The US Food and Drug Administration has approved a new diagnostic test, the CDC DENV-1-4 Real Time RT PCR Assay developed by the Centers for Disease Control and Prevention to detect the dengue virus in people with symptoms of dengue or dengue hemorrhagic fever.
The test is for use in the US and can be conducted by using equipment and supplies that are already in use in many public health laboratories to diagnose influenza.
Dengue is caused by one of four dengue viruses that are transmitted through Aedes mosquitoes. Dengue is a major public health problem, which occurs mainly in the tropics and subtropics, including Puerto Rico and the U.S. Virgin Islands but has also occasionally been detected in areas of the US were Aedes mosquitos are present. Each year, thousands of US visitors develop dengue fever, which manifests itself through high fever, severe headaches or pain behind the eyes, joint -, muscle -, and bone pain, rash and mild bleeding of the nose or gums, as well as easy bruising. In severe cases, dengue can lead to hemorrhage, shock, and even death.
There are currently no FDA-licensed vaccines on the market to prevent or treat dengue, but early medical care can greatly decrease the possibility of death. People who think they may have contracted dengue should therefore immediately seek professional medical advice, considering that an early detection of the disease can prove extremely beneficial in determining the best course of treatment.
With the new test, laboratories are now able to diagnose all four dengue virus types within the first seven days after the appearance of any dengue-related symptoms. This coincides with the time the majority of people generally take in order to visit a health care professional whilst the dengue virus may already be present in their blood. The test is the first FDA-approved molecular dengue test, which detects the actual virus in comparison with other available FDA-approved tests, which just detect immunoglobin M (IgM) a certain type of antibody of the dengue virus. Although the majority of patients start developing antibodies within four days after falling ill, the antibodies are not present in everyone until seven days after they have become infected dengue, meaning that health care professionals cannot always recognize early enough that a person has become infected with dengue. Jorge L. Munoz-Jordan, Ph.D., chief of the Molecular Diagnostics and Research at the CDC Dengue Branch remarked:
“The need for the new dengue diagnostic test was high. 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.”
One of the big advantages of the new test is the fact that it can be performed with equipment and supplies that is already in use in many public health laboratories for diagnosing influenza. This means that it is possible to implement the test immediately in all US and international laboratories, which already run influenza Real-time PCR assays, i.e. a commonly used influenza test that was also developed by CDC. As of July 2, 2012, test kits will be available for distribution.
Written By Petra Rattue