Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2021 Apr 15;4(2):67-75.
doi: 10.31662/jmaj.2021-0012. Epub 2021 Apr 2.

Microbiological Testing for Coronavirus Disease 2019

Kei Yamamoto  1 , Norio Ohmagari  1
Affiliations
Review

Microbiological Testing for Coronavirus Disease 2019

Kei Yamamoto et al. JMA J. .

Abstract

Microbiological diagnosis of coronavirus disease 2019 (COVID-19) is mainly performed through nucleic acid amplification test (NAAT) and antigen test. Although NAAT is the standard diagnostic test, its use is limited by insufficient laboratory resources and long turnaround time. Point-of-care NAAT tests have been introduced to address these shortcomings, but their varied sensitivity and resource constraints remain a concern. Antigen tests require fewer resources but have low sensitivity. Nevertheless, low-sensitivity tests may be useful depending on the situation. In contrast, in some clinical phases of COVID-19, high-sensitivity tests may provide false-negative results. Therefore, the right testing strategy is needed for an accurate diagnosis. In this review, the characteristics and clinical applications of microbiological tests available in Japan (NAAT, antigen test, and antibody test) are discussed. The clinical diagnosis of COVID-19 is slightly complicated, and cases in which the infection spreads from asymptomatic infected individuals are many; hence, laboratory diagnosis is essential to prevent further transmission.

Keywords: COVID-19; Japan; antigen test; microbiological test; nucleic acid detection test.

PubMed Disclaimer

Conflict of interest statement

K.Y. received research grants from Fujirebio, Inc., Mizuho Medy, Co., Ltd., and VisGene Inc.; N.O. received grants from Sanofi Pasteur and Eiken Chemical Co., Ltd., outside the submitted work.

Figures

Figure 1.
Figure 1.
The measurement principle of real-time reverse transcription polymerase chain reaction.
Figure 2.
Figure 2.
The serological course of coronavirus disease 2019. Reproduced from Galipeau Y, Greig M, Liu G, et al. Humoral responses and serological assays in SARS-CoV-2 infections. Front Immunol. 2020;11:610688 with permission. © 2020 Galipeau, Greig, Liu, Driedger and Langlois.
Figure 3.
Figure 3.
Repeat testing strategy for the patients of coronavirus disease 2019 who need aiding in therapeutic intervention. NAAT, nucleic acid amplification tests; BALF, bronchoalveolar lavage fluid. *Consider antibody testing, if necessary.
See this image and copyright information in PMC

References

    1. NIID-J. Validation of SARS-CoV-2 gene testing method in which clinical evaluation results were obtained using clinical specimens [Internet]. [updated 2020 Oct 23; cited 2001 Jan 25]. Available from: https://www.niid.go.jp/niid/images/lab-manual/2019-nCoV-17-current.pdf. Japanese.
    1. MHLW. List of authorized In Vitro Diagnostics (IVDs) for COVID-19 [Internet]. [updated 2001 Jan 22; cited 2021 Jan 25]. Available from: https://www.mhlw.go.jp/stf/newpage_11332.html.
    1. Hanson KE, Caliendo AM, Arias CA, et al. The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: molecular diagnostic testing. Clin Infect Dis. 2021;ciab048. - PMC - PubMed
    1. MHLW. Guideline on the diagnosis of COVID-19, 3rd ed [Internet]. [cited 2021 Jan 25]. Available from: https://www.mhlw.go.jp/content/000725966.pdf. Japanese.
    1. Meister TL, Brüggemann Y, Todt D, et al. Virucidal efficacy of different oral rinses against severe acute respiratory syndrome coronavirus 2. J Infect Dis. 2020;222(8):1289-92. - PMC - PubMed

LinkOut - more resources