Sedef Zeliha ÖNER, Büşra DÖNMEZ, İlknur KALELİ, Melek DEMİR, Ergun METE, Ahmet ÇALIŞKAN, Cagri ERGİN

Omicron varyantının RT-PCR ve hızlı antijen testi (ExacTest™ COVID-19 Antijen Hızlı Testi) ile değerlendirilmesi

Amaç: Çalışmamızda, koronavirüs hastalığı (COVID-19) şüphesi olan kişilerin örneklerinde COVID-19 hızlı antijen testi (ExacTest™ COVID-19 Antigen Rapid Test) ve gerçek zamanlı polimeraz zincir reaksiyonu (RT-PCR) testi sonuçlarının karşılaştırılması amaçlanmıştır.Gereç ve yöntem: Ocak 2022-Mart 2022 tarihleri arasında COVID-19 şüphesi ile gönderilen örneklerde eş zamanlı COVID-19 RADT (Rapid Antigen Detection Test) ve RT-PCR çalışılan 299 örnek retrospektif olarak değerlendirilmiştir. Real-Time PCR testi, DS CORONEX COVID-19 Multiplex Real Time-qPCR Test Kiti (DS Nano and Biotechnology Product Tracing and Tracking Co.,Türkiye) ile ve hızlı antijen testi immünokromatografi yöntemi ile ExacTest™ COVID-19 Antigen Rapid Test Cassette (General Diagnostica inc., California, USA) kitiyle çalışılmıştır. RADT testi sonuçları floresan immünoassay analiz cihazı (FIATEST Analyzer, Hangzhou Alltest Bıotech Co.,Ltd. China) ile değerlendirildi. Bulgular: RT-PCR testi 53 (%17,7) örnekte pozitif olarak saptanmıştır. RADT duyarlılığı 88,7 (%95 Cl 77,0-95,7), özgüllüğü 98,0 (%95 Cl 95,3-99,3), pozitif öngörü değeri 90,4 (%95 Cl 79,7-95,8), negatif öngörü değeri 97,6 (%95 Cl 95,0-98,8) ve doğruluğu 96,3 (%95 Cl 93,5-98,2) olarak bulunmuştur. 18 yaş altı ve 18 yaş ve üstü hastaların örnek duyarlılıkları sırasıyla 75 (%95 Cl 19,4-99,4), 89,8 (%95 Cl 77,8-96,6) olarak tespit edilmiştir. Semptomu olan ve olmayan hastaların duyarlılığı sırasıyla 95,5 (%95 Cl 77,2-99,9), 83,9 (%95 Cl 66,3-94,6) olarak saptanmıştır. Döngü eşiği (Ct) <20, 20-<25, 25-<30, 30-<35 olan örneklerde testin uyumu sırasıyla %100, %92,9, %78,9, %80 olarak bulunmuştur. Sonuç: Çalışılan hızlı antijen kiti dünya sağlık örgütünün önerdiği kullanılabilirlik kriterleri ile uyumludur ve semptomatik hastaların COVID-19 tanısında hızlı sonuç alınması açısından oldukça yararlıdır.

Anahtar Kelimeler:

COVID-19, RT-PCR, RADT, immünokromatografi yöntemi

Evaluation of the Omicron variant by RT-PCR and rapid antigen testing (ExacTest™ COVID-19 Antigen Rapid Test)

