배경 : 샤가스병은 크루스 파동편모충(Trypanosoma cruzi) 이 원인으로 빈대에 물리거나 수혈과 장기 이식 등에 의해 감염 되는 중남미 지역의 풍토병이다. 국내의 경우 감염된 사례는 없 으나 중남미 지역의 해외여행자를 통한 샤가스병의 감염을 관 리할 필요가 있다. 본 연구에서는 최근 국내에서 개발된 면역크 로마토그래피법의 SD Bioline Chagas Ab Rapid (에스디, 대 한민국)를 세 가지 면역크로마토그래피법시약과 비교 평가하고 자 하였다. 방법 : 온두라스 국립 샤가스 연구원으로부터 수집한 검체 320건(샤가스 양성 검체 140건, 음성 검체 180건)을 대상으로, SD Bioline Chagas Ab Rapid 키트를 Chagas Stat-Pak Assay (Chembio Diagnositc Systems, USA), OnSite Chagas Ab Rapid test-Cassette (CTK Biotech, USA), Trypanosoma Detect Rapid Test (InBios International, USA) 등과 비교하였다. 온두라스 국립 샤가스 연구원의 결과에 대한 민감도와 특이도를 비교하였고, 다른 기생충 질환과의 교차반 응을 평가하였다. 결과 : 온두라스 국립 샤가스 연구원 검사에 의한 결과와 비 교 시 각 검사 키트의 민감도와 특이도는 SD 키트와 Chembio 키트는 99.3%, 100%이었고, InBios 키트는 97.2%, 100%, CTK 키트는 97.9%, 98.8%이었다. 다른 기생충 질환과의 교차 반응 은 없었다. 결론 : SD Bioline Chagas Ab Rapid 키트는 온두라스 국립 샤가스 연구원 결과와의 일치율이 우수하였다. 따라서 국내에 서 개발된 SD Bioline Chagas Ab Rapid 키트는 샤가스병이 풍토병인 지역의 감염 진단과 해외여행자를 통한 국내 샤가스 병 감염 관리에 유용할 것이다.

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.

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.