Internal control management (Exo-IC)
Mobiolink follows the full lifecycle of exogenous internal controls (Exo-IC) across the molecular diagnostics workflow, from assay-specific reference-data configuration to post-amplification interpretation. By linking IC target values and tolerances to each reagent batch, the software calculates the required IC quantities and automatically checks that every target PCR well contains the expected IC eluate. The software assists interpretation; the final release remains a human decision, and Mobiolink falls outside the scope of the IVDR.
Overview
The module provides a multi-stage validation framework for exogenous internal controls in quantitative and qualitative PCR workflows. Internal controls are required to rule out false-negative results caused by faulty extraction or enzymatic PCR inhibition. On complex multi-assay plates, however, manual monitoring is error-prone. Mobiolink connects assay parameters with real-time liquid-handling tracking and automated checking of results.
Reference data and batch-specific limits
In the reference data, users define which Exo-IC and which standard quantity an assay requires. In the reagent batches, the precise target values and their tight tolerances are recorded for each active IC batch.
- Reference data: Exo-IC and standard quantity per assay
- Reagent batches: batch-specific target values and tolerances as the baseline for automated quality control (QC)
Preparation-plate layout and lysis strategy
After the preparation plate is laid out, Mobiolink determines the required IC profile from the planned assays and calculates the necessary quantities. The system shows directly which Exo-ICs must be added collectively to the lysis step and which controls must be pipetted individually into the relevant preparation wells.
PCR-setup verification and dynamic rescue
During PCR setup, Mobiolink checks in the background, for each individual well, whether the required Exo-IC is present in the eluate. If a control is missing, the system issues a message and adjusts the pipetting instruction so that the control is added to that specific well directly as an RNA-DLA well. This prevents the sample from being lost.
Result interpretation and QC enforcement
When the final results are imported, or the curves interpreted, Mobiolink isolates the IC-channel readings and checks whether the defined QC target values were met for every sample category. Any well that fails to meet the target values is flagged with a message, which prevents the release of invalid results.
- Negative control (NC): confirms the absence of contamination alongside a regular IC signal
- Positive control (PC): confirms the correct amplification kinetics of the assay and the IC
- UNKNOWN (patient samples): checks the individual sample matrix and flags partial or full PCR inhibition