FDA has approved a
new diagnostic test that detects dengue fever using existing equipment for diagnosing flu, the Centers for Disease Control and Prevention report. Called the CDC DENV-1-4 Real Time RT PCR Assay, the test is the first FDA-approved molecular diagnostic for dengue that detects evidence of the virus itself, according to the CDC. The rapid test allows healthcare professionals to use equipment and supplies already available in public health labs.
The assay can identify all four dengue viruses within the first seven days after symptoms appear, the CDC says. It is the first test approved by FDA that detects evidence of the dengue virus itself, while the other available FDA-approved test detects a certain type of antibody to the 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 the illness, according to the CDC.
"The need for the new dengue diagnostic test was high," says Jorge L. Munoz-Jordan, chief of 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."
---John Conroy