Frequently asked questions

We designed the Mobiolink App around one principle: “as simple as possible for IT, as comfortable as possible for users”.

The database and the application run on one or more Linux servers provided by the laboratory or the IT department. Installation, updates and new releases are delivered with Docker and installed in a standardised, controlled way.

Nobody installs software on the workstations. The Mobiolink App is a web application: a recent browser on a PC, a laptop or a thin client is enough.

Administration effort drops accordingly: no client installations, no local updates, no version conflicts, no dependence on a particular operating system at the workstations. The platform is simple to run, managed centrally and easy to extend.

A total laboratory automation line (TLA) was designed for routine laboratories. Thousands of samples are transported, distributed, analysed and archived automatically, one after the other. The strength of a TLA is the physical automation of standardised individual processes at very high sample throughput.

In specialty analysis, the work runs quite differently. PCR, LC-MS/MS, NGS, ELISA and other batch methods do not handle samples one by one. They work with sequences, plates or whole runs. The difficulty lies less in moving samples than in organising and monitoring the many steps before, during and after the measurement.

This is where the Mobiolink App comes in. It steers the whole workflow: taking over the orders from the LIS, pre-analytics, sample composition, quality controls, internal controls, standard curves, interpretation of raw data, technical validation and repeats, up to the export of results.

A TLA moves samples. The Mobiolink App moves information and decisions. Each step is documented, checked automatically and linked to the next. The result is the same continuous, controlled process, without conveyor belts or special hardware.

Then there is flexibility. A TLA is built for defined routine processes, and changing it is costly. In the Mobiolink App, a new assay, a new analyser or a changed process can usually be added through configuration.

In short: a TLA automates the logistics of a routine laboratory. The Mobiolink App steers the organisation, quality assurance and processes of batch-based specialty analysis. Both aim for efficiency, safety and traceability, with very different means.

Each laboratory department manages its own users and their access rights. It decides which functions and which data each employee can reach. The needs of laboratory heads, technicians, validators and administrators are reproduced precisely.

For login, the Mobiolink App supports two-factor authentication (2FA). It can also be linked through Single Sign-On (SSO) to the central user management of the laboratory or the company. The user then logs in once to the company network and reaches the functions opened to them.

A user's ID stays the same in every department where they have rights. This simplifies administration and keeps a clear view across sites and departments.

When an employee leaves the department or the company, their user is archived. Their access to the Mobiolink App is blocked at once. All their past actions, releases, validations and decisions stay in the audit history. The Mobiolink App thus meets the requirements of quality management and compliance systems without losing the history.

The Mobiolink App is built for laboratories where roles with very different responsibilities work together. Its permission system is therefore detailed and flexible.

For each table, separate rights are granted for reading, referencing, creating, changing, deleting and archiving. On top of that, almost every function and every action has its own access rights. Even complex organisational, regulatory or quality requirements find their place.

As a rule, each user belongs to one or more groups. These groups carry the standard rights of roles such as technician, laboratory head, validator, quality manager or administrator. Management stays clear, even with many users.

Where needed, a user can receive additional individual rights or complete sets of rights.

The interface follows the rights. Menus, buttons and functions that are not authorised are hidden. Use becomes simpler, handling errors decrease and security increases.

This permission system is a central part of meeting compliance requirements. In specialty analysis, responsibilities, releases, validations and quality-related decisions must be clearly assigned and traceable.

Traditional LIS usually do not offer this level of detail, because they were designed for other ways of working. The Mobiolink App adds to the LIS the fine-grained rights management that batch-based specialty analysis, quality management and full traceability need. Compliance becomes part of daily work instead of adding bureaucracy.

We made security a core principle of the Mobiolink App, and it fits into the existing infrastructure of hospitals and laboratories.

The main security features:

• On-site installation on a dedicated Linux server in the laboratory or hospital network.
• Single Sign-On (SSO) with the organisation's identity management: users need no separate accounts or passwords.
• Two-factor authentication (2FA) against unauthorised access.
• Role-based user management with department-specific rights. Each person reaches only the functions and data their role requires.
• Central storage and automatic backup of all laboratory data, raw instrument data included. The risk of data loss through an instrument failure or a local PC goes down.
• Separate TEST and PRODUCTION environments, as a paid option. New assays, workflows, software updates and interfaces are validated on the test system before they go into production.
• Central management of instrument connections: fewer unmanaged data silos, simpler administration.

The Mobiolink App brings analytical data, user management and instrument communication together in one place. This strengthens cybersecurity and operational continuity, and supports the laboratory's quality and security requirements.

The Mobiolink App is a web application. All users reach the same central system through a standard web browser. Nobody installs or maintains software on the workstations.

The advantages:

• Access from anywhere in the laboratory network, or remotely when the organisation's security rules allow it.
• Central updates and maintenance. New versions, improvements and fixes are installed once on the server and are available to all users at once.
• Lower hardware and IT costs. Workstations only need a browser: hardware lasts longer and workstation management becomes simpler.
• Platform independence. Windows, macOS, Linux and thin clients reach the same application without any change to the software.
• Scalability. New users or workstations are added quickly, without complicated installation.
• One user experience. Everyone works with the same interface, the same functions and the same software version. Training takes less effort and support requests go down.
• Operational reliability. Central administration limits version conflicts, and everyone works with validated software.

