Leica Autostainer XL ST5010 Automated Tissue Stainer

Overview

The Leica Autostainer XL ST5010 is a fully automated, high-throughput tissue stainer engineered for routine and specialized histopathology laboratories. Based on precise fluidics control, programmable reagent dispensing, and temperature-regulated incubation modules, the ST5010 delivers reproducible hematoxylin–eosin (H&E), special stain, and immunohistochemistry (IHC) protocols with exceptional inter- and intra-batch consistency. Its modular architecture supports integration into end-to-end digital pathology workflows—most notably via seamless interface with the Leica TS5015 slide transfer station and CV5030 coverslipper—enabling unattended staining-to-cover-slipping operation for up to 300 slides per run. Designed in accordance with ISO 13485-certified manufacturing standards and compliant with EU IVDR (In Vitro Diagnostic Regulation) requirements for laboratory instrumentation, the ST5010 meets core quality system expectations for GLP- and CAP-accredited labs.

Key Features

• High-capacity batch processing: accommodates up to 10 standard slide racks (30 slides per rack), enabling 300-slide runs without manual intervention.
• 15 programmable user-defined staining protocols stored locally on the instrument’s embedded controller, supporting lab-specific optimization of fixation, deparaffinization, hydration, staining, differentiation, bluing, dehydration, and clearing steps.
• Independent temperature control across multiple reagent stations (e.g., 37°C for enzymatic antigen retrieval; 60°C for dewaxing; ambient for counterstains), ensuring protocol fidelity and reagent stability.
• Low-volume reagent dispensing system minimizes consumable waste while maintaining precise volumetric accuracy (±2% CV) across all liquid handling steps.
• Compact footprint (W × D × H: 760 × 720 × 680 mm) optimized for space-constrained core lab environments without compromising throughput or service accessibility.
• Integrated diagnostics and real-time status monitoring—including reagent level sensors, pump pressure feedback, and door interlock validation—support proactive maintenance and audit-ready operational logs.

Sample Compatibility & Compliance

The ST5010 processes standard 1″ × 3″ (25 × 75 mm) glass microscope slides, compatible with paraffin-embedded tissue sections (3–5 µm thickness), cytology preparations, and bone marrow smears. It supports common histological reagents—including xylene substitutes, alcohol gradients, hematoxylin variants (Mayer’s, Gill’s), eosin Y, Masson’s trichrome, PAS, and IHC detection kits from major vendors (Dako, Ventana, Biocare). All hardware and software functions comply with IEC 61010-1 (safety of laboratory equipment) and IEC 62304 (medical device software lifecycle). Audit trail functionality satisfies FDA 21 CFR Part 11 requirements when operated with validated Leica Application Suite (LAS) software version 4.5 or later.

Software & Data Management

Controlled via Leica’s intuitive touch-screen interface running embedded Linux OS, the ST5010 features password-protected user roles (Operator, Supervisor, Administrator) and encrypted local storage of protocol parameters, run history, and error logs. Protocol editing is performed offline using Leica ST-Editor PC software (Windows 10/11), which exports validated .stp files via USB or network upload. All run data—including start/end timestamps, reagent lot numbers, temperature profiles, and operator ID—are exportable as CSV or PDF reports for QA documentation. Optional integration with LIS/HIS systems is supported through HL7 v2.5.1 messaging over TCP/IP.

Applications

• Routine H&E staining for surgical pathology reporting
• Special stains (e.g., Alcian Blue/PAS, Gomori’s reticulin, Ziehl–Neelsen) requiring precise timing and thermal control
• Antigen retrieval–dependent IHC protocols (heat-induced and enzyme-based)
• High-volume screening applications in reference labs, biobanks, and clinical trial support facilities
• Standardized staining for proficiency testing and inter-laboratory comparison studies

FAQ

Can the ST5010 be retrofitted with the TS5015 transfer station and CV5030 coverslipper after initial installation?
Yes—hardware mounting brackets and communication interfaces are pre-engineered for field upgrade; Leica Field Service performs integration with full functional validation.
Does the instrument support remote monitoring or troubleshooting?
Remote diagnostic access is available via secure VPN connection under Leica’s Remote Support Agreement (RSA), subject to customer IT policy approval.
What is the recommended maintenance schedule?
Daily cleaning of fluid paths and waste lines; quarterly calibration of temperature modules and dispensing accuracy; annual preventive maintenance by certified Leica Service Engineers.
Is third-party reagent compatibility verified?
Leica provides a list of validated third-party reagents; non-validated reagents may be used at the user’s discretion but void warranty coverage for protocol-related performance issues.
How does the ST5010 handle reagent expiration tracking?
Reagent cartridges include RFID tags or barcodes scanned during loading; the system logs lot number, expiry date, and first-use timestamp, issuing warnings 72 hours prior to expiration.