HealthDay News — The FDA has approved a new test that simultaneously detects the bacteria that causes tuberculosis and determines if it is drug resistant in about two hours.
The Xpert MTB/RIF Assay (Cepheid) is less complex to administer than other traditional screening tests for TB, which take up to several months to yield results, the agency said in a press release.
Although U.S. TB rates are at its lowest level since 1953, rapid and accurate diagnosis of TB continues to be a challenge, especially among immunocompromised patients and the elderly. The symptoms of TB in its early stages are similar to many different types of infections, thus having an accurate test to rule out the disease is critical for managing patients.
“Less complex tests such as the Xpert MTB/RIF Assay can be used in more diverse settings,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement. “The early and rapid detection of rifampin-resistant TB can help curb the spread of drug-resistant TB, a major public health threat.”
TB is caused by bacteria that belong to a group known as Mycobacterium tuberculosis complex, which usually attacks the lungs. Not everyone infected with M. tuberculosis develops active TB, and only people with active TB can spread the bacteria to other people.
People with weakened immune systems are most likely to develop full-blown TB once infected with the disease-causing bacteria, according to the FDA. TB is a leading killer globally of people with HIV/AIDS.
Common signs and symptoms of TB include a bad cough lasting three weeks or longer, chest pain, coughing up blood, weakness and fatigue and weight loss.
“Early diagnosis and effective treatment for both drug-susceptible and drug-resistant cases are essential for improving patient health, preventing the spread of disease to others, and ultimately, achieving our goal of TB elimination in the United States,” Kenneth G. Castro, MD, director of CDC’s Division of Tuberculosis Elimination, said in a press release.