title: Limited diagnostic value of two commercial rapid tests for acute leptospirosis detection in Malaysia.
abstract: This study evaluated 2 rapid leptospirosis serological tests, Leptorapide® (Linnodee, Northern Ireland) and VISITECT®-LEPTO (Omega Diagnostics, Scotland, UK), which are commonly used in Malaysia. A total of 183 samples comprised 113 sera from leptospirosis patients, and 70 sera from other infections and healthy controls were used. The leptospirosis sera were grouped into 2 serum panels, i.e., Group I (MAT+, PCR+) and Group II (MAT+). When inconclusive results were interpreted as positives, both tests showed lower diagnostic sensitivities (≤ 34%) with Group I sera, as compared to Group II sera (Leptorapide®, 93%; VISITECT®-LEPTO, 40%). When inconclusive results were interpreted as negatives, the 2 tests showed ~20% sensitivity with both serum panels. The diagnostic specificity of VISITECT®-LEPTO (94%) was superior to Leptorapide® (69%). Since both tests had misdiagnosed a large proportion of Group I patients and showed many inconclusive results among Group II patients, they have limited diagnostic value in detecting acute leptospirosis.
authors.affiliation: Institute for Research in Molecular Medicine (INFORMM), Universiti Sains Malaysia, 11800 Penang, Malaysia.
authors.forename: Chiat Han
authors.initials: CH
authors.lastname: Chang
authors.affiliation: School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Penang, Malaysia.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Riazi
authors.affiliation: Institute for Research in Molecular Medicine (INFORMM), Universiti Sains Malaysia, 11800 Penang, Malaysia.
authors.forename: Muhammad Hafiznur
authors.initials: MH
authors.lastname: Yunus
authors.affiliation: Institute for Research in Molecular Medicine (INFORMM), Universiti Sains Malaysia, 11800 Penang, Malaysia.
authors.forename: Sabariah
authors.initials: S
authors.lastname: Osman
authors.affiliation: Institute for Research in Molecular Medicine (INFORMM), Universiti Sains Malaysia, 11800 Penang, Malaysia. Electronic address: rahmah8485@gmail.com.
authors.forename: Rahmah
authors.initials: R
authors.lastname: Noordin
mesh_terms: D000372:Agglutination Tests; D016022:Case-Control Studies; D003429:Cross Reactions; D003951:Diagnostic Errors; D006801:Humans; D007106:Immune Sera / Q000276:immunology; D007922:Leptospirosis / Q000175:diagnosis*; D008296:Malaysia; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods*
chemical_list: D007106:Immune Sera
keywords: Diagnostic value; Lateral flow; Latex agglutination; Leptorapide®; Leptospirosis; VISITECT®-LEPTO