Öz
Giriş: Şiddetli akut solunum sendromu-Koronavirüs-2 (SARS-CoV-2) enfeksiyonunun tanısında altın standart yöntem olarak gerçek zamanlı ters transkripsiyon polimeraz zincir reaksiyonu (RT-PZR) önerilmektedir. Ancak bu yöntem zaman alıcı ve pahalı olması, özel laboratuvar koşulları ve deneyimli personel gereksinimi gibi dezavantajlara sahiptir. Bu nedenle, daha hızlı ve gerçekleştirilmesi daha kolay antijen tespit eden hızlı tanı testlerinin (Ag-RDT’ler) tanısal önemi artmıştır. Yerinde uygulama ve hızlı geri dönüş süresiyle Ag-RDT’ler hızlı izolasyon sağlayarak bulaşma riskini en aza indirir. Bu çalışmanın amacı Mö-Screen Corona Antigen Testi (MöLab, Langenfeld, Almanya) ve gerçek zamanlı RT-PZR sonuçlarının karşılaştırılmasıdır.
Gereç ve Yöntem: Ocak-Mart 2022 tarihleri arasında 863 farklı hastadan alınan nazofaringeal sürüntü çalışmaya dahil edildi. Tüm sürüntü örneklerinde Mö-Screen Corona Antigen Testi ile SARS-CoV-2 antijeni arandı. Aynı zamanda bu hastaların 417’sinin iki gün içinde elde edilmiş SARS-CoV-2 gerçek zamanlı RT-PZR sonuçları mevcuttu.
Bulgular: Gerçek zamanlı-PZR ve Ag-RDT sonuçları %96,2 uyumlu bulunmuştur. Ag-RDT için duyarlılık ve özgüllük değerleri sırasıyla %84,8 ve %100 olarak belirlenmiştir. Ct değeri <25 olan örneklerde duyarlılığın %92’ye yükseldiği belirlenmiştir.
Sonuç: Mö-Screen Corona Antigen Test (MöLab, Langenfeld, Almanya) sonuçları göz önüne alındığında, özgüllüğü ve duyarlılığı yüksek olan bu Ag-RDT testinin, SARS-CoV-2 tanısında gerçek zamanlı RT-PZR’ye bir alternatif olabileceği düşünülmektedir.
Anahtar Kelimeler: SARS-CoV-2, antijen testi, COVID-19
Kaynakça
Zhang JJ, Dong X, Liu GH, Gao YD. Risk and Protective Factors for COVID-19 Morbidity, Severity, and Mortality. Clin Rev Allergy Immunol. 2023;64:90-107.
Hirotsu Y, Maejima M, Shibusawa M, Nagakubo Y, Hosaka K, Amemiya K, Sueki H, Hayakawa M, Mochizuki H, Tsutsui T, Kakizaki Y, Miyashita Y, Yagi S, Kojima S, Omata M. Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients. Int J Infect Dis. 2020;99:397-402.
World Health Organization (WHO) Coronavirus (COVID-19) Dashboard 2022. Last Accessed Date: 2022 March 10. Available from: https://covid19. who.int/
Li R, Pei S, Chen B, Song Y, Zhang T, Yang W, Shaman J. Substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS-CoV-2). Science. 2020;368:489-93.
Villaverde S, Domínguez-Rodríguez S, Sabrido G, Pérez-Jorge C, Plata M, Romero MP, Grasa CD, Jiménez AB, Heras E, Broncano A, Núñez MDM, Illán M, Merino P, Soto B, Molina-Arana D, Bermejo A, Mendoza P, Gijón M, Pérez-Moneo B, Moraleda C, Tagarro A; Epidemiological Study of COVID-19 in Children of the Spanish Society of Pediatric (EPICO-AEP) Working Group. Diagnostic Accuracy of the Panbio Severe Acute Respiratory Syndrome Coronavirus 2 Antigen Rapid Test Compared with Reverse-Transcriptase Polymerase Chain Reaction Testing of Nasopharyngeal Samples in the Pediatric Population. J Pediatr. 2021;232:287-9.
