Rapid Antigen Tests for COVID-19: Are Their Specificity, Sensivity and Accuracy Sufficient?
Yıl 2023,
Cilt: 9 Sayı: 3, 387 - 393, 31.08.2023
Hulya Sinan
,
Emel Uzunoğlu
,
Mediha Uğur
,
Esin Avci
,
Cihangir Akdemir
,
Şahin Direkel
Öz
Objective: The aim of our study was to determine the sensitivity and specificity of rapid antigen and Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) tests which are widely used today in patients presenting with Covid-19 complaints and to evaluate these tests’ routine usability.
Methods: Two samples were taken from oropharyngeal and nasopharyngeal from 100 patients (50 women, 50 men) who applied to the Covid-19 outpatient clinic of our hospital between April and May 2022. The patients attended to the study were volunteers between the ages of 18-90. One of the samples was studied with the BNG SARS-CoV-2 Antigen Rapid Test (Saliva) and evaluated with the naked eye after 15 minutes according to the company's recommendations. The other sample was studied with RT-PCR on BIO-RAD CFX Real Time System with DSCoronex Covid-19 QPCR Test Kit. The epidemiological data and clinical conditions of the patients were determined by questionnaires. The age, gender, symptoms (fever, cough, headache, diarrhea, sore throat, shortness of breath, loss of taste and smell, myalgia) of the patient and the day of the symptoms were noted down.
Results: It is known that technically rapid antigen tests generally have lower sensitivity and higher specificity than RT-PCR. In our study, the sensitivity was 71% and the specificity was 100%. The Accuracy (Diagnostic Value) rate of the rapid antigen test was determined as 90%. Our results suggest that rapid antigen tests are inexpensive and practical tests to reduce transmission, especially in epidemics however they should be selected carefully by the health care authorities.
Conclusion: The prevalence of self-reported FA based on web-based survey in Eastern Black Sea residents is relatively high and specific to the region.
Destekleyen Kurum
There was no special support
Kaynakça
- 1. WHO. Antigen detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays. Interim Guidance 06 Ocrober 2021. Available from:URL: https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays
- 2. CDC. Interim Guidance for Antigen Testing for SARS-CoV-2. Güncelleme: 4 Nisan 2022. Available from:URL: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html#table1
- 3. FDA. In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 Available from:URL: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- 4. European Centre for Disease Prevention and Control. COVID-19. Options fot the use of rapid antigen tests for COVID-19 in the EU/EEA-first update. 26 Oct 2012. Available from:URL: https://www.ecdc.europa.eu/en/publications-data/options-use-rapid-antigen-tests-covid-19-eueea-first-update
- 5. Shreffler J, Huecker MR. Diagnostic Testing Accuracy: Sensitivity, Specificity, Predictive Values and Likelihood Ratios. StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557491/
- 6. Dinnes J, Deeks JJ, Berhane S, Taylor M, Adriano A, Davenport C, et al. Rapid, point‐of‐care antigen and molecular‐based tests for diagnosis of SARS‐CoV‐2 infection. Cochrane Database Syst Rev, 2021;3:1-412. doi: 10.1002/14651858.CD013705
- 7. Togay A, Yılmaz N, SARS-CoV-2’nin Laboratuvar Tanısı. Tepecik Egit. Arast. Hast. Derg, 2020;30:70-5. doi: 10.5222/terh.2020.13007
- 8. Scohy A, Anantharajah A, Bodéus M, Kabamba-Mukadi B, Verroken A, Rodriguez-Villalobos H, Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J ClinVirol, 2020 doi: 10.1016/j.jcv.2020.104455
- 9. Porte L, Legarraga P, Vollrath V, Aguilera X, Munita JM, Araos R, et al. Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples. Int J Infect Dis, 2020;99:328-33. doi: 10.1016/j.ijid.2020.05.098.