For the laboratory, this means less IT effort, lower running costs, new functions available sooner and a more efficient working environment.

A typical laboratory middleware mainly handles communication between the analysers and the LIS. It collects results, converts data formats and passes the results on to the right systems. For routine analysis, that is often enough.

The Mobiolink App, by contrast, is built for specialty laboratories that work in batches: PCR, NGS, LC-MS/MS, ELISA, toxicology or newborn screening, for example. There, the real work starts long before the measurement and ends only after the technical validation of the whole run.

The Mobiolink App therefore digitalises the whole laboratory process:

• Taking over orders from one or more LIS.
• Steering pre-analytics, including the management of samples and eluates.
• Planning and composing batches and plates.
• Managing standards, internal controls, quality controls, replicates (from version 2.6, in test) and repeats.
• Taking over and archiving raw data for the long term.
• Transparent interpretation of measurement data with user-defined algorithms.
• Automatic real-time quality control of the whole run.
• Consistent technical validation, whatever the analyser.
• Traceability of all samples, reagents, lots and work steps.
• Automatic export of released results to the LIS.

A classic middleware mainly moves data. The Mobiolink App organises the whole analytical process. That is why we call it “Operating System for Specialty Laboratories”.

So the difference does not lie in a few extra functions, but in the concept: the Mobiolink App replaces data silos, manual intermediate steps and instrument-specific ways of working with one continuous, transparent and standardised laboratory process.

“Shoe-leather IT” describes a daily routine many specialty laboratories know. Staff go back and forth between analysers, instrument PCs, Excel files, home-made tools, middleware and the LIS. They check, transfer or compare data by hand. The instruments are often in separate rooms, where working conditions are not very comfortable.

The result: unnecessary walking, media breaks, training time and avoidable sources of error. Every additional program has its own logic, its own interface and its own data formats.

The Mobiolink App replaces this fragmented work with one central digital workstation. Almost all tasks, from batch preparation through quality controls and result review to technical validation, are done from any authorised workstation, in the browser.

Instead of five programs, staff use one consistent, intuitive interface. Getting started takes less time and the work is more efficient. Less walking, fewer program switches, fewer sources of error, more time for the real laboratory work.

We speak of a media break when data loses its digital link and someone has to transfer, copy out, copy or re-enter it from one system to another.

Common examples in specialty laboratories:

• Transferring sample lists from the LIS to Excel
• Creating plate layouts by hand
• Exporting and importing CSV files between instruments
• Copying Ct values, peak areas or concentrations into calculation sheets
• Documenting quality controls on paper
• Entering results or releases by hand in several systems
• Storing important raw data on individual instrument PCs

Each of these steps takes work and carries a risk of transfer errors, mix-ups or incomplete documentation. Traceability suffers, because the information is scattered.

This is where the Mobiolink App comes in. It supports the analytical process digitally, from the arrival of the order from the LIS through pre-analytics, batch composition, quality controls, interpretation and validation, to the transmission of the result to the LIS.

All relevant information sits in one central repository. Raw data, quality controls, standard curves, internal controls, reagent lots, user actions and results stay linked to each other for the long term. Users work in one integrated environment. They no longer push data from Excel to the instrument software, then to paper forms, then to the LIS.

The result: fewer errors, less time spent searching, better traceability and a higher level of automation. This is the basis of digital specialty analysis.

The Mobiolink App does not only digitalise individual steps, it closes the gaps between them. The result is one continuous digital process, without Excel islands, paper lists, manual data transfers or isolated instrument PCs. Every media break is a possible source of error. The Mobiolink App turns many separate steps into one digital workflow, from the sample to the validated result.

One of the first configuration steps in the Mobiolink App is defining the Sample Classes. They set the name or number structure by which the app recognises each sample type.

As soon as a sample is read, the Mobiolink App assigns it to the right class and activates the rules, controls and automations that go with it. It automatically recognises, for example, patient samples, positive controls (PC), negative controls (NC), orientation controls (OC), reference controls (RC), blanks, calibrators or standard curves, study samples and other laboratory-specific sample types. Samples can also be assigned to sender groups, studies or other organisational categories.

The Sample Class sets more than the sample type. It defines which target values or acceptance criteria apply to the sample, how results are interpreted, whether they count in the calculation of a standard curve or a quality control, and how, when and where results are exported. The laboratory can decide, for example, that patient results go to the LIS while controls and standards are documented internally only.

Through these rules, the Mobiolink App also steers the release of a whole run. If required quality controls, standard curves or internal controls fall outside the permitted limits, it blocks the patient results automatically. Results go to the LIS only when all defined quality criteria are met, or when an authorised user gives a documented release. Results from a batch that has not been validated cannot be released by mistake.

Automatic classification is the basis for steering a batch safely: the right batch composition, the check of minimum quality-control requirements, the calculation of standard curves and the assessment of the run. It prevents input errors and mix-ups, enforces consistent sample naming and stops each user from inventing their own labels. Each laboratory stays free to define its own naming convention. The Mobiolink App adapts to the laboratory's standards, not the other way round.

