Beginning next week, the Centers for Disease Control (CDC) will have new dengue virus (DENV) diagnostics kits available for distribution to clinical and public health laboratories within the United States and internationally.
The test, called the CDC DENV-1-4 Real Time RT PCR Assay, was developed by CDC researchers utilizing the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument. This platform was distributed by the CDC to over 100 US and international public health laboratories as part of the response to the 2009 H1N1 epidemic. CDC adapted their dengue test to take advantage of this widely used testing platform.
The assay is the first nucleic acid diagnostic device for detection and typing of DENV nucleic acid in suspected, symptomatic cases approved by the FDA for use in the United States. This assay detects DENV serotypes 1, 2, 3 or 4 from human serum or plasma collected from patients with signs and symptoms consistent with dengue infection.
The other available FDA-approved dengue tests detect certain type of antibody (immunoglobin M (IgM) class antibodies) to dengue virus. Most patients begin to develop these antibodies four days after they become ill. However, because not everyone develops these antibodies until seven days after they get sick, these antibody tests might not recognize dengue early in a patient’s illness. The CDC RT PCR assay is the first FDA-approved molecular test for dengue that detects evidence of the virus itself.
“The need for the new dengue diagnostic test was high,” said Jorge L. Munoz-Jordan, Ph.D., chief of the Molecular Diagnostics and Research at the CDC Dengue Branch. “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.”
Dengue fever is caused by any of four mosquito-transmitted dengue viruses, particularly prevalent in the tropics and sub-tropics. Symptoms include high fever, severe headache, severe pain behind the eyes, joint pain, muscle and bone pain, rash and mild bleeding involving the nose or gums, and easy bruising. Severe infections can result in hemorrhage, shock, and death. Although there are no FDA-licensed vaccines to prevent dengue, timely medical care can greatly reduce the possibility of death.