Hardy Diagnostics announced the FDA clearance of the NG-TEST CTX-M Multi, an in vitro, rapid, and visual immunoassay for the qualitative detection of most prevalent CTX-M enzymes (groups 1, 2, 8, 9, and 25) from pure colonies of Enterobacterales suspected of ESBL production.
This breakthrough assay rapidly confirms the presence of CTX-M enzymes in minutes, not hours.
The rapid and widespread emergence of extended-spectrum beta-lactamases (ESBLs) is a growing global health concern. These enzymes confer resistance to many beta-lactam antibiotics, making infections more difficult to treat.
First reported in 1989 in Germany, CTX-M β-lactamases were considered rare in North America until 2003, when the Centers for Disease Control and Prevention identified them in nine Escherichia coli isolates from five U.S. states. Since then, CTX-M ESBLs have become the most prevalent type in the U.S. and globally.
Over 100 variants within the five major CTX-M groups are known, with CTX-M variants belonging to groups 1 and 9 being the most widespread. CTX-M enzymes are found in various bacterial species, including E. coli, Klebsiella pneumoniae and Proteus mirabilis.
Antibiotic resistance continues to pose significant challenges worldwide. ESBL-related infections lead to increased healthcare costs due to the use of broad-spectrum antibiotics, extended hospital stays, increased risk of side effects, and more complex treatment regimens. Early detection concurrent with the traditional antimicrobial susceptibility testing in critical cases or in instances of suspicion of resistant Enterobacterales, leading to timely treatment, and appropriate antibiotic selection are key to improving patient outcomes.
As prevalence continues to rise, so does the need for increased CTX-M ESBL testing. Detection has primarily relied on MIC and disk diffusion susceptibility testing, molecular techniques like PCR, or screening culture media. These methods can be time-consuming or expensive.
NG-TEST CTX-M Multi delivers results in just 15 minutes.
Learn more about CTX-M Multi here
