The U.S. Food and Drug Administration (FDA) recently approved the Xpert Carba-R Assay test, which is designed to detect certain genetic markers that signify antibiotic-resistant bacteria within clinical specimens.
The test is an infection control tool that finds genetic markets in patient specimens. The markers are connected to bacteria that have developed resistance against Carbapenem antibiotics, which hospitals typically use for treating serious infections.
The antibiotic resistant bacteria are called Carbapenem-resistant Enterbacteriaceae (CRE). Unfortunately, the bacteria has been found in nearly all of the U.S. states.
As of today, traditional methods for detecting CRE or other bacteria colonies depend on bacterial growth from fecal material cultures. These cultures are grown and used for antimicrobial susceptibility testing. Through the testing, the scientists evaluate the in vitro susceptibility of the bacteria to antimicrobial agents.
The traditional process can require four days to complete. Further tests are frequently needed to guarantee that carbapenemase -- an enzyme that counteracts Carbapenem antibiotics -- is found within the cultures.
The new approach is pivotal for tests detecting antibiotic resistant bacteria.
“By using a specimen taken directly from a patient to test for the presence of genetic markers, hospitals can more quickly identify these dangerous bacteria resistant to certain antibiotics,” Dr. Alberto Gutierrez, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health within the Center for Devices and Radiological Health, said.
