Ella Automated Microfluidic ELISA System by ProteinSimple

Overview

The Ella Automated Microfluidic ELISA System by ProteinSimple is a benchtop, fully integrated immunoassay platform engineered for precision, reproducibility, and walk-away operation in quantitative protein biomarker analysis. Unlike conventional microplate ELISA systems that rely on multi-step manual washes, plate transfers, and user-dependent incubation timing, Ella leverages proprietary microfluidic cartridge technology to encapsulate the entire ELISA workflow — from sample loading and reagent delivery to incubation, washing, and fluorescence detection — within single-use, pre-primed cartridges. Each cartridge contains eight independent microfluidic channels, enabling parallel quantification of up to eight analytes per run (or eight replicates of a single target) with minimal hands-on time (<2 minutes). The system operates on the principle of sandwich immunoassay detection using fluorescence intensity readout at 530/580 nm (excitation/emission), calibrated against internal reference standards embedded in every cartridge. Designed for mid-throughput research and translational labs, Ella delivers picogram-per-milliliter sensitivity across validated human, mouse, and rat cytokine and phosphoprotein panels — all without requiring assay development, optimization, or curve-fitting software.

Key Features

• Fully automated end-to-end workflow: Sample-to-result in under 90 minutes, including onboard reagent storage, temperature-controlled incubations (4–40 °C), and integrated optical detection.
• Microfluidic cartridge architecture: Eliminates cross-contamination risk, reduces reagent consumption by >90% versus 96-well plate formats, and ensures consistent fluidic handling via capillary-driven flow and pneumatic valving.
• No manual standard curve generation: Each cartridge includes pre-loaded, lyophilized calibrators and controls; instrument software automatically performs 5-parameter logistic (5PL) curve fitting and concentration interpolation in real time.
• Onboard QC monitoring: Real-time tracking of binding kinetics, signal-to-noise ratios, and cartridge integrity metrics ensures assay validity before result export.
• Regulatory-ready data management: Audit-trail enabled software logs all user actions, instrument events, and raw fluorescence data with timestamped metadata compliant with 21 CFR Part 11 requirements for electronic records and signatures.
• Modular scalability: Supports integration with LIMS via ASTM E1384-compliant HL7 messaging and offers optional barcode scanning for sample traceability.

Sample Compatibility & Compliance

Ella accepts native biological matrices including serum, plasma (EDTA, heparin, citrate), cell culture supernatants, cerebrospinal fluid (CSF), and tissue lysates — with built-in dilution capability (1:2 to 1:100) and matrix interference compensation algorithms. All assays are developed and verified per ISO 13485–certified manufacturing processes and meet analytical validation criteria outlined in ICH M10 and CLSI EP17-A2 guidelines for sensitivity, precision, and linearity. Cartridge-based design inherently satisfies GLP/GMP requirements for defined lot traceability, closed-system operation, and elimination of operator-induced variability. System validation packages include IQ/OQ documentation templates aligned with FDA and EMA expectations for regulated bioanalysis environments.

Software & Data Management

The Ella Software Suite (v5.x) provides a secure, role-based interface for assay setup, run monitoring, and report generation. Raw fluorescence intensity values, background-subtracted signals, and fitted concentration outputs are stored in an encrypted SQLite database with automatic daily backups. Export options include CSV, PDF, and XML formats compatible with downstream statistical platforms (e.g., GraphPad Prism, R). The software supports user-defined pass/fail criteria based on control acceptance thresholds and flags outliers using Grubbs’ test. Electronic signature functionality enables dual-user review/approval workflows, while full audit trail logging meets ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

Applications

Ella is routinely deployed in academic core facilities, biopharma discovery units, and clinical research laboratories for longitudinal biomarker profiling in oncology, neurodegeneration, immunology, and infectious disease studies. Typical use cases include monitoring PD-1/PD-L1 axis proteins in checkpoint inhibitor trials, quantifying IL-6 and TNF-α dynamics during sepsis modeling, measuring phosphorylated ERK and AKT in kinase inhibitor pharmacodynamics, and validating extracellular vesicle surface markers in liquid biopsy development. Its robustness across low-volume samples (as little as 25 µL per analyte) makes it especially suited for pediatric cohorts and serial sampling protocols where specimen volume is constrained.

FAQ

Does Ella require assay development or antibody pairing?
No. Each validated assay panel uses ProteinSimple-qualified capture/detection antibody pairs pre-immobilized in the cartridge — no user optimization is needed.
Can Ella be used for custom analyte detection?
Yes. Custom cartridge development services are available through ProteinSimple’s Contract Assay Development program, supporting non-standard targets under NDA-protected workflows.
How is calibration maintained across instrument lifetime?
Cartridge-integrated calibrators are lot-specific and traceable to NIST-traceable reference materials; system performance verification is performed daily using the included QC cartridge.
Is remote monitoring supported?
Yes. Secure HTTPS-based web dashboard allows real-time run status viewing and email/SMS alerts upon completion or error conditions.
What regulatory documentation is provided with system installation?
Full validation support package includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, along with Certificate of Conformance and software version release notes.