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Introduction: Nucleic acid amplification test such as RT-PCR of SARS-CoV-2 virus RNA has been the de fact standard diagnostic test for COVID-19. However, non-negligible false negative rate of nucleic test disturbs the quarantine of SARS-CoV-2 infected individuals for infection control of COVID-19. Methods: We conducted prevalence survey of SARS-CoV-2 by nucleic and serologic test in COVID-19 outbreak hit hospital in Japan. In the hospital employee cohort, healthcare workers (HCWs) were surveyed by the comprehensive cross-sectional nucleic acid test at outbreak. Subsequent comprehensive cross-sectional serologic test was also performed three weeks after nucleic acid test. Results: Total 537 HCWs were surveyed by nucleic acid test for SARS-CoV-2 and 42 HCWs were tested positive, and 538 HCWs were surveyed by subsequent serological test and 52 HCWs confirmed SARS-CoV-2 infection. 19.2% of SARS-CoV-2 infected HCWs were not found at outbreak. Most of nucleic acid test negative infected HCWs were less symptomatic and were not aware of contact to COVID-19 patients. Because of no awareness of contact to COVID-19 patients and no subjective symptoms, 70% of nucleic test negative infected HCWs were not quarantined and continued patient care. Conclusions: Nucleic acid test for SARS-CoV-2 lost non-negligible infected HCWs in hospital outbreak. Incomplete quarantine of silent SARS-CoV-2 infected individuals might be a possible pit hole of infection control for COVID-19. Trial Registration: This study was registered in the University Hospital Medical Information Network (UMIN) clinical trials registry in Japan (UMIN000040453). Funding Statement: This work was supported by research grants from Japan Agency for Medical Research and Development (AMED) (grant no. 18059042 and JP19ek0109307, 200705710 and JP20fk0108265, 200705079 and JP20nk0101612 to A.K.); Center of Innovation (COI) stream and Sports Research Innovation Project (SRIP) grants from the Ministry of Education, Culture, Sports, Science and Technology (MEXT) of Japan (to A.K.); grants from MEXT/Japan Society for the Promotion of Science (JSPS) KAKENHI (grant no. JP18H05282 to A.K.). Declaration of Interests: AO; personal fees: Chugai, Eli Lilly, Asahi-Kasei Pharma, Daiichi Sankyo, Bristol- Myers Squibb, Janssen, Sanofi, GlaxoSmithKline. Dr. Higa reports other from Amgen Astellas BioPharma K.K., other from Takeda Pharmaceutical Company Ltd., other from Bristol-Myers Squibb., other from Bayer Yakuhin, Ltd., outside the submitted work. Dr. Sata reports personal fees from NOVARTIS, personal fees from Otsuka Pharmaceutical, personal fees from Ono Pharmaceutical, personal fees from Eisai, personal fees from Bristol-Myers Squibb, personal fees from Takeda Pharmaceutical, personal fees from janssen, outside the submitted work. The remaining authors have no competing interests to declare. Ethics Approval Statement: The study was approved by the local Ethics Committee of DOPH. |