Korean J Lab Med.  2009 Feb;29(1):48-52. 10.3343/kjlm.2009.29.1.48.

Evaluation of SD BIOLINE Chagas Ab Rapid Kit

• Ji MJ
• Noh JS
• Cho BK
• Cho YS
• Kim SJ
• Yoon BS

• KMID: 1781593
• DOI: http://doi.org/10.3343/kjlm.2009.29.1.48

Abstract

BACKGROUND
Chagas' disease is caused by Trypanosoma cruzi, a protozoan parasite, which is transmitted by blood-sucking bugs or through blood transfusion or organ transplantation. It is endemic in Central and South America. The objective of this study was to compare the performance of immunochromatographic SD Bioline Chagas Ab Rapid (Standard Diagnostics, Korea) with three immunochromatographic kits for the detection of antibodies to T. cruzi.
METHODS
A total of 320 serum specimens (140 positive and 180 negative) from National Reference Laboratory for Chagas and Leishmaniasis (NRLCL, Honduras) were used for the evaluation of four different test kits: SD Bioline Chagas Ab Rapid, Chagas Stat-Pak Assay (Chembio Diagnositc Systems, USA), OnSite Chagas Ab Rapid test-Cassette (CTK Biotech, USA), and Trypanosoma Detect Rapid Test (InBios International, USA). The results of four kits were compared with those of NRLCL. Cross-reactivity with other parasites was also evaluated.
RESULTS
Compared with the results of NRLCL, sensitivity and specificity were 99.3% and 100% for both of SD and Chembio kits, 97.2% and 100% for InBios kit, and 97.9% and 98.8% for CTK kit. None of other parasites showed cross-reactivity.
CONCLUSIONS
SD Bioline Chagas Ab Rapid kit showed test results highly correlating with those of National Reference Laboratory for Chagas and Leishmaniasis. It can be used for a rapid detection of Chagas' disease in endemic region and monitoring the disease among overseas travelers in Korea.

Keyword

Chagas' disease; Trypanosoma cruzi; Immunochromatography

MeSH Terms

Animals
Antibodies, Protozoan/*blood/immunology
Blood Specimen Collection
Chagas Disease/*diagnosis/immunology/parasitology
Chromatography/methods
Humans
*Reagent Kits, Diagnostic
Sensitivity and Specificity
Trypanosoma cruzi/*immunology

Reference

1.Cheng KY., Chang CD., Salbilla VA., Kirchhoff LV., Leiby DA., Schochetman G, et al. Immunoblot assay using recombinant antigens as a supplemental test to confirm the presence of antibodies to Trypanosoma cruzi. Clin Vaccine Immunol. 2007. 14:355–61.

2.Umezawa ES., Bastos SF., Camargo ME., Yamauchi LM., Santos MR., Gonzalez A, et al. Evaluation of recombinant antigens for serodiagnosis of Chagas' disease in South and Central America. J Clin Microbiol. 1999. 37:1554–60.

3.Oelemann WM., Teixeira MD., Veríssimo Da Costa GC., Borges-Pereira J., De Castro JA., Coura JR, et al. Evaluation of three commercial enzyme-linked immunosorbent assays for diagnosis of Chagas' disease. J Clin Microbiol. 1998. 36:2423–7.

4.Hoft DF., Kim KS., Otsu K., Moser DR., Yost WJ., Blumin JH, et al. Trypanosoma cruzi expresses diverse repetitive protein antigens. Infect Immun. 1989. 57:1959–67.

5.Houghton RL., Benson DR., Reynolds LD., McNeill PD., Sleath PR., Lodes MJ, et al. A multi-epitope synthetic peptide and recombinant protein for the detection of antibodies to Trypanosoma cruzi in radioimmunoprecipitation-confirmed and consensus-positive sera. J Infect Dis. 1999. 179:1226–34.

