Performance of Two Commercial Dengue NS1 Rapid Tests for the Diagnosis of Adult Patients with Dengue Infection

Main Article Content

Yupin Suputtamongkol
Panisadee Avirutnan
https://orcid.org/0000-0003-0053-3045
Ekkarat Wongsawat
https://orcid.org/0000-0001-7624-9150
Yoon-Won Kim
https://orcid.org/0000-0002-2242-2664

Abstract

Objective: To determine the diagnostic performance of two commercially available dengue NS1 antigen rapid detection tests (RDTs), namely, SD BIOLINE Dengue NS1Ag and ImmuneMed Dengue NS1 Rapid, for the diagnosis of adult patients with dengue infection


Methods: The study was performed by using archived samples from 237 patients with laboratory-confirmed dengue infection. Archived, well-characterized samples from an additional 208 febrile individuals from Thailand were used as the control group. Reference testing to confirm the diagnosis in the dengue patients included RT-PCR and in-house NS1 ELISA, in-house IgM, and IgG capture ELISAs.


Results: The sensitivity of the SD BIOLINE Dengue NS1 Ag was 100%, and its specificity was 99% (95% CI; 96.6–99.7%). False positive results were found in 2 samples, specifically from patients with scrub typhus. The sensitivity and specificity of the ImmuneMed Dengue NS1 Ag Rapid were 97.4% (95% CI, 95.5–99.5%) and 96.6% (95% CI; 93.5–98.4%), respectively. False positive results were found in 7 patients, specifically from patients with murine typhus, scrub typhus, and influenza.  


Conclusion: Both RDTs showed comparable sensitivity and specificity in this study population. Data from this study could be used to facilitate data-driven laboratory test choices for managing patient care during dengue outbreaks.

Downloads

Download data is not yet available.

Article Details

How to Cite
Suputtamongkol, Y., Avirutnan, P., Wongsawat, E., & Kim, Y.-W. (2020). Performance of Two Commercial Dengue NS1 Rapid Tests for the Diagnosis of Adult Patients with Dengue Infection. iriraj edical ournal, 72(1), 74-78. etrieved from https://he02.tci-thaijo.org/index.php/sirirajmedj/article/view/221540
Section
Original Article

References

1. Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, Drake JM, Brownstein JS, Hoen AG, Sankoh O, Myers MF, George DB, Jaenisch T, Wint GR, Simmons CP, Scott TW, Farrar JJ, Hay SI. The global distribution and burden of dengue. Nature. 2013; 496 (7446):504–7.
2. World Health Organization. Dengue guidelines for diagnosis, treatment, prevention and control: New Edition. WHO/HTM/NTD/DEN/2009.1 (World Health Organization, 2009).
3. Centers for Disease Control and Prevention. 2012. Laboratory guidance and diagnostic testing. Centers for Disease Control and Prevention, Atlanta, GA: http://www.cdc.gov/ dengue/clinicalLab/laboratory.html.
4. Andries AC, Duong V, Ngan C, Ong S, Huy R, Sroin KK, Te V, Try Y BPL, Buchy P. 2012. Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG. PLoS Negl Trop Dis 6: e1993. doi:10.1371/ journal. pntd.0001993.
5. Hyeyoung Lee, Ji Hyeong Ryu, Hye-Sun Park, Ki Hyun Park, Hyunjin Bae, Sojeong Yun, Ae-Ran Choi, Sung-Yeon Cho, Chulmin Park, Dong-Gun Lee, Jihyang Lim, Jehoon Lee, Seungok Lee, Soyoung Shin, Haeil Park, Eun-Jee Oh. Comparison of Six Commercial Diagnostic Tests for the Detection of Dengue Virus Non-Structural-1 Antigen and IgM/IgG Antibodies. Ann Lab Med. 2019; 39:566–571.
6. Yenchitsomanus PT, Sricharoen P, Jaruthasana I, et al. Rapid detection and identification of dengue viruses by polymerase chain reaction (PCR). The Southeast Asian journal of tropical medicine and public health. 1996; 27:228–236.
7. Puttikhunt C, Prommool T, N Ut, et al. The development of a novel serotyping-NS1-ELISA to identify serotypes of dengue virus. J Clin Virol. 2011; 50:314–319.
8. Innis BL, Nisalak A, Nimmannitya S, et al. An enzyme-linked immunosorbent assay to characterize dengue infections where dengue and Japanese encephalitis co-circulate. Am J Trop Med Hyg. 1989; 40:418–427.
9. Shu PY, Chang SF, Kuo YC, et al. Development of group- and serotype-specific one-step SYBR green I-based real-time reverse transcription-PCR assay for dengue virus. J Clin Microbiol. 2003; 41:2408–2416.
10. Suttinont C, Losuwanaluk K, Niwatayakul K, Hoontrakul S, Intaranongpai W, Silpasakorn S, et al. Causes of acute undifferentiated febrile illness in rural Thailand: a prospective observational study. Ann Trop Med Hyg. 2006; 100: 363–70.
11. Suputtamongkol Y, Niwattayakul K, Suttinont C, Losuwanaluk K, Limpaiboon R, W. Chierakul W, et al. An open, randomized, controlled trial of penicillin, doxycycline, and cefotaxime for patients with severe leptospirosis. Clin Infect Dis. 2004; 39: 1417–24.
12. Thipmontree W, Suputtamongkol Y, Tantibhedhyangkul W, Suttinont C, Wongsawat E, Silpasakorn S. Human leptospirosis trends: northeast Thailand, 2001-2012. Int J Environ Res Public Health. 2014; 11(8):8542–51. doi: 10.3390/ijerph110808542.
13. Teparrukkul P, Hantrakun V, Day NPJ, West TE. Management and outcomes of severe dengue patients presenting with sepsis in a tropical country. PloS One. 2017; 12(4): e0176233.
14. Tricou V, Vu HT, Quynh NV, Nguyen CV, Tran HT, Farrar J, Wills B, Simmons CP. Comparison of two dengue NS1 rapid tests for sensitivity, specificity and relationship to viraemia and antibody responses. BMC Infect Dis. 2010; 10:142. doi:10.1186/1471-2334-10-142. 19.
15. Hsieh CJ, Chen MJ. The commercial dengue NS1 antigen-capture ELISA may be superior to IgM detection, virus isolation and RT-PCR for rapid laboratory diagnosis of acute dengue infection based on a single serum sample. J Clin Virol. 2009; 44:102. doi: 10.1016/j.jcv.2008.10.003
16. Pal S, Dauner AL, Mitra I, Forshey BM, Garcia P, Morrison AC, Halsey ES, Kochel TJ, Wu SJ. Evaluation of dengue NS1 antigen rapid tests and ELISA kits using clinical samples. PLoS One. 2014; 9: e113411. doi: 10.1371/journal.pone.0113411.