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Evaluation of SARS-CoV-2 Detection Systems Using Clinical Samples and Standard Material: A Comparative Study

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Author(s)
Sunggyun ParkDo-Hoon Kim
Keimyung Author(s)
Park, Sung GyunKim, Do Hoon
Department
Dept. of Laboratory Medicine (진단검사의학)
Journal Title
Diagnostics (Basel)
Issued Date
2023
Volume
13
Issue
12
Keyword
COVID-19SARS-CoV-2limit of detection
Abstract
Due to the decreasing trends in daily confirmed COVID-19 cases and daily confirmed tests, there is a need for a new testing system capable of quickly and efficiently testing small amounts of samples. Therefore, we compared and evaluated the testing performance of the Aptima SARS-CoV-2 assay, an automated testing system that allows continuous loading of samples, and the Real-Q Direct SARS-CoV-2 detection kit that is currently being used in our laboratory. We compared the results of the two testing systems using 259 residual individual nasopharyngeal specimens and 91 residual pooled nasopharyngeal specimens that were submitted for COVID-19 testing in January and February 2023. The 95% limit of detection (LoD) for the Aptima SARS-CoV-2 assay determined using reference material for SARS-CoV-2 nucleic acid was confirmed to be 17.793 copies/mL, while the LoD for the Real-Q Direct SARS-CoV-2 detection kit was determined to be 131.842 copies/mL for the RdRP gene and 241.77 copies/mL for the E gene. The comparative study using clinical specimens showed almost perfect agreement. Our data showed that the Aptima SARS-CoV-2 assay has a very low LoD. In addition, the Aptima SARS-CoV-2 assay and Real-Q Direct detection kit have comparable clinical performance for SARS-CoV-2 for individual and pooled samples.
Keimyung Author(s)(Kor)
박성균
김도훈
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
2075-4418
Source
https://www.mdpi.com/2075-4418/13/12/2046
DOI
10.3390/diagnostics13122046
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/45201
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학)
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