Features

Overcoming the limits of standard batch pre-analytics

In modern laboratories, standard pre-analytical tasks such as general centrifugation or basic specimen splitting are typically driven by the LIS or automated bulk systems using sequence-based tracking. However, high-complexity matrices require localized, specialized preparation before they can safely be introduced to analytical instruments. Mobiolink actively identifies these outliers at the point of entry, avoiding the risk of sporadic mis-sorting that leads to severe downstream testing errors.

Multi-criteria detection and smart isolation

Mobiolink continuously monitors incoming samples and flags those requiring specialized departmental preparation through three detection layers. Once detected, these samples are immediately isolated from the standard automation line and routed to a dedicated specialized workstation.

• Material type and matrix: automated recognition of matrices needing manual or mechanical modification (e.g. suspension/liquefaction of stool samples, shredding, homogenization).
• Analysis-driven rules: automated detection based on specific ordered tests that demand preparation (e.g. localized centrifugation, protocol-driven dilutions).
• Optical assessment: operators can flag samples manually directly at the workstation based on visual characteristics (e.g. lipemic, icteric, or highly viscous states).

Secure aliquoting and closed-loop LIS mapping

When a sample must be split or transferred to a secondary container, human transcription errors pose a major risk. Mobiolink eliminates this threat by automatically generating a unique, distinct Sample ID and printing a barcode label for the new daughter tube. To maintain total data integrity with external systems, this daughter ID is managed exclusively inside Mobiolink. When the analysis is completed, Mobiolink automatically translates the data back and transmits the results to the LIS under the original mother tube's ID number.

Seamless re-integration

After the specialized pre-analytical steps are completed, the sample is not left adrift. Mobiolink routes the prepared sample back to the initial registration or sorting/routing line. This ensures it is seamlessly integrated back into the standard batch flow alongside all other routine samples, maintaining a continuous, uncompromised chain of custody.

Overcoming the batch-processing challenge in specialized analytics

Unlike high-throughput routine laboratories, specialized diagnostic departments operate predominantly in batches. Organizing complex sample sequences on microtiter plates or measurement series requires precise control. Because standard LIS rarely provide dedicated tools for complex spatial plate-layout mapping, laboratories frequently resort to external spreadsheets or paper lists. This creates fragmented workflows, introduces media disruptions, and significantly increases the risk of sample misalignment, especially since batch-oriented workflows often operate without continuous positive sample identification at every sub-step.

The Mobiolink solution: seamless, secure, and automated workflows

Mobiolink eliminates these risks by digitizing and automating the entire sequence-management lifecycle. By establishing an unbroken digital chain of custody, the module ensures that sample-to-well assignments are immutable and fully traceable. Key components include:

• Dynamic layout frameworks: users can define custom plate sizes and dimensions tailored to specific analytical instruments or assay kits.
• Process-specific templates: standardize layouts by pre-defining the exact positioning of calibrators (standards), quality controls (QC), and blanks. This guarantees compliance with assay protocols and speeds up routine setups.
• Intelligent data integration: eliminate manual data entry. Populate plates effortlessly via barcode scans or flexible file uploads (supporting spreadsheets, CSV, and direct instrument output files) using a robust, configurable field-matching engine.
• Advanced grid manipulation: accelerate plate mapping with sector-initialization tools and intuitive copy/paste functionality for specific plate quadrants or rows.
• Automated sequence generation: the system automatically computes and assigns internal sequence and sample numbers across the test-execution path to ensure systematic tracking.
• Real-time LIS synchronization: continuous background synchronization keeps worklists, patient demographics, and test orders updated between Mobiolink and the primary LIS without manual intervention.

Measurable benefits

By removing manual interventions, Mobiolink minimizes cross-contamination layout errors, shortens turnaround times (TAT), and elevates compliance with institutional and regulatory quality standards.

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

Inline standard curves (automatic detection)

Mobiolink bridges the gap between raw outputs (Ct values) and absolute quantitative results (copy numbers). When standard samples are placed directly on the PCR plate, the system recognizes them by the names defined in the assay master data, instantly computes the regression line (Ct value vs. concentration) and quantifies every sample marked 'Unknown' in the same run, with no manual mapping required.

