Countstar Rigel S2

Fluorescence cell analyzer

The Countstar Rigel S2 is equipped with two fluorescent excitation wavelengths and two detection filters. It offers additionally a bright field view on all samples in the digital microscope optics. The analyzer allows for the routine analysis of cell density and viability, and transfection efficiency. The pre-configured BioApps (assay protocol templates) guarantee an easy, anyhow safe execution of all tests. The protocols of the BioApps are optimized for the most frequently executed tests in production monitoring of cell-based therapies, investigation of primary cell material and composition of PBMC samples, modified CAR-T, NK and stem cells.

Excitation wavelengths: 480nm, 525nm
Emission filters: 535/40nm, 600nmLP

Frequently Used Cell Lines

• PBMCs, CAR-T cells, whole blood cells
• Stem Cells
• Splenocytes
• Monocytes
• Other Primary Cells

User Benefits

• Intuitive user-friendly operation
• All-in-one design with an ultra-sensitive 10.4-inch touchscreen
• Maintenance-free design and durable components

Technical Features

• 2 Fluorescent channels
• 3 customizable BioApps (assay templates) pre-installed – free places for more BioApps
• Automated analysis sequence of 5 samples in less than 2 min
• FDA’s 21CFR Part 11 compliant operation
• Validation is possible according to cGxP regulations

Overview

Our Patented Fixed Focus Technology

The Countstar Rigel is equipped with a highly precise, full-metal optical bench, based on our patented “Fixed Focus Technology” (pFFT), never demanding a user-dependent focusing prior to any image acquisition.

Our Innovative Image Recognition Algorithms

Our protected image recognition algorithms analyze more than 20 single parameters of each classified object.

Intuitive, Three-step Analysis

The Countstar Rigel is designed to guide you from sample to results in less time than comparable methods. It simplifies your work flow, allow-ing for increased productivity, and increases efficiency by analysis more parameters than classical methods.

Step One: Staining and injecting the sample
Step Two: Selecting appropriate BioApp and start analysis
Step Three: Viewing Images and checking result data

Compact, All-in-one Design

Ultra-sensitive 10.4’’ touchscreen

App-structured user interface allows for an intuitive, 21CFR Part 11 compliant, user experience. Personalized user profiles guarantee for a fast access to specific menu features.

Individually Designed and Customizable BioApps

Individually designed and customizable BioApps (assay protocol tem-plates) offer the access to an in-depth analysis of cells.

Up to Three Fields of View per Sample with High Repeatability

Up to three fields of interest selectable views per chamber to increase accuracy and precision of low concentrated sample analysis

Up to Four LED Wavelengths for up to 13 Fluorescence Channel Combinations

Available with up to 4 LED excitation wavelengths and 5 detection filters, allowing for 13 different combinations of fluorescent analysis.

Filter combinations of the Countstar Rigel series for popular fluorophores

Acquisition of bright-field and up to 4 fluorescent images automatically

in a single test sequence

Accuracy and Precision

The Countstar Rigel hard- and software creates trust by its ability to analyze five samples at a time producing accurate and precise results. The patented Fixed Focus Technology in combination with the exact chamber height of 190µm in each Countstar chamber are the basis for a coefficient of variation (cv) of less than 5% regarding cell concentration and viability in the range of 2×105 to 1×107 cells/mL.

Reproducibility tests chamber to chamber= cv <5 %
Reproducibility test slide to slide; cv <5 %
Reproducibility test Countstar Rigel to Countstar Rigel: cv < 5%

Accuracy and Reproducibility Test between 6 Countstar Rigel analyzers

Meeting the Actual Requirements of Modern cGMP Biopharmaceutical Research and Manufacturing

The Countstar Rigel is designed to meet all actual requirements in modern cGMP regulated biopharmaceutical research and production environments. The software can be operated compliantly to FDA’s 21 CFR Part 11 regulations. Key features include tamper-resistant software, encrypted storage results and image data, multi-role user access management, electronic signatures and log files, that provide for a secure audit trail. Customizable IQ/OQ document editorial service and PQ support by ALIT experts are offered to guarantee a seamless integration of Countstar Rigel analyzers in the validated productions and laboratories.

User Login

Four-level user access management

E-Signatures and Log Files

IQ/OQ Dodumentation Service

Standard Particle Portfolio

Certified Standard Particles Suspensions (SPS) for concentration, diameter, fluorescence intensity, and viability confirmation

Optional Data Export for Analysis in Flow Cytometry Software (FCS)

The DeNovo™ FCS Express image series software can transfer exportedCountstar Rigel images and results into highly dynamic data. The FCS software allows for in-depth analysis of cell populations to boost your experimental reach and publishes your results in a new dimensions. The Countstar Rigel in combination with the optional available FCS Express Image Image guarantees the user efficient data analysis of apoptosis progress, cell cycle status, transfection efficiency, CD marker phenotyping, or antibody affinity kinetic experiment.

Data Management

The Countstar Rigel Data Management Module is user-friendly, clear, and contains intuitive search functions. It gives the operators maximum flexibility in regards to data storage, safe data export in various formats, and traceable data and image transfers to central data servers.

Data Storage

The data storage volume of 500 GB on the internal HDD of a Countstar Rigel guarantees an archive capacity of up to 160,000 complete sets of experimental data including images.

Data Export Formats

Choices for data export include various options: MS-Excel, pdf reports, jpg images, and FCS export, and encrypted, original data and image archive files. Exports can be accomplished using either the USB2.0 or 3.0 ports or the ethernet ports.

BioApp (Assay) based Data Storage Management

Experiments are sorted in the internal Database by the BioApp (Assay) names. Consecutive experiments of an assay will be linked to the corresponding BioApp folder automatically, allowing for fast and easy retrieval.

Search Options for Easy Retrieval

Data can be searched for or selected by analysis dates, test names, or keywords. All acquired experiments and images can be reviewed, re-analyzed, printed, and exported via the above-named formats and methods.

The Countstar Chamber Slide

Compare

Experimental Assay	Rigel S2	Rigel S3	Rigel S5
Trypan Blue Cell Count	✓	✓	✓
Dual-fluorescence AO/PI method	✓	✓	✓
Cell cycle(PI)	✓∗	✓∗	✓
Cell Apoptosis(Annexin V-FITC/PI)	✓∗	✓∗	✓
Cell Apoptosis(Annexin V-FITC/PI/Hoechst)		✓∗	✓
GFP Transfection	✓	✓	✓
YFP Transfection			✓
RFP Transfection	✓	✓	✓
Cell Killing(CFSE/PI/Hoechst)		✓	✓
Antibodies Affinity (FITC)	✓	✓	✓
CD Marker Analysis(three channel)			✓
FCS Express Software	optional	optional	✓

✓∗. This mark indicates that the instrument can be used for this experiment with the optional FCS software