Abstract
Amaç: SARS-CoV-2 için tanı testleri, COVID-19 pandemisinde kontrol stratejisinin önemli bir bileşenidir. SARS-CoV-2 ile enfekte olmuş bireyler için erken teşhis, izolasyon ve tedavi stratejileri kritik öneme sahiptir. Lateral akış testleri (LFA) kullanılarak antijen tespiti, ucuz ve basit olmakla birlikte hızlı sonuçlar sağlar. Bu çalışmada, COVID-19 şüpheli vakalarda hızlı antijen testinin başarısını ve ayrıca tutarsız sonuçların özelliklerini belirlemek hedeflenmiştir.
Yöntemler: Ege Üniversitesi Tıp Fakültesi Hastanesi Enfeksiyon Hastalıkları ve Klinik Mikrobiyoloji Kliniği ile COVID-19 acil servisine yatırılan, 8 günden daha kısa süredir COVID-19 ilişkili semptomları olan 352 yetişkin hastadan üst solunum yolu örnekleri rutin olarak kullanılan SARS- CoV-2 RNA testi ve TOYO COVID-19 (Türklab-Türkiye)antijen testi ile değerlendirildi .
Bulgular: Akut COVID-19 vakalarından şüphelenilen 352 yetişkin hasta arasında 164 kadın ve 184 erkek mevcuttu. Hastaların yaşları 18 ile 88 arasında olup ortanca yaş 41.25 idi. Rutin olarak çalışılan SARS-CoV-2 RNA PCR testi hastaların 127'sinde (%37.1) pozitif, 225'inde (%63.9) negatif olarak saptandı. Bu hastaların nazal sürüntü örneklerinin 116'sında (%33.0) COVID-19 antijen testi pozitif ve 236'sında (%67.0) negatif saptandı. COVID-19 hızlı antijen testinin duyarlılığı ve özgüllüğü sırasıyla %89.7 ve %99 olarak saptandı.
Sonuç: Sağlık personeli için kullanımı kolay ve hızlı bir SARS-CoV-2 antijen testi, semptomatik hastalar veya çok sayıda virüs saçan asemptomatik bireyler için acil izolasyon kararı vermede yardımcı olabilir. Bu çalışmada, düşük viral yükler, yanlış negatif antijen testi sonuçlarıyla daha yakın olarak ilişkilendirilmiştir.
References
- Coutard B, Valle C, de Lamballerie X, Canard B, Seidah NG, Decroly E. The spike glycoprotein of the new coronavirus 2019-nCoV contains a furin-like cleavage site absent in CoV of the same clade. Antiviral Res 2020;176:104742.
- Kurekci Y, Gumus HH, Ezirmik H. Evaluation of clinical Symptoms, laboratory Findings, radiological characteristics and treatments of adult patients with severe COVID-19 pneumonia. Mediterr J Infect Microb Antimicrob 2021;10:64.
- Vandenberg O, Martiny D, Rochas O, van Belkum A, Kozlakidis Z. Considerations for diagnostic COVID-19 tests. Nat Rev Microbiol 2021;19(3):171–3.
- World Health Organisation Antigen-detection in the diagnosis of SARS-CoV-2 infection [updated 6 October 2021]; [cited 23 June 2022]. Available from: www.who.int/publications/i/item/antigen-detection-in-thediagnosis- of-sars-cov-2infection-using-rapid-immunoassays
- Çiçek C, Soylu M, Özarslan MA, et al. Characteristics of Laboratory-Confirmed Positive Cases in the First Year of the COVID-19 Pandemic in a University Hospital. FLORA 2021;26(3):446–59.
- Corman VM, Haage VC, Bleicker T, et al. Comparison of seven commercial SARS-CoV-2 rapid point-of-care antigen tests: a single-centre laboratory evaluation study. Lancet Microbe 2021;2(7):e311–9.
- He X, Lau EHY, Wu P, et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med 2020;26(5):672–5.
- Wölfel R, Corman VM, Guggemos W, et al. Virological assessment of hospitalized patients with COVID-2019. Nature 2020;581(7809):465–9.
- Van Kampen JJA, van de Vijver DAMC, Fraaij PLA, et al. Duration and key determinants of infectious virus induction in hospitalized patients with coronavirus disease-2019 (COVID-19). Nat Commun 2021;12(1):267.
- Kim MC, Cui C, Shin KR, et al. The duration of Culturable SARS-CoV-2 in Hospitalized Patients with COVID- 19. N Engl J Med 2021;384(7):671–3.
- Kipritci Z, Keskin AÜ, Çıragil P, Topkaya AE. Evaluation of a Visually-Read Rapid Antigen Test Kit (SGA VChek) for Detection of SARS-CoV-2 virus. Mikrobiyol Bul 2021;55(3):461–4.
- Shaikh N, Friedlander EJ, Tate PJ, et al. The performance of a Rapid SARS-CoV-2 Antigen Detection Assay in Symptomatic Children. Pediatrics 2021;148(3):e2021050832.
- Mahmoudinobar F, Britton D, Montclare JK. Protein-based lateral flow assays for COVID-19 detection. Protein Eng Des Sel 2021;34:gzab010.
- Li D, Li J. Immunologic Testing for SARS-CoV-2 Infection from the Antigen Perspective. J Clin Microbiol 2021;59(5):e02160–20.
