Abbott AxSYM random and continuous access immunoassay system for improved workflow in the clinical laboratory

Area of Science:

• Clinical Laboratory Science
• Biomedical Instrumentation
• Diagnostic Immunoassays

Background:

• Clinical laboratories require efficient and versatile immunoassay testing platforms.
• Existing analyzers may have limitations in throughput, assay flexibility, or technology integration.

Purpose of the Study:

• To introduce and describe the Abbott AxSYM, a novel clinical laboratory instrument.
• To highlight its capabilities in random- and continuous-access immunoassay testing.

Main Methods:

• The Abbott AxSYM system was developed, incorporating microparticle enzyme immunoassay, fluorescence polarization immunoassay, and ion-capture immunoassay technologies.
• The instrument supports primary tube sampling, onboard reagent management, and a real-time software scheduling processor.
• Assays can be processed in various formats with customizable parameters for pipetting, incubation, and detection.

Main Results:

• The AxSYM offers a throughput of 80-120 tests per hour with a 15-25 minute time to first result for routine assays.
• It demonstrated comparable performance to existing Abbott analyzers (IMx, TDx) for 23 assays, with high specimen correlation (R=0.97-0.99).
• Within-run imprecision (CV) was generally low, with 19 of 23 assays showing CVs ≤ 8.0%.

Conclusions:

• The Abbott AxSYM is a capable clinical laboratory instrument for immunoassay testing.
• Its advanced technologies, random-access capability, and performance metrics support efficient and reliable diagnostic testing.
• The system offers a broad menu including tests for infectious diseases, tumor markers, and therapeutic drug monitoring.