Standard Assay Kits Allow for Rapid Deployment
The Accellix Platform automates your entire GMP cell phenotyping process from sample preparation to data acquisition and analysis, to generate rapid results directly in the manufacturing suite.
Standard Assay Kits
Central to our enabling technology are standard and custom assays. These assays enable sample preparation in a stable, single-use microfluidic cartridge using unitized and dried reagents that are stable at ambient temperatures. The dried reagent also has control beads, enabling cell counting and in-run QC for every assay. Each assay incorporates an Accellix cartridge with a unique QR code, simplifying the workflow and reducing the chances for human error.
- Fluidics contained in a cartridge, not in an instrument
- Minimal sample handling
- Ambient temperature storage
- Control beads in dried formulation for in-run QC and cell counting
- QR code holds necessary information to run the assay
T Cell Subset Assays
The T Cell Subset assays are used for the enumeration (frequencies and counts) of various T cell subsets including, viable CD45+ leukocytes, CD3+ T cells, CD4+ T helper cells, and CD8+ cytotoxic T cells.
The lyse (L) assays may be used for staining apheresis, whole blood, and other samples that require differential RBC (red blood cell) lysis The non-lyse (NL) version may be used for staining purified white blood cells.
N-1 and N-2 test kits contain only CD45 and CD3 antibodies, enabling customers to add AF488 and/or PE-conjugated liquid antibodies to test on the Accellix Platform.
Please visit the Accellix Assay Kit Instructions for Use for a detailed protocol.
T Cell Subset Sample Data
IMMUNO-TROL control blood was stained with T Cell RTF Assay (L)
T Cell Health Assays – Coming Soon!
The T Cell Health assays are used for the detection and enumeration of early and late apoptotic T cell subsets, including CD45+ leukocytes, CD3+ T cells, CD4+ T helper cells, and CD8+ cytotoxic T cells in purified, cultured or cryopreserved samples.
The non-lyse (NL) assays are not intended for samples that require red blood cell lysis.
Dual cartridge assays include full stain (FS) cartridge and fluorescence minus one (FMO) negative control cartridge containing non-lyse buffer.
Please visit the Accellix Assay Instructions for Use for a detailed protocol and the Instructions for Analysis for guidance with analyzing data.
T Cell Health Sample Data
Lymphocyte Subset Assays
The Lymphocyte Subset assays are used for the enumeration (frequencies and counts) of various lymphocyte subsets including viable CD45+ leukocytes, CD3+ T-cells, CD14+ monocytes, CD19+ B cells, and CD3- CD56/CD16+ Natural Killer (NK) cells.
The TBNK assays include CD56 antibodies, while the TBNK-16 assays include both CD56 and CD16 antibodies conjugated to AF488.
The lyse (L) assays may be used for staining apheresis, whole blood, and other samples that require differential RBC (red blood cells) lysis, The non-lyse (NL) version may be used for staining purified white blood cells.
Please visit the Accellix Assay Kit Instructions for Use for a detailed protocol.
Lymphocyte Subset Assay Sample Data
IMMUNO-TROL control blood was stained with TBNK-16 RTF Assay (L)
Stem Cell Assays
The Stem Cell assays are used for the enumeration (frequencies and counts) of hematopoietic stem cells (HSCs) by measuring viable CD45+ leukocytes, CD34+ HSCs, and CD3+ T-cells (optional).
The Stem Cell assays do not include CD3 antibodies, while the Stem Cell-3 assays include CD3 antibody conjugated to PECy5.
The lyse (L) assays may be used for staining apheresis, whole blood, and other samples that require differential RBC (red blood cells) lysis, The non-lyse (NL) version may be used for staining purified white blood cells.
N-1 test kits contain only CD45, CD34 with CD3 (optional) antibodies, enabling customers to add AF488 conjugated liquid antibodies to test on the Accellix Platform.
Please visit the Accellix Assay Kit Instructions for Use for a detailed protocol.
Stem Cell Assay Sample Data
IMMUNO-TROL control blood was stained with TBNK-16 RTF Assay (L)
QC Assays
The Accellix QC assay is used for routine verification of Accellix instrument performance. The assay contains a series of fluorescent particles that have a defined fluorescence intensity across all channels utilized to assess parameters such as optical alignment, sensitivity, linearity, and calibration of the Accellix instrument. QC assay results are displayed automatically on the screen in less than 20 minutes, clearly indicating the instrument integrity.
Please visit the Accellix Assay Kit Instructions for Use for a detailed protocol.
QC Assay Sample Data
Example of On-Screen Summarized Results of the QC Assay
PARAMETER
PASS/FAIL
Bead Count
PASS
Linearity (R2)
PASS
Sensitivity (Stain Index)
PASS
Sensitivity (% CV)
PASS
Calibration (% Difference)
PASS
Results Output: Summarized results indicating pass/fail are displayed on the screen at the completion of each assay run.
Detailed results and all relevant run information are provided in a pdf report:
- Summarized QC assay results table
- Detailed QC assay results table showing measured values and pass/fail for each parameter
- Associated graphs, including cumulative QC results over time to monitor potential trends
- Audit trail information, including date, time, operator, instrument ID, cartridge ID, lot number
Measured values for each parameter and the defined tolerance limits are provided in a csv file for simplified data retention and analysis. In the event of a QC failure, the operator is instructed to restart the instrument and re-run the QC assay.
CUSTOM ASSAY KITS
In addition to standard assay kits, Accellix develops custom assay kits tailored for specific cell therapy manufacturing workflows, including drug-release assays.
Custom Assays