Comparison of Six Commercial Diagnostic Tests for the Detection of Dengue Virus Non-Structural-1 Antigen and IgM/IgG Antibodies

• Published in: Annals of Laboratory Medicine Vol. 39; no. 6; pp. 566 - 571
• Main Authors: Lee, Hyeyoung, Ryu, Ji Hyeong, Park, Hye-Sun, Park, Ki Hyun, Bae, Hyunjoo, Yun, Sojeong, Choi, Ae-Ran, Cho, Sung-Yeon, Park, Chulmin, Lee, Dong-Gun, Lim, Jihyang, Lee, Jehoon, Lee, Seungok, Shin, Soyoung, Park, Haeil, Oh, Eun-Jee
• Format: Journal Article
• Language: English
• Published: Korea (South) Annals of Laboratory Medicine 01.11.2019; The Korean Society for Laboratory Medicine; 대한진단검사의학회
• Subjects: Antibodies, Viral; Antibodies, Viral - blood; Brief Communication; Cross Reactions; Dengue; Dengue - diagnosis; Dengue - virology; Dengue Virus; Dengue Virus - immunology; Dengue Virus - isolation & purification; Dengue Virus - metabolism; Enzyme-Linked Immunosorbent Assay; Enzyme-Linked Immunosorbent Assay - methods; Humans; Immunoglobulin G; Immunoglobulin G - blood; Immunoglobulin M; Immunoglobulin M - blood; Reagent Kits, Diagnostic; Sensitivity and Specificity; Viral Nonstructural Proteins; Viral Nonstructural Proteins - analysis; 병리학; Rapid diagnostic tests; Diagnosis; Dengue virus; Performance; ELISA
• ISSN: 2234-3806; 2234-3814; 2234-3814
• DOI: 10.3343/alm.2019.39.6.566

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.