Process

Systematic processing and classification

Following initial registration in the Laboratory Information System (LIS), Mobiolink imports all order data fully automatically. The software instantly translates single administrative requests into the specific multiplex assays to be processed. Simultaneously, an automated pre-sorting of primary samples takes place in the background based on distinct criteria:

• Categorization by analysis groups and material type.
• Identification of required physical pre-processing and preparation chemistry.
• Provision of clear, visual sorting instructions for the operator, eliminating any need for manual interpretation of the request profile.

Intelligent error and exception management

The system acts as a digital filter directly at the process boundary. Incomplete orders, contradictory data, or samples with specific anomalies are automatically flagged. These critical cases are intentionally isolated and prevented from entering the routine workflow. This effectively protects downstream laboratory operations from disruption, allowing staff to focus exclusively on samples that are immediately ready for processing.

Guided pre-processing

Samples requiring preparatory steps such as centrifugation, dilution, or splitting are separated organizationally. Mobiolink displays the specific Standard Operating Procedure (SOP) for each sample and guides the operator through the process in the correct sequence. When secondary tubes are required, a new barcode is generated immediately, while the digital link to the primary sample remains seamlessly intact. This workstation operates independently from the main sample receipt to eliminate time pressure caused by accumulating standard samples.

Dynamic sorting logic and workflow optimization

Instead of performing a complex final sort during initial receipt, samples are temporarily transferred into structured pooling groups to save time. The final, system-driven assignment to specific work areas occurs flexibly in the background. The underlying sorting logic is defined centrally within Mobiolink. Any modifications – such as altered prioritization in the afternoon or modified workflows on weekends – take effect instantly across all users without requiring team training or internal communication.

Optimised Range Picking (ORP) for PCR preparation

Serving as a strategic interface to downstream analysis, Mobiolink arranges primary samples in an optimized sequence prior to their transfer into deepwell plates. This ORP sorting is performed precisely according to assay combinations and pipetting logic. This method ensures that eluates can later be transferred with maximum efficiency using multi-channel pipettes or accelerated pipetting robots, significantly reducing manual placement errors and unnecessary handling steps.

Structured batch generation and control spiking

Mobiolink manages the assembly of the extraction plate or extraction sequence based on predefined templates. Individual primary samples are precisely combined with all mandatory control samples, standards, blanks, and quality controls into a unified batch. Immediately before the start of the actual extraction, the system supports the precise addition of internal controls (for PCR assays) or internal standards (for analytical chemistry) to each individual sample to ensure seamless analytical monitoring.

Cycle of sequential process units

The subsequent extraction process – whether performed manually or managed via automated liquid handling systems – is structured into a sequence of predefined, cyclic process units. The system guides and logs each sub-step, which is executed batch-wise and sequentially across all samples within the run:

• Precise addition of specific reagents and buffer solutions
• Temperature-controlled incubation phases
• Mechanical shaking and mixing workflows
• Selective washing steps for purification
• Centrifugation or separation cycles

Provision of measurement-ready eluates

The ultimate output of this coordinated batch run is a homogeneous, purified eluate. System-wide tracking of reagent lots, volumes, and operational steps guarantees that nucleic acids or target analytes remain stable. The resulting eluates are thus flawlessly prepared for the immediate subsequent measurements and the respective molecular or chemical detection techniques.

Strategic consolidation and flexibility (n:n logic)

Mobiolink consolidates the eluents obtained from the extraction stage into efficient measurement series based directly on LIS request data. The system breaks down operational silos: a single measurement series can flexibly combine samples from entirely different preceding extraction runs. The planning matrix scales from simple sequential transfers (where the extraction plate matches the PCR plate layout) to highly complex scenarios where samples from multiple extraction runs are dynamically distributed and mapped across several distinct measurement plates.

Digital safeguarding and rule verification prior to execution

The digital planning mode functions as a critical quality barrier. Before any physical assembly or pipetting begins in the laboratory, Mobiolink subjects the entire planned plate layout to an automated validation check. The software cross-references the setup against stored methodological guidelines, verifying that all mandatory auxiliary samples—such as quality controls (QC), blanks, standards, and replicates—are scheduled at their correct positions and that all pairing rules are fully respected.

The core USP for PCR laboratories

Due to the vast diversity of parameters and control instances, the manual setup of PCR plates in daily laboratory operations is exceptionally error-prone and time-consuming. Mobiolink's algorithmic support eliminates this risk entirely. By automatically resolving highly complex multiplex and control structures into error-free digital allocation patterns, the system transforms the most logistically demanding stage of the entire workflow into a secure, reproducible routine.

Generation of precise physical operational instructions

The system releases the setup for physical execution only after successful digital validation. It then generates unmistakable, precise instructions for manual operators or directly executable transfer files (pipetting worklists) for automated liquid handling workstations. These operational directives define the exact pipetting volumes, the error-free transfer sequence of the eluents, and the precise handling and positioning of all required control and reference substances.

Seamless data import at the analytical device

The physical process begins with the digital data transfer. At the measurement instrument or its connected software, the operator directly accesses the setup file generated by Mobiolink in Stage 3. This import completely eliminates error-prone, manual entry of sample IDs, grid positions, or protocol parameters on the instrument console. The hardware immediately identifies which well or position is linked to which assay and runtime profile.