Sümbül B, Doymaz M. Microbiological Diagnosis of COVID-19. Bezmiâlem Science. 2021;9:55-60.
Clerc O, Greub G. Routine use of point-of-care tests: usefulness and application in clinical microbiology. Clin Microbiol Infect. 2010;16:1054-61.
Lai CC, Wang CY, Ko WC, Hsueh PR. In vitro diagnostics of coronavirus disease 2019: Technologies and application. J Microbiol Immunol Infect. 2021;54:164-74.
Wurtz N, Lacoste A, La Scola B. Real-time detection of Covid-19 positive persons using sniffer dog. Infect Dis (Lond). 2022;54:384-6.
Ricks S, Kendall EA, Dowdy DW, Sacks JA, Schumacher SG, Arinaminpathy N. Quantifying the potential value of antigen-detection rapid diagnostic tests for COVID-19: a modelling analysis. BMC Med. 2021;19:75.
World Health Organization (WHO) COVID-19: Laboratory and diagnosis, interim guidance - Antigen-detection in the diagnosis of SARS-CoV-2 infection. [Last accessed date: 2022 May 25]. Available from: https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2-infection-using-rapid-immunoassays
Mane A, Jain S, Jain A, Pereira M, Sirsat A, Pathak G, Bhoi V, Bhavsar S, Panda S. Diagnostic performance of oral swab specimen for SARS-CoV-2 detection with rapid point-of-care lateral flow antigen test. Sci Rep. 2022;12:7355.
Ollier Q, Pillet S, Mory O, Gagnaire J, Thuiller C, Annino N, Gagneux- Brunon A, Botelho-Nevers E, Bourlet T, Pozzetto B, Cantais A. Prospective evaluation of the point-of-care use of a rapid antigenic SARS-CoV-2 immunochromatographic test in a paediatric emergency department. Clin Microbiol Infect. 2022;28:734.e1-6.
Akashi Y, Horie M, Takeuchi Y, Togashi K, Adachi Y, Ueda A, Notake S, Nakamura K, Terada N, Kurihara Y, Kiyasu Y, Suzuki H. A prospective clinical evaluation of the diagnostic accuracy of the SARS-CoV-2 rapid antigen test using anterior nasal samples. J Infect Chemother. 2022;28:780-5.
Bornemann L, Dähne T, Fomenko A, Kaup O, Kleideiter J, Kulis-Horn R, Ruprecht B, Wehmeier M, Panning M. Performance of the Sofia SARS-CoV-2 rapid antigen test as frontline test in a university hospital, Germany. Diagn Microbiol Infect Dis. 2022;103:115663.
Cattelan AM, Sasset L, Zabeo F, Ferrari A, Rossi L, Mazzitelli M, Cocchio S, Baldo V. Rapid Antigen Test LumiraDxTM vs. Real Time Polymerase Chain Reaction for the Diagnosis of SARS-CoV-2 Infection: A Retrospective Cohort Study. Int J Environ Res Public Health. 2022;19:3826.
Cirit OS, Mutlu E, Sancak B, Kocagöz T, Can Ö, Çicek C, Arzu Sayiner A, Appak Ö, Uyar NY, Külah C, Çiçek AÇ, Özgümüs OB, Ay Altintop Y, Saatçi E, Karsligil T, Zer Y, Özen NS, Çekin Y, Karahan ZC, Evren E, Karakoç AE, Orhan SG, Mutlu D, Bozdemir T, Çayci YT, Çinar C, Tasbakan M, Mert M, Çinar E, Kutsoylu OÖE, Kocagöz S, Ertürk A, Çelik I, Mete AÖ, Günalp Eneyli M, Akdemir I, Karakök T, Inan D, Atilla A, Taflan ŞO, Yörük KE. Comparison of a novel antigen detection test with reverse transcription polymerase chain reaction assay for laboratory diagnosis of SARS-CoV-2 infection. Infection. 2023;51:91-6.
