A prospective study to evaluate the accuracy of rapid diagnostic tests for diagnosis of human leptospirosis: Result from THAI-LEPTO AKI study.

Background: Rapid diagnostic tests (RDTs) have become widely used in low-resource settings for leptospirosis diagnostic. This study aims to evaluate the diagnostic performance of the five commercially available RDTs to detect human IgM against Leptospira spp. in Thai population. Methodology/Principal findings: Ninety-nine serum samples from Leptospirosis suspicious patients were tested with five RDTs, including Medical Science Public Health, Leptocheck-WB, SD bioline, TRUSTline, and J.Mitra. The case definition was based on MAT, qPCR, and culture results. Diagnostic accuracy was determined based on the first day of enrollment in an overall analysis and stratified according to days post-onset of fever. The five RDTs had overall sensitivity ranging from 1.8% to 75% and specificity ranging from 52.3% to 97.7%. Leptocheck-WB had high sensitivity of 75.0%. The sensitivity of five RDTs increased on days 4–6 post-onset of fever, while the specificity of all tests remained relatively stable at different days post-onset of fever. Conclusions/Significance: The tested RDTs showed low sensitivity. Therefore, based on the present study, five commercially available RDTs might not be an appropriate test for acute leptospirosis screening in the Thai population. Author summary: Leptospirosis is an important zoonosis, especially in the tropics. Rapid diagnostic tests (RDTs) have become widely used in low-resource settings for leptospirosis diagnostics. In this study, we evaluated the diagnostic performance of five commercially available RDTs in Thai population. The overall sensitivity ranged from 1.8% to 75%, and specificity was 52.3% to 97.7%. Leptocheck-WB had the highest sensitivity of 75.0%. The sensitivity of five RDTs increased on days 4–6 post onset of fever, while the specificity of all tests remained relatively stable at different days post onset of fever. Based on these results, RDTs showed low sensitivity and might not be an appropriate test for acute leptospirosis screening in the Thai population. [ABSTRACT FROM AUTHOR]