Abstract
In the present study, we developed a genus-specific rGroEL1-524 IgM-ELISA assay for use in screening diagnosis of suspected leptospirosis among acute undifferentiated febrile illness patients during acute fever. The diagnostic accuracies of the rGroEL1–524 IgM-ELISA, commercial Panbio IgM-ELISA, and Virion-Serion Classic IgG-ELISA were evaluated using 133 Thai leptospirosis sera and 210 controls. Sensitivities were 91.7%, 59.6%, and 17.7% for acute infection, and the specificities were 92.6%, 90.2%, and 88.3% for the non-leptospirosis control, respectively. The rGroEL1-524 IgM-ELISA had high sensitivity, at 92.3% and 91.7%, among culture-positive and MAT-negative cases at 1–3 days post-onset of symptoms (DPO1–3), respectively. Impaired specificity on scrub typhus was found, possibly from antibody cross-reaction to ortholog GroEL. Commercial Panbio IgM-ELISA had sensitivities at DPO1–3 of 30.8% and 41.7% for culture-positive and MAT-negative cases whereas Virion-Serion IgG-ELISA showed sensitivities of 5.9% and 13.3%, respectively. The rGroEL1-524 IgM-ELISA could be useful as a screening test for early diagnosis. The performance of the commercial ELISA suggests the applicability of IgM-ELISA for diagnosis, while IgG-ELISA is useful for seroprevalence surveys. However, confirmation by reference tests is recommended.
Highlights
Leptospirosis is recognized as a waterborne zoonosis with high incidence in tropical and sub-tropical areas, rural areas and urban slum communities in developing and industrialized countries
We developed an immunoglobulin M (IgM)-ELISA screening test using a genus-conserved region of G roEL1-524 as antigen to detect specific IgM antibody in blood specimens of suspected leptospirosis cases among acute undifferentiated febrile illness (AUFI) patients
The present study developed a prototype IgM-ELISA using a recombinant GroEL1-524 formatted antigen as an early laboratory screening test for leptospirosis and evaluated its diagnostic accuracy in the context of disease outbreaks in Thailand compared with reference methods
Summary
Leptospirosis is recognized as a waterborne zoonosis with high incidence in tropical and sub-tropical areas, rural areas and urban slum communities in developing and industrialized countries. The Thai Bureau of Epidemiology, Department of Disease Control, Ministry of Public Health, reported incidence and case fatality rates in 2019 of 3.26 and 0.04 per 100,000/population, respectively, with demographic shifts in southern Ranong, Phang Nga, Yala, and northeastern Sisaket and Yasothon provinces. MAT provides low sensitivity at the early course of infection, as MAT can detect IgM antibodies after DPO 8 and requires paired-sera testing to confirm diagnosis. We developed an IgM-ELISA screening test using a genus-conserved region of G roEL1-524 (recombinant G roEL1–524) as antigen to detect specific IgM antibody in blood specimens of suspected leptospirosis cases among AUFI patients. We assessed the usefulness of commercial ELISAs, Panbio Leptospira IgM-ELISA and the VirionSerion classic Leptospira IgG-ELISA, as screening tests for detecting anti-leptospiral antibodies using Thai blood samples in the context of disease outbreaks and compared to Leptospira culture and MAT
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