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Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens.
J Clin Microbiol. 2020 Jul 23; 58(8)JC

Abstract

Several point-of-care (POC) molecular tests have received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The test performance characteristics of the Accula (Mesa Biotech) SARS-CoV-2 POC test need to be evaluated to inform its optimal use. The aim of this study was to assess the test performance of the Accula SARS-CoV-2 test. The performance of the Accula test was assessed by comparing results of 100 nasopharyngeal swab samples previously characterized by the Stanford Health Care EUA laboratory-developed test (SHC-LDT), targeting the envelope (E) gene. Assay concordance was assessed by overall percent agreement, positive percent agreement (PPA), negative percent agreement (NPA), and Cohen's kappa coefficient. Overall percent agreement between the assays was 84.0% (95% confidence interval [CI], 75.3 to 90.6%), PPA was 68.0% (95% CI, 53.3 to 80.5%), and the kappa coefficient was 0.68 (95% CI, 0.54 to 0.82). Sixteen specimens detected by the SHC-LDT were not detected by the Accula test and showed low viral load burden, with a median cycle threshold value of 37.7. NPA was 100% (95% CI, 94.2 to 100%). Compared to the SHC-LDT, the Accula SARS-CoV-2 test showed excellent negative agreement. However, positive agreement was low for samples with low viral load. The false-negative rate of the Accula POC test calls for a more thorough evaluation of POC test performance characteristics in clinical settings and for confirmatory testing in individuals with moderate to high pretest probability of SARS-CoV-2 who test negative on Accula.

Authors+Show Affiliations

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

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article

Language

eng

PubMed ID

32461285

Citation

Hogan, Catherine A., et al. "Comparison of the Accula SARS-CoV-2 Test With a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens." Journal of Clinical Microbiology, vol. 58, no. 8, 2020.
Hogan CA, Garamani N, Lee AS, et al. Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens. J Clin Microbiol. 2020;58(8).
Hogan, C. A., Garamani, N., Lee, A. S., Tung, J. K., Sahoo, M. K., Huang, C., Stevens, B., Zehnder, J., & Pinsky, B. A. (2020). Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens. Journal of Clinical Microbiology, 58(8). https://doi.org/10.1128/JCM.01072-20
Hogan CA, et al. Comparison of the Accula SARS-CoV-2 Test With a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens. J Clin Microbiol. 2020 Jul 23;58(8) PubMed PMID: 32461285.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens. AU - Hogan,Catherine A, AU - Garamani,Natasha, AU - Lee,Andrew S, AU - Tung,Jack K, AU - Sahoo,Malaya K, AU - Huang,ChunHong, AU - Stevens,Bryan, AU - Zehnder,James, AU - Pinsky,Benjamin A, Y1 - 2020/07/23/ PY - 2020/05/11/received PY - 2020/05/26/accepted PY - 2020/5/29/pubmed PY - 2020/8/5/medline PY - 2020/5/29/entrez KW - COVID-19 KW - Mesa Accula KW - SARS-CoV-2 KW - laboratory-developed test KW - point-of-care test JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 58 IS - 8 N2 - Several point-of-care (POC) molecular tests have received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The test performance characteristics of the Accula (Mesa Biotech) SARS-CoV-2 POC test need to be evaluated to inform its optimal use. The aim of this study was to assess the test performance of the Accula SARS-CoV-2 test. The performance of the Accula test was assessed by comparing results of 100 nasopharyngeal swab samples previously characterized by the Stanford Health Care EUA laboratory-developed test (SHC-LDT), targeting the envelope (E) gene. Assay concordance was assessed by overall percent agreement, positive percent agreement (PPA), negative percent agreement (NPA), and Cohen's kappa coefficient. Overall percent agreement between the assays was 84.0% (95% confidence interval [CI], 75.3 to 90.6%), PPA was 68.0% (95% CI, 53.3 to 80.5%), and the kappa coefficient was 0.68 (95% CI, 0.54 to 0.82). Sixteen specimens detected by the SHC-LDT were not detected by the Accula test and showed low viral load burden, with a median cycle threshold value of 37.7. NPA was 100% (95% CI, 94.2 to 100%). Compared to the SHC-LDT, the Accula SARS-CoV-2 test showed excellent negative agreement. However, positive agreement was low for samples with low viral load. The false-negative rate of the Accula POC test calls for a more thorough evaluation of POC test performance characteristics in clinical settings and for confirmatory testing in individuals with moderate to high pretest probability of SARS-CoV-2 who test negative on Accula. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/32461285/Comparison_of_the_Accula_SARS_CoV_2_Test_with_a_Laboratory_Developed_Assay_for_Detection_of_SARS_CoV_2_RNA_in_Clinical_Nasopharyngeal_Specimens_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=32461285 DB - PRIME DP - Unbound Medicine ER -