Automated Sepsis Test System Enables Rapid Diagnosis for Patients with Severe Bloodstream Infections

By LabMedica International staff writers
Posted on 07 May 2024

Image: The ASTar System has received US FDA 510(k) clearance (Photo courtesy of Q-linea AB)

Sepsis affects up to 50 million people globally each year, with bacteraemia, formerly known as blood poisoning, being a major cause. In the United States alone, approximately two million individuals are affected by sepsis annually, resulting in around 250,000 deaths. Similar statistics are reported in the European Union. Sepsis is characterized by life-threatening organ failure due to a dysfunctional systemic immune response. Rapid and accurate diagnostic methods are essential for timely and effective treatment, which is critical for patient survival. Now, a fully automated system for rapid antimicrobial susceptibility testing (AST) significantly reduces the time required to obtain clinically actionable results, thereby speeding up the administration of optimal treatments from days to just hours.

The ASTar System from Q-linea AB (Uppsala, Sweden) revolutionizes the treatment of sepsis by enabling a rapid therapeutic response directly from a positive blood culture in about six hours. This system equips physicians with the necessary tools to enhance patient outcomes and reduce mortality rates. The fully automated ASTar instrument ensures robust and consistent preparation of inoculums for AST, utilizing high-speed time-lapse microscopy to observe bacterial growth in broth, which helps determine the minimum inhibitory concentration (MIC). The ASTar system can be integrated with any rapid identification (ID) technology, enhancing laboratory capabilities and fulfilling the clinical demand for quicker diagnostic results.

The system includes an ASTar Consumable kit, which comprises two disposable components: a sample preparation Cartridge and an AST Disc. The Cartridge serves as a mini-lab, equipped with all necessary reagents and disposable items for sample preparation, concentration measurement, dilution, and growth medium adaptation. The AST Disc, used for AST and concentration determination, features over 330 culturing chambers pre-filled with antimicrobials at various concentrations, along with chambers for growth controls and bacterial concentration assessment for inoculum preparation. The ASTar system also combines high throughput with a user-friendly interface and simple load-and-go operation. Q-linea AB has recently received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the ASTar System, which allows for its use in hospitals and laboratories across the United States.

“The approval is a significant step for Q-linea in the infectious disease diagnostics field in the U.S.,” said Stuart Gander, CEO of Q-linea. “Feedback from hospitals that have had early access to ASTar has been very positive, and we are excited to now be able to bring the system to labs across the U.S., which will make a real difference for patients with severe blood stream infections. We are pleased with the panel of drug-bug combinations which has been approved.”

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Q-linea AB