kjlm The Korean Journal of Laboratory Medicine Korean J Lab Med 2383-5702 2383-5710 The Korean Society for Laboratory Medicine 10.3343/kjlm.2009.29.1.48 kjlm-29-48 Original Article Evaluation of SD BIOLINE Chagas Ab Rapid Kit JiMi Jung 1 2 NohJae Sang 2 ChoByung KiPh.D. 2 ChoYoung ShikPh.D. 2 KimSun JooM.D. 3 YoonByoung SuPh.D. 1 Department of Life Science, College of Natural Science, Kyonggi University, Suwon, Korea Biotech Laboratory, Standard Diagnostics Inc., Yongin, Korea Department of Laboratory Medicine, Gyeongsang National University, School of Medicine, Jinju, Korea Corresponding author: Byoung Su Yoon, Ph.D. Department of Life Science, College of Natural Science, Kyonggi University, San 94-6, Yiui-dong, Suwon 443-760, Korea Tel: +82-31-249-9645, Fax: +82-31-243-1707 E-mail: bsyoon@kyonggi.ac.kr

∗This study was performed by the research fund from Standard Diagnostic Inc.

 022009 14022009 291 4852 27102008 08122008 12122008 Copyright © 2009 by the Korean Society for Laboratory Medicine 2009 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 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.

 Chagas’ disease Trypanosoma cruzi Immunochromatography REFERENCES Cheng KY Chang CD Salbilla VA Kirchhoff LV Leiby DA Schochetman G Immunoblot assay using recombinant antigens as a supplemental test to confirm the presence of antibodies to Trypanosoma cruzi Clin Vaccine Immunol 200714 35561 Umezawa ES Bastos SF Camargo ME Yamauchi LM Santos MR Gonzalez A Evaluation of recombinant antigens for serodiagnosis of Chagas' disease in South and Central America J Clin Microbiol 199937 155460 Oelemann WM Teixeira MD Veríssimo Da Costa GC Borges-Pereira J De Castro JA Coura JR Evaluation of three commercial enzyme-linked immunosorbent assays for diagnosis of Chagas' disease J Clin Microbiol 199836 24237 Hoft DF Kim KS Otsu K Moser DR Yost WJ Blumin JH Trypanosoma cruzi expresses diverse repetitive protein antigens Infect Immun 198957 195967 Houghton RL Benson DR Reynolds LD McNeill PD Sleath PR Lodes MJ 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 1999179 122634 Paranhos GS Cotrim PC Mortara RA Rassi A Corral R Freilij HL Trypanosoma cruzi: cloning and expression of an antigen recognized by acute and chronic human chagasic sera Exp Parasitol 199071 28493 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 200139 43905 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 200644 30057 Bern C Montgomery SP Herwaldt BL Rassi A Jr Marin-Neto JA Dantas RO Evaluation and treatment of Chagas disease in the United States: a systematic review JAMA 2007298 217181 Sánchez Negrette O Sánchez Valdez FJ Lacunza CD García Bustos MF Mora MC Uncos AD Serological evaluation of specific-antibody levels in patients treated for chronic Chagas' disease Clin Vaccine Immunol 200815 297302 Ponce C Ponce E Vinelli E Montoya A de Aguilar V Gonzalez A 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 200543 50658 Saez-Alquezar A Sabino EC Salles N Chamone DF Hulstaert F Pottel H Serological confirmation of Chagas' disease by a recombinant and peptide antigen line immunoassay: INNO-LIA Chagas J Clin Microbiol 200038 8514 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 200038 63942 Sánchez-Guillén Mdel C López-Colombo A Ordóñez-Toquero G Gomez-Albino I Ramos-Jimenez J Torres-Rasgado E Clinical forms of Trypanosoma cruzi infected individuals in the chronic phase of Chagas disease in Puebla, Mexico Mem Inst Oswaldo Cruz 2006101 73340 Umezawa ES Luquetti AO Levitus G Ponce C Ponce E Henriquez D 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 200442 44952 Peralta JM Teixeira MG Shreffler WG Pereira JB Burns JM Jr Sleath PR Serodiagnosis of Chagas' disease by enzyme-linked immunosorbent assay using two synthetic peptides as antigens J Clin Microbiol 199432 9714 Luquetti AO Ponce C Ponce E Esfandiari J Schijman A Revollo S Chagas' disease diagnosis: a multicentric evaluation of Chagas Stat-Pak, a rapid immunochromatographic assay with recombinant proteins of Trypanosoma cruzi Diagn Microbiol Infect Dis 200346 26571 Marcipar IS Risso MG Silber AM Revelli S Marcipar AJ Antibody maturation in Trypanosoma cruzi-infected rats Clin Diagn Lab Immunol 20018 8025 Tables

Characteristics of the four different test kits for the detection of antibodies to Trypanosoma cruzi

Methods SD BIOLINE Chagas Ab Rapid CTK Onsite Chagas Ab Rapid InBios Trypanosoma Detect Rapid Test CHEMBIO Chagas Stat-Pack Assay
Type Device Device Strip Device
Specimen volume Serum, plasma 5 μL Serum, plasma 5 μL Serum 10 μL Serum, plasma 5 μL
  Whole Blood 10 μL   Whole Blood 20 μL Whole Blood 10 μL
Diluent volume 3 drops (90-120 μL) 2 drops (70-100 μL) 4 drops (150-200 μL) 6 drops (−240 μL)
Analysis time 15 min 15 min 10 min 15 min

Performance of four test kits in comparison with the results of National Reference Laboratory for Chagas and Leishmaniasis (Tegucigalpa, Honduras)

Parameter SD BIOLINE Chagas Ab Rapid CTK Onsite Chagas Ab Rapid InBios Trypanosoma Detect Rapid Test CHEMBIO Chagas Stat-Pack Assay
Positive (N=140) 139 137 136 139
Negative (N=180) 180 178 180 180
Sensitivity (%) 99.3 97.9 97.2 99.3
Specificity (%) 100 98.8 100 100
Kappa agreement (95% CI) 0.997 (0.981-1) 0.984 (0.941-0.996) 0.988 (0.95-0.999) 0.997 (0.981-1)

Abbreviation: CI, confidence interval.

Results of 8 discordant cases of four test kits for the detection of antibodies to Trypanosoma cruzi in comparison with the results of NRLCL

Specimen No. (onset day) Result of NRLCL SD BIOLINE Chagas Ab Rapid CTK Onsite Chagas Ab Rapid InBios Trypanosoma Detect Rapid Test CHEMBIO Chagas Stat-Pack Assay
1 (3) + - - + +
2 (2) + + - - +
3 (6) + + + - +
4 (4) + + - + +
5 (2) + + + - -
6 (5) + + + - +
7 - - + - -
8 - - + - -

Abbreviation: NRLCL, National Reference Laboratory for Chagas and Leishmaniasis (Tegucigalpa, Honduras).