Frequently Asked Questions

During installation, we perform standard QC runs and laser alignment.

Samples are excited with a 488 nm laser diode. Fluorescence emission signals ranging from 500-800 nm are detected in 11 different spatial locations along a silicon photomultiplier array. High sensitivity of the detector array along with efficient compensation of spectral spillover allows for the combination of up to 6 unique fluorescent markers per assay panel.

All fluidics are contained within the single-use microfluidic cartridge, so there is little to no maintenance required by the operator.

The instrument software is compatible with electronic data security requirements (e.g. 21CFR Part 11), and can be configured to comply with customer’s organizational policies as well. The instrument can be connected to a LIMS interface, according to customer’s requirements.

The instrument can be connected to the customer’s LAN via ethernet cable and/or wifi. Results are automatically saved in a destination according to the customer’s request. Also, printouts can be automatically sent to a local or network printer. Sample ID can be input via instrument touchscreen, external keyboard, or standard barcode reader.

Accellix personnel will confirm that the instrument is operating within specifications during installation. No calibration or user maintenance is required.

Most users can complete training in less than an hour.

Each kit comes with a single-use microfluidic cartridge and an assay-specific dried reagent tube containing all necessary components to stain a cell sample. The operator simply adds the cell sample to the tube, mixes for 2 minutes on a pulse vortexer to reconstitute the dried reagents, then pipettes the sample into the cartridge. In addition, each reagent tube also contains fluorescent control beads that serve two functions:

1. ratio-metric counting of cells, providing total cells/mL, and
2. in-run instrument performance check.

Yes, we specialize in migrating custom flow cytometry assays to the Accellix platform. Any assay panel with up to 6 different fluorophores can be developed into a custom assay kit, allowing you to bring the power of flow cytometry to the manufacturing floor.

12 months at room temperature (18C – 22C). No cold chain required.

The operator adds 40uL of sample to the dried reagent tube, mixes for 2 minutes to reconstitute the reagents, then pipettes 10-25µl into the cartridge.

We recommend the customer use samples at 10-20 million cells/mL. The instrument can handle samples from 1-50 million cells/mL. The cell concentration used depends on the frequency of the population of interest. Low frequencies will require a higher event count, which can be achieved by using more concentrated cell samples or by configuring the cartridge protocol to use a lower sample dilution.

This is sample- and assay-dependent, but a typical range of total cell events is 20k-100k. For dilute samples or low-frequency cell subsets, cell event count can be increased by increasing the sample volume added to the cartridge (max of 25 uL), decreasing the dilution within the cartridge, and/or increasing acquisition time.

Many sample types can be used on the Accellix platform, including whole blood, apheresis samples and purified cells. The cells can be in a wide range of matrices such as cell culture media, commercial staining buffers, PBS, and in some cases cryo-preservation media.

The Accellix platform automates the entire process, from sample preparation to spectral compensation and voltage settings, to auto-analysis. After reconstituting the dried reagents with the cell sample by mixing on a pulse vortexer for 2 minutes, the operator pipettes the sample into the cartridge. Upon inserting the cartridge into the instrument, the operator is prompted to enter a sample ID. From this point on, the instrument takes over.

Every cartridge has a unique QR code that is read automatically by the instrument. It contains all relevant information for that specific run, including assay type, serial number, lot number and expiration date. Using the QR code, the instrument will execute the appropriate assay protocol.

Each individual assay kit contains everything needed for automated sample preparation, data acquisition and analysis of one cell sample, returning valuable time back to the operator.

30 minutes for most assays.

Actuators within the instrument compress and release two individual bellows on the cartridge, enabling controlled movement of the sample through the microfluidic channels and mixing chambers. Three blisters on the cartridge containing assay-specific buffer are used to dilute and fix the stained cells. Upon completion of all incubations and dilutions, the sample is moved through a 50 µm diameter channel within the flow cell region of the cartridge, where cell fluorescence and forward scatter signals are then detected.

The n-1 and n-2 kits are intended for use as proof of concept or testing feasibility of an assay by adding one or two conjugates by the customer. We recommend that the customer test the antibody conjugate at the titer recommended by the vendor. You may titrate the antibody at your end if you are not obtaining desired results. Once you demonstrate basic feasibility, customers typically move towards a custom development project. We can provide you with all reagents in dried down format for your use at the end of phase 1 development. This will allow you to have a customized kit with minimal operator input and reproducible results from run to run.

We generate FCS files (for manual analysis/review) as well as CSV and PDF reports (generated from our autoanalysis).

The collected data is analytically processed utilizing a proprietary algorithm and in-process software quality controls, computing the customer’s predefined parameters of interest. The algorithm dynamically (no hard threshold) defines the boundaries of the cell subsets and applies multiparametric analysis to classify the cells. The reported values are configurable depending on the customer requirements.

We use a training data set (at least thirty runs) of customer provided data with representative samples to develop the autoclassification algorithm. We recommend that the customer use the algorithm and run additional samples to determine if the counts and frequencies are as expected. They can run the sample alongside a predicate device for comparison. We do caution that sampling handling procedures usually vary between the Accellix and the predicate device and may contribute to minor differences in counts and frequencies between the Accellix and predicate device.

Remotely if the Accellix platform is connected to the internet. Otherwise by customer’s IT or Accellix service engineer.

Yes, Accellix will fine-tune the algorithm to meet the customer’s requirements depending on their gating approach.

The software is constantly checking for limits, abnormal conditions and minimal amounts of cells detected to allow accurate cells classification.

The instrument uses internal machine-vision software to detect proper insertion of the cartridge.

The instrument measures the laser intensity, testing the motors and the data acquisition board on startup.

The instrument can report the beads, MFI, sample volume for clog detection and, CV% for device stability and performance for each sample per customer.

The maintenance contract includes:

• Onsite service
• Preventive Maintenance per year per instrument

An Accellix Service Engineer will perform an alignment of the laser at installation and then annual preventative maintenance. The first year is included in the price of the instrument and then subsequent years can be purchased at a reduced cost.

Accellix consumables are manufactured under ISO 13485:2016 compliant Quality Management System. The Accellix instrument is manufactured under ISO 13485:2016 compliant Quality Management System.