- 10. Takeuchi Y, Akashi Y, Kato D, Kuwahara M, Muramatsu S, Ueda A, et al. The evaluation of a newly developed antigen test (QuickNavi™ COVID19 Ag) for SARS-CoV-2: A prospective observational study in Japan J Infect Chemother, 2021;27(6):890-94. doi: 10.1016/j.jiac.2021.02.029
- 11. Ristić M, Nikolić N, Čabarkapa V, Turkulov V, Petrović V, Validation of the STANDARD Q COVID-19 antigen test in Vojvodina, Serbia. PLoSOne, 2021;16(2):1-13. doi: 10.1371/journal.pone.0247606
- 12. Mak GC, Cheng PK, Lau SS, Wong KK, Lau CS, Lam ET, et al. Evaluation of rapid antigen test for detection of SARS-CoV-2 virus. J ClinVirol, 2020;129(104500):1-4.
- 13. Ford L, Lee C, Pray IW, Cole D, Bigouette JP, Abedi GR, et al. Epidemiologic Characteristics Associated With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen-Based Test Results, Real-Time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) Cycle Threshold Values, Subgenomic RNA, and Viral Culture Results From University Testing. Clin Infect Dis, 2021;73(6):1348-55. doi: 10.1093/cid/ciab303.
Yıl 2023,
Cilt: 9 Sayı: 3, 387 - 393, 31.08.2023
Hulya Sinan
,
Emel Uzunoğlu
,
Mediha Uğur
,
Esin Avci
,
Cihangir Akdemir
,
Şahin Direkel
Kaynakça
- 1. WHO. Antigen detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays. Interim Guidance 06 Ocrober 2021. Available from:URL: https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays
- 2. CDC. Interim Guidance for Antigen Testing for SARS-CoV-2. Güncelleme: 4 Nisan 2022. Available from:URL: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html#table1
- 3. FDA. In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 Available from:URL: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- 4. European Centre for Disease Prevention and Control. COVID-19. Options fot the use of rapid antigen tests for COVID-19 in the EU/EEA-first update. 26 Oct 2012. Available from:URL: https://www.ecdc.europa.eu/en/publications-data/options-use-rapid-antigen-tests-covid-19-eueea-first-update
- 5. Shreffler J, Huecker MR. Diagnostic Testing Accuracy: Sensitivity, Specificity, Predictive Values and Likelihood Ratios. StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557491/
- 6. Dinnes J, Deeks JJ, Berhane S, Taylor M, Adriano A, Davenport C, et al. Rapid, point‐of‐care antigen and molecular‐based tests for diagnosis of SARS‐CoV‐2 infection. Cochrane Database Syst Rev, 2021;3:1-412. doi: 10.1002/14651858.CD013705
- 7. Togay A, Yılmaz N, SARS-CoV-2’nin Laboratuvar Tanısı. Tepecik Egit. Arast. Hast. Derg, 2020;30:70-5. doi: 10.5222/terh.2020.13007
- 8. Scohy A, Anantharajah A, Bodéus M, Kabamba-Mukadi B, Verroken A, Rodriguez-Villalobos H, Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J ClinVirol, 2020 doi: 10.1016/j.jcv.2020.104455
- 9. Porte L, Legarraga P, Vollrath V, Aguilera X, Munita JM, Araos R, et al. Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples. Int J Infect Dis, 2020;99:328-33. doi: 10.1016/j.ijid.2020.05.098.
- 10. Takeuchi Y, Akashi Y, Kato D, Kuwahara M, Muramatsu S, Ueda A, et al. The evaluation of a newly developed antigen test (QuickNavi™ COVID19 Ag) for SARS-CoV-2: A prospective observational study in Japan J Infect Chemother, 2021;27(6):890-94. doi: 10.1016/j.jiac.2021.02.029
- 11. Ristić M, Nikolić N, Čabarkapa V, Turkulov V, Petrović V, Validation of the STANDARD Q COVID-19 antigen test in Vojvodina, Serbia. PLoSOne, 2021;16(2):1-13. doi: 10.1371/journal.pone.0247606
- 12. Mak GC, Cheng PK, Lau SS, Wong KK, Lau CS, Lam ET, et al. Evaluation of rapid antigen test for detection of SARS-CoV-2 virus. J ClinVirol, 2020;129(104500):1-4.
- 13. Ford L, Lee C, Pray IW, Cole D, Bigouette JP, Abedi GR, et al. Epidemiologic Characteristics Associated With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen-Based Test Results, Real-Time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) Cycle Threshold Values, Subgenomic RNA, and Viral Culture Results From University Testing. Clin Infect Dis, 2021;73(6):1348-55. doi: 10.1093/cid/ciab303.