Autobio AutoMic i600 Automated Microbial Identification and Antimicrobial Susceptibility Testing (AST) System

Overview

The Autobio AutoMic i600 is a fully automated, walk-away microbial identification and antimicrobial susceptibility testing (AST) platform engineered for clinical microbiology laboratories seeking high-throughput, standardized, and regulatory-compliant workflows. It operates on the principle of kinetic turbidimetric and colorimetric detection across four simultaneous wavelengths (typically 405 nm, 540 nm, 600 nm, and 700 nm), enabling real-time monitoring of microbial growth and metabolic activity in commercial microtiter test panels. The system integrates precise liquid handling, temperature-controlled incubation, optical reading, and AI-driven interpretation to deliver CLSI- and EUCAST-aligned results without manual intervention. Designed for ISO 15189-accredited labs and compliant with FDA 21 CFR Part 11 requirements for electronic records and signatures (when configured with audit trail and user access controls), the AutoMic i600 supports GLP/GMP-aligned quality assurance protocols across hospital, public health, and reference laboratory settings.

Key Features

• Intelligent bidirectional plate–specimen matching: Random placement of multiple panel types (ID/AST, ID-only, AST-only) enabled by dual barcode recognition (plate and sample tube)
• Robust XYZ robotic architecture with tower-style incubation module: Fully automated aspiration, dispensing, incubation, and optical readout — no user-defined pipetting parameters required
• Dispensing range: 30–1000 µL; accuracy: ±1 µL for volumes <100 µL; single-panel dispensing time ≤5 minutes
• High-capacity incubation chamber accommodating up to 64 test panels simultaneously, supporting tiered workload management
• Continuous, time-resolved optical measurement using dual-mode (turbidimetry + chromogenic assay) detection at four wavelengths
• Turnaround time: ≤5 hours for common bacteria; Gram-negative organisms (GN): 2–10 hours; Gram-positive organisms (GP): 2–8 hours; yeasts and Bacillus spp.: up to 18 hours

Sample Compatibility & Compliance

• Validated for use with aerobic, facultative anaerobic, and fastidious organisms including Enterobacterales, non-fermenters (e.g., Pseudomonas, Acinetobacter), Staphylococcus, Streptococcus, Enterococcus, Candida, Haemophilus, Neisseria, Corynebacterium, Campylobacter, and anaerobes
• All reagent test panels are NMPA-certified, including composite ID/AST cards (three configurations), Gram-positive, Gram-negative, non-fermenter, streptococcal, and fungal AST panels
• Compliance with CLSI M100 and EUCAST v14.0 breakpoints for MIC interpretation; built-in expert rules for intrinsic resistance, inducible clindamycin resistance, ESBL, CRE, MRSA, VRE, PRSP, and high-level aminoglycoside resistance
• Meets ISO/IEC 17025 and ISO 15189 documentation and traceability requirements via integrated LIS bi-directional interface and full barcode-based specimen tracking

Software & Data Management

• Bilingual UI (English/Chinese) with context-sensitive help, role-based access control, and customizable dashboard views
• LIS integration via ASTM E1384 and HL7 v2.x protocols; supports two-way data exchange, automatic result transmission, and electronic signature capture
• AI-powered identification algorithm trained on multi-center strain libraries; ≥95% accuracy and ≥95% repeatability for QC strains (ATCC and NCTC reference isolates)
• Audit trail functionality compliant with FDA 21 CFR Part 11 (when enabled), including user logins, result modifications, and system configuration changes
• Customizable report templates supporting institutional branding, regulatory reporting formats (e.g., antimicrobial stewardship dashboards), and export to PDF, CSV, or XML
• Cloud-enabled database updates: Real-time synchronization with Autobio’s central knowledge base for organism identification and breakpoint revisions

Applications

• Routine identification and AST in clinical microbiology laboratories serving hospitals, diagnostic centers, and academic medical institutions
• Antimicrobial stewardship program (ASP) support through rapid, actionable MIC and categorical interpretations (S/I/R)
• Outbreak investigation and surveillance where reproducible, standardized phenotypic profiling is required
• Reference lab confirmation testing and proficiency testing (PT) participation
• Research applications requiring high-fidelity phenotypic characterization of clinical isolates under standardized conditions
• Regulatory submissions requiring documented, auditable, and repeatable AST methodology per CLIA, CAP, or JCI standards

FAQ

What regulatory standards does the AutoMic i600 comply with?

The system supports compliance with CLSI M100, EUCAST v14.0, ISO 15189, ISO/IEC 17025, and FDA 21 CFR Part 11 (with optional audit trail and electronic signature modules).
Can the AutoMic i600 interpret complex resistance mechanisms such as ESBL or carbapenemase production?

Yes — its embedded expert system applies rule-based algorithms aligned with current CLSI and EUCAST guidelines to infer ESBL, CRE, MRSA, VRE, and other clinically relevant resistance phenotypes from AST patterns.
Is database update performed automatically or manually?

Database updates are delivered via secure cloud synchronization; users may schedule or trigger updates manually, with version history and change logs retained for audit purposes.
Are all test panels NMPA-certified?

Yes — all commercially supplied ID and AST panels, including three composite ID/AST configurations, hold valid NMPA registration certificates.
Does the system support custom panel development or third-party reagents?

Autobio offers OEM and co-development pathways for customized panel design; however, only NMPA-registered Autobio-branded panels are validated for use with the AutoMic i600 platform.