World Health Organization (WHO) COVID-19: Laboratory and diagnosis, interim guidance - Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing. Last Accessed Date: 2022 May 29. Available from: https://www.who.int/publications/i/item/WHO-2019-nCoV-Ag-RDTs-Self_testing-2022.1
Pray IW, Ford L, Cole D, Lee C, Bigouette JP, Abedi GR, Bushman D, Delahoy MJ, Currie D, Cherney B, Kirby M, Fajardo G, Caudill M, Langolf K, Kahrs J, Kelly P, Pitts C, Lim A, Aulik N, Tamin A, Harcourt JL, Queen K, Zhang J, Whitaker B, Browne H, Medrzycki M, Shewmaker P, Folster J, Bankamp B, Bowen MD, Thornburg NJ, Goffard K, Limbago B, Bateman A, Tate JE, Gieryn D, Kirking HL, Westergaard R, Killerby M; CDC COVID-19 Surge Laboratory Group. Performance of an Antigen-Based Test for Asymptomatic and Symptomatic SARS-CoV-2 Testing at Two University Campuses - Wisconsin, September-October 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1642-7.
He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, Lau YC, Wong JY, Guan Y, Tan X, Mo X, Chen Y, Liao B, Chen W, Hu F, Zhang Q, Zhong M, Wu Y, Zhao L, Zhang F, Cowling BJ, Li F, Leung GM. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020;26:672-5. Erratum in: Nat Med. 2020;26:1491-3.
Bayram G, Gülbudak H, Bekçi A, Tezcan Ülger S, Yapıcı G, Aslan G. Evaluation of Real-Time PCR Cycle Threshold Value, Clinical and Epidemiological Characteristics of SARS-CoV-2 Positive Healthcare Workers. Turk Hij Den Biyol Derg. 2022;79:13-24.
Drain PK. Rapid Diagnostic Testing for SARS-CoV-2. N Engl J Med. 2022;386:264-72.
Arons MM, Hatfield KM, Reddy SC, Kimball A, James A, Jacobs JR, Taylor J, Spicer K, Bardossy AC, Oakley LP, Tanwar S, Dyal JW, Harney J, Chisty Z, Bell JM, Methner M, Paul P, Carlson CM, McLaughlin HP, Thornburg N, Tong S, Tamin A, Tao Y, Uehara A, Harcourt J, Clark S, Brostrom-Smith C, Page LC, Kay M, Lewis J, Montgomery P, Stone ND, Clark TA, Honein MA, Duchin JS, Jernigan JA; Public Health–Seattle and King County and CDC COVID-19 Investigation Team. Presymptomatic SARS-CoV-2 Infections and Transmission in a Skilled Nursing Facility. N Engl J Med. 2020;382:2081-90.
La Scola B, Le Bideau M, Andreani J, Hoang VT, Grimaldier C, Colson P, Gautret P, Raoult D. Viral RNA load as determined by cell culture as a management tool for discharge of SARS-CoV-2 patients from infectious disease wards. Eur J Clin Microbiol Infect Dis. 2020;39:1059-61.
Singanayagam A, Patel M, Charlett A, Lopez Bernal J, Saliba V, Ellis J, Ladhani S, Zambon M, Gopal R. Duration of infectiousness and correlation with RT-PCR cycle threshold values in cases of COVID-19, England, January to May 2020. Euro Surveill. 2020;25:2001483. Erratum in: Euro Surveill. 2021;26.
Park JY, Lee JH, Cha BK, Kim BS, Lee HJ, Kim GH, Kang KT, Lee YS, Ahn SK, Kim SH. Analysis of the Efficacy of Universal Screening of Coronavirus Disease with Antigen-Detecting Rapid Diagnostic Tests at Point-or-Care Settings and Sharing the Experience of Admission Protocol-A Pilot Study. J Pers Med. 2022;12:319.