External standard curves with anchor recalibration

Running a full set of standards on every plate is costly and often unnecessary thanks to modern cycler stability. A validated standard curve is saved as a reference; in subsequent runs you only include a single anchor sample with a known concentration. Mobiolink detects the anchor, calculates its deviation and automatically shifts the Y-intercept of the stored regression formula so the anchor sits exactly on the line. This allows precise quantification of unknown samples without spending valuable plate space on full calibration curves. While workflows in analytical chemistry often require continuous inline curves, Mobiolink lets molecular biology labs choose the most cost-effective and automated approach.

Clear definition

A replicate is strictly defined as the execution of identical measurements — sharing the exact same sample ID, the same assay, and the same reagents — performed within a single run. This clear definition prevents any confusion with other laboratory processes, such as lot or batch validations.

Flexible configuration and rule engine

The behavior of replicates is highly customizable and governed by rules mapped directly within the assay master data.

• Permissibility matrix: for each assay, replicates can be configured as systematic (mandatory), optional, or not allowed; these rules can be further conditioned on specific BIOGROUPS or other criteria.
• Consolidation rules: every assay is linked to a replicate definition master file that defines the mathematical and statistical rules used to generate the final result — such as the calculation method (e.g. mean or median) and acceptance criteria (e.g. maximum allowable deviation between individual measurements).

Automated workflow and downstream integration

Once a run is executed, Mobiolink automatically detects the presence of replicates and processes them according to the linked definition file.

• Consolidated result: a single, validated result is calculated.
• Unified pipeline: all subsequent laboratory steps — validation, quality control (QC), interface displays, and external exports — exclusively use this consolidated result, preventing data clutter and ensuring consistency.
• Transparency and compliance: while the complex calculation happens transparently in the background, full auditability is preserved. With a single click on the consolidated result, users can review all individual raw values, the calculation steps, and the specific exclusion reasons at any time.

The challenge of batch-wise technical validation

Unlike continuous sample workflows, batch-oriented testing creates complex interdependencies between samples within the same run. A single outlier, a localized contamination event or a drifting calibration curve can compromise the integrity of an entire batch. Standard Laboratory Information Systems lack the architectural capability to display and analyze these run-level dynamics.

The four pillars of comprehensive validation

Mobiolink bridges this gap by consolidating four critical technical validation dimensions into a single dashboard:

• Complete run overview: immediate visibility into standard curves, blank values, localized contamination risks and internal control trends. It tracks key performance indicators both within the current run and longitudinally over extended periods to detect subtle systemic drifts.
• Run-wide result analytics: a holistic visualization of all results within a specific batch, letting operators easily spot cross-contamination or carry-over effects caused by extremely high-concentration samples on subsequent positions.
• Raw data and curve evaluation: direct access to underlying measurement raw data, including internal standards, kinetic curve profiles and comparative curve overlays.
• Pre-analytical traceability: full integration of data from the pre-analytical phase, such as eluate extraction logs and sample preparation conditions.

Ending the back-and-forth between instrument software

Relying on native instrument software to perform these checks results in fragmented workflows, varying user interfaces and physical movement between workstations. Mobiolink eliminates this operational overhead by standardizing the interface across all instrument types. It further strengthens technical validation by cross-referencing run metrics with patient-specific demographics (age, gender) and sample matrix details to deliver unparalleled analytical precision.

Architecture and safety levels

Validation relies on an access-control matrix that ensures compliance and data fidelity. Each target result passes through up to two standard levels. Mobiolink never makes a diagnostic decision on the validator's behalf and stays outside the scope of the IVDR: the software prepares the review and records it in a fully traceable way.

• Level 1 validator (Val1): performs the first technical or clinical review.
• Level 2 validator (Val2): performs the final verification; when assigned to different people, this enforces a strict four-eyes principle.
• Expert validation: activated manually in cases of high uncertainty; the result stays locked until an authorised person makes the final decision.

