We generate FCS files (for manual analysis/review) as well as CSV and PDF reports (generated from our autoanalysis).
How does the analytical data processing stage work?
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.
How is the automated data analysis validated?
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.
How can the software on the instrument be updated?
Remotely if the Accellix platform is connected to the internet. Otherwise by customer’s IT or Accellix service engineer.
Can Accellix fine-tune the algorithm to match the customer’s need related to a specific assay requirement?
Yes, Accellix will fine-tune the algorithm to meet the customer’s requirements depending on their gating approach.
How does the error-detection feature ensure that the results are accurate and precise?
The software is constantly checking for limits, abnormal conditions and minimal amounts of cells detected to allow accurate cells classification.
How does the software make sure that the cartridge has been inserted correctly into the instrument?
The instrument uses internal machine-vision software to detect proper insertion of the cartridge.
What type of built-in test does the software have?
The instrument measures the laser intensity, testing the motors and the data acquisition board on startup
What type of software controls are available/implemented in the instrument?
The instrument can report the beads, MFI, sample volume for clog detection and, CV% for device stability and performance for each sample per customer.
What is included in a maintenance contract?
The maintenance contract includes:
Preventive Maintenance per year per instrument
Does the instrument need any sort of alignment?
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.