Bio-Rad iQ-Check Prep Automated Fluorescent qPCR Reaction Setup Workstation

Overview

The Bio-Rad iQ-Check Prep Automated Fluorescent qPCR Reaction Setup Workstation is an integrated liquid handling platform engineered to standardize and accelerate the pre-analytical phase of quantitative polymerase chain reaction (qPCR) workflows—specifically targeting pathogen detection in food safety, environmental monitoring, and industrial microbiology laboratories. Unlike generic pipetting robots, the iQ-Check Prep is purpose-built to execute protocol-defined reagent dispensing, sample transfer, and master mix preparation steps using Bio-Rad’s CE-IVD marked iQ-Check assay kits. Its operation relies on precise air-displacement pipetting technology with multi-channel (up to 96-well) capability, calibrated for low-volume accuracy (1–200 µL) across viscous and volatile qPCR reagents including Taq polymerase, probe-based detection chemistries, and internal controls. The system does not perform DNA extraction itself but interfaces directly with validated upstream extraction modules (e.g., iQ-Check DNA Extraction Kits or third-party ISO 16140-2 compliant instruments), ensuring traceable sample-to-result continuity under defined SOPs.

Key Features

• Pre-configured, kit-specific protocols for all iQ-Check certified assays—including Salmonella, Listeria monocytogenes, E. coli O157, and Campylobacter—with automatic calibration checks and tip-tracking logic.
• Integrated barcode scanning for sample tube, reagent lot, and consumable tracking—enabling full chain-of-custody documentation per ISO/IEC 17025 requirements.
• Onboard thermal control module maintains reagent stability at 4–10 °C during setup, minimizing degradation of temperature-sensitive enzymes and probes.
• Modular deck layout supports concurrent processing of up to 48 samples per run, scalable to 500+ samples in an 8-hour shift via batch queuing and walk-away automation.
• Self-diagnostic routines verify pipette performance (accuracy ±2%, precision CV ≤1.5%) prior to each run, generating instrument qualification reports compliant with FDA 21 CFR Part 11 Annex 11 expectations.

Sample Compatibility & Compliance

The iQ-Check Prep accepts primary sample containers ranging from 2-mL screw-cap tubes to 96-deep-well plates, accommodating both enriched broth cultures and purified nucleic acid eluates. It is validated for use with Bio-Rad’s iQ-Check DNA Extraction Kits (including magnetic bead-based and spin-column formats), as well as select ISO 16140-2 verified extraction systems when operated under documented bridging protocols. All consumables—including sterile filter tips, PCR plates (0.2 mL skirted/unskirted), and sealing films—are certified DNase/RNase-free and non-pyrogenic. The workstation meets IEC 61000-6-2/6-3 EMC standards and carries CE marking under IVDD 98/79/EC (now transitioned to IVDR 2017/746 compliance pathways). Method validation data are provided in accordance with AOAC PTM and NF VALIDATION guidelines.

Software & Data Management

Controlled by the iQ-Check Operating System v4.x, the workstation employs a role-based access interface with configurable user permissions (operator, supervisor, administrator). All run logs—including timestamps, operator ID, reagent lot numbers, error flags, and electronic signatures—are stored locally and exportable in CSV or XML format for LIMS ingestion. Audit trails are immutable and time-stamped to meet GLP/GMP data integrity principles (ALCOA+). Software updates follow a formal change control process, with version history and impact assessments archived per ISO 13485 clause 7.5.2. Optional integration with Bio-Rad’s Telemark™ cloud platform enables remote monitoring, predictive maintenance alerts, and centralized fleet management across multi-site laboratories.

Applications

• Routine screening of raw ingredients, finished products, and environmental swabs for regulated pathogens in USDA-FSIS, FDA, and EFSA-regulated facilities.
• High-throughput verification testing in contract laboratories performing accredited methods (e.g., ISO 22118 for Listeria, ISO 21528-2 for Enterobacteriaceae).
• Method transfer and harmonization across global manufacturing sites using identical instrumentation and software baselines.
• Supporting rapid response during outbreak investigations where same-day result turnaround is critical to containment decisions.

FAQ

Does the iQ-Check Prep perform DNA extraction?
No—it is designed exclusively for automated qPCR reaction setup. DNA extraction must be completed upstream using validated kits or instruments; the system interfaces seamlessly with iQ-Check DNA Extraction Kits.
Can it be used with non-Bio-Rad qPCR instruments?
Yes—the workstation prepares reactions in standard 96-well or 384-well formats compatible with any real-time PCR cycler, though optimal integration (e.g., direct result import) is achieved with Bio-Rad CFX instruments.
Is 21 CFR Part 11 compliance built-in?
The system supports Part 11 requirements through electronic signatures, audit trails, and role-based access—but final validation and configuration must be performed by the end-user laboratory per their quality management system.
What maintenance is required?
Daily tip waste disposal and weekly calibration verification are recommended; annual preventive maintenance by Bio-Rad Field Service Engineers ensures continued performance adherence to ISO 8655-6 specifications.