ASTar BC G- Kit

The ASTar BC G- Kit is a fully automated system for rapid antimicrobial susceptibility testing (AST) of Gram-negative bacteria directly from positive blood culture samples. It uses high-speed, time-lapse microscopy imaging to measure bacterial growth in the presence of antimicrobial agents and report results within approximately six hours, requiring organism identification input for final AST result interpretation.

The device updates software algorithms to improve performance for specific antimicrobial-organism combinations, expands the panel to include five new antimicrobials (Cefotaxime, Cefoxitin, Ceftolozane-tazobactam, Ceftriaxone, Ertapenem), adds additional organisms to cleared antimicrobials, and updates nomenclature to report results for organism complexes/groups rather than single species. Clinical breakpoints are updated to FDA-recognized Susceptibility Test Interpretive Criteria (STIC) current as of February 5, 2026, based on CLSI M100, 36th Edition.

CLSI M100 36th Edition Performance Standards; CLSI M07 12th Edition for frozen broth microdilution (BMD) reference testing; FDA-recognized Susceptibility Test Interpretive Criteria (STIC); ISO 13485 (Quality Management System); essential agreement (EA), category agreement (CA), very major discrepancy (VMJ), major discrepancy (MAJ), and minor discrepancy (MIN) metrics for AST performance assessment.