Abstract
Background In critically ill patients, carbapenems are often used as the last line of treatment. Carbapenem-resistant Enterobacterales (CRE) present an extreme challenge to treatment due to their resistance to various antibiotics. Optimal therapy for patients and infection control relies on the early and accurate diagnosis of these infections. The K.N.I.V.O. Detection K-Set is a newly developed immunological rapid test developed to identify the presence of carbapenemase in Gram-negative bacteria resistant to multiple drugs. Objectives This study evaluates a new K.N.I.V.O. Detection K-Set and its application for the rapid detection of isolates of multidrug-resistant Escherichia coli (MDR E. coli) that produce carbapenemase. This test aims to compare the test's performance to the polymerase chain reaction (PCR) method. Methods The study included 150 MDR E. coli isolates that were confirmed to be resistant to at least three groups of antibiotics, including carbapenems. The test followed the manufacturer's instructions using the K.N.I.V.O. Detection K-Set. The outcomes were compared with carbapenemase gene detection (bla-KPC, bla-NDM, bla-OXA-48, bla -VIM, and bla -IMP) using the PCR. The K-Set's sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated and studied. Results The K.N.I.V.O. Detection K-Set showed highly effective diagnostic performance with a 97.1% sensitivity, 97.5% specificity, 97.1% positive predictive value, and 98.7% negative predictive value. Seventy-eight of the 150 isolates were proven to be producers of carbapenemase, with 68 of those cases having an accurate identification. The remaining isolates were found to be non-producers. Within 15 minutes, the rapid test provided results. Conclusion The K.N.I.V.O. Detection K-Set is an effective and rapid method for identifying carbapenemase producers among MDR E. coli isolates. Its rapid processing time, associated with its high sensitivity and specificity, indicates that it can increase the effectiveness of diagnostic laboratories and better patient care in clinical settings. Implementing such rapid screenings could be vital for controlling the spread of drug-resistant infections and enhancing antimicrobial stewardship. This also ensures that patients receive timely treatment and effective care.