| Penulis/Author |
Marsha S. Santoso (1); Prof. dr. Eggi Arguni, M.Sc., Ph.D., Sp.A(K). (2); Bunga Rana (3); Mercy E. Adiniko (4); Dionisius Denis (5); Endah Supriyati (6); dr. Citra Indriani, MPH. (7); Leily Trianty (8); dr. Riris Andono Ahmad, MPH, Ph.D (9); Rintis Noviyanti (10); R. Tedjo Sasmono (11) |
| Abstrak/Abstract |
Background: Dengue is a systemic, viral, mosquito-borne infection that continues to be a major public health issue in endemic regions in tropical and subtropical climates. Accurate tests for rapid diagnosis in point-of-care settings are important to reduce the fatality rates of severe dengue. We evaluated the diagnostic accuracy of the Standard M10 DENV 1-4 system (SD Biosensor, Gyeonggi, Korea), which is a cartridge-based, automated system that integrates nucleic acid extraction, reverse transcription-PCR (RT-PCR) amplification, and detection of dengue virus (DENV) serotypes.
Methods: This was a retrospective diagnostic evaluation study. The index test, Standard M10 DENV 1-4, was evaluated using 320 dengue-positive and 279 dengue-negative archived samples. The reference tests were a combination of Centers for Disease Control and Prevention (CDC) DENV 1-4 real-time RT-PCR, dengue NS1 antigen and IgM antibody detection, and DENV whole-genome sequencing.
Results: The overall sensitivity and specificity of Standard M10 DENV 1-4 were 94% and 100%, respectively. By serotype, the highest sensitivity was 100% for DENV-1, and the lowest was 82% for DENV-4. The overall between the CDC RT-PCR dengue serotyping method and the Standard M10 DENV 1-4 was 95%. Standard M10 DENV 1-4 RT-PCR had comparable sensitivity and specificity to CDC DENV RT-PCR.
Conclusions: Based on its commensurate performance to an established RT-PCR method combined with additional benefits of convenient storage and transport, easy use, and rapid processing, the Standard M10 DENV 1-4 system has potential for DENV detection and serotyping in point-of-care settings. |
