Clinical Evaluation of Rapid Diagnostic Test Kit for Scrub Typhus with Improved Performance.
10.3346/jkms.2016.31.8.1190
- Author:
Young Jin KIM
1
;
Sungman PARK
;
Ranjan PREMARATNA
;
Stephen SELVARAJ
;
Sang Jin PARK
;
Sora KIM
;
Donghwan KIM
;
Min Soo KIM
;
Dong Hoon SHIN
;
Kyung Chan CHOI
;
Soon Hwan KWON
;
Wonjun SEO
;
Nam Taek LEE
;
Seung Han KIM
;
Heui Keun KANG
;
Yoon Won KIM
Author Information
1. Institute of Medical Science, School of Medicine, Hallym University, Chuncheon, Korea. ywkim@hallym.ac.kr
- Publication Type:Comparative Study ; Evaluation Studies ; Original Article
- Keywords:
Rapid Diagnostic Test;
Scrub Typhus;
Orientia tsutsugamushi
- MeSH:
Antibodies, Bacterial/blood;
Enzyme-Linked Immunosorbent Assay;
Fluorescent Antibody Technique, Indirect;
Humans;
Immunoglobulin G/blood;
Immunoglobulin M/blood;
Orientia tsutsugamushi/immunology;
Reagent Kits, Diagnostic;
Retrospective Studies;
Scrub Typhus/*diagnosis/microbiology;
Sensitivity and Specificity
- From:Journal of Korean Medical Science
2016;31(8):1190-1196
- CountryRepublic of Korea
- Language:English
-
Abstract:
Diagnosis of scrub typhus is challenging due to its more than twenty serotypes and the similar clinical symptoms with other acute febrile illnesses including leptospirosis, murine typhus and hemorrhagic fever with renal syndrome. Accuracy and rapidity of a diagnostic test to Orientia tsutsugamushi is an important step to diagnose this disease. To discriminate scrub typhus from other diseases, the improved ImmuneMed Scrub Typhus Rapid Diagnostic Test (RDT) was evaluated in Korea and Sri Lanka. The sensitivity at the base of each IgM and IgG indirect immunofluorescent assay (IFA) in Korean patients was 98.6% and 97.1%, and the specificity was 98.2% and 97.7% respectively. The sensitivity and specificity for retrospective diagnosis at the base of IFA in Sri Lanka was 92.1% and 96.1%. ImmuneMed RDT was not reactive to any serum from seventeen diseases including hemorrhagic fever with renal syndrome (n = 48), leptospirosis (n = 23), and murine typhus (n = 48). ImmuneMed RDT shows superior sensitivity (98.6% and 97.1%) compared with SD Bioline RDT (84.4% at IgM and 83.3% at IgG) in Korea. The retrospective diagnosis of ImmuneMed RDT exhibits 94.0% identity with enzyme-linked Immunosorbent assay (ELISA) using South India patient serum samples. These results suggest that this RDT can replace other diagnostic tests and is applicable for global diagnosis of scrub typhus. This rapid and accurate diagnosis will be beneficial for diagnosing and managing scrub typhus.
