Ann Lab Med 2019; 39(6): 566-571  https://doi.org/10.3343/alm.2019.39.6.566
Comparison of Six Commercial Diagnostic Tests for the Detection of Dengue Virus Non-Structural-1 Antigen and IgM/IgG Antibodies
Hyeyoung Lee , M.D.1,2, Ji Hyeong Ryu , B.S.3, Hye-Sun Park , M.S.3, Ki Hyun Park , M.S.3, Hyunjin Bae , B.S.3, Sojeong Yun , B.S.3, Ae-Ran Choi , B.S.1, Sung-Yeon Cho , M.D.4,5, Chulmin Park , Ph.D.5, Dong-Gun Lee , M.D.4,5, Jihyang Lim , M.D.6, Jehoon Lee , M.D.6, Seungok Lee , M.D.7, Soyoung Shin , M.D.8, Haeil Park , M.D.9, and Eun-Jee Oh , M.D.1
1Department of Laboratory Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea Seoul, Korea; 2Department of Laboratory Medicine, Catholic Kwandong University International St. Mary’s Hospital, Incheon, Korea; 3Department of Convergence Medical Science, Graduate School, The Catholic University of Korea, Seoul, Korea; 4Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea; 5Vaccine Bio Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Korea; 6Department of Laboratory Medicine, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea Seoul, Korea; 7Department of Laboratory Medicine, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea Seoul, Korea; 8Department of Laboratory Medicine, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea Seoul, Korea; 9Department of Laboratory Medicine, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea Seoul, Korea
Corresponding author: Eun-Jee Oh, M.D., Ph.D.
Department of Laboratory Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea
Tel: +82-2-2258-1641 Fax: +82-2-2258-1719 E-mail: ejoh@catholic.ac.kr
Received: January 3, 2019; Revised: March 29, 2019; Accepted: June 9, 2019; Published online: November 1, 2019.
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Abstract
ELISAs and rapid diagnostic tests (RDTs) are widely used for diagnosing dengue virus (DENV) infection. Using 138 single blood samples, we compared the ability to detect non-structural (NS)-1 antigen and anti-DENV IgM/IgG antibodies among (1) DENV Detect NS1 ELISA, DENV Detect IgM capture ELISA and DENV Detect IgG ELISA (InBios International, Inc.); (2) Anti-Dengue virus IgM Human ELISA and Anti-Dengue virus IgG Human ELISA (Abcam); (3) Dengue virus NS1 ELISA, Anti-Dengue virus ELISA (IgM) and Anti-Dengue virus ELISA (IgG) (Euroimmun); (4) Asan Easy Test Dengue NS1 Ag 100 and Asan Easy Test Dengue IgG/IgM (Asan Pharm); (5) SD BIOLINE Dengue Duo (Standard Diagnostics); and (6) Ichroma Dengue NS1 and Ichroma Dengue IgG/IgM (Boditech Med). For NS1 antigen detection, InBios and Euroimmun showed higher sensitivities (100%) than the RDTs (42.9–64.3%). All tests demonstrated variable sensitivities for IgM (38.1–90.5%) and IgG (65.7–100.0%). InBios and Boditech Med demonstrated higher sensitivity (95.6% and 88.2%, respectively) than the other tests for combined NS1 antigen and IgM antibody. Five NS1 antigen tests had good agreement (92.8–98.6%) without showing positivity for chikungunya. However, all IgG tests demonstrated potential false-positivity with variable ranges. Clinical laboratories should note performance variations across tests and potential cross-reactivity.
Keywords: Dengue virus, Diagnosis, Rapid diagnostic tests, ELISA, Performance



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