Comparison of a Point-of-Care Assay and a High-Complexity Assay for Detection of SARS-CoV-2 RNA.
J Appl Lab Med
; 5(6): 1307-1312, 2020 11 01.
Article
in English
| MEDLINE | ID: covidwho-696741
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.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Pneumonia, Viral
/
RNA, Viral
/
Coronavirus Infections
/
Clinical Laboratory Techniques
/
Molecular Diagnostic Techniques
/
Betacoronavirus
Type of study:
Diagnostic study
/
Experimental Studies
/
Observational study
/
Prognostic study
Limits:
Humans
Country/Region as subject:
North America
Language:
English
Journal:
J Appl Lab Med
Year:
2020
Document Type:
Article
Affiliation country:
Jalm
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