The global spread of carbapenem-resistant bacteria continues to threaten effective antimicrobial therapy, making rapid identification of carbapenemase-producing organisms more important than ever. To support timely clinical decision-making and antimicrobial resistance (AMR) surveillance, Macro & Micro-Test is proud to introduce its Carbapenemase Detection Kit with IVDR certification, complying with the stringent requirements of the European In Vitro Diagnostic Regulation (EU 2017/746).

Designed for rapid and accurate molecular detection of the six most clinically significant carbapenemase genes—KPC, NDM, OXA-48, OXA-23, VIM and IMP—the assay provides laboratories with a reliable solution for infection control, antimicrobial stewardship and optimized patient management. The solution is available for both conventional real-time PCR platforms and the fully automated Eudemon^TM AIO800 Nucleic Acid Amplification Analyzer, enabling flexible deployment across diverse laboratory settings.

Why Carbapenemase Detection Matters

Carbapenems remain one of the most important treatment options for severe bacterial infections. However, the increasing emergence of carbapenemase-producing organisms has significantly reduced their clinical effectiveness.

According to the World Health Organization (WHO), antimicrobial resistance is among the world’s leading public health threats, while carbapenem-resistant Enterobacterales (CRE) are recognized as one of the most critical priority pathogens requiring continuous surveillance and rapid diagnosis.

Early molecular identification of carbapenemase genes enables healthcare professionals to:

• · Initiate appropriate antimicrobial therapy sooner
• · Support antimicrobial stewardship programs
• · Implement timely infection prevention and control measures
• · Monitor the spread of resistant organisms within healthcare facilities

Targeting the Most Clinically Relevant Carbapenemases

Macro & Micro-Test’s assay simultaneously detects six major resistance genes responsible for the majority of clinically significant carbapenem-resistant infections.

Rapid PCR Testing for Confident Clinical Decisions

Compared with conventional phenotypic methods, PCR-based molecular detection offers superior sensitivity, specificity and turnaround time. Rapid identification of resistance genes helps clinicians make evidence-based treatment decisions while supporting hospital infection control and antimicrobial resistance surveillance.

IVDR-Certified Carbapenemase Detection Solution

-Simultaneous detection of KPC, NDM, OXA-48, OXA-23, VIM and IMP in human sputum and culture isolates;

-High specificity with no cross-reactivity to non-target pathogens or resistance genes; 

-High sensitivity down to 100 CFU/mL or 500 copies/mL; 

-Broad Compatibility with ABI 7500, SLAN-96P and other mainstream real-time PCR systems; 

Full automation on Eudemon ^TM AIO800 

The AIO800 integrates sample preparation, nucleic acid extraction, amplification and result interpretation into one compact platform, delivering fast and reliable molecular testing with minimal hands-on time.

-Sample to Answer fully automated workflow.

-Fast results in approximately 80 minutes.

-Integrated contamination control system ensures accurate and dependable results.

Supporting Better Antimicrobial Stewardship

With IVDR certification, Macro & Micro-Test further demonstrates its commitment to providing high-quality molecular diagnostic solutions for laboratories across Europe and worldwide.

The IVDR-certified Carbapenemase Detection Solution enables healthcare providers to strengthen antimicrobial resistance surveillance, improve infection control strategies and deliver more precise treatment decisions for patients facing multidrug-resistant bacterial infections.

Precise Diagnosis Shapes a Better Future.

For more information, please contact: marketing@mmtest.com