Purpose: The present study aims to compare the results of the COVID-19 rapid antigen test (ExacTest™ COVID-19 Antigen Rapid Test) and real-time polymerase chain reaction (RT-PCR) test in samples of people suspected of coronavirus disease (COVID-19).Materials and methods: Among the samples submitted between January 2022 and March 2022 with suspicion of COVID-19, 299 samples subject to simultaneous COVID-19 RADT (Rapid Antigen Detection Test) and RT-PCR were evaluated retrospectively. The Real-Time PCR test was studied with the DS CORONEX COVID-19 Multiplex Real time-qPCR Test Kit (DS Nano and Biotechnology Product Tracing and Tracking Co., Turkey) and the rapid antigen test was studied by the immunochromatographic method with ExacTest™ COVID-19 Antigen Rapid Test Cassette kit (General Diagnostica inc., California, USA). Ag-RDT test results were evaluated with the fluorescent immunoassay analyzer (FIATEST Analyzer, Hangzhou Alltest Biotech Co., Ltd. China). Results: RT-PCR test was positive in 53 (17.7%) samples. The RADT's sensitivity was found 88.7 (95% Cl 77.0-95.7), specificity 98.0 (95% Cl 95.3-99.3), positive predictive value 90.4 (95% Cl 79.7-95.8), negative predictive value 97.6 (95% Cl 95.0-98.8), and accuracy 96.3 (95% Cl 93.5-98.2). Sample sensitivities of patients under and over 18 years of age have been identified as 75 (95% Cl 19.4-99.4) and 89.8 (95% Cl 77.8-96.6), respectively. The sensitivity of patients with and without symptoms was 95.5 (95% Cl 77.2-99.9) and 83.9 (95% Cl 66.3-94.6), respectively. For samples with a cycle threshold (Ct) of <20, 20-<25, 25-<30 and 30-<35, the concordance of testing was 100%, 92.9%, 78.9% and 80%, respectively. Conclusion: The rapid antigen kit studied complies with the use criteria recommended by the World Health Organization and is quite useful for the rapid diagnosis of symptomatic patients in COVID-19.

Keywords:

