FDA approves dengue virus diagnostic test

Singapore: Food and Drug Administration has approved a new diagnostic test to detect the presence of dengue virus in people with symptoms of dengue fever or dengue hemorrhagic fever. The test, called the CDC DENV-1-4 Real Time PCR Assay is developed by Centers for Disease Control and Prevention, US.

The new test will help diagnose dengue within the first seven days after symptoms of the illness appear, which is when most people are likely to see a health care professional and the dengue virus is likely to be present in their blood. The test can identify all four dengue virus types.

This is the first FDA-approved molecular test for dengue that detects evidence of the virus. The other available FDA-approved test detects a 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, the antibody test might not recognize dengue early in a patient's illness.

"The need for the new dengue diagnostic test was high," said Dr Jorge L Munoz-Jordan, 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."

One of the new test's most important features is that it can be performed using equipment and supplies that many public health laboratories already use to diagnose influenza. This makes it possible to begin using the test in the many laboratories in the United States and internationally that already run influenza Real-Time PCR assays, a frequently used flu test also developed by CDC. The new test will be available to clinical and public health laboratories within the United States and internationally. Kits will be available for distribution beginning July 2, 2012.