Performance of seven serological assays for diagnosing tularemia

BMC Infectious Diseases

Herbert Tomaso¹  Roland Diller¹  George Araj⁴  Konrad Sachse²  Wolfgang Müller¹  Diana Klimpel¹  Peter Otto¹  Anke Ruettger²  Marina Djordjevic-Spasic³  Valérie Chaignat¹ 

[1] Institute of Bacterial Infections and Zoonoses, Friedrich-Loeffler-Institut (Federal Research Institute for Animal Health), Naumburger Str. 96a, Jena 07743, Germany;Institute of Molecular Pathogenesis, Friedrich-Loeffler-Institut (Federal Research Institute for Animal Health), Naumburger Str. 96a, Jena 07743, Germany;Clinical Centre Niš, Clinic for Infectious Diseases, Bulevar Zorana Djindjica 48, Niš 18000, Serbia;Clinical Microbiology, Department of Pathology & Laboratory Medicine, American University of Beirut Medical Center, Beirut 1107-2020, Lebanon

关键词: Diagnostic specificity;    Diagnostic sensitivity;    Tularemia;    Serology;   

Others  :  1133958
DOI  :  10.1186/1471-2334-14-234

 received in 2013-08-02, accepted in 2014-04-15,  发布年份 2014

【 摘 要 】

Background

Tularemia is a rare zoonotic disease caused by the Gram-negative bacterium Francisella tularensis. Serology is frequently the preferred diagnostic approach, because the pathogen is highly infectious and difficult to cultivate. The aim of this retrospective study was to determine the diagnostic accuracy of tularemia specific tests.

Methods

The Serazym®Anti-Francisella tularensis ELISA, Serion ELISA classic Francisella tularensis IgG/IgM, an in-house ELISA, the VIRapid® Tularemia immunochromatographic test, an in-house antigen microarray, and a Western Blot (WB) assay were evaluated. The diagnosis tularemia was established using a standard micro-agglutination assay. In total, 135 sera from a series of 110 consecutive tularemia patients were tested.

Results

The diagnostic sensitivity and diagnostic specificity of the tests were VIRapid (97.0% and 84.0%), Serion IgG (96.3% and 96.8%), Serion IgM (94.8% and 96.8%), Serazym (97.0% and 91.5%), in-house ELISA (95.6% and 76.6%), WB (93.3% and 83.0%), microarray (91.1% and 97.9%).

Conclusions

The diagnostic value of the commercial assays was proven, because the diagnostic accuracy was >90%. The diagnostic sensitivity of the in-house ELISA and the WB were acceptable, but the diagnostic accuracy was <90%. Interestingly, the antigen microarray test was very specific and had a very good positive predictive value.

【 授权许可】

   
2014 Chaignat et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Ellis J, Oyston PC, Green M, Titball RW: Tularemia. Clin Microbiol Rev 2002, 15(4):631-646.
• [2]Sjostedt A: Tularemia: history, epidemiology, pathogen physiology, and clinical manifestations. Ann N Y Acad Sci 2007, 1105:1-29.
• [3]Rotz LD, Khan AS, Lillibridge SR, Ostroff SM, Hughes JM: Public health assessment of potential biological terrorism agents. Emerg Infect Dis 2002, 8(2):225-230.
• [4]Dennis DT, Inglesby TV, Henderson DA, Bartlett JG, Ascher MS, Eitzen E, Fine AD, Friedlander AM, Hauer J, Layton M, Lillibridge SR, McDade JE, Osterholm MT, O’Toole T, Parker G, Perl TM, Russell PK, Tonat K, Working Group on Civilian Biodefense: Tularemia as a biological weapon: medical and public health management. JAMA 2001, 285(21):2763-2773.
• [5]Splettstoesser W, Guglielmo-Viret V, Seibold E, Thullier P: Evaluation of an immunochromatographic test for rapid and reliable serodiagnosis of human tularemia and detection of Francisella tularensis-specific antibodies in sera from different mammalian species. J Clin Microbiol 2010, 48(5):1629-1634.
• [6]Splettstoesser WD, Tomaso H, Al Dahouk S, Neubauer H, Schuff-Werner P: Diagnostic procedures in tularaemia with special focus on molecular and immunological techniques. J Vet Med B Infect Dis Vet Public Health 2005, 52(6):249-261.
• [7]Grunow R, Splettstoesser W, McDonald S, Otterbein C, O’Brien T, Morgan C, Aldrich J, Hofer E, Finke EJ, Meyer H: Detection of Francisella tularensis in biological specimens using a capture enzyme-linked immunosorbent assay, an immunochromatographic handheld assay, and a PCR. Clin Diagn Lab Immunol 2000, 7(1):86-90.
• [8]Johansson A, Berglund L, Eriksson U, Goransson I, Wollin R, Forsman M, Tarnvik A, Sjostedt A: Comparative analysis of PCR versus culture for diagnosis of ulceroglandular tularemia. J Clin Microbiol 2000, 38(1):22-26.
• [9]WHO: World health organization guidelines on Tularaemia. In Epidemic and Pandemic Alert and Response. Geneva: World Health Organization; 2007.
• [10]Schmitt P, Splettstoesser W, Porsch-Ozcürümez M, Finke EJ, Grunow R: A novel screening ELISA and a confirmatory Western blot useful for diagnosis and epidemiological studies of tularemia. Epidemiol Infect 2005, 133(4):759-766.
• [11]Porsch-Ozcürümez M, Kischel N, Priebe H, Splettstoesser W, Finke EJ, Grunow R: Comparison of enzyme-linked immunosorbent assay, Western blotting, microagglutination, indirect immunofluorescence assay, and flow cytometry for serological diagnosis of tularemia. Clin Diagn Lab Immunol 2004, 11(6):1008-1015.
• [12]Rusnak JM, Kortepeter MG, Hawley RJ, Anderson AO, Boudreau E, Eitzen E: Risk of occupationally acquired illnesses from biological threat agents in unvaccinated laboratory workers. Biosecur Bioterror 2004, 2(4):281-293.
• [13]Ericsson M, Sandstrom G, Sjostedt A, Tarnvik A: Persistence of cell-mediated immunity and decline of humoral immunity to the intracellular bacterium Francisella tularensis 25 years after natural infection. J Infect Dis 1994, 170(1):110-114.
• [14]Bockemühl J, Roth J: Brucella titers in subclinical infections due to Yersinia enterocolitica serotype O:9 in a pig-breeding farm (author’s transl). Zentralbl Bakteriol Orig A 1978, 240(1):86-93.
• [15]Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Moher D, Rennie D, de Vet HC, Lijmer JG: Standards for reporting of diagnostic accuracy group: the STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration: the standards for reporting of diagnostic accuracy group. Croat Med J 2003, 44(5):639-50.
• [16]Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Lijmer JG, Moher D, Rennie D, de Vet HC: Standards for reporting of diagnostic accuracy group: towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative: the standards for reporting of diagnostic accuracy group. Croat Med J 2003, 44(5):635-8.
• [17]Anjum MF, Tucker JD, Sprigings KA, Woodward MJ, Ehricht R: Use of miniaturized protein arrays for Escherichia coli O serotyping. Clin Vaccine Immunol 2006, 13(5):561-567.
• [18]Tärnvik A, Priebe HS, Grunow R: Tularaemia in Europe: an epidemiological overview. Scand J Infect Dis 2004, 36(5):350-5.
• [19]Eliasson H, Back E: Tularaemia in an emergent area in Sweden: an analysis of 234 cases in five years. Scand J Infect Dis 2007, 39(10):880-889.
• [20]Evans ME, Gregory DW, Schaffner W, McGee ZA: Tularemia: a 30-year experience with 88 cases. Medicine (Baltimore) 1985, 64(4):251-269.
• [21]Meric M, Willke A, Finke EJ, Grunow R, Sayan M, Erdogan S, Gedikoglu S: Evaluation of clinical, laboratory, and therapeutic features of 145 tularemia cases: the role of quinolones in oropharyngeal tularemia. APMIS 2008, 116(1):66-73.
• [22]Sharma N, Hotta A, Yamamoto Y, Fujita O, Uda A, Morikawa S, Yamada A, Tanabayashi K: Detection of Francisella tularensis-specific antibodies in patients with tularemia by a novel competitive enzyme-linked immunosorbent assay. Clin Vaccine Immunol 2013, 20(1):9-16.
• [23]Cubero Ribas A, Menegotto F, González Cabrero S, Gutiérrez P, Bratos Pérez MA, Delgado JM, Orduña A: Evaluación de un nuevo test inmunocromatográfico (Virapid®Tularemia) para el diagnóstico serológico de tularemia humana. Malaga, Spain: ; 2011.
• [24]Kiliç S, Celebi B, Yeşilyurt M: Evaluation of a commercial immunochromatographic assay for the serologic diagnosis of tularemia. Diagn Microbiol Infect Dis 2012, 74(1):1-5.
• [25]Tomaso H, Mooseder G, Dahouk SA, Bartling C, Scholz HC, Strauss R, Treu TM, Neubauer H: Seroprevalence of anti-Yersinia antibodies in healthy Austrians. Eur J Epidemiol 2006, 21(1):77-81.