Evaluation of four commercial severe acute respiratory coronavirus 2 antibody tests |
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| Authors: | Nobuyuki Ashizawa Takahiro Takazono Kaname Ohyama Yoji Nagasaki Masaki Okamoto Tatsuro Hirayama Kensuke Takahashi Hirotomo Yamanashi Masato Tashiro Naoki Hosogaya Takeshi Tanaka Kazuko Yamamoto Yuichi Fukuda Yoshifumi Imamura Toshinori Kawanami Taiga Miyazaki Toyomitsu Sawai Kiyoyasu Fukushima Hiroshi Mukae |
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| Affiliation: | 1. Department of Respiratory Medicine, Nagasaki University Hospital, Nagasaki, Japan;2. Department of Infectious Diseases, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan;3. Department of Pharmacy Practice, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan;4. Division of Infectious Diseases, Clinical Research Institute, National Hospitalization Organization, Kyushu Medical Center, Fukuoka, Japan;5. Department of Respiratory Medicine, Clinical Research Institute, National Hospitalization Organization, Kyushu Medical Center, Fukuoka, Japan;6. Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan;7. Department of Clinical Medicine, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan;8. Department of General Medicine, Nagasaki University Hospital, Nagasaki, Japan;9. Infection Control and Education Center, Nagasaki University Hospital, Nagasaki, Japan;10. Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan;11. Department of Respiratory Medicine, Sasebo City General Hospital, Sasebo, Japan;12. Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan;13. Department of Respiratory Medicine, Nagasaki Harbor Medical Center, Nagasaki, Japan;14. Department of Respiratory Medicine, Japanese Red Cross Nagasaki Genbaku Isahaya Hospital, Isahaya, Japan;15. Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan |
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| Abstract: | IntroductionNumerous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests exists commercially; however, their performance using clinical samples is limited. Although insufficient to detect SARS-CoV-2 in the early phase of infection, antibody assays can be of great use for surveillance studies or for some coronavirus disease 2019 (COVID-19) patients presenting late to the hospital.MethodsThis study evaluated the sensitivity and specificity of four commercial SARS-CoV-2 lateral flow antibody tests using 213 serum specimens from 90 PCR-positive confirmed COVID-19 patients. Of 59 negative control sera, 50 were obtained from patients with other respiratory infectious diseases before COVID-19 pandemic began while nine were from patients infected with other respiratory viruses, including two seasonal coronaviruses.ResultsThe varied sensitivities for the four commercial kits were 70.9%, 65.3%, 45.1%, and 65.7% for BioMedomics, Autobio Diagnostics, Genbody, and KURABO, respectively, between sick days 1 and 155 in COVID-19 patients. The sensitivities of the four tests gradually increased over time after infection before sick day 5 (15.0%, 12.5%, 15.0%, and 20.0%); from sick day 11–15 (95.7%, 87.2%, 53.2%, and 89.4%); and after sick day 20 (100%, 100%, 68.6%, and 96.1%), respectively. For severe illness, the sensitivities were quite high in the late phase after sick day 15. The specificities were over 96% for all four tests. No cross-reaction due to other pathogens, including seasonal coronaviruses, was observed.ConclusionsOur results demonstrated the large differences in the antibody test performances. This ought to be considered when performing surveillance analysis. |
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| Keywords: | SARS-CoV-2 COVID-19 IgM IgG Antibody tests |
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