Interactive validation workflows

Depending on assay design and lab preference, validation runs assay-wise (all results of a run at once, optimised for high throughput) or target-wise (one target across several samples, for focused assessment). For clear, compliant runs a single-click global validation moves every standard result forward; for anomalies, a detail view opens the raw data, allows measured values to be adjusted (with the right permissions), or flags a sample for a repeat run.

Automatic gates and compliance rules

Automatic criteria are built directly into the logic, sparing the validator avoidable sources of error:

• Flagged results: any result classified as borderline or erroneous is excluded from one-click validation and must be reviewed individually.
• Mandatory justification: accepting an erroneous or borderline result requires a formal justification; for quality-control (QC) samples outside the reference values it is strictly required.
• Multiplex dependencies: for multiplex assays, every target result of a sample must be validated before a single result of that sample can be exported.
• Run interlocks: export of every measured value stays blocked until all run KPIs and QC samples are validated or fall within the reference values.

Granular control and scope definition

In modern laboratories, a 'repeat' can mean many things. Mobiolink lets you trigger and manage re-testing at exactly the granularity your workflow requires.

• Batch-level: re-run an entire batch based on overall run KPI criteria.
• Assay and target-level: repeat all samples of a specific assay, or restrict the re-test to a single target within an assay.
• Sample-level: isolate individual samples for tailored re-processing.

Analytical vs. pre-analytical processing

Efficiency depends on knowing exactly where a failure occurred. Mobiolink differentiates the depth of the repeat workflow.

• Pure analytics (eluate repeat): save time and resources by repeating only the measurement step using the existing eluate.
• Full process (pre-analytics and analytics): trigger a complete re-run from the initial sample preparation and extraction phase when necessary.

Dilution and multi-measurement protocols

When repeating individual samples, Mobiolink adapts to complex clinical requirements.

• Auto-configure single repetitions or set up structured dilution sequences.
• Manage multi-measurement protocols (replicates) to ensure statistical confidence.

Reason-driven auditing

Every decision matters. When triggering a repeat test, operators can classify the root cause directly within Mobiolink.

• Technical reasons: instrument flags, failed internal controls or processing errors.
• Confirmation reasons: suspected contamination, borderline or grey-zone results, or clinical verification.

One-click comparative analytics

Stop digging through historical archives. Mobiolink automatically flags all related runs and provides a unified, side-by-side comparison matrix. With a single click, users can analyse:

• Raw data curves and final results across all iterations.
• Dilution factors and their impact on the calculation.
• Cross-batch KPI trends, to quickly tell systemic patterns from isolated sample issues.

Smart lot detection & status management

The moment new reagents are checked into the laboratory inventory, Mobiolink identifies the new lot numbers and automatically assigns them a 'To be tested' (pending validation) status. No manual logging or tracking is required.

Context-aware alerts during batch setup

Users do not need to plan separate, dedicated validation runs. When setting up a routine processing batch — such as a Preparation Run or a PCR Run — Mobiolink scans the components in use in the background. If a new, unvalidated lot is detected for any of the reagents, the system immediately displays a smart reminder.

Seamless routine integration

Instead of stopping the routine workflow, the operator can choose to validate the new reagent lot on the fly:

• Sample selection: the user selects an existing sample within the current run to act as the parallel test matrix.
• Smart positioning: the operator defines the position of the test sample within the run and maps the specific pending reagent to it.
• Background execution: the routine test and the parallel validation test run simultaneously within the exact same batch.

Automated evaluation & reporting

Upon completion of the run, Mobiolink imports and interprets the raw measurement data and immediately evaluates whether the parallel test results fall within the predefined quality control thresholds. Once processed, the designated validator receives an instant system notification to review and sign off on the run. Mobiolink automatically generates a fully compliant validation protocol, archives it, and links it directly to the reagent lot. As soon as all reagents within a kit have passed validation, the lot is cleared and can be promoted to the 'Current Lot' at the scheduled activation time.