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Evaluation of Commercially Available Chikungunya Virus Immunoglobulin M Detection Assays
Barbara W Johnson1, Christin H Goodman1, Kimberly Holloway2
1Diagnostic and Reference Laboratory, Arboviral Diseases Branch, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, Fort Collins, Colorado.
Insights
Several commercial chikungunya virus (CHIKV) IgM detection kits show high concordance with reference laboratory results. Laboratories can utilize these validated kits for accurate CHIKV serological diagnosis.
Area of Science:
- Medical diagnostics
- Virology
- Immunology
Background:
- Chikungunya virus (CHIKV) poses a significant public health threat, necessitating reliable diagnostic tools.
- Accurate serological detection of CHIKV-specific IgM antibodies is crucial for timely diagnosis and disease management.
Purpose of the Study:
- To evaluate the performance of commercially available chikungunya virus (CHIKV)-specific IgM detection kits.
- To compare the concordance and sensitivity of various kits against reference laboratory standards.
Main Methods:
- Commercial CHIKV IgM ELISA and IIFT kits were evaluated by multiple reference laboratories, including CDC, Public Health Agency of Canada, and CARPHA.
- Performance was assessed based on concordance with reference results, limit of detection via serial dilution, and retesting rates for equivocal results.
Main Results:
- The Euroimmun Anti-CHIKV IgM ELISA kit demonstrated ≥95% concordance across all reference laboratories.
- The InBios CHIKjj Detect MAC-ELISA showed high concordance (98-100%) and sensitivity comparable to CDC's in-house assay.
- The Abcam Anti-CHIKV IgM ELISA required reformatting but achieved 97% concordance post-modification; other rapid tests and MAC-ELISAs showed low sensitivity.
Conclusions:
- Validated commercial kits, such as Euroimmun and InBios, offer reliable options for CHIKV IgM detection.
- Laboratories have access to multiple effective commercial kits for chikungunya virus serological diagnosis.
- Ongoing quality assurance and reevaluation are important for ensuring the consistent performance of diagnostic kits.
Abstract:
Commercial chikungunya virus (CHIKV)-specific IgM detection kits were evaluated at the Centers for Disease Control and Prevention (CDC), the Public Health Agency of Canada National Microbiology Laboratory, and the Caribbean Public Health Agency (CARPHA). The Euroimmun Anti-CHIKV IgM ELISA kit had ≥ 95% concordance with all three reference laboratory results. The limit of detection for low CHIK IgM+ samples, as measured by serial dilution of seven sera up to 1:12,800 ranged from 1:800 to 1:3,200. The Euroimmun IIFT kit evaluated at CDC and CARPHA performed well, but required more retesting of equivocal results. The InBios CHIKjj Detect MAC-ELISA had 100% and 98% concordance with CDC and CARPHA results, respectively, and had equal sensitivity to the CDC MAC-ELISA to 1:12,800 dilution in serially diluted samples. The Abcam Anti-CHIKV IgM ELISA had high performance at CARPHA, but at CDC, performance was inconsistent between lots. After replacement of the biotinylated IgM antibody controls with serum containing CHIKV-specific IgM and additional quality assurance/control measures, the Abcam kit was rereleased and reevaluated at CDC. The reformatted Abcam kit had 97% concordance with CDC results and limit of detection of 1:800 to 1:3,200. Two rapid tests and three other CHIKV MAC-ELISAs evaluated at CDC had low sensitivity, as the CDC CHIKV IgM in-house positive controls were below the level of detection. In conclusion, laboratories have options for CHIKV serological diagnosis using validated commercial kits.
