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Comparative Study
. 2020 Dec 10;12(12):1420.
doi: 10.3390/v12121420.

Comparison of Rapid Antigen Tests for COVID-19

Seiya Yamayoshi  1 , Yuko Sakai-Tagawa  1 , Michiko Koga  2   3 , Osamu Akasaka  4 , Ichiro Nakachi  5 , Hidefumi Koh  6 , Kenji Maeda  7 , Eisuke Adachi  3 , Makoto Saito  2   3 , Hiroyuki Nagai  3 , Kazuhiko Ikeuchi  2   3 , Takayuki Ogura  8 , Rie Baba  5 , Kensuke Fujita  8 , Takahiro Fukui  6 , Fumimaro Ito  6 , Shin-Ichiro Hattori  7 , Kei Yamamoto  9 , Takato Nakamoto  9 , Yuri Furusawa  1 , Atsuhiro Yasuhara  1 , Michiko Ujie  1 , Shinya Yamada  1 , Mutsumi Ito  1 , Hiroaki Mitsuya  7 , Norio Omagari  9 , Hiroshi Yotsuyanagi  2   3 , Kiyoko Iwatsuki-Horimoto  1 , Masaki Imai  1 , Yoshihiro Kawaoka  1   10   11
Affiliations
Comparative Study

Comparison of Rapid Antigen Tests for COVID-19

Seiya Yamayoshi et al. Viruses. .

Abstract

Reverse transcription-quantitative PCR (RT-qPCR)-based tests are widely used to diagnose coronavirus disease 2019 (COVID-19). As a result that these tests cannot be done in local clinics where RT-qPCR testing capability is lacking, rapid antigen tests (RATs) for COVID-19 based on lateral flow immunoassays are used for rapid diagnosis. However, their sensitivity compared with each other and with RT-qPCR and infectious virus isolation has not been examined. Here, we compared the sensitivity among four RATs by using severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) isolates and several types of COVID-19 patient specimens and compared their sensitivity with that of RT-qPCR and infectious virus isolation. Although the RATs read the samples containing large amounts of virus as positive, even the most sensitive RAT read the samples containing small amounts of virus as negative. Moreover, all RATs tested failed to detect viral antigens in several specimens from which the virus was isolated. The current RATs will likely miss some COVID-19 patients who are shedding infectious SARS-CoV-2.

Keywords: COVID-19; SARS-CoV-2; diagnosis; rapid antigen test.

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Conflict of interest statement

Yoshihiro Kawaoka obtained funds to organize a symposium, “Influenza and Other Infections” in 2019 from TAUNS Laboratories, Inc. Kei Yamamoto has received grant support from Fujirebio, Inc.

Figures

Figure 1
Figure 1
Results of RATs plotted based on the Cq value of RT-qPCR and days after onset. Viral antigens in 76 clinical specimens (7 gargle lavages, 27 saliva, 2 T swabs, 1 nasal vestibule swabs, 18 N swabs, 4 sputum, and 17 tracheal aspirates) were examined by Standard Q COVID-19 Ag, Espline SARS-CoV-2, QuickNavi COVID19 Ag, and ImmunoAce SARS-CoV-2. Two independent experiments were performed. All specimens were also tested by RT-qPCR and subjected to virus isolation. Open red circles indicate specimens from which virus was isolated; open black circles indicate specimens from which virus was not isolated. Circles filled in black indicate both results were positive, those filled in gray indicate that one was positive, no color indicates both were negative.
Figure 2
Figure 2
Results of RATs using N swabs and saliva specimens plotted based on the Cq value of RT-qPCR and days after onset. The results from the N swabs and saliva samples were extracted from Figure 1.
See this image and copyright information in PMC

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