Accuracy of Rapid Antigen Screening Tests for SARS-CoV-2 Infection at Correctional Facilities in Korea: March - May 2022
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Background: The number of confirmed cases of individuals with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection increased rapidly due to the Omicron variant. Correctional facilities are vulnerable to infectious diseases, and they introduced rapid antigen tests (RATs) to allow for early detection and rapid response. We aimed to evaluate the diagnostic performance and usefulness of SARS-CoV-2 RATs in newly incarcerated people. Materials and Methods: We conducted a cross-sectional study at correctional facilities in Korea from 9 March to 22 May 2022. The study population was newly incarcerated people who were divided into two groups. In one group, 799 paired SARS-CoV-2 RATs and real-time polymerase chain reaction (RT-PCR) were conducted simultaneously in 522 individuals in March 2022. In the other group, 4,034 paired RATs and RT-PCR consecutively in 4,034 participants; only individuals with negative RATs results underwent RT-PCR from April to May 2022. We analyzed data using descriptive statistics and a logistic regression model. Results: Among the 799 specimens in March, RT-PCR was positive in 72 (9.0%), and among the 4,034 specimens in April - May 2022, RT-PCR was positive in 40 (1.0%). Overall, the RATs had a sensitivity of 58.3%, specificity of 100.0%, positive predictive value (PPV) of 100.0%, and negative predictive value (NPV) of 96.0%. Asymptomatic individuals constituted 98.2% of the study group, and symptomatic individuals 1.8%. In asymptomatic cases, the sensitivity of RATs was 52.5%, specificity was 100.0%, PPV was 100.0%, and NPV was 96.3%. In symptomatic cases, the sensitivity of RATs was 84.6%, specificity was 100.0%, PPV was 100.0%, and NPV was 33.3%. Sensitivity (P = 0.034) and NPV (P = 0.004) differed significantly according to the presence and absence of symptoms, and the F1 score was the highest at 0.9 in symptomatic individuals in March. There was a positive linear trend in the proportion of false-negative RATs in newly incarcerated people following the weekly incidence of SARS-CoV-2 (P = 0.033). The best-associated predictors of RATs for SARS-CoV-2 infection involved symptoms, timing of sample collection, and repeat testing. Conclusion: Sensitivity and NPV significantly depend on whether symptoms are present, and the percentage of false negatives is correlated with the incidence. Thus, using RATs should be adjusted according to the presence or absence of symptoms and the incidence of SARS-CoV-2 infection in the community. RATs could be a useful screening tool as an effective first-line countermeasure because they can rapidly identify infectious patients and minimize SARS-CoV-2 transmission in correctional facilities.
Abstract
Background: The number of confirmed cases of individuals with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection increased rapidly due to the Omicron variant. Correctional facilities are vulnerable to infectious diseases, and they introduced rapid antigen tests (RATs) to allow for early detection and rapid response. We aimed to evaluate the diagnostic performance and usefulness of SARS-CoV-2 RATs in newly incarcerated people. Materials and Methods: We conducted a cross-sectional study at correctional facilities in Korea from 9 March to 22 May 2022. The study population was newly incarcerated people who were divided into two groups. In one group, 799 paired SARS-CoV-2 RATs and real-time polymerase chain reaction (RT-PCR) were conducted simultaneously in 522 individuals in March 2022. In the other group, 4,034 paired RATs and RT-PCR consecutively in 4,034 participants; only individuals with negative RATs results underwent RT-PCR from April to May 2022. We analyzed data using descriptive statistics and a logistic regression model. Results: Among the 799 specimens in March, RT-PCR was positive in 72 (9.0%), and among the 4,034 specimens in April - May 2022, RT-PCR was positive in 40 (1.0%). Overall, the RATs had a sensitivity of 58.3%, specificity of 100.0%, positive predictive value (PPV) of 100.0%, and negative predictive value (NPV) of 96.0%. Asymptomatic individuals constituted 98.2% of the study group, and symptomatic individuals 1.8%. In asymptomatic cases, the sensitivity of RATs was 52.5%, specificity was 100.0%, PPV was 100.0%, and NPV was 96.3%. In symptomatic cases, the sensitivity of RATs was 84.6%, specificity was 100.0%, PPV was 100.0%, and NPV was 33.3%. Sensitivity (P = 0.034) and NPV (P = 0.004) differed significantly according to the presence and absence of symptoms, and the F1 score was the highest at 0.9 in symptomatic individuals in March. There was a positive linear trend in the proportion of false-negative RATs in newly incarcerated people following the weekly incidence of SARS-CoV-2 (P = 0.033). The best-associated predictors of RATs for SARS-CoV-2 infection involved symptoms, timing of sample collection, and repeat testing. Conclusion: Sensitivity and NPV significantly depend on whether symptoms are present, and the percentage of false negatives is correlated with the incidence. Thus, using RATs should be adjusted according to the presence or absence of symptoms and the incidence of SARS-CoV-2 infection in the community. RATs could be a useful screening tool as an effective first-line countermeasure because they can rapidly identify infectious patients and minimize SARS-CoV-2 transmission in correctional facilities.