COVID-19, RT-PCR, RADT, immunochromatography method,

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1. World Health Organization (2021). Antigen-detection in the diagnosis of SARS-CoV-2 infection: interim guidance [online]. Website https://apps.who.int/iris/handle/10665/345948 (Erişim tarihi 7 Haziran 2022)
2. World Health Organization (2021). Recommendations for national SARS-CoV-2 testing strategies and diagnostic capacities: interim guidance [online]. Website https://www.who.int/publications/i/item/WHO-2019-nCoV-lab-testing-2021.1-eng (Erişim tarihi 7 Haziran 2022)
3. Drain P, Sulaiman R, Hoppers M, Lindner NM, Lawson V, Ellis JE. Performance of the LumiraDx Microfluidic Immunofluorescence Point-of-Care SARS-CoV-2 Antigen Test in asymptomatic adults and children. Am J Clin Pathol 2022;157:602-607. doi: 10.1093/ajcp/aqab173
4. Wölfl-Duchek M, Bergmann F, Jorda A, Weber M, Müller M, Seitz T, et al. Sensitivity and specificity of SARS-COV-2 rapid antigen detection tests using oral, anterior nasal, and nasopharyngeal swabs: a diagnostic accuracy study. Microbiol Spectr 2022;10:e0202921. doi: 10.1128/spectrum.02029-21
5. Elli S, Blasi F, Brignolo B, Ceriotti F, Gori A, Piatti A, et al. Diagnostic accuracy of rapid antigen test for COVID-19 in an emergency department. Diagn Microbiol Infect Dis 2022;102:115635. doi: 10.1016/j.diagmicrobio.2022.115635
6. Jääskeläinen AE, Ahava MJ, Jokela P, Szirovicza L, Pohjala S, Vapalahti O, et al. Evaluation of three rapid lateral flow antigen detection tests for the diagnosis of SARS-CoV-2 infection. J Clin Virol 2021;137:104785. doi: 10.1016/j.jcv.2021.104785
7. Lau CS, Aw TC. Disease prevalence matters: Challenge for SARS-CoV-2 testing. Antibodies (Basel) 2021;10:50. doi: 10.3390/antib10040050
8. Khalid MF, Selvam K, Jeffry AJN, Salmi MF, Najib MA, Norhayati MN, et al. Performance of rapid antigen tests for COVID-19 diagnosis: A systematic review and meta-analysis. Diagnostics (Basel) 2022;12:110. doi: 10.3390/diagnostics12010110
9. World Health Organization (2020). SARS-CoV-2 Antigen-Detecting Rapid Diagnostic Tests: An Implementation Guide [online]. Website https://www.who.int/publications/i/item/9789240017740 (Erişim tarihi 10 Haziran 2022)
10. Turcato G, Zaboli A, Pfeifer N, Sibilio S, Tezza G, Bonora A, et al. Rapid antigen test to identify COVID-19 infected patients with and without symptoms admitted to the Emergency Department. Am J Emerg Med 2022;51:92-97. doi: 10.1016/j.ajem.2021.10.022
11. Torres I, Poujois S, Albert E, Álvarez G, Colomina J, Navarro D. Point-of-care evaluation of a rapid antigen test (CLINITESTⓇ Rapid COVID-19 Antigen Test) for diagnosis of SARS-CoV-2 infection in symptomatic and asymptomatic individuals. J Infect 2021;82:e11-2. doi: 10.1016/j.jinf.2021.02.010
12. Chiu RYT, Kojima N, Mosley GL, Cheng KK, Pereira DY, Brobeck M, et al. Evaluation of the INDICAID COVID-19 rapid antigen test in symptomatic populations and asymptomatic community testing. Microbiol Spectr 2021;9:e0034221. doi: 10.1128/Spectrum.00342-21
13. Siddiqui ZK, Chaudhary M, Robinson ML, McCall AB, Peralta R, Esteve R, et al. Implementation and accuracy of BinaxNOW Rapid Antigen COVID-19 Test in asymptomatic and symptomatic populations in a high-volume self-referred testing site. Microbiol Spectr 2021;9:e0100821. doi: 10.1128/Spectrum.01008-21
14. Mitchell SL, Orris S, Freeman T, Freeman MC, Adam M, Axe M, et al. Performance of SARS-CoV-2 antigen testing in symptomatic and asymptomatic adults: a single-center evaluation. BMC Infect Dis 2021;21:1071. doi: 10.1186/s12879-021-06716-1
15. de Michelena P, Torres I, Ramos-García Á, Gozalbes V, Ruiz N, Sanmartín A, et al. Real-life performance of a COVID-19 rapid antigen detection test targeting the SARS-CoV-2 nucleoprotein for diagnosis of COVID-19 due to the Omicron variant. J Infect 2022;84:e64-6. doi: 10.1016/j.jinf.2022.02.022
16. Albert E, Torres I, Bueno F, Huntley D, Molla E, Fernández-Fuentes MÁ, et al. Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres. Clin Microbiol Infect 2021;27:472.e7-472.e10. doi: 10.1016/j.cmi.2020.11.004
17. Favresse J, Gillot C, Oliveira M, Cadrobbi J, Elsen M, Eucher C, et al. Head-to-head comparison of rapid and automated antigen detection tests for the diagnosis of SARS-CoV-2 infection. J Clin Med 2021;10:265. doi: 10.3390/jcm10020265
18. Brümmer LE, Katzenschlager S, Gaeddert M, Erdmann C, Schmitz S, Bota M, et al. Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis. PLoS Med 2021;18:e1003735. doi: 10.1371/journal.pmed.1003735
19. 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:e1348-55. doi: 10.1093/cid/ciab303
20. Kanaujia R, Ghosh A, Mohindra R, Singla V, Goyal K, Gudisa R, et al. Rapid antigen detection kit for the diagnosis of SARS-CoV-2 - are we missing asymptomatic patients? Indian J Med Microbiol 2021;39:457-61. doi: 10.1016/j.ijmmb.2021.07.003
21. Yang YP, Huang LL, Pan SJ, Xu D, Jiesisibieke ZL, Tung TH. False-positivity results in rapid antigen tests for SARS-CoV-2: an umbrella review of meta-analyses and systematic reviews. Expert Rev Anti Infect Ther 2022;1-9. doi: 10.1080/14787210.2022.2070152