- Schuit E, Veldhuijzen IK, Venekamp RP, et al. Diagnostic accuracy of rapid antigen tests in asymptomatic and presymptomatic close contacts of individuals with confirmed SARS-CoV-2 infection: cross-sectional study. BMJ 2021;374:n1676.
Abstract
Aim: Diagnostic testing for SARS-CoV-2 is an important component of the overall COVID-19 prevention and control strategy. Antigen detection using lateral flow assay (LFA) platforms can be performed at the point-of-care, providing quick results while being inexpensive and simple to perform. The current study sought to determine the success of a rapid antigen test in COVID-19 suspected cases, as well as the characteristics of discrepant results.
Materials and Methods: Upper respiratory samples from 352 adult patients suspected of acute COVID-19 cases with related symptoms for <8 days, who were admitted to Ege University Faculty of Medicine Department of Infectious Diseases and Department of Emergency Unit were tested routinely for SARS-CoV-2 RNA and evaluated with TOYO COVID-19 antigen test (Türklab-Turkey).
Results: There were 164 females and 184 males among the 352 adult patients (>18 years old) suspected of acute COVID-19 cases. The patients ranged in age from 18 to 88 years old, with a median age of 41.25 years. A routine test for SARS-CoV-2 RNA found positive results in 127 (37.1%) of the patients and negative results in 225 (63.9%). The COVID-19 Ag test was positive in 116(33%) of these patients' nasal swab samples and negative in 236 (67%). The sensitivity and specificity of the COVID-19 Ag test was 89.7% and 99%, respectively.
Conclusion: A rapid SARS-CoV-2 antigen test, which will be tested easily and supervised by medical personnel, could help decide for immediate isolation for patients or asymptomatic individuals that are shedding large number of viruses. In this study, lower viral loads can be strongly linked to the false negative antigen test results.
Supporting Institution
Türklab Medical Devices Company supported this study by providing test kits free of charge.
References
- Coutard B, Valle C, de Lamballerie X, Canard B, Seidah NG, Decroly E. The spike glycoprotein of the new coronavirus 2019-nCoV contains a furin-like cleavage site absent in CoV of the same clade. Antiviral Res 2020;176:104742.
- Kurekci Y, Gumus HH, Ezirmik H. Evaluation of clinical Symptoms, laboratory Findings, radiological characteristics and treatments of adult patients with severe COVID-19 pneumonia. Mediterr J Infect Microb Antimicrob 2021;10:64.
- Vandenberg O, Martiny D, Rochas O, van Belkum A, Kozlakidis Z. Considerations for diagnostic COVID-19 tests. Nat Rev Microbiol 2021;19(3):171–3.
- World Health Organisation Antigen-detection in the diagnosis of SARS-CoV-2 infection [updated 6 October 2021]; [cited 23 June 2022]. Available from: www.who.int/publications/i/item/antigen-detection-in-thediagnosis- of-sars-cov-2infection-using-rapid-immunoassays
- Çiçek C, Soylu M, Özarslan MA, et al. Characteristics of Laboratory-Confirmed Positive Cases in the First Year of the COVID-19 Pandemic in a University Hospital. FLORA 2021;26(3):446–59.
- Corman VM, Haage VC, Bleicker T, et al. Comparison of seven commercial SARS-CoV-2 rapid point-of-care antigen tests: a single-centre laboratory evaluation study. Lancet Microbe 2021;2(7):e311–9.
- He X, Lau EHY, Wu P, et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med 2020;26(5):672–5.
- Wölfel R, Corman VM, Guggemos W, et al. Virological assessment of hospitalized patients with COVID-2019. Nature 2020;581(7809):465–9.
- Van Kampen JJA, van de Vijver DAMC, Fraaij PLA, et al. Duration and key determinants of infectious virus induction in hospitalized patients with coronavirus disease-2019 (COVID-19). Nat Commun 2021;12(1):267.
- Kim MC, Cui C, Shin KR, et al. The duration of Culturable SARS-CoV-2 in Hospitalized Patients with COVID- 19. N Engl J Med 2021;384(7):671–3.
- Kipritci Z, Keskin AÜ, Çıragil P, Topkaya AE. Evaluation of a Visually-Read Rapid Antigen Test Kit (SGA VChek) for Detection of SARS-CoV-2 virus. Mikrobiyol Bul 2021;55(3):461–4.
- Shaikh N, Friedlander EJ, Tate PJ, et al. The performance of a Rapid SARS-CoV-2 Antigen Detection Assay in Symptomatic Children. Pediatrics 2021;148(3):e2021050832.
- Mahmoudinobar F, Britton D, Montclare JK. Protein-based lateral flow assays for COVID-19 detection. Protein Eng Des Sel 2021;34:gzab010.
- Li D, Li J. Immunologic Testing for SARS-CoV-2 Infection from the Antigen Perspective. J Clin Microbiol 2021;59(5):e02160–20.
- Schuit E, Veldhuijzen IK, Venekamp RP, et al. Diagnostic accuracy of rapid antigen tests in asymptomatic and presymptomatic close contacts of individuals with confirmed SARS-CoV-2 infection: cross-sectional study. BMJ 2021;374:n1676.
Details
| Primary Language | English |
|---|---|
| Subjects | Medical Microbiology (Other) |
| Journal Section | Research Articles |
| Authors | |
| Publication Date | June 12, 2023 |
| Submission Date | June 23, 2022 |
| Published in Issue | Year 2023 |