Hardy Diagnostics has announced that the U.S. Food and Drug Administration (FDA) has approved the NG-TEST® CTX-M Multi, a rapid immunoassay for the detection of the most widespread CTX-M type extended-spectrum beta-lactamases (ESBLs) in Enterobacterales.
This includes CTX-M groups 1, 2, 8, 9, and 25, which are commonly linked to antibiotic resistance.
Designed for use on isolated bacterial colonies suspected of ESBL production, the test delivers clear results in just 15 minutes—a significant improvement over traditional laboratory techniques that can take several hours or more.
CTX-M enzymes, originally discovered in Germany, are now the most frequently encountered form of ESBL worldwide, including in the United States.
Their rapid dissemination presents a major public health challenge due to the enzymes’ ability to break down a wide range of beta-lactam antibiotics, complicating treatment and increasing healthcare costs.
Prompt and accurate detection of these resistance markers is essential for selecting appropriate antibiotic therapies and enhancing patient care.
Current diagnostic methods, such as PCR, disk diffusion, MIC testing, and selective media, often require more time, specialized equipment, or higher costs.
The NG-TEST® CTX-M Multi addresses these challenges by offering a fast, dependable, and cost-effective solution that complements standard antimicrobial susceptibility testing, allowing healthcare providers to make more informed treatment decisions.