참고문헌 (40)
- Fernandez-Montero A, "Validation of a rapid antigen test as a screening tool for SARS-CoV-2 infection in asymptomatic populations. Sensitivity, specificity and predictive values", EClinicalMedicine, 37, pp.100954~ (2021)
- "Options for the use of rapid antigen tests for COVID-19 in the EU/EEA and the UK" (2020)[URL]
- "Overview of testing for SARS-CoV-2, the virus that cause COVID-19" (2022)[URL]
- Vashist SK, "In vitro diagnostic assays for COVID-19 : recent advances and emerging trends", Diagnostics(Basel), 10, pp.202~ (2020)
- "Coronavirus infectious disease-19 outbreak in Korea (January 31, 2022, press release)" (2022)[URL]
- "Coronavirus infectious disease-19 outbreak in Korea (March 14, 2022, press release)" (2022)[URL]
- Korean Society for Preventive Medicine, "Preventive Medicine and Public Health", pp.151~ (2021), Gyechuk Culture Publishing
- Verde P, "Diagnostic accuracy of a SARS-CoV-2 rapid antigen test among military and civilian personnel of an Air Force airport in central Italy", PLoS One, 17, pp.e0277904~ (2022)
- Kweon Oh Joo, "Positivity of Rapid Antigen Testing for SARS-CoV-2 With Serial Followed-up Nasopharyngeal Swabs in Hospitalized Patients due to COVID-19", Journal of Korean Medical Science, 37(21), pp.1~6 (2022), 대한의학회[DOI]
- Kweon Oh Joo, "Real-World Accuracy of a SARS-CoV-2 Rapid Diagnostic Tests in the Republic of Korea", Journal of Korean Medical Science, 37(43), pp.1~4 (2022), 대한의학회[DOI]
- Lee H, "Diagnostic performance of the rapid antigen test as a screening tool for SARS-CoV-2 infection in the emergency department", J Pers Med, 12, pp.1172~ (2022)
- "Guidance on management of COVID-19 in homeless service sites and in correctional and detention facilities" (2023)[URL]
- "Changes in the criminal justice system in the post-corona era (II) -changes in corrections and probation during the pandemic and adaptation to new trend" (2022)[URL]
- "Countermeasures to prevent the spread of infectious diseases in correctional facilities (January 20, 2021, press release)" (2021)[URL]
- "Correctional facility COVID-19 outbreak and quarantine management status (August 3, 2021, press release)" (2021)[URL]
- "Coronavirus infectious disease-19 outbreak in Korea (April 24, 2022, press release)" (2022)[URL]
- "Coronavirus infectious disease-19 outbreak in Korea (May 1, 2022, press release)" (2022)[URL]
- "Coronavirus infectious disease-19 outbreak in Korea (May 8, 2022, press release)" (2022)[URL]
- "Coronavirus infectious disease-19 outbreak in Korea (May 15, 2022, press release)" (2022)[URL]
- "Coronavirus infectious disease-19 outbreak in Korea (May 22, 2022, press release)" (2022)[URL]
- "Coronavirus infectious disease-19 outbreak in Korea (May 29, 2022, press release)" (2022)[URL]
- Schrom J, "Comparison of SARS-CoV-2reverse transcriptase polymerase chain reaction and BinaxNOW rapid antigen tests at a community site during an Omicron surge : a cross-sectional study", Ann Intern Med, 175, pp.682~690 (2022)
- Dinnes J, "Rapid, pointof-care antigen tests for diagnosis of SARS-CoV-2 infection", Cochrane Database Syst Rev, 7, pp.CD013705~ (2022)
- Farhana A, "Diagnostic utility and performance of rapid antigen test in SARS CoV-2 in symptomatic and asymptomatic patients during the second pandemic wave in Kashmir, North India", Indian J Med Microbiol, 40, pp.572~576 (2022)
- Peeling RW, "Scaling up COVID-19 rapid antigen tests : promises and challenges", Lancet Infect Dis, 21, pp.e290~5 (2021)
- Khalid MF, "Performance of rapid antigen tests for COVID-19diagnosis : a systematic review and meta-analysis", Diagnostics(Basel), 12, pp.110~ (2022)
- Prestedge J, "The performance of rapid antigen tests against SARS-CoV-2 variants", Lancet Infect Dis, 23, pp.883~884 (2023)
- Seymen AA, "Clinical evaluation of DIAGNOVIR SARS-CoV-2ultra-rapid antigen test performance compared to PCR-based testing", Sci Rep, 13, pp.4438~ (2023)
- Polechová J, "SARS-CoV-2 rapid antigen tests provide benefits for epidemic control-observations from Austrian schools", J Clin Epidemiol, 145, pp.14~19 (2022)
- Leiner J, "SARSCoV-2 rapid antigen testing in the healthcare sector : a clinical prediction model for identifying false negative results", Int J Infect Dis, 112, pp.117~123 (2021)
- "Considerations for SARS-CoV-2 antigen testing for healthcare providers testing individuals in the community" (2022)[URL]
- "Options for the use of rapid antigen detection tests for COVID-19in the EU/EEA and the UK – First update" (2021)[URL]
- "Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays" (2022)[URL]
- Alemany A, "Analytical and clinical performance of the panbio COVID-19 antigen-detecting rapid diagnostic test", J Infect, 82, pp.186~230 (2021)
- Saloner B, "COVID-19cases and deaths in federal and state prisons", JAMA, 324, pp.602~603 (2020)
- Natoli LJ, "Incarceration and COVID-19 : Recommendations to curb COVID-19 disease transmission in prison facilities and surrounding communities", Int J Environ Res Public Health, 18, pp.9790~ (2021)
- Beaudry G, "Managing outbreaks of highly contagious diseases in prisons : a systematic review", BMJ Glob Health, 5, pp.e003201~ (2020)
- "Survey on the right to health of detainees in detention facilities" (2016)[URL]
- Choi Sejin, "High Prevalence of Human Immunodeficiency Virus Infection among Inmates in Korean Correctional Facilities", Journal of Korean Medical Science, 36(14), pp.1~5 (2021), 대한의학회[DOI]
- Stufano A, "Efficacy of the measures adopted to prevent COVID-19 outbreaks in an Italian correctional facility for inmates affected by chronic diseases", Front Public Health, 9, pp.694795~ (2021)