Specialty laboratories often work with a mix of LIS, instrument software, Excel files, paper lists, e-mails and personal notes. This mix does not usually come from poor organisation, quite the opposite. It is a pragmatic answer to needs that the existing standard systems do not cover well enough.

Excel is a powerful and flexible tool for this. Specialists use it to build their own calculations, worklists, batch compositions, quality analyses or overview tables quickly.

The limits appear when these tools become a fixed part of daily production. Information then has to be transferred by hand and kept in sync. Several versions can circulate. The links between sample, eluate, batch, reagents, instrument, raw data, quality controls and results have to be documented on top, and part of the process knowledge stays with a few people.

The Mobiolink App does not set out to simply replace ways of working that have proved themselves. The know-how they contain should move into structured, versioned and traceable digital processes.

Rules, calculations, quality criteria, steps and decisions thus become part of one shared system. Information is entered, as far as possible, only once, and used wherever it is needed.

Manual transfers and duplicate documentation decrease. Traceability, reproducibility and compliance improve.

The change does not have to happen all at once. Existing tools can keep running at first, then be replaced step by step, where structured digitalisation brings the most.

Start slow. Grow smart. Stay free.

Many digitalisation projects fail because they try to change everything at once. Laboratory reality is more complex. Many practices, decisions and experiences exist only in people's heads. That knowledge does not move into software overnight.

This is what Mobiolink's signature says: “Start slow. Grow smart. Stay free.”

The first step is usually to digitalise and simplify existing processes. Mobiolink starts with targeted improvements where media breaks, Excel lists, manual checks or unnecessary double entry cost the most.

In the next step, more and more knowledge moves from people's heads into traceable digital processes. Quality rules, batch checks, standard curves, repeat rules, interpretation logic and release processes are recorded in the system, systematically. Personal experience becomes knowledge of the organisation.

Only then does real transformation happen. Decisions become reproducible, processes transparent, and quality standards are secured for the long term. The information no longer sits in a few heads or a few files: the whole laboratory can reach it, in a structured way.

Automation has its place too. But Mobiolink follows a central approach: instruments, robots and automation systems should not build their own data silos or their own process logic. The intelligence stays in the central platform. Laboratories keep control of their data, their rules and their processes at all times.

Start slow means: start small, at your own pace.

Grow smart means: digitalise knowledge step by step and keep improving processes.

Stay free means: no new dependencies, no data silos, no media breaks, but full control over your own future.

Behind every function of the Mobiolink App there is one goal: make laboratory work simpler for the people who do it every day.

Comfort

• Access to every instrument and every run from any workstation, without having to work directly on the analyser PC.
• One consistent interface and the same workflow for all instruments: less complexity, less training.

Efficiency

• All information is a few clicks away.
• Colour-coded dashboards show complete runs, without endless scrolling.
• Raw data is interpreted automatically, with assay- and instrument-specific algorithms.
• Real-time quality control checks controls, standards, internal controls and replicates (from version 2.6, in test) while the results come in.

Speed

• Fully evaluated and checked results are available as soon as the data is imported.
• Filters show at once only the samples that need attention.
• Fewer handwritten notes and spreadsheets to keep track of routine work. Communication in the laboratory (repeat lists sent to the right workstation, instructions between teams) is planned.

Safety

• Manual transcription errors decrease.
• Every action is documented in a complete audit trail.
• All raw data, calculations and validation steps stay transparent and traceable.

Fewer repeats, less administrative time

• Less time on repetitive administrative tasks.
• Fewer repeat analyses caused by avoidable errors.
• Better plate layouts and batch planning improve instrument use.
• A single connection to the LIS replaces many instrument integrations, which reduces set-up and maintenance effort.

Other benefits

• A failed quality control or an exceeded limit is flagged in the app as soon as the results arrive.
• Immediate access to quality-control history and long-term trends.
• Flexible visualisations to detect contamination, analyse curves and review results.
• Faster onboarding for new staff, and less dependence on a few experts or on instrument manufacturers.

For many laboratories, the greatest benefit is not one particular function but the working experience as a whole: less searching, less waiting, fewer errors, and more confidence in every validated result.

Taking over all raw data is one of the main conditions for real digitalisation in specialty analysis.

If only the final results are stored, curves, peaks, Ct values, standard curves, internal controls, replicates and other measurement information stay on the instrument PCs. Data silos form, which have to be backed up and maintained separately, and which often have to be searched laboriously during an audit or when tracing an error.

The Mobiolink App therefore takes over the complete raw data in addition to the final results. All information is available centrally, for the whole department, whatever the instrument type or manufacturer.

From this raw data, the Mobiolink App interprets the results itself and compares them automatically with the values calculated by the instrument. At the same time, it checks standard curves, internal controls, replicates (from version 2.6, in test), batch criteria and other quality rules in real time.

Quality control thus moves from the instrument PCs to a central platform. Users no longer juggle several instrument programs. They work in one environment, with the same processes and the same documentation.

