Evaluation of the Diagnostic Performance of Recombinant Antigen B1 for Detection of Cystic Echinococcosis Using Lateral Flow Dipstick Test
Background: Human echinococcosis is a neglected zoonotic disease distributed worldwide. It comprises cystic and alveolar forms, the former being the more prevalent disease. Imaging techniques are the first choice for diagnosis of cystic echinococcosis and serology is used as an additional diagnostic technique in doubtful cases or as the sole test in low-resource settings. Rapid diagnostic tests are useful and convenient for immunodiagnosis of cystic echinococcosis in endemic areas, where medical facilities often struggle with limited resources.
Methods: Recently, we have developed Hyd Rapid™, an IgG4 lateral flow dipstick test using recombinant antigen B1 for detection of cystic echinococcosis. This study was performed between 2016 until 2018 at the Institute for Research in Molecular Medicine, Universiti Sains Malaysia. The diagnostic performance of Hyd Rapid™ was tested in-house and at two international laboratories in Switzerland and Iran.
Results: The overall diagnostic sensitivity for detection of cystic and alveolar echinococcosis was 95% (56/59). Meanwhile, the diagnostic specificity, with and without exclusion of cysticercosis and fascioliasis, was 100% (n=48) and 88% (63/72), respectively.
Conclusion: Hyd Rapid™ detected cystic echinococcosis as well as probable cases of alveolar echinococcosis. Therefore, Hyd Rapid™ showed good potential as a serological tool for echinococcosis, and merits further evaluation.
2. Moro P, Schantz PM. Echinococcosis: a review. Int J Infect Dis. 2009; 13 (2):125-133.
3. Budke CM, Deplazes P, Torgerson PR. Global socioeconomic impact of cystic echinococcosis. Emerg Infect Dis. 2006; 12 (2):296-303.
4. Agudelo Higuita NI, Brunetti E, McCloskey C. Cystic Echinococcosis. J Clin Microbiol. 2016; 54 (3):518-523.
5. Deplazes P, Rinaldi L, Alvarez Rojas CA, et al. Global Distribution of Alveolar and Cystic Echinococcosis. Adv Parasitol. 2017; 95:315-493.
6. Del Carpio M, Mercapide CH, Salvitti JC, et al. Early diagnosis, treatment and follow-up of cystic echinococcosis in remote rural areas in Patagonia: impact of ultrasound training of non-specialists. PLoS Negl Trop Dis. 2012; 6 (1):e1444.
7. McManus DP, Gray DJ, Zhang W, et al. Diagnosis, treatment, and management of echinococcosis. BMJ. 2012; 344:e3866.
8. Brunetti E, Kern P, Vuitton DA, et al. Expert consensus for the diagnosis and treatment of cystic and alveolar echinococcosis in humans. Acta Trop. 2010; 114 (1):1-16.
9. WHO Informal Working Group. International classification of ultrasound images in cystic echinococcosis for application in clinical and field epidemiological settings. Acta Trop. 2003; 85 (2):253-261.
10. Mariconti M, Bazzocchi C, Tamarozzi F, et al. Immunoblotting with human native antigen shows stage-related sensitivity in the serodiagnosis of hepatic cystic echinococcosis. Am J Trop Med Hyg. 2014; 90 (1):75-79.
11. Carmena D, Benito A, Eraso E. Antigens for the immunodiagnosis of Echinococcus granulosus infection: An update. Acta Trop. 2006; 98 (1):74-86.
12. Zhang W, Wen H, Li J, et al. Immunology and immunodiagnosis of cystic echinococcosis: an update. Clin Dev Immunol. 2012; 2012:101895.
13. Manzano-Roman R, Sanchez-Ovejero C, Hernandez-Gonzalez A, et al. Serological Diagnosis and Follow-Up of Human Cystic Echinococcosis: A New Hope for the Future? Biomed Res Int. 2015; 2015:428205.
14. Siles-Lucas M, Casulli A, Conraths FJ, et al. Laboratory Diagnosis of Echinococcus spp. in Human Patients and Infected Animals. Adv Parasitol. 2017; 96:159-257.
15. Al-Sherbiny MM, Farrag AA, Fayad MH, et al. Application and assessment of a dipstick assay in the diagnosis of hydatidosis and trichinosis. Parasitol Res. 2004; 93 (2):87-95.
16. Pagnozzi D, Biosa G, Addis MF, et al. An easy and efficient method for native and immunoreactive Echinococcus granulosus antigen 5 enrichment from hydatid cyst fluid. PloS One. 2014; 9 (8):e104962.
17. Reiterova K, Auer H, Altintas N, et al. Evaluation of purified antigen fraction in the immunodiagnosis of cystic echinococcosis. Parasitol Res. 2014; 113 (8):2861-2867.
18. Sadjjadi SM, Abidi H, Sarkari B, et al. Evaluation of enzyme linked immunosorbent assay, utilizing native antigen B for serodiagnosis of human hydatidosis. Iran J Immunol. 2007; 4 (3):167-172.
19. Khabiri AR, Bagheri F, Assmar M, et al. Analysis of specific IgE and IgG subclass antibodies for diagnosis of Echinococcus granulosus. Parasite Immunol. 2006; 28 (8):357-362.