6.Paranhos GS., Cotrim PC., Mortara RA., Rassi A., Corral R., Freilij HL, et al. Trypanosoma cruzi: cloning and expression of an antigen recognized by acute and chronic human chagasic sera. Exp Parasitol. 1990. 71:284–93.

7.Ferreira AW., Belem ZR., Lemos EA., Reed SG., Campos-Neto A. Enzyme-linked immunosorbent assay for serological diagnosis of Chagas' disease employing a Trypanosoma cruzi recombinant antigen that consists of four different peptides. J Clin Microbiol. 2001. 39:4390–5.

8.Cardinal MV., Reithinger R., G?rtler RE. Use of an immunochromatographic dipstick test for rapid detection of Trypanosoma cruzi in sera from animal reservoir hosts. J Clin Microbiol. 2006. 44:3005–7.

9.Bern C., Montgomery SP., Herwaldt BL., Rassi A Jr., Marin-Neto JA., Dantas RO, et al. Evaluation and treatment of Chagas disease in the United States: a systematic review. JAMA. 2007. 298:2171–81.

10.Sánchez Negrette O., Sánchez Valdez FJ., Lacunza CD., García Bustos MF., Mora MC., Uncos AD, et al. Serological evaluation of specific-antibody levels in patients treated for chronic Chagas' disease. Clin Vaccine Immunol. 2008. 15:297–302.

11.Ponce C., Ponce E., Vinelli E., Montoya A., de Aguilar V., Gonzalez A, et al. Validation of a rapid and reliable test for diagnosis of Chagas' disease by detection of Trypanosoma cruzi-specific antibodies in blood of donors and patients in Central America. J Clin Microbiol. 2005. 43:5065–8.

12.Saez-Alquezar A., Sabino EC., Salles N., Chamone DF., Hulstaert F., Pottel H, et al. Serological confirmation of Chagas' disease by a recombinant and peptide antigen line immunoassay: INNO-LIA Chagas. J Clin Microbiol. 2000. 38:851–4.

13.Leiby DA., Wendel S., Takaoka DT., Fachini RM., Oliveira LC., Tibbals MA. Serologic testing for Trypanosoma cruzi: comparison of radioimmunoprecipitation assay with commercially available indirect immunofluorescence assay, indirect hemagglutination assay, and enzyme-linked immunosorbent assay kits. J Clin Microbiol. 2000. 38:639–42.

14.Sánchez-Guillén Mdel C., López-Colombo A., Ordóñez-Toquero G., Gomez-Albino I., Ramos-Jimenez J., Torres-Rasgado E, et al. Clinical forms of Trypanosoma cruzi infected individuals in the chronic phase of Chagas disease in Puebla, Mexico. Mem Inst Oswaldo Cruz. 2006. 101:733–40.

15.Umezawa ES., Luquetti AO., Levitus G., Ponce C., Ponce E., Henriquez D, et al. Serodiagnosis of chronic and acute Chagas' disease with Trypanosoma cruzi recombinant proteins: results of a collaborative study in six Latin American countries. J Clin Microbiol. 2004. 42:449–52.

16.Peralta JM., Teixeira MG., Shreffler WG., Pereira JB., Burns JM Jr., Sleath PR, et al. Serodiagnosis of Chagas' disease by enzyme-linked immunosorbent assay using two synthetic peptides as antigens. J Clin Microbiol. 1994. 32:971–4.

17.Luquetti AO., Ponce C., Ponce E., Esfandiari J., Schijman A., Revollo S, et al. Chagas' disease diagnosis: a multicentric evaluation of Chagas Stat-Pak, a rapid immunochromatographic assay with recombinant proteins of Trypanosoma cruzi. Diagn Microbiol Infect Dis. 2003. 46:265–71.

18.Marcipar IS., Risso MG., Silber AM., Revelli S., Marcipar AJ. Antibody maturation in Trypanosoma cruzi-infected rats. Clin Diagn Lab Immunol. 2001. 8:802–5.