QUANTOM Tx™ Microbial Cell Counter
| Brand | Aligned Genetics |
|---|---|
| Origin | South Korea |
| Model | Q10001 |
| Detection Time | 30 s |
| Cell Concentration Range | 2 × 10⁵ to 1 × 10⁹ cells/mL |
| Sample Loading Volume | 5–6 µL |
| Measured Volume per Analysis | 0.09 µL (across 10 fields of view) |
| Detectable Cell Size Range | 0.3–50 µm |
Overview
The QUANTOM Tx™ Microbial Cell Counter is a benchtop, image-based automated cell counting system engineered for rapid, label-free and fluorescence-enabled quantification of microbial cells—including bacteria, yeasts, and small eukaryotic microorganisms—without reliance on culture-based colony formation or optical density (OD) extrapolation. Utilizing high-resolution auto-fluorescence microscopy coupled with multi-field-of-view (FOV) acquisition and AI-assisted segmentation algorithms, the instrument captures and analyzes up to 10 distinct microscopic fields within approximately 30 seconds. Its detection principle is rooted in digital fluorescence imaging cytometry: cells are stained with membrane-permeant or impermeant nucleic acid dyes (e.g., SYTO 9/PI), enabling simultaneous enumeration of total and viable cells based on membrane integrity. Designed specifically for low-volume, high-precision microbiological workflows, the QUANTOM Tx™ eliminates inter-operator variability inherent in manual hemocytometer counting and avoids the time lag and physiological bias associated with CFU plating.
Key Features
- Sub-30-second analysis cycle—from sample loading to quantitative output of total and viable cell concentrations.
- High-fidelity fluorescence imaging platform with motorized Z-stack capability and adaptive focus tracking across heterogeneous samples.
- Validated detection range spanning 0.3–50 µm in diameter, accommodating cocci, bacilli, filaments, and clumped or chain-forming morphologies without preprocessing.
- Integrated 1280 × 800-pixel capacitive touchscreen interface with intuitive workflow navigation and real-time preview of acquired images.
- Robust architecture compliant with ISO 13485-aligned manufacturing practices; CE-marked for in vitro diagnostic (IVD) support use in research and quality control environments.
- No consumables beyond standard microscope slides and certified fluorescent dyes—no proprietary cartridges or disposable chambers required.
Sample Compatibility & Compliance
The QUANTOM Tx™ accepts untreated or minimally processed liquid suspensions—including broth cultures, fermentation broths, environmental water extracts, and bioprocess harvest streams. It supports common viability dyes (SYTO 9, propidium iodide, DAPI, acridine orange) and is compatible with both Gram-positive and Gram-negative species across diverse taxonomic groups (e.g., Escherichia coli, Bacillus subtilis, Saccharomyces cerevisiae). The system meets analytical performance criteria outlined in ASTM E2874–21 (Standard Guide for Enumeration of Microorganisms by Fluorescence Microscopy) and supports documentation traceability aligned with GLP and GMP principles. Audit trail functionality records user ID, timestamp, instrument settings, and raw image metadata—facilitating compliance with FDA 21 CFR Part 11 requirements when deployed with validated software configuration.
Software & Data Management
The embedded QUANTOM Analysis Suite v3.x provides on-device image acquisition, cell segmentation, classification (viable/non-viable), concentration calculation, and statistical reporting. Each analysis generates a PDF report containing summary metrics (mean concentration, CV%, field-by-field counts), annotated TIFF stacks, and histogram distributions of cell area and fluorescence intensity. Data export options include CSV, Excel-compatible .xlsx, and DICOM-compliant image archives. Remote data synchronization via encrypted HTTPS is supported for integration into LIMS environments. Software validation packages—including IQ/OQ documentation templates and electronic signature workflows—are available upon request for regulated laboratories.
Applications
- Biopharmaceutical upstream process monitoring: rapid assessment of inoculum density and viability pre-fermentation.
- Microbial QC in food, beverage, and cosmetic manufacturing per ISO 4833-1 and USP .
- Antibiotic susceptibility testing (AST) endpoint determination via time-kill kinetics.
- Environmental microbiology: enumeration of heterotrophic plate count (HPC) organisms in drinking water and wastewater.
- Academic and industrial strain screening where single-cell resolution and morphological fidelity are critical.
- Validation of sterilization efficacy and bioburden reduction studies.
FAQ
What sample preparation is required prior to analysis?
Minimal preparation is needed: samples must be diluted to fall within the optimal concentration range (1 × 10⁶–5 × 10⁸ cells/mL) and stained with a validated fluorescent nucleic acid dye. No centrifugation, filtration, or fixation is required.
Can the QUANTOM Tx™ distinguish between live and dead cells in mixed populations?
Yes—using dual-stain protocols (e.g., SYTO 9 + PI), the system classifies cells based on membrane integrity with >95% concordance versus flow cytometry reference methods under controlled conditions.
Is calibration traceable to national standards?
Instrument optical path calibration is verified using NIST-traceable fluorescent microsphere standards (e.g., Thermo Fisher Fluoresbrite YG, 3.0 µm). Daily system suitability checks are configurable within the software.
Does the system support regulatory submissions?
When operated under validated conditions—including documented software configuration, user access controls, and audit-trail-enforced workflows—the QUANTOM Tx™ supports data integrity requirements for regulatory filings under ICH M7, FDA guidance on analytical procedure validation, and EU Annex 11.
What maintenance is required?
Routine maintenance consists of weekly cleaning of the objective lens and fluidics pathway with isopropanol; no alignment or lamp replacement is necessary—the system uses solid-state LED excitation sources with >20,000-hour lifetime.
