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. 2021 Dec;101(4):115490.
doi: 10.1016/j.diagmicrobio.2021.115490. Epub 2021 Jul 16.

Evaluation of automated antigen detection test for detection of SARS-CoV-2

Gannon C K Mak  1 , Stephen S Y Lau  2 , Kitty K Y Wong  2 , Nancy L S Chow  2 , C S Lau  2 , Ken H L Ng  2 , Edman T K Lam  2 , Rickjason C W Chan  2 , Dominic N C Tsang  2
Affiliations

Evaluation of automated antigen detection test for detection of SARS-CoV-2

Gannon C K Mak et al. Diagn Microbiol Infect Dis. 2021 Dec.

Abstract

RT-PCR is the gold standard to detect SARS-CoV-2, however, its capacity is limited. We evaluated an automated antigen detection (AAD) test, Elecsys SARS-CoV-2 Antigen (Roche, Germany), for detecting SARS-CoV-2. We compared the limit of detection (LOD) between AAD test, rapid antigen detection (RAD) test; SARS-CoV-2 Rapid Antigen Test (SD Biosensor, Korea), and in-house RT-PCR test. LOD results showed that the AAD test was 100 fold more sensitive than the RAD test, while the sensitivity of the AAD test was comparable to the RT-PCR test. The AAD test detected between 85.7% and 88.6% of RT-PCR-positive specimens collected from COVID-19 patients, false negative results were observed for specimens with Ct values >30. Although clinical sensitivity for the AAD test was not superior or comparable to the RT-PCR test in the present study, the AAD test may be an alternative to RT-PCR test in terms of turn-around time and throughput.

Keywords: Automated Antigen Detection; COVID-19; RT-PCR; Rapid Antigen Detection; SARS-CoV-2.

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