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논문 기본 정보

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저자정보
Aoki Kotaro (Department of Microbiology and Infectious Diseases Toho University School of Medicine Tokyo Japan) Takai Kunitomo (Research and Development Abbott Japan LLC Chiba Japan) Nagasawa Tatsuya (Department of Microbiology and Infectious Diseases Toho University School of Medicine Tokyo Japan) Kashiwagi Katsuhito (General Medicine and Emergency Center (Internal Medicine) Toho University Omori Medical Center Toky) Mori Nobuaki (Department of General Internal Medicine and Infectious Diseases National Hospital Organization Toky) Matsubayashi Keiji (Central Blood Institute Blood Service Headquarters Japanese Red Cross Society Tokyo Japan) Satake Masahiro (Central Blood Institute Blood Service Headquarters Japanese Red Cross Society Tokyo Japan) Tanaka Ippei (Research and Development Abbott Japan LLC Chiba Japan) Kodama Nanae (Department of Clinical Laboratory Toho University Omori Medical Center Tokyo Japan) Shimodaira Takahiro (Department of Clinical Laboratory Toho University Omori Medical Center Tokyo Japan) Ishii Yoshikazu (Department of Microbiology and Infectious Diseases Toho University School of Medicine Tokyo Japan) Miyazaki Taito (General Medicine and Emergency Center (Internal Medicine) Toho University Omori Medical Center Toky) Ishii Toshiaki (Department of Clinical Laboratory Toho University Omori Medical Center Tokyo Japan) Morita Toshisuke (Department of Laboratory Medicine Toho University School of Medicine Tokyo Japan) Yoshimura Toru (Research and Development Abbott Japan LLC Chiba Japan) Tateda Kazuhiro (Department of Microbiology and Infectious Diseases Toho University School of Medicine Tokyo Japan)
저널정보
대한진단검사의학회 Annals of Laboratory Medicine Annals of Laboratory Medicine 제41권 제6호
발행연도
2021.11
수록면
568 - 576 (9page)
DOI
10.3343/alm.2021.41.6.568

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Background: Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is generally diagnosed by reverse transcription (RT)-PCR or serological assays. The SARS-CoV-2 viral load decreases a few days after symptom onset. Thus, the RT-PCR sensitivity peaks at three days after symptom onset (approximately 80%). We evaluated the performance of the ARCHITECT® SARS-CoV-2 IgG assay (henceforth termed IgG assay; Abbott Laboratories, Lake County, IL, USA), and the combination of RT-PCR and the IgG assay for COVID-19 diagnosis. Methods: In this retrospective study, 206 samples from 70 COVID-19 cases at two hospitals in Tokyo that were positive using RT-PCR were used to analyze the diagnostic sensitivity. RT-PCR-negative (N=166), COVID-19-unrelated (N=418), and Japanese Red Cross Society (N=100) samples were used to evaluate specificity. Results: Sensitivity increased daily after symptom onset and exceeded 84.4% after 10 days. Specificity ranged from 98.2% to 100% for samples from the three case groups. Seroconversion was confirmed from 9 to 20 days after symptom onset in 18 out of 32 COVID-19 cases with multiple samples and from another case with a positive result in the IgG assay for the first available sample. Conclusions: The combination of RT-PCR and IgG assay improves the robustness of laboratory diagnostics by compensating for the limitations of each method.
#COVID-19 #SARS-CoV-2 IgG #Immunoassay #ARCHITECT® #Reverse transcription (RT)-PCR #Sensitivity #Specificity

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참고문헌 (19)

참고문헌 신청
Zhu N / 2020 / A novel coronavirus from patients with pneumonia in China, 2019 / N Engl J Med 382:727~733 google schola Lauer SA / 2020 / The incubation period of coronavirus disease 2019 (COVID-19) from publicly reported confirmed cases: estimation and application / Ann Intern Med 172:577~582 google schola Guan WJ / 2020 / Clinical characteristics of coronavirus disease 2019 in China / N Engl J Med 382:1708~1720 google schola Wang W / 2020 / Detection of SARS-CoV-2 in different types of clinical specimens / JAMA 323:1843~1844 google schola Sethuraman N / 2020 / Interpreting diagnostic tests for SARS-CoV-2 / JAMA 323:2249~2251 google schola

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