Molecular Assay Approved for Dengue Diagnosis

A molecular diagnostic test has been developed and officially approved to detect the dengue virus in people with symptoms of dengue or dengue hemorrhagic fever.

The DENV-1-4 Real Time Polymerase Chain Reaction (RT-PCR) Assay was developed by the US Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA) for use in the USA and can be conducted by using equipment and supplies that are already performed in many public health laboratories to diagnose influenza.

With the RT-PCR 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 molecular dengue test approved by the US Food and Drug Administration (FDA, Silver Springs, MD, USA), which detects the actual virus in comparison with other available FDA-approved tests, which just detect immunoglobin M (IgM) a certain type of antibody to 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, which means that health care professionals cannot always recognize early enough that a person has become infected with dengue. Each year, thousands of US visitors develop dengue fever, which manifests itself through high fever, severe headaches or pain behind the eyes, aching joints, muscles, and bones, 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.

Jorge L. Munoz-Jordan, PhD, chief of the Molecular Diagnostics and Research at the CDC Dengue Branch, said "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." The DENV-1-4 RT-PCR Test kits will be available for distribution to clinical and public health laboratories in the USA and abroad from July 2, 2012.

Related Links:
US Centers for Disease Control and Prevention
US Food and Drug Administration