ÖZGEN ALPAY ÖZBEK, YAVUZ DOĞAN, İlknur Ebru AKYÜZ AKÇAKANAT

Rekombinant antijenler kullanan bir enzim “immunassay” testinin sifiliz taraması için değerlendirilmesi

Amaç: Bu çalışmada, anti-Treponema pallidum antikorlarını saptamak için rekom- binant antijen kullanan ve enzim “immunoassay” (EIA) prensibi ile çalışan bir testin (Trep-Screen ELISA) sifiliz taramasındaki performansının değerlendirilmesi amaçlanmıştır. Gereç ve yöntem: Çalışmada, 2 örnek grubu kullanıldı. Birinci grupta kemilüminesan mikropartikül enzim “immunoassay” (CMIA) yöntemi ile yapılan taramada pozitif bulunan ve Treponema pallidum hemaglütinasyon, Western Blot IgM ve IgG testleri ile doğrulanan 79 örnek yer aldı. İkinci grupta CMIA taramasında pozitif bulunan ancak diğer testlerle doğrulanmayan 71 örnek değerlendirildi. Örneklerin tümü değerlendirilen EIA testi ile çalışıldı. Bulgular: Testin duyarlılığı %97,5 (%95 güvenlik aralığı, %90,3-%99,6) olarak bulundu. EIA testinin ikinci gruptaki örneklerin %73,2’sinde negatif, %26,8’inde pozitif sonuç verdiği belirlendi. Sonuç: Değerlendirmeye alınan EIA testinin kullanımı kolay ve sifiliz taraması için yeterli duyarlılığa sahip olduğu sonucuna varıldı.

Evaluation of an enzyme immunassay using recombinant antigens for syphilis screening

Objective: The aim of this study is to evaluate the performance of an enzyme immunoassay (Trep-Screen ELISA) using recombinant antigens for determining anti- Treponema pallidum antibodies in screening syphilis. Material and method: Two group of samples were used in the study. The first group composed of 79 samples which were positive in the chemiluminescent microparticle immunoassay (CMIA) screening and were confirmed with Treponema pallidum haemagglutination assay, Western Blot IgM and IgG. The second group included 71 samples which were assessed to be positive in the CMIA screening but were not confirmed by the other tests. All of the samples were tested by evaluated EIA. Results: the sensitivity of the test was calculated as 97.5% (95% contidence internal, 90.3%-99.6%). With the EIA, 73.2% of the results were negative and 26.8% of the re-sults were positive when second group samples were tested. Conclusion: It was concluded that evaluated EIA test is easy to use and sensitive enough for syphilis screening.

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Peeling RW, Mabey DC. Syphilis. Nat Rev Microbiol 2004;2:448-449.
Ağaçfidan A, Akın L. Türkiye’de Cinsel Yolla Bulaşan Enfeksiyonlar (CYBE) ve HIV/AİDS’in Sürveyans Sistemine İlişkin Durum Analizi. T.C.Sağlık Bakanlığı Ana Çocuk Sağlığı ve Aile Planlaması Genel Müdürlüğü. 2007.
World Health Organization. Screening donated blood for Transfusion-Transmissible Infections, Recommendations. Ed. Dhingra N, 2009;30-35.
Knight CS, Crum MA, Hardy RW. Evaluation of the LIAISON chemiluminescence immunoassay for diagnosis of syphilis. Clin Vaccine Immunol 2007;14:710- 713.
Marangoni A, Sambri V, Accardo S, et al. Evaluation of LIAISON Treponema Screen, a novel recombinant antigen-based chemiluminescence immunoassay for laboratory diagnosis of syphilis. Clin Diagn Lab Immunol 2005;12:1231-1234.
Sambri V, Marangoni A, Simone MA, D'Antuono A, Negosanti M, Cevenini R. Evaluation of recomWell Treponema, a novel recombinant antigen-based enzyme-linked immunosorbent assay for the diagnosis of syphilis. Clin Microbiol Infect 2001;7:200-205.
Tsang RS, Martin IE, Lau A, Sawatzky P. Serological diagnosis of syphilis: comparison of the Trep-Chek IgG enzyme immunoassay with other screening and confirmatory tests. FEMS Immunol Med Microbiol 2007;51:118-124.
Ebel A, Bachelart L, Alonso JM. Evaluation of a new competitive immunoassay (BioElisa Syphilis) for screening for Treponema pallidum antibodies at various stages of syphilis. J Clin Microbiol. 1998;36:358-361.
Manavi K, Young H, McMillan A. The sensitivity ofsyphilis assays in detecting different stages of early syphilis. Int J STD AIDS 2006;17:768–771.
Schmidt BL, Edjlalipour M, Luger A. Comparative evaluation of nine different enzyme-linked immunosorbent assays for determination of antibodies against Treponema pallidum in patients with primary syphilis. J Clin Microbiol 2000; 38:1279-1282.
Young H, Pryde J, Duncan L, Dave J. The Architect Syphilis assay for antibodies to Treponema pallidum: an automated screening assay with high sensitivity in primary syphilis. Sex Transm Infect 2009;85:19-23.
Cole MJ, Perry KR, Parry JV. Comparative evaluation of 15 serological assays for the detection of syphilis infection. Eur J Clin Microbiol Infect Dis 2007;26:705-713.
French P, Gomberg M, Janier M, Schmidt B, van Voorst Vader P, Young H. IUSTI: 2008 European Guidelines on the Management of Syphilis. Int J STD AIDS 2009; 20: 300-309.
Banoo S, Bell D, Bossuyt P, et al. Evaluation of diagnostic tests for infectious diseases: general principles. Nat Rev Microbiol 2006; 4:21-31.
Elder, BL, Hansen, SA, Kellogg, JA, Marsik, FJ, and Zabransky, RJ. Verification and Validation Procedures in the Clinical Microbiology Laboratory, Cumitech 31, coordinating eds, BW McCurdy, American Society for Microbiology, Washington, DC.
Larsen SA, Steiner BM, Rudolph AH. Laboratory diagnosis and interpretation of tests for syphilis. Clin Microbiol Rev 1995;8:1-21.
Nandwani R, Evans DT. Are you sure it’s syphilis? A review of false positive serology. Int J STD AIDS. 1995;6:241-248.
Marangoni A, Moroni A, Accardo S, Cevenini R. Laboratory diagnosis of syphilis with automated immunoassays. J Clin Lab Anal 2009;23:1-6.
Norris SJ. Polypeptides of Treponema pallidum: progress toward understanding their structural, functional, and immunologic roles. Treponema Pallidum Polypeptide Research Group. Microbiol Rev 1993; 57: 750-779.