Autonomous execution and optional real-time tracking

Once initiated, the measurement run executes independently on the respective target instrument. For modern analytical systems and specific PCR technologies, Mobiolink offers an integrated real-time interface. Laboratory staff can monitor the progress of the active run and track emerging measurement curves from a central dashboard without needing to be physically present at the device, ensuring continuous process oversight during autonomous hardware operation.

Structured data export as a trigger for downstream stages

As soon as the instrument completes the entire series, the user exports the resulting data package. This includes the pure raw data (e.g., fluorescence values) as well as any primary evaluations automatically generated by the device software. The export is saved dynamically into a designated laboratory network directory. Mobiolink continuously monitors this target folder, allowing for automated data ingestion and interpretation in the subsequent validation stage without manual intervention.

Background ingestion and precise sample mapping

Mobiolink continuously monitors the designated target directories of the analytical instruments. As soon as an exported file from Stage 4 becomes available, the system ingests the raw data (curve kinetics, fluorescence signals, or raw values) fully automatically. Utilizing the allocation matrix documented in Stage 3, the software flawlessly maps each measurement result back to its corresponding primary sample and the administrative patient data from the LIS, completely eliminating manual transcription efforts.

Algorithmic curve evaluation and Ct value calculation

Following data ingestion, Mobiolink applies standardized mathematical evaluation algorithms to the raw data. The system analyzes the kinetics of the measurement curves, calculates the exact Ct (threshold cycle) values or concentrations, and performs the primary interpretation (positive, negative, equivocal). The parameters for this process are stored centrally and securely within the assay master data, guaranteeing absolutely reproducible results.

Comprehensive technical validation

Before any individual result is validated, the entire measurement series undergoes an automated technical review. Mobiolink validates the run performance systematically by verifying:

• The presence and correct signal intensity of the internal controls (ICs) within each individual well.
• The evaluation of global control references (positive controls, negative controls, blanks) to authorize the overall run validity.
• The cross-checking of replicates and standard curves for mathematical plausibility and defined tolerance thresholds.

Automated release and proactive flagging

Samples that have successfully passed all technical controls and display clear measurement signals are automatically cleared by the system for final medical review and subsequent LIS transmission. However, if the system detects a breached quality control rule, an insufficient internal control signal, or an atypical curve trajectory, the affected sample is restricted. It is assigned a specific technical “flag” (warning label) and automatically routed to the laboratory supervisor for targeted manual inspection.

Efficient release matrix and targeted expert focus

Mobiolink presents the validating physician or laboratory director with an aggregated overview of all measurement results. The system effectively separates routine operations from critical exceptions: standard findings, where all technical quality controls from previous stages remain valid, are grouped for rapid clearance. The expert's focus is instantly directed toward complex or borderline cases where curve kinetics, melting points, or control signals demand manual inspection.

Interactive curve analysis within the reporting dashboard

To support well-founded medical decisions, Mobiolink provides all relevant primary data directly within the validation workspace. The validator does not need to switch back to the instrument manufacturer's native software. With a single click, fluorescence curves, amplification trajectories, and historical patient data can be overlaid and displayed, allowing for a fast visual plausibility check directly on screen.

Complete documentation and audit trail

Every medical decision—whether it is a final release, an extraction repeat, or a manual result modification—is recorded in a tamper-proof manner within Mobiolink's audit trail. The system logs which user performed which validation step at what exact time, including any comments or justifications for exceptional releases. This guarantees absolute compliance with all accreditation-relevant guidelines (e.g., RiliBÄK, ISO 15189).

Fully automated LIS ingestion

The moment medical authorization is granted, Mobiolink triggers the final data export. The interface translates the measurement metrics into the native protocol of the primary Laboratory Information System (LIS). Alongside the qualitative test result (positive/negative), quantitative values, specific Ct indices, and technical comments are transmitted in a structured format. This successfully closes the digital loop, making the report immediately available to the requesting physician.

Quality-driven export barrier and authorization concept

A core protective principle secures the data transmission: as long as the quality controls (QC) of an assay are not fully validated and samples have not successfully passed technical validation, Mobiolink blocks the export. Incomplete or uncertain results are systemically prevented from reaching the LIS. As an additional layer of security, this functionality is tied to dedicated user permissions within the system's user management, natively fulfilling critical QM regulations.

Intelligent method mapping and multi-LIS routing

Mobiolink automatically cross-references measurement metrics with the originally requested LIS procedure. During export, this mapping occurs entirely in the background without requiring any manual selection or adjustment. If a laboratory or network is connected to multiple distinct LIS platforms, the software autonomously detects the target architecture and routes each result to the correct system without additional operational steps.

Automated code conversion

The system manages the complete bidirectional translation between internal laboratory assay codes and the specific target codes utilized by the LIS. All abbreviations, test designations, and units are adapted automatically. This consistent communication framework completely rules out translation errors or data inconsistencies between the platforms from the outset.

Process transformation in daily laboratory operations

From the perspective of the Laboratory Information System, Mobiolink interfaces smoothly like a single, standardized analytical instrument, making technical integration exceptionally straightforward. Because method-specific selections, mappings, and target system verifications are fully automated, the risk of incorrect data assignment is eliminated. Laboratory staff are liberated from administrative burdens, allowing them to focus entirely on analysis and medical validation.