Janejira Dinhuzen1,2,3, Umaporn Limothai1,2, Sasipha Tachaboon1,2, Panadda Krairojananan4, Bangon Laosatiankit5, Sakarin Boonprasong5, Nuttha Lumlertgul1,2,6, Sadudee Peerapornratana1,2,6,7, Nattachai Srisawat1,2,6,8,9,10. 1. Excellence Center for Critical Care Nephrology, King Chulalongkorn Memorial Hospital, Bangkok, Thailand. 2. Critical Care Nephrology Research Unit, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. 3. Master of science program in Medical Science, Faculty of Medicine, Chulalongkorn university, Bangkok, Thailand. 4. Department of Entomology, Armed Forces Research Institute of Medical Sciences (AFRIMS), Bangkok, Thailand. 5. Sisaket Provincial Public Health Office, Sisaket, Thailand. 6. Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, and King Chulalongkorn Memorial Hospital, Bangkok, Thailand. 7. Department of Laboratory Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. 8. Academy of Science, Royal Society of Thailand, Bangkok, Thailand. 9. Tropical Medicine Cluster, Chulalongkorn University, Bangkok, Thailand. 10. Excellence Center for Critical Care Medicine, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Abstract
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.
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.
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