Ann Lab Med.  2019 Nov;39(6):566-571. 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

• Lee H
• Ryu JH
• Park HS
• Park KH
• Bae H
• Yun S
• Choi AR
• Cho SY
• Park C
• Lee DG
• Lim J
• Lee J
• Lee S
• Shin S
• Park H
• Oh EJ

• KMID: 2450952
• DOI: http://doi.org/10.3343/alm.2019.39.6.566

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.

Keyword

Dengue virus; Diagnosis; Rapid diagnostic tests; ELISA; Performance

MeSH Terms

Antibodies*
Chungcheongnam-do
Dengue Virus*
Dengue*
Diagnosis
Diagnostic Tests, Routine*
Enzyme-Linked Immunosorbent Assay
Humans
Immunoglobulin G
Immunoglobulin M
Antibodies
Immunoglobulin G
Immunoglobulin M

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