University of Hawai`i at Mānoa scientists have found that a commercially available, FDA-approved dengue detection kit bests the former “gold standard” test by producing results in under five hours.
A study conducted at the John A. Burns School of Medicine (JABSOM) sought to evaluate the use of the commercially available, Food and Drug Administration (FDA) approved InBios Dengue virus IgM ELISA kit for rapid diagnosis of dengue virus infection. This kit detects anti-dengue virus IgM antibodies, which are produced within three to five days after the onset of dengue fever.
Dengue virus clinical manifestations vary from asymptomatic infection, mild fever to a severe disease characterized by hemorrhage and shock. Dengue virus outbreaks occurred in Hawai`i in 2001 and 2011 with 153 and four dengue cases, respectively.
Rapid diagnosis of dengue virus infection is critical for effective patient management, thus can prevent the severe dengue disease. In addition, it also helps to prevent the spread of dengue virus infection, which can occur after the bite of dengue-virus infected mosquitoes.
In the study, reported in the Journal of Clinical Microbiology, JABSOM’s Department of Tropical Medicine, Medical Microbiology and Pharmacology tested 79 well characterized clinical serum samples collected from Hawai`i, Vietnam, Niue, Singapore and American Samoa, where dengue virus outbreaks occurred in the past, using InBios DENV IgM ELISA kit and results were compared to that of “gold standard’ DENV IgM antibody capture ELISA (MAC-ELISA). The agreement, sensitivity, and specificity of the InBios assay were 94, 92 and 94% respectively. The study found that InBios’ DENV Detect IgM Capture ELISA is advantageous compared to the in-house MAC-ELISA, as the results can be obtained in less than five hours, whereas the in-house MAC-ELISA requires 2 to 3 days. The researchers concluded that InBios DENV IgM Capture ELISA can be effectively used for rapid diagnosis of acute or recent DENV infection.
This study was supported in part by grants P20GM103516, U01AI078213 and U54MD007584 from the National Institutes of Health, grant W81XWH0720073 from the Department of Defense and by institutional funds.
Dengue is a significant human pathogen of global importance. Today about 2.5 billion people, or 40% of the world’s population, live in areas where there is a risk of dengue transmission. Dengue is endemic in at least 100 countries in Asia, the Pacific, the Americas, Africa and the Caribbean. Recent reports indicate that there are about 350 million people infected with the dengue virus annually worldwide, triple the World Health Organization (WHO) estimates of 50 to 100 million annual infections, mostly among children. Recently there have been reported outbreaks in Kenya (May 2013) and Angola (June 2013). Although most of the reported cases in the United States are acquired by travelers or immigrants, autochthonous dengue fever outbreaks have occurred in Brownsville, TX (2005), southern Florida (2009-2011) and Hawai`i (2011).
About the Department of Tropical Medicine:
The mission of the Department of Tropical Medicine, Medical Microbiology and Pharmacology is to train and educate future leaders in Tropical Medicine and Pharmacology to conduct transdisciplinary research, training and teaching that focuses on basic, translational, and field research on microbial diseases of public health importance to Hawai`i and the Asia-Pacific region.
About InBios International, Inc.:
InBios International, Inc., located at 562 1st Ave. South, Suite 600, Seattle, WA, USA, manufactures diagnostic tests for infectious diseases. InBios is an FDA registered facility and ISO 13485:2003 Certified. The company manufactures a full range of dengue products including ELISA kits for Dengue IgM, IgG, and NS1 and a rapid test for Dengue NS1. All products are manufactured in the USA.
Source: This tropical medicine story was issued by the John A. Burns School of Medicine.