Evaluation of a Newly Developed Rapid Automated Fluorescent Lateral Flow Immunoassay to Detect IgG and IgM Antibodies to Chikungunya Virus

The ichroma Chikungunya virus (CHIKV) IgG/IgM (Boditech Med Inc., Chuncheon, Korea) is a newly developed rapid lateral flow immunoassay for detection of anti- CHIKV-IgG/ IgM. This study conducted with thirty-six anti-CHIKV IgG positive sera, 57 anti-CHIKV IgM positive sera and 163 anti-CHIKV IgG/IgM negative sera which were confirmed by commercial enzyme-linked immunosorbent assays (ELISAs) (Inbios CHIKjj Detect™ IgM Capture ELISA, Inbios CHIKjj Detect™ IgG ELISA (InBios International Inc., Seattle, WA, USA), Anti-CHIKV ELISA (IgM), Anti- CHIKV ELISA (IgG) (Euroimmun, Lübeck, Germany)). The ichroma detected all 36 anti-CHIKV IgG and 57 anti-CHIKV IgM positivity (100% sensitivity). For 163 anti-CHIKV IgG/IgM negative sera, the ichroma showed one false positive for IgM (99.4% specificity). The ichroma showed no cross-reactivity and no interference. The ichroma demonstrated good diagnostic performance compared to the current ELISAs.

Evaluation of a Newly Developed Rapid Automated Fluorescent Lateral Flow Immunoassay to Detect IgG and IgM Antibodies to Chikungunya Virus

The ichroma Chikungunya virus (CHIKV) IgG/IgM (Boditech Med Inc., Chuncheon, Korea) is a newly developed rapid lateral flow immunoassay for detection of anti- CHIKV-IgG/ IgM. This study conducted with thirty-six anti-CHIKV IgG positive sera, 57 anti-CHIKV IgM positive sera and 163 anti-CHIKV IgG/IgM negative sera which were confirmed by commercial enzyme-linked immunosorbent assays (ELISAs) (Inbios CHIKjj Detect™ IgM Capture ELISA, Inbios CHIKjj Detect™ IgG ELISA (InBios International Inc., Seattle, WA, USA), Anti-CHIKV ELISA (IgM), Anti- CHIKV ELISA (IgG) (Euroimmun, Lübeck, Germany)). The ichroma detected all 36 anti-CHIKV IgG and 57 anti-CHIKV IgM positivity (100% sensitivity). For 163 anti-CHIKV IgG/IgM negative sera, the ichroma showed one false positive for IgM (99.4% specificity). The ichroma showed no cross-reactivity and no interference. The ichroma demonstrated good diagnostic performance compared to the current ELISAs.

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

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.