The result: fewer media breaks, safer processes, full traceability and one central knowledge base for all analytical decisions. This central availability of all data is the basis for automation, compliance and future AI-assisted analysis.

End-to-end digitalisation is not a one-off technology leap. It is a continuous development. Hardly any laboratory becomes fully digital overnight. Successful laboratories start with the areas that bring the most, then extend digitalisation step by step.

With each digitalised process, manual tasks, media breaks and transfer errors decrease. Data is available at once to all authorised staff, whichever workstation it was created at. Decisions are documented traceably, quality controls monitored automatically, and the system takes over more and more routine tasks.

But the real value appears only when all the digital building blocks are connected. Only when instruments, pre-analytics, analytics, quality management, validation and the LIS work together does a continuous flow of information emerge, without data silos. The laboratory gains transparency, safety and speed at the same time.

End-to-end digitalisation prepares the ground for shorter turnaround times, better quality, better traceability, easier onboarding of new staff and more flexibility when sample numbers grow. It also produces reliable indicators on which processes can be improved continuously.

This is exactly Mobiolink's approach. As Mobiolink's signature says, “Start slow. Grow smart. Stay free.”: every laboratory can start with a manageable partial project, then extend digitalisation at its own pace. Digitalisation becomes a lasting change rather than a risky large project.

Yes. Since February 2026, AI has been an integral part of our development process. Today, we carry out extensions, bug fixes, migrations to new versions of programming languages, frameworks and development tools, and many technical adaptations with the help of AI.

The results have exceeded our expectations. With AI, we have seen errors caused by changes drop drastically. AI has greatly reduced technical debt: most of the code has been rewritten.

One point matters especially to us: the Mobiolink App deliberately does not use AI to interpret measured values automatically or to make diagnostic decisions on its own. In the medical field, all decisions must be fully traceable, verifiable and reproducible. The interpretation of raw data, quality controls, standard curves, replicates and release rules therefore always relies only on transparent, configurable and documented algorithms.

Mobiolink thus combines both: AI where it improves development, quality and the pace of innovation, and fully traceable, rule-based methods where clinical responsibility and patient safety are at the centre.

Our customers benefit too. AI gives a deliberately small and highly specialised development team the means to develop the Mobiolink App faster, more consistently and with high quality, without giving up the independence and long-term direction of the company. Mobiolink also commits to setting up a source code escrow for each customer: a deposit of the code with a third party, for the customer's benefit, should Mobiolink cease to exist. Our signature, “Start slow. Grow smart. Stay free.”, therefore applies to our customers, and just as much to the development of Mobiolink itself.

Most laboratory regulations share one goal: every reported result must be fully traceable, reproducible and produced within controlled processes. The Mobiolink App was designed with these principles in mind, and it includes many functions that support regulatory compliance.

The main functions:

• Complete audit trail. Every relevant action is recorded automatically: who performed it, when, what was changed and, where applicable, why. The whole analytical process becomes traceable.
• Electronic user management. Role-based rights ensure that each person performs only the actions that match their responsibilities. Validation, approval and release can be separated according to the laboratory's rules.
• Integrated quality control. The Mobiolink App automatically evaluates quality controls, internal controls, standard curves, replicates (from version 2.6, in test) and batch acceptance criteria before patient results are released. For critical workflows, two-step or four-eyes validation is possible where required.
• Secure data storage. Raw data, calculated results, quality-control data, reagent information, batch records and validation decisions are stored centrally, protected against unauthorised changes and kept for long-term traceability.

The Mobiolink App centralises all analytical information, removes media breaks and keeps every step traceable. It thus gives laboratories working under regulated quality management systems a sound technical basis.

Disclaimer: the Mobiolink App provides the technical infrastructure that supports compliant workflows. Meeting specific regulatory requirements, validating the laboratory's procedures and the final responsibility for released patient results remain with the laboratory.

Intended use

The Mobiolink App is software (Operating System for Specialty Laboratories) for managing, steering and technically supporting laboratory processes in specialty laboratories. The software processes laboratory and instrument data. It performs only mathematical calculations and data processing, based on the parameters and algorithms defined by the user.

All limits, calculation parameters, quality criteria and evaluation algorithms are set and validated by the laboratory, and released by suitably qualified staff. The Mobiolink App does not make clinical diagnoses on its own, makes no medical decisions and replaces neither the professional interpretation nor the medical release of test results.

Responsibility for the correct configuration of the software, the validation of the algorithms used, and the clinical evaluation and release of results lies solely with the user or the organisation operating the software.

IVDR/MDR disclaimer

The Mobiolink App is designed as administrative and technical software. The software makes no diagnostic interpretation on its own initiative. It processes data only according to the rules defined and validated by the user.

The Mobiolink App is therefore not a standalone in vitro diagnostic medical device within the meaning of Regulation (EU) 2017/746 (IVDR) and not a standalone medical device within the meaning of Regulation (EU) 2017/745 (MDR), provided that the decision rules are defined and validated by the laboratory and that the software is used only in line with its intended use.

Compliance with all regulatory requirements, the validation of the methods used and the medical responsibility for reporting remain entirely with the operator of the laboratory.

The Mobiolink App is management and workflow software for specialty laboratories. It organises, documents and steers the whole analytical process. But it makes no medical diagnosis, and it replaces neither a CE-IVD assay nor the laboratory's professional judgement. This deliberate architecture has several advantages.

Faster development. The Mobiolink App does not have to go through the approval procedure of a medical device. New functions, improvements and optimisations are therefore developed and delivered much faster. The laboratory benefits from new features continuously, without waiting for long release cycles.

Less regulatory burden. Developing certified medical devices requires a great deal of documentation, validation and certification. Without that classification, more resources go directly into new functions, ease of use and what serves the customer.

Adaptability. Every specialty laboratory works a little differently. The Mobiolink App therefore adapts quickly, through configuration, to each laboratory's processes, without every change triggering a heavy recertification under medical device law.

Simpler updates and maintenance. New versions install quickly. Laboratories always work with up-to-date software, benefit from improvements sooner and do not have to go through long release procedures for every functional extension.

Quick response to new needs. New analytical methods, new instrument generations, new regulatory requirements or customer requests can be implemented at short notice. A development requested by one customer and useful to other laboratories goes into the standard, and all customers have access to it. Configuration and settings remain specific to each customer. The laboratory stays technologically flexible and ready for what comes next.

Free choice of instruments and assays. The Mobiolink App does not tie the laboratory to particular manufacturers. Analysers, pipetting robots and assays are chosen and combined freely. The software creates no dependence on a manufacturer and no vendor lock-in.

Full support for Laboratory Developed Tests (LDTs). Many specialty laboratories develop and validate their own methods. The Mobiolink App supports these processes without restriction, for the development, validation and introduction of new LDTs. The laboratory keeps its full scientific and methodological freedom.

A clear separation of responsibilities. The Mobiolink App manages samples, raw data, quality controls, standard curves, internal controls, batch releases and technical validations. But the medical meaning of a result always comes from the validated assay and from the judgement of the responsible laboratory. This clear separation brings transparency, reduces regulatory complexity and leaves the laboratory as much flexibility as possible.

A strategic advantage in the IVDR era

With the introduction of the IVDR, the regulatory burden on in vitro diagnostic products has risen sharply. At the same time, Laboratory Developed Tests (LDTs), assay validation and the flexible use of new methods matter more and more to many specialty laboratories.

As long as the decision rules are defined and validated by the laboratory, the Mobiolink App is not itself a medical device. The software thus stays separate from the regulatory requirements that apply to diagnostic methods. The laboratory can introduce, validate and optimise new assays, new instruments or new LDTs without changes to the Mobiolink App requiring a new medical device certification.

For this, the Mobiolink App provides the infrastructure for documentation, traceability, quality control, audit trail and technical validation. Regulatory responsibility for the diagnostic method remains with the assay concerned or with the laboratory.

The Mobiolink App does not decide the medical meaning of a result. It makes sure that the whole laboratory process, from the arrival of the sample to the validated result, runs safely, traceably, efficiently and fully documented.

PCR curve interpretation in the Mobiolink App standardises the whole interpretation process, while adapting to the requirements of each assay.

Each assay has its own interpretation algorithm. Different targets, fluorescence channels, evaluation methods and limits are taken into account. And the same algorithm works whatever the thermocycler. The laboratory gets identical, comparable results, even when several instrument types run in parallel.

During interpretation itself, the Mobiolink App runs extensive quality controls automatically. Beyond the classic positive and negative controls, it monitors all internal controls (EXO-IC, ENDO-IC) and other assay-specific quality criteria. Errors and anomalies are detected and documented at once.

Instead of only separating “positive” from “negative”, the Mobiolink App classifies results more finely. It recognises clearly positive and clearly negative samples, but also positive results with unusual characteristics that need a further look. Technical validation becomes faster and safer.

All decisions rest on transparent, traceable rules. Interpretation is reproducible, fully documented and independent of the individual user. Laboratories can add their own decision rules: automatic releases, repeat measurements, reflex testing or specific alerts, for example.

The result is an interpretation that follows the same rules on every instrument. It is also the basis for largely automated, quality-assured PCR diagnostics.

Commercial assays are often certified for several analysers or instrument types. In the Mobiolink App, there is therefore no need to create an assay for each instrument.

The assay is defined once, centrally. The differences specific to each instrument, for example in raw data formats, measurement channels, interpretation rules, export parameters or instrument settings, are recorded within this assay, separately for each instrument type.

The user therefore chooses the instrument for the measurement only when composing or loading the run. The laboratory responds flexibly to workload, maintenance or an instrument failure, without duplicating assays or changing the way it works.

In some cases, a second identical instrument kept only as a backup is no longer needed, provided another certified instrument type is available.

This concept also interests kit manufacturers. They can supply an assay, with its variants for all certified instrument types, in one reference data set and pass it on to their customers. Configuration at the customer's site becomes much simpler, and all instrument variants rest on the same assay basis.

Applying Color Compensation to the raw measured values is essential for interpreting the LC480's amplification and melting curves correctly. The instrument's own software performs this correction reliably, but exports only uncorrected raw data. Neither the Color Compensation runs nor the correction values calculated from them are exported.

Until now, laboratories therefore had no choice but to interpret directly on the analyser, print reports or leave the data on the instrument PCs. Central evaluation, full traceability and consistent data management were practically impossible.

The Mobiolink App therefore reproduces the whole evaluation and application of Color Compensation. It recognises Color Compensation runs automatically by their name, calculates the correction profiles and stores them for the long term. Each assay is linked to its Color Compensation profile, and the correction is applied automatically when the raw data is interpreted.

The user can switch at any time, for a whole run or for individual wells, between the raw data and the corrected curves, and compare the effect directly. Experienced users can, where needed, check the calculated correction parameters and adjust them in case of systematic over- or under-compensation.

Color Compensation, until now hidden in the instrument, becomes fully transparent and available at every workstation. Interpretation, internal controls, quality checks and lot evaluation take place centrally in the Mobiolink App, without data silos on the analysers.

The Mobiolink App integrated the LC PRO at its market launch, in 2024.

As with all supported thermocyclers, the Mobiolink App imports not only the final results but all the raw data of the run. Amplification and melting curves are evaluated together, interpreted automatically and checked by real-time quality control at the same time. Internal controls, standard curves, batch parameters and all other release criteria are checked automatically.

Manual review and interpretation in the LC PRO software are no longer needed. The isolated data silo on the instrument disappears too: all measurement data is stored centrally in the Mobiolink App and stays available for the long term.

Another advantage is a consistent way of working. For the user, it makes no difference whether the data comes from an LC PRO, an LC480 or a thermocycler from another manufacturer. Validation, visualisation and release always use the same interface, the same rules and the same quality controls. Training, routine work and instrument changes become much simpler, and the result is one continuous workflow, independent of the manufacturer.

Routine areas such as clinical chemistry, haematology or many immunology methods usually process samples one by one. Each sample goes through the same largely automated process and produces its own result.

In specialty analysis, for example in PCR, NGS, LC-MS/MS, ELISA or other complex methods, the batch is at the centre. A batch, run or experiment contains, besides the patient samples, controls, standards, calibrators, replicates and blanks. The results of individual samples can be evaluated and released only when the quality parameters of the whole batch are within the defined limits.

These methods are often preceded by substantial pre-analytical steps. Samples have to be sorted, aliquoted, extracted, diluted, pooled or distributed on plates. These steps are often manual, in several stages, and must be documented in a fully traceable way.

The difficulty: the central unit of work is not the sample but the whole batch. Yet many LIS were designed for sample-by-sample processing. They reproduce batch work, quality assessment and pre-analytics only in part.

The Mobiolink App was developed for these needs. It manages the whole batch process, from sample preparation through run composition and quality control to technical validation and the transmission of results to the LIS. Specialty analysis thus gets digital support that matches the way it really works.

In most specialty laboratories, quality requirements are in principle the same as in the routine laboratory. Control samples, calibrators and quality rules must, of course, stay within defined limits.

The real challenge starts where specialty analysis differs from routine: processing samples in batches. It is not enough for the analyser to work correctly. The whole batch, pre-analytical steps included, must show that it was carried out within the quality criteria defined by the laboratory.

There is a further point. In many methods, internal controls (EXO-IC) or internal standards are added to each sample. Endogenous controls (Endo-IC) may also be present. These controls show whether extraction, preparation and measurement went right for that particular sample.

Checking these values is one of the most important quality assurance measures. In many laboratories, it is still done by hand, directly in the instrument software, and then has to be documented. Traditional LIS usually do not cover these needs, or only to a very limited extent.

The Mobiolink App monitors batch controls, internal standards, EXO-IC and Endo-IC automatically. It checks the defined acceptance limits, documents all results in a tamper-proof way and blocks the release of faulty results. Quality control becomes safer, more traceable and more efficient.

Positive sample identification by barcode is now the norm in the routine laboratory. Each step actively confirms the identity of the sample.

In specialty analysis such as PCR, NGS, LC-MS/MS or ELISA, however, samples are mostly processed in batches. Once transferred into extraction plates, microplates or other batch structures, they are often no longer identified by the sample itself, but by their position in the batch.

A single mix-up during pipetting, a transfer or batch composition is enough for results to be assigned to the wrong patient. That is why these steps are traditionally accompanied by manual checks, the four-eyes principle, paper lists and a heavy documentation load.

The Mobiolink App reduces this risk with complete digital traceability of all transfers. Every position, every transfer and every step is documented and stored traceably. The result is a virtual positive sample identification, even where a direct barcode check is no longer technically possible. Safety, quality and confidence in the results increase.

The Mobiolink App brings all the instruments of a specialty laboratory together in one working environment. This includes analysers, pipetting robots, liquid handlers, sorting systems, thermocyclers, LC-MS/MS, HPLC, spectrometry and ELISA systems, and many others.

Fully automated analysers and point-of-care (POC) systems are usually connected through standard protocols such as HL7 or ASTM. Where the manufacturer supports it, the instrument communicates in both directions: the Mobiolink App sends the orders to the instrument, then receives the results back automatically.

For batch methods, integration often uses file exchange. In that case, the Mobiolink App prepares the whole batch composition and writes the worklists, plate layouts or sample information to an exchange folder defined by the laboratory. The instrument imports this data.

Once the measurement is finished, the instrument exports the results to the same folder, raw data included: curves, Ct values, peak areas, peak heights or other instrument-specific information. The Mobiolink App takes over this data automatically, assigns it to the right batch and runs all the defined checks.

These checks include quality controls, the review of standard curves, internal controls, the review of replicates (from version 2.6, in test), batch releases and the automatic interpretation of raw data. Problem cases are flagged specifically and put to the user for action.

The result: the user no longer works with a host of instrument programs, but centrally in the Mobiolink App. The instruments deliver the measured values. The Mobiolink App takes care of process control, quality monitoring, documentation, technical validation and the export of results to the LIS.

The outcome is one continuous digital chain, in which each instrument is used to the full and all data is managed centrally, securely and traceably.

The whole logic of a standard curve is recorded in the assay definition. This includes in particular the standard samples and their target concentrations, the mandatory calibrators, the number of replicates, the regression algorithm used and all relevant quality criteria: R² limits, LLOQ, ULOQ, permitted deviations for each calibrator and other assay-specific parameters. Replicates are managed from version 2.6 of the Mobiolink App, now in test; they are not yet in the version installed at customers.

In plate layout templates, the positions of standards and controls can be predefined. But the Mobiolink App does not depend on fixed positions. From the batch composition, it recognises by itself which standards, controls and patient samples the batch contains, and checks on its own that the minimum configuration required by the assay is present.

After the measurement data is imported, the Mobiolink App calculates the standard curve automatically, evaluates each calibrator against the regression function, checks all defined quality criteria and calculates the results for each sample. Faulty or incomplete curves are detected and documented at once.

If the assay allows it, the Mobiolink App can also use external standard curves. Certain analyses can then be evaluated even when the current batch has no calibration of its own.

The Mobiolink App also stores all relevant batch indicators for the long term and shows them, like quality controls, in trend charts. These include R², slope, Y-intercept, efficiency values, mean values of internal controls, calibrator recovery rates and other assay-specific indicators. They are compared automatically with the defined target values and limits: trends, drift and slow changes are spotted early.

The result is fully automated, traceable and auditable management of standard curves and batch performance, whatever the instrument and manufacturer. The standard curve is no longer a one-off calibration. It becomes a central tool for continuous quality monitoring.

An analyser's software usually knows only the data of that instrument and that run. The Mobiolink App, by contrast, brings together all the information needed for a sound technical validation.

Before the validator even sees a result, the Mobiolink App checks automatically whether quality controls, internal controls and standard curves meet the defined target values. It also takes lot-specific target values into account.

The Mobiolink App also evaluates the main indicators of the whole run: R², slope, Y-intercept, mean values of internal controls or other assay-specific quality indicators, for example. Limit violations and trends are detected and highlighted at once.

During validation, the user has information that an analyser usually does not have:

• The results of other analyses of the same sample.
• Earlier measurements and repeats of the same sample.
• Pre-analytical events and particularities.
• Full traceability of all steps.

The validator acts on the decision directly: request a repeat, trigger a reflex test, order a dilution, block a sample or document a result given by telephone, without switching between systems.

The result: more efficient technical validation. Highly qualified staff spend less time looking for information and more time on the decisions that matter. Standardisation, traceability and process safety increase. It is not the analyser that is validated, but the whole diagnostic process.

Molecular biology (PCR, NGS, etc.) and analytical chemistry (LC-MS/MS, HPLC, GC, AAS, ICP, etc.) differ widely in their measurement methods, raw data and results. The organisational and quality assurance workflow, however, is almost identical.

Both fields work in batches. Individual results can be interpreted and released only once the whole run has been completed successfully, with its quality controls, standards, internal controls and indicators.

The process is also very similar in both disciplines:

• Taking over the orders from the LIS
• Registering and sorting the primary tubes
• Pre-analytics and eluate preparation, or sample preparation
• Composing the batches with patient samples, standards, controls and replicates
• Performing the measurement
• Taking over the raw data
• Interpreting the raw data and real-time quality control
• Technical validation, repeats or reflex tests
• Exporting the released results to the LIS

On top of this, both fields use more and more multiplex assays, where a single measurement produces several results, sometimes more than a hundred. Interpretation then depends even more on the whole batch.

The Mobiolink App reproduces exactly this shared workflow. It takes the differences between technologies into account in the instrument-specific evaluation methods, while the whole organisational process stays the same for the user. The same platform is therefore used in molecular biology and in analytical chemistry, and also in other specialty laboratories that work in batches, such as ELISA, toxicology, newborn screening or forensic medicine. Staff do not have to learn a different program for each technology, and the laboratory gets one consistent, transparent and fully digital way of working.

The biggest difficulties vary from one discipline to another, but almost all specialty laboratories have one thing in common: it is not the analytics itself that weighs most today, but everything that happens before, between and after.

Modern analysers usually work reliably and deliver reproducible results. At the same time, the requirements for quality assurance, documentation, traceability and regulatory evidence keep rising. More and more time therefore goes into administrative tasks instead of the diagnostics itself.

Information is often spread across the LIS, instrument software, quality-control programs, Excel files, e-mails and paper. Data is entered or transferred several times, shift handovers are oral, and many decisions stay only in the memory of a few staff: why a quality control was accepted, a sample repeated or a result released.

Taken one by one, each of these small media breaks seems harmless. Together, they cause significant losses. Highly qualified staff spend an ever larger share of their working time searching, checking, documenting, coordinating and organising.

As sample volumes rise, this organisational complexity often grows faster than the analytics itself. The result is time pressure, stress and rising costs. At the same time, the shortage of qualified staff and financial pressure are a major pain: fewer qualified staff, fewer resources.

Since laboratories can influence neither the labour market nor regulatory requirements, many invest in more automation. Mobiolink is in favour of automation. The Mobiolink App keeps in one place the intelligence and the data that automated systems scatter, and steers the automated systems from there. Organised, well-structured automation thus becomes possible, if the laboratory wants it. Specialty laboratories gain time for their real task: high-quality diagnostics.

For Mobiolink, raw data is the real measurement result. The final result shown by an analyser is the product of the instrument's own evaluation algorithm.

The Mobiolink App therefore takes over, as a rule, all available raw data and stores it centrally, in a uniform, instrument-independent format. Depending on the method, this may be amplification and melting curves, peaks, spectra, intensities or other measured values.

The Mobiolink App then interprets this raw data with an algorithm defined by the laboratory, documented and open to checking. The calculated result is compared automatically with the result delivered by the instrument. This gives a second opinion, a double check: the user decides.

Not every analyser provides all the details of its measurement curves or peak profiles. In most cases, however, the exported raw data is enough for the Mobiolink App to detect anomalies automatically and point them out to the user. The validator has to check the curves directly on the analyser only when such anomalies appear, or when the instrument does not export certain information at all. The time-consuming review of every curve disappears. Only the few cases that really need it are looked at.

A further advantage: technical validation no longer has to take place on the analyser. All raw data is available at every authorised workstation. Media breaks decrease, the data silos scattered across instrument PCs disappear, and backup, archiving and compliance become simpler.

Because the raw data is stored for the long term in a standardised format, it stays available even when the original analyser has long been replaced. It can still be used for quality analyses and scientific questions, independently of any instrument manufacturer.

In molecular biology and analytical chemistry, repeats are more complex than in the routine laboratory. The Mobiolink App therefore distinguishes several types of repeat:

• Repeat of a complete batch or run
• Repeat of individual samples
• Repeat of the analytics only
• Repeat of pre-analytics and analytics
• Repeats with automatic dilution (for example 1:10, 1:100)

The decision to repeat can be taken automatically, through freely configurable rules, or triggered case by case by the user. Common triggers are invalid internal controls, quality problems in the batch, values outside the measuring range, or release rules specific to the laboratory.

The Mobiolink App orchestrates the whole repeat process, independently of the LIS. The analyses concerned automatically move to the right status, samples can re-enter the pre-analytical workflow, and the dilutions or new preparations needed are fully documented.

All steps remain fully traceable: who triggered the repeat, why it was needed, which steps were redone and which result was finally released. Errors are avoided, traceability improves and the workload of staff drops noticeably.

The Mobiolink App was developed to fit into existing laboratory IT environments. Towards the LIS, each instance of a department behaves like a modern analyser.

As soon as a sample is recognised in the department, the Mobiolink App asks the LIS for the relevant information: requested analyses, material type, patient data, priorities and other order information. This is translated automatically into the department's own working structure and is available to staff at once.

Once the analytics and the technical validation are complete, the Mobiolink App sends back the released results just as an analyser would. Communication uses established standards such as HL7, ASTM, messaging systems or file exchange.

The existing LIS infrastructure therefore stays unchanged. No complex custom development is needed, and the IT department relies on a familiar, proven integration architecture.

Other systems, such as automation solutions, liquid handlers, analysers, archiving systems or third-party applications, connect to the Mobiolink App in the same way. It thus becomes the central integration platform for specialty analysis.

The big advantage: from the IT point of view, introducing the Mobiolink App is usually no more complicated than connecting one more analyser. The benefit for the department, however, is far greater.

Yes. The Mobiolink App can be connected to several laboratory information systems (LIS) at the same time. This is particularly useful for central specialty laboratories that receive samples from several sites, laboratory groups or external institutions.

Each connected LIS can keep its own analysis codes, material names and organisational structures. Through the Sample Classes mechanism, the Mobiolink App recognises from the sample number alone which LIS a sample comes from. The right rules, reference data and mapping tables are then applied automatically.

The translation of each LIS's analysis codes into the Mobiolink App's internal assays is automatic, as is the reverse translation of validated results when they are exported to the right LIS. For the user, everything runs the same way.

Even when a specialty laboratory is connected to only one production LIS, many laboratories also create one or more test LIS. They can be defined, for example, as simple Excel or text files, and simulate a complete laboratory information system.

New assