Performance Evaluation of VIDAS® Diagnostic Assays Detecting Anti-Chikungunya Virus IgM and IgG Antibodies: An International Study

Chikungunya (CHIK) is a debilitating mosquito-borne disease with an epidemiology and early clinical symptoms similar to those of other arboviruses-triggered diseases such as dengue or Zika. Accurate and rapid diagnosis of CHIK virus (CHIKV) infection is therefore challenging. This international study evaluated the performance of the automated VIDAS(& REG;) anti-CHIKV IgM and IgG assays compared to that of manual competitor IgM and IgG ELISA for the detection of anti-CHIKV IgM and IgG antibodies in 660 patients with suspected CHIKV infection. Positive and negative agreements of the VIDAS(& REG;) CHIKV assays with ELISA ranged from 97.5% to 100.0%. The sensitivity of the VIDAS(& REG;) CHIKV assays evaluated in patients with a proven CHIKV infection confirmed reported kinetics of anti-CHIKV IgM and IgG response, with a positive detection of 88.2-100.0% for IgM & GE; 5 days post symptom onset and of 100.0% for IgG & GE; 11 days post symptom onset. Our study also demonstrated the superiority of ELISA and VIDAS(& REG;) assays over rapid diagnostic IgM/IgG tests. The analytical performance of VIDAS(& REG;) anti-CHIKV IgM and IgG assays was excellent, with a high precision (coefficients of variation & LE; 7.4%) and high specificity (cross-reactivity rate & LE; 2.9%). This study demonstrates the suitability of the automated VIDAS(& REG;) anti-CHIKV IgM and IgG assays to diagnose CHIKV infections and supports its applicability for epidemiological surveillance and differential diagnosis in regions endemic for CHIKV.

Automated summary

This international study evaluated the performance of the automated VIDAS® anti-CHIKV IgM and IgG assays compared to that of manual competitor IgM and IgG ELISA for the detection of anti-CHIKV IgM and IgG antibodies in patients with suspected CHIKV infection. The VIDAS® assays showed high accuracy and sensitivity, with positive and negative agreements ranging from 97.5% to 100.0%, and a high detection rate for IgM and IgG antibodies. The study also demonstrated the superiority of ELISA and VIDAS® assays over rapid diagnostic tests.