New Dengue Test Approved by the FDA
Joe Barber Jr, PhD
June 21, 2012 — The DENV-1-4 Real Time RT PCR Assay, developed by the US Centers for Disease Control and Prevention (CDC), was recently authorized for use by the US Food and Drug Administration (FDA), according to a CDC news release.
Unlike other approved assays that detect antibodies against the dengue virus, the CDC test is the first approved assay that detects the dengue virus itself. The test uses equipment that is already used in influenza tests and thus can be run in laboratories that perform real-time polymerase chain reaction (PCR) assays.
"The need for the new dengue diagnostic test was high," said Jorge L. Munoz-Jordan, PhD, chief of the Molecular Diagnostics and Research at the CDC Dengue Branch, in the release. "Patients will be diagnosed sooner than before, and public health laboratories will have a clearer picture of the true number of dengue cases. Dengue is now a reportable disease in the United States, and the availability of state-of-the-art dengue diagnostics will improve patient management and the public health response to dengue."
The CDC test kits will be available for distribution on July 2 to clinical and public health laboratories in the United States and abroad. The assay detects all 4 types of the dengue virus, which is transported by Aedes mosquitoes.
The majority of patients begin to develop antibodies against the dengue virus 4 days after becoming ill; however, early diagnosis is not available for all patients because some of them do not develop these antibodies until 7 days after becoming ill. According to the news release, the CDC test will permit earlier diagnosis of dengue virus infection.
The release also noted that timely care reduces the risk of death, although no vaccines or medicines that specifically target the dengue virus have been approved by the FDA.
Dengue remains a major public health problem in many tropical and subtropical regions that are frequently visited by US travelers, including Asia, Latin America, and the Caribbean. In addition, dengue transmission has been reported occasionally in regions of the contiguous United States in which Aedesmosquitoes are present.© 2012 WebMD, LLC
Full Article: Medscape
CDC Dengue Branch