Panther Fusion as a reference standard, the Xpert demonstrated an overall agreement of 99.0% [95% confidence interval (CI): 94.8-100], positive percent agreement of 98.1% (95% CI: 90.1-100), and a negative percent agreement of 100% (95% CI: 94.2-100). The kappa coefficient was 0.98 (95% CI: 0.94-1.0). One sample positive by the Panther Fusion with a cycle threshold (Ct) of 38.6 was found to be reproducibly negative by the Xpert assay.

CONCLUSIONS

The Cepheid Xpert Xpress SARS-CoV-2 assay provides test performance comparable to the Hologic Panther Fusion SARS-CoV-2 assay while offering laboratories rapid, on-demand testing capacity.

Authors+Show Affiliations

Department of Pathology, Stanford University School of Medicine, Stanford, CA. Clinical Virology Laboratory, Stanford Health Care, Stanford, CA.Department of Pathology, Stanford University School of Medicine, Stanford, CA. Clinical Virology Laboratory, Stanford Health Care, Stanford, CA.Department of Pathology, Stanford University School of Medicine, Stanford, CA.Department of Pathology, Stanford University School of Medicine, Stanford, CA.Department of Pathology, Stanford University School of Medicine, Stanford, CA.Department of Pathology, Stanford University School of Medicine, Stanford, CA.Department of Pathology, Stanford University School of Medicine, Stanford, CA.Department of Pathology, Stanford University School of Medicine, Stanford, CA. Clinical Virology Laboratory, Stanford Health Care, Stanford, CA. Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, CA.

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

32761092

Citation

Stevens, Bryan, et al. "Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA." The Journal of Applied Laboratory Medicine, vol. 5, no. 6, 2020, pp. 1307-1312.
Stevens B, Hogan CA, Sahoo MK, et al. Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA. J Appl Lab Med. 2020;5(6):1307-1312.
Stevens, B., Hogan, C. A., Sahoo, M. K., Huang, C., Garamani, N., Zehnder, J., Kurzer, J., & Pinsky, B. A. (2020). Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA. The Journal of Applied Laboratory Medicine, 5(6), 1307-1312. https://doi.org/10.1093/jalm/jfaa135
Stevens B, et al. Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA. J Appl Lab Med. 2020 11 1;5(6):1307-1312. PubMed PMID: 32761092.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA. AU - Stevens,Bryan, AU - Hogan,Catherine A, AU - Sahoo,Malaya K, AU - Huang,ChunHong, AU - Garamani,Natasha, AU - Zehnder,James, AU - Kurzer,Jason, AU - Pinsky,Benjamin A, PY - 2020/06/08/received PY - 2020/07/15/accepted PY - 2020/8/8/pubmed PY - 2020/12/2/medline PY - 2020/8/8/entrez KW - COVID-19 KW - Cepheid GeneXpert KW - Panther Fusion KW - SARS-CoV-2 SP - 1307 EP - 1312 JF - The journal of applied laboratory medicine JO - J Appl Lab Med VL - 5 IS - 6 N2 - BACKGROUND: Numerous nucleic acid amplification assays utilizing different target genes of the SARS-CoV-2 genome have received emergency use authorization (EUA) by the United States Food and Drug Administration (FDA). Limited data are available comparing the test performance characteristics of these assays. METHODS: A diagnostic comparison study was performed to evaluate the performance of the Cepheid Xpert Xpress SARS-CoV-2 assay compared to the Hologic Panther Fusion SARS-CoV-2 assay using clinical nasopharyngeal specimens. Agreement between the two assays was assessed by overall, positive, and negative percent agreement and Cohen's kappa coefficient. RESULTS: A total of 104 (54 positive and 50 negative) clinical nasopharyngeal samples were tested by both assays. Using the Panther Fusion as a reference standard, the Xpert demonstrated an overall agreement of 99.0% [95% confidence interval (CI): 94.8-100], positive percent agreement of 98.1% (95% CI: 90.1-100), and a negative percent agreement of 100% (95% CI: 94.2-100). The kappa coefficient was 0.98 (95% CI: 0.94-1.0). One sample positive by the Panther Fusion with a cycle threshold (Ct) of 38.6 was found to be reproducibly negative by the Xpert assay. CONCLUSIONS: The Cepheid Xpert Xpress SARS-CoV-2 assay provides test performance comparable to the Hologic Panther Fusion SARS-CoV-2 assay while offering laboratories rapid, on-demand testing capacity. SN - 2576-9456 UR - https://www.unboundmedicine.com/medline/citation/32761092/Comparison_of_a_Point_of_Care_Assay_and_a_High_Complexity_Assay_for_Detection_of_SARS_CoV_2_RNA_ L2 - http://jalm.aaccjnls.org/cgi/pmidlookup?view=long&pmid=32761092 DB - PRIME DP - Unbound Medicine ER -