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Evaluation of Two Enzyme-Linked Immunosorbent Assay Kits for Chikungunya Virus IgM Using Samples from Deceased Organ
Harry E Prince1, Michelle L Altrich2, Marek J Nowicki2
1Serology Laboratory, Viracor-IBT Laboratories, Los Angeles, California, USA harry.prince@viracoribt.com.
Insights
Chikungunya virus (CHIKV) testing in organ donors is crucial. Two ELISAs were evaluated; one showed false positives, while the other indicated true CHIKV infection, highlighting the need for optimized donor screening.
Area of Science:
- Virology
- Immunology
- Transplant Science
Background:
- Increasing chikungunya virus (CHIKV) cases in returning travelers raise concerns for organ and tissue transplant safety.
- Potential transmission of CHIKV to recipients via infected organ/tissue donors necessitates donor screening methods.
- Evaluation of diagnostic tests for CHIKV infection in potential donors is critical for preventing transmission.
Purpose of the Study:
- To evaluate the performance of two commercially available enzyme-linked immunosorbent assays (ELISAs) for detecting chikungunya virus (CHIKV) IgM in U.S. organ and tissue donors.
- To assess the accuracy and reliability of these ELISAs in identifying recent CHIKV infections among donors.
- To understand the limitations of current CHIKV IgM ELISAs and explore optimization strategies for donor screening.
Main Methods:
- Evaluated two CHIKV IgM ELISAs (Euroimmun and InBios) using 1,000 deidentified serum/plasma specimens from organ donors (Nov 2014–Mar 2015).
- Confirmed reactive specimens using immunofluorescence assays (IFAs) and plaque reduction neutralization testing (PRNT) at reference laboratories.
- Employed background subtraction modification for the InBios assay to identify potential false reactivity.
Main Results:
- The Euroimmun indirect ELISA yielded 38 falsely reactive specimens, negative by IFA for both CHIKV IgM and IgG.
- The InBios IgM-capture ELISA identified 26 reactive samples; one specimen remained reactive after modification and showed CHIKV-specific IgG and PRNT reactivity, despite a negative IgM IFA.
- This single InBios reactive specimen suggests true CHIKV infection, indicating potential utility but also limitations in IgM detection.
Conclusions:
- Current CHIKV IgM ELISAs demonstrate limitations in specificity, with potential for false-positive results in organ donor screening.
- The InBios assay, with modifications, showed promise for detecting true CHIKV infection, even with discordant IgM IFA results.
- Understanding ELISA limitations and optimizing testing strategies are essential to prevent unnecessary organ/tissue wastage due to inaccurate CHIKV screening.
Abstract:
The identification of nearly 3,500 cases of chikungunya virus (CHIKV) infection in U.S. residents returning in 2014 and 2015 from areas in which it is endemic has raised concerns within the transplant community that, should recently infected individuals become organ and/or tissue donors, CHIKV would be transmitted to transplant recipients. Thus, tests designed to detect recent CHIKV infection among U.S. organ and tissue donors may become necessary in the future. Accordingly, we evaluated 2 enzyme-linked immunosorbent assays (ELISAs) for CHIKV IgM readily available in the United States using 1,000 deidentified serum or plasma specimens collected from donors between November 2014 and March 2015. The Euroimmun indirect ELISA identified 38 reactive specimens; however, all 38 were negative for CHIKV IgG and IgM in immunofluorescence assays (IFAs) conducted at a reference laboratory and, thus, were falsely reactive in the Euroimmun CHIKV IgM assay. The InBios IgM-capture ELISA identified 26 reactive samples, and one was still reactive (index ≥ 1.00) when retested using the InBios kit with a background subtraction modification to identify false reactivity. This reactive specimen was CHIKV IgM negative but IgG positive by IFAs at two reference laboratories; plaque reduction neutralization testing (PRNT) demonstrated CHIKV-specific reactivity. The IgG and PRNT findings strongly suggest that the InBios CHIKV IgM-reactive result represents true reactivity, even though the IgM IFA result was negative. If testing organ/tissue donors for CHIKV IgM becomes necessary, the limitations of the currently available CHIKV IgM ELISAs and options for their optimization must be understood to avoid organ/tissue wastage due to falsely reactive results.
