İnfluenza Tanısında Kullanlılan Hızlı Tanı Kitlerinin RT-PCR yöntemi ile Karşılaştırılması

Year 2020, Volume: 4 Issue: 3, 277 - 282, 31.12.2020

Ayşe Başak Altaş Yasemin Cosgun Fatma Bayrakdar Gülay Korukluoğlu Selçuk Kılıç

https://doi.org/10.34084/bshr.801586

Abstract

Amaç: İnfluenza rutin tanısında yüksek duyarlılık ve özgüllüğü nedeniyle real-time PCR testi tercih edilmektedir. Ancak PCR testlerinin yüksek maliyet ve deneyimli personel gereksinimi, laboratuvar ortamına ve cihazlarına ihtiyaç duyulması, numune transferi ve hekime sonucun ulaşmasında geçen süre gibi nedenlerle hasta başı kullanılan hızlı influenza tanı testlerinin kullanımı gündeme gelmiştir. Bu çalışmanın amacı, influenza enfeksiyonu tanısında kullanılan 3 farklı hızlı tanı testinin gerçek zamanlı RT-PCR yöntemi ile karşılaştırılması ve tanısal performansının belirlenmesidir.
Yöntem: Çalışmamıza 2017-2018 influenza sezonunda laboratuvarımıza gönderilen toplam 209 solunum yolu örneği dahil edilmiştir. Örnekler Humasis Influenza antigen card plus (Kore), SD Biosensor Standard-Q Influenza A/B (Kore) ve SD Biosensor Standard-F Influenza A/B FIA (Kore) hızlı antijen tanı kitleri ile üretici firmaların önerileri doğrultusunda test edilmiştir.
Bulgular: Çalışmamızda Humasis kiti ile İnfluenza A için duyarlılık %80,99, İnfluenza B için %68,66 hesaplanmıştır. SD Biosensor Standard Q Influenza A/B ve SD Biosensor Standard F Influenza A/B FIA kiti ile her iki virüs için de duyarlılık %70’in altında bulunmuştur. Humasis kitinin duyarlılığı diğer kitlere oranla daha yüksek saptanır- ken özgüllük tüm kitlerde %90’ın üzerinde belirlenmiştir.
Sonuç: Bu çalışma ile hızlı antijen testlerinin, influenza virüs aktivitesinin yoğun olduğu influenza sezonu dönemi veya salgın durumlarında influenza virüs enfeksiyonu tanısında tarama testi veya destekleyici test olarak kullanılabileceği sonucuna varılmıştır.

Keywords

İnfluenza, PCR, hızlı test, virüs kültürü

Comparison of Rapid Diagnostic Kits with RT-PCR in the Diagnosis of Influenza

Abstract

Aim: Due to its high sensitivity and specificity, real-time PCR testing is preferred for routine diagnosis. However, for PCR tests, the use of rapid influenza diagnostic tests at bedside due to reasons such as high cost, experienced personnel, laboratory conditions and equipment requirement, sample transfer and test time has come to the fore. Purpose of the study was to compare three different diagnostic tests used in the diagnosis of influenza infection with the real-time RT-PCR method and to determine the diagnostic performance.
Methods: A total of 209 respiratory tract samples sent to our laboratory during the 2017-2018 influenza season were included in our study. The samples were tested with Humasis Influenza antigen card plus, SD Biosensor Standard-Q Influenza A/B, and SD Biosensor Standard-F Influenza A/B FIA rapid antigen diagnostic kits according to the recommendations of the manufacturers.
Results: In our study, susceptibility was calculated 80.99% for influenza A and 68.66% for influenza B with Humasis kit. With the SD Biosensor Standard Q Influenza A/B and the SD Biosensor Standard F Influenza A/B FIA kit, the sensitivity for both viruses was below 70%. While the sensitivity of the humasis kit was higher than the other kits, the specificity was higher than 90% in all kits.
Conclusion: n this study, it was concluded that rapid antigen tests can be used as a screening test or supportive test for the diagnosis of influenza virus infection during the influenza season period or epidemic conditions during which influenza virus activity is intense.

Keywords

Influenza, Rapid test, PCR, Virus culture

References

• WHO Global Influenza Surveillance Network. Manual for the laboratory diagnosis and virological surveillance of influenza. Available at: http://apps.who.int/iris/bitstream/10665/44518/1/9789241548090_eng.pdf
• Yıldırım D, Özdoğru Sağdıç D, Şeflek B, Çimentepe M, Bayram İ, Yarkın F. Detection of influenza virus infections by molecular and immunofluorescence methods. [Article in Turkish] Mikrobiyol Bul. 2017; 51(4): 370-7.
• Ozdemir M, Yavru S, Baysal B. Comparison of the detection of influenza A and B viruses by different methods. J Int Med Res 2012; 40(6): 2401-8.
• Zhang G, Hu Y, Wang H, Zhang L, Bao Y, Zhou X. High incidence of multiple viral infections identified in upper respiratory tract infected children under three years of age in Shanghai, China. PLoS One 2012; 7(9): e44568.
• Matsuzaki Y. Detection of influenza virus (RT-PCR assay and others). [Article in Japanese] Nihon Rinsho. 2003; 61(11): 1909-13.
• Reina J, Plasencia V, Leyes M, Nicolau A, Galmés A, Arbona G. Comparison study of a real-time reverse transcription polymerase chain reaction assay with an enzyme immunoassay and shell vial culture for influenza A and B virus detection in adult patients. [Article in Spanish] Enferm Infecc Microbiol Clin. 2010; 28(2):95-8.
• Mahony JB, Petrich A, Smieja M. Molecular diagnosis of respiratory virüs infections. Crit Rev Clin Lab Sci. 2011; 48: 217–49.
• Zambon M, Hays J, Webster A, Newman R, Keene O. Diagnosis of influenza in the community: relationship of clinical diagnosis to confirmed virological, serologic, or molecular detection of influenza. Arch Intern Med. 2001; 161: 2116–22.
• Dunn J, Obuekwe J, Baun T, Rogers J, Patel T, Snow L. Promptdetection-of-influenza-A-and-B-viruses-using-the-BD-Veritor-System-Flu-A-B-Quidel-Sofia-Influenza-A-B-FIA-and-Alere-BinaxNOW® Influenza A&B compared to real-time reverse transcription-polymerase chain reaction (RT-PCR). Diagn Microbiol Infect Dis. 2014; 79(1): 10–3.
• Allen AJ, O'Leary RA, Davis S, Graziadio S, Jones WS, Simpson AJ, et al. Cost implications for the NHS of using the Alere™ i Influenza A & B near patient test with nasal swabs. Diagn Progn Res. 2018; 1;2: 15.
• Centers for Disease Control and Prevention. Rapid diagnostic testing for influenza: information for clinical laboratory directors. Centers for Disease Control and Prevention, Atlanta, GA. Available at: https://www.cdc.gov/flu/professionals/diagnosis/rapidlab.htm.
• WHO Global Influenza Surveillance Network. Manual for the laboratory diagnosis and virological surveillance of influenza. Available at: http://apps.who.int/iris/bitstream/10665/44518/1/9789241548090_eng.pdf
• World Health Organisation (WHO). CDC protocol of realtime RTPCR for influenza A(H1N1). Available at: www.who.int/csr/resources/publications/swineflu/CDCRealtimeRTPCR_SwineH1Assay-2009_20090430.pdf?ua=1.
• Chartrand C, Leeflang MM, Minion J, Brewer T, Pai M. Accuracy of rapid influenza diagnostic tests: a meta-analysis. Ann Intern Med. 2012; 156(7): 500-11.