20. Hernandez-Gonzalez A, Muro A, Barrera I, et al. Usefulness of four different Echinococcus granulosus recombinant antigens for serodiagnosis of unilocular hydatid disease (UHD) and postsurgical follow-up of patients treated for UHD. Clin Vaccine Immunol. 2008; 15 (1):147-153.
21. Mohammadzadeh T, Sako Y, Sadjjadi SM, et al. Comparison of the usefulness of hydatid cyst fluid, native antigen B and recombinant antigen B8/1 for serological diagnosis of cystic echinococcosis. Trans R Soc Trop Med Hyg. 2012; 106 (6):371-375.
22. Khalilpour A, Sadjjadi SM, Moghadam ZK, et al. Lateral flow test using Echinococcus granulosus native antigen B and comparison of IgG and IgG4 dipsticks for detection of human cystic echinococcosis. Am J Trop Med Hyg. 2014; 91 (5):994-999.
23. Khanbabaie S, Riazi M, Chang CH, et al.. Lateral flow dipstick antigen assay for human cystic echinococcosis. Acta Trop. 2018; 190:171-176.
24. Yunus MH, Tan Farrizam SN, Abdul Karim IZ, et al. A Lateral Flow Rapid Test for Human Toxocariasis Developed Using Three Toxocara canis Recombinant Antigens. Am J Trop Med Hyg. 2018; 98 (1):32-38.
25. Vola A, Tamarozzi F, Noordin R, et al. Preliminary assessment of the diagnostic performances of a new rapid diagnostic test for the serodiagnosis of human cystic echinococcosis. Diagn Microbiol Infect Dis. 2018; 92 (1):31-33.
26. Makhsin SR, Razak KA, Noordin R, et al. The effects of size and synthesis methods of gold nanoparticle-conjugated MalphaHIgG4 for use in an immunochromatographic strip test to detect brugian filariasis. Nanotechnology. 2012; 23 (49):495719.
27. Sunita T, Dubey ML, Khurana S, et al. Specific antibody detection in serum, urine and saliva samples for the diagnosis of cystic echinococcosis. Acta Trop. 2007; 101 (3):187-191.
28. Santivanez SJ, Rodriguez ML, Rodriguez S, et al. Evaluation of a New Immunochromatographic Test Using Recombinant Antigen B8/1 for Diagnosis of Cystic Echinococcosis. J Clin Microbiol. 2015; 53 (12):3859-3863.
29. Yang YR, Craig PS, Ito A, et al. A correlative study of ultrasound with serology in an area in China co-endemic for human alveolar and cystic echinococcosis. Trop Med Int Health. 2007; 12 (5):637-646.
30. Wang JY, Gao CH, Steverding D, et al. Differential diagnosis of cystic and alveolar echinococcosis using an immunochromatographic test based on the detection of specific antibodies. Parasitol Res. 2013; 112 (10):3627-3633.
31. Sbihi Y, Gil JR, Alvarez PA, et al. Development of a dipstick dye immunoassay for diagnosing hydatidosis. J Clin Lab Anal. 2003; 17 (6):219-222.
32. Zhang W, Zhang Z, Wu W, et al. Epidemiology and control of echinococcosis in central Asia, with particular reference to the People's Republic of China. Acta Trop. 2015; 141 (Pt B):235-243.
33. Gao CH, Wang JY, Shi F, et al. Field evaluation of an immunochromatographic test for diagnosis of cystic and alveolar echinococcosis. Parasit Vectors. 2018; 11 (1):311.
34. Tamarozzi F, Covini I, Mariconti M, et al. Comparison of the Diagnostic Accuracy of Three Rapid Tests for the Serodiagnosis of Hepatic Cystic Echinococcosis in Humans. PLoS Negl Trop Dis. 2016; 10 (2):e0004444.
35. Sarkari B, Ghobakhloo N, Moshfea A, et al. Seroprevalence of human fasciolosis in a new-emerging focus of fasciolosis in yasuj district, southwest of iran. Iran J Parasitol. 2012; 7 (2):15-20.
36. Ashrafi K. The Status of Human and Animal Fascioliasis in Iran: A Narrative Review Article. Iran J Parasitol. 2015; 10 (3):306-328.
37. Li J, Zhang WB, McManus DP. Recombinant antigens for immunodiagnosis of cystic echinococcosis. Biol Proced Online. 2004; 6:67-77.
38. Chen X, Chen X, Lu X, et al. The production and comparative evaluation of native and recombinant antigens for the fast serodiagnosis of cystic echinococcosis with dot immunogold filtration assay. Parasite Immunol. 2015; 37 (1):10-15.
39. Schweiger A, Grimm F, Tanner I, et al. Serological diagnosis of echinococcosis: the diagnostic potential of native antigens. Infection. 2012; 40 (2):139-152.
40. Baraquin A, Zait H, Grenouillet FE, et al. Large-scale evaluation of a rapid diagnostic test for human cystic echinococcosis. Diagn Microbiol Infect Dis. 2017; 89 (1):20-25.
41. Tamer GS, Dündar D, Uzuner H, et al. Evaluation of immunochromatographic test for the detection of antibodies against Echinococcosis granulosus. Med Sci Monit. 2015; 21:1219-1222.
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