Evaluation of SD BIOLINE Chagas Ab Rapid Kit

Mi Jung Ji; Jae Sang Noh; Byung Ki Cho; Young Shik Cho; Sun Joo Kim; Byoung Su Yoon

doi:10.3343/kjlm.2009.29.1.48

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Ji, Noh, Cho, Cho, Kim, and Yoon: Evaluation of SD BIOLINE Chagas Ab Rapid Kit

Original Article

Korean J Leg Med 2009;29(1):48-52.

Published online: 14 February 2009

DOI: https://doi.org/10.3343/kjlm.2009.29.1.48

Evaluation of SD BIOLINE Chagas Ab Rapid Kit

Mi Jung Ji^1,², Jae Sang Noh², Byung Ki Cho, Ph.D.², Young Shik Cho, Ph.D.², Sun Joo Kim, M.D.³, Byoung Su Yoon, Ph.D.^1,

¹Department of Life Science, College of Natural Science, Kyonggi University, Suwon, Korea

²Biotech Laboratory, Standard Diagnostics Inc., Yongin, Korea

³Department 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.

Received 27 October 20088 December 2008 Accepted 12 December 2008

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.

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.

Keywords: Chagas’ disease, Trypanosoma cruzi, Immunochromatography

REFERENCES

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.

Table 1.

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

Table 2.

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.

Table 3.

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).

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