Author:
Ota Kenji,Kodama Hina,Kawamoto Yasuhide,Sasaki Daisuke,Mitsumoto-Kaseida Fujiko,Sakamoto Kei,Kosai Kosuke,Hasegawa Hiroo,Takazono Takahiro,Izumikawa Koichi,Mukae Hiroshi,Tun Mya Myat Ngwe,Morita Kouichi,Yanagihara Katsunori
Abstract
Abstract
Background
A test-based strategy against coronavirus disease 2019 (COVID-19) is one of the measures to assess the need for isolation and prevention of infection. However, testing with high sensitivity methods, such as quantitative RT-PCR, leads to unnecessary isolation, whereas the lateral flow antigen test shows low sensitivity and false negative results. The purpose of this study was to evaluate the performance of the LumiraDx SARS-CoV-2 Ag test (Lumira Ag), a rapid microfluidic immunofluorescence method, in assessing infectivity.
Methods
This study was performed from March 2022 to July 2022. A pair of nasopharyngeal swab samples were obtained from each patient with mild COVID-19. One swab was used for Lumira Ag testing, and the other for quantitative RT-PCR testing and virus culture.
Results
A total of 84 patients were included in the study. Among them, PCR, Lumira Ag test, and virus culture indicated positivity for 82, 66, and 24 patients, respectively. When comparing the Lumira Ag test to virus culture, its sensitivity was 100.0% (24/24), specificity, 30.0% (18/60); positive predictive value, 36.3% (24/66); and negative predictive value (NPV), 100.0% (18/18). The positive sample for virus culture was observed until the ninth day from the onset of symptoms, while the Lumira Ag test was observed until day 11.
Conclusions
The Lumira Ag test showed high sensitivity and NPV (100% each) compared to virus culture. A test-based strategy using the Lumira Ag test can effectively exclude COVID-19 infectiousness.
Funder
Ministry of Education, Culture, Sports, Science and Technology
Shionogi
Publisher
Springer Science and Business Media LLC
Reference30 articles.
1. Center for Disease Control and Prevention. Isolation and Precautions for People with COVID-19. Vol. 0, Center for Disease Control and Prevention. 2022. p. 7–11. Available from: https://www.cdc.gov/coronavirus/2019-ncov/your-health/isolation.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fyour-health%2Fquarantine-isolation.html. Accessed 16 Nov 2023.
2. European Centre for Disease Prevention and Control E. Guidance on quarantine of close contacts to COVID-19 cases and isolation of COVID-19 cases, in the current epidemiological situation, 7 January 2022. 2022. 2022;(January 2022). Available from: https://www.ecdc.europa.eu/en/covid-19/prevention-and-control/quarantine-and-isolation. Accessed 16 Nov 2023.
3. Boucau J, Marino C, Regan J, Uddin R, Choudhary MC, Flynn JP, et al. Duration of Shedding of Culturable Virus in SARS-CoV-2 Omicron (BA.1) Infection. N Engl J Med. 2022;387(3):275–7. Available from: http://www.nejm.org/doi/10.1056/NEJMc2202092.
4. Keske Ş, Güney-Esken G, Vatansever C, Beşli Y, Kuloğlu ZE, Nergiz Z, et al. Duration of infectious shedding of SARS-CoV-2 Omicron variant and its relation with symptoms. Clin Microbiol Infect. 2022;xxxx:7–10.
5. Takahashi K, Ishikane M, Ujiie M, Iwamoto N, Okumura N, Sato T, et al. Duration of Infectious Virus Shedding by SARS-CoV-2 Omicron Variant-Infected Vaccinees. Emerg Infect Dis. 2022;28(5):998–1001. Available from: https://wwwnc.cdc.gov/eid/article/28/5/22-0197_article.htm.