Mabtech Apex™ 2.1 update: enhanced regulatory compliance
Published: February 11, 2026
5 minute read
Authored by: Berend Bassleer
The latest update of Mabtech Apex™, to version 2.1, for Mabtech ASTOR™ and Mabtech IRIS™ is another step in Mabtech's commitment to providing reliable and user-friendly software experience to our customers. With Mabtech Apex 2.1, we introduce new features designed to further meet regulatory expectations, on top of including an automated artifact removal algorithm and optimizing FociSpot analysis through the addition of a new morphology-based algorithm.
Expanding 21 CFR part 11 and annex 11 compliance
Mabtech Apex 2.1 implements a range of tools further strengthening compliance with 21 CFR part 11 and Good Laboratory Practice (GLP) requirements. Created in collaboration with high-profile customers who adhere to regulations set by the FDA and EMA, we made updates to data recording to make it easier for customers to meet ALCOA+ principles* throughout the data lifecycle. Administrators can now set stricter requirements for users on data handling, including:
- Electronic signatures for all changes affecting data output, including mandatory motivations logged in the operational audit trail for a contemporaneous and attributable data record.
- Session-based administrative audit logs, capturing detailed user activities for traceability and archiving.
- Force "Save as" and autosave functionality to ensure a complete data record.
- Configurable permissions for saving, exporting and signing data for role-based access and workflow management.
In combination with other changes, these additions reduce the need for non-software process controls while enhancing Apex's applicability to GLP workflows, an important step for our customers working in drug development.
*ALCOA+ principles are the best way to generalize how to meet compliance. Data should be: 1) Attributable 2) Legible 3) Contemporaneous 4) Original 5) Accurate 6) Complete 7) Consistent 8) Enduring 9) Available
A new FociSpot algorithm for cluster detection in focus-forming assays
This Apex update introduces a new FociSpot algorithm, designed for detecting foci that resemble clusters, often resulting from multiple replication rounds in viral infection assays.
Two preset modes for detecting foci are now available in FociSpot:
- Mabtech Default Spots: useful for single-round infections, for experiments that resemble ELISpot spots, using our validated algorithm for ELISpot, RAWspot™.
- Mabtech Default Clusters: a new morphology-based algorithm designed for multi-round infections and cluster-like morphologies.
This morphology-based algorithm introduces new tunable parameters, Sensitivity, Specificity, Min/Max Area and Split, allowing fine-tuned analysis of cluster-like morphologies.
See the following blogpost for an explanation on how to count foci from focus-forming assays.
Preset options in FociSpot
Spot-like foci in Influenza A were detected with the Mabtech Spots algorithm
Cluster-like foci in SARS-CoV-2 were detected the Mabtech Clusters algorithm
Automated artifact removal
Cleaner data through automated artifact removal
Artifacts such as fibers, scratches, or debris can interfere with spot detection. The Apex 2.1 update includes an automated artifact removal algorithm in ELISpot and FluoroSpot modes. This algorithm was created using machine-learning to optimize it's approach to artifact detection and removal from data collection.
It can be automatically applied during readout, or retroactively during quality control. When the algorithm has detected and masked an artifact, a specific icon is displayed on the well, compliant with regulations. A sensitivity slider adjusts the algorithm's sensitivity towards detection of artifacts and a 'Clump Detection' checkbox, in case the artifact is more resemblant of a clump than a fiber. The addition of this algorithm aims to minimize manual intervention in data clean-up processes. Give it a try next time you encounter artifacts during your readouts!
An example of a well with too many spots to count, using the "Excluded" preset is recommended in this situation
Excluding wells from data reporting
A new "Excluded" preset in ELISpot, FluoroSpot and FociSpot lets users omit wells from data reporting, particularly useful in wells where the RAWspot™ algorithm fails to accurately determine the number of spots due to oversaturation. This preset allows for such wells to be transparently flagged within Mabtech Apex, and subsequent data exports, without affecting data-acquisition or having to deal with other methods of reporting such inconsistencies.
Automation through REST API
To support automation integrated workflows, Mabtech Apex 2.1 enables REST API for automated plate reading with systems like Thermo Fisher Momentum™. This automation effort strengthens Mabtech's readers as flexible platforms for automation platforms.
We recently wrote a blogpost on a case study on automating immune monitoring with IRIS 2 to get you inspired of what such an automated workflow would look like and how it could be of benefit to you.
Summary
Mabtech Apex 2.1 delivers on three core pillars, aligned with our customer needs and desires:
- Compliance: features aligning with 21 CFR part 11 and GLP requirements.
- Precision: introduction of a new FociSpot algorithm and an "Excluded" preset for more accurate data output and GLP workflows.
- Automation: REST API implementation to offer flexible automation integrations.
We continuously strive to advance immunoassay analysis through software updates. If ever you have any requests or input, we are always ear how we can meet your requirements!
Legal Information
Mabtech Apex, Mabtech ASTOR and Mabtech IRIS are registered trademarks of the Mabtech Ab company.
Thermo Scientific Momentum is a registered trademark of Thermo Fisher Scientific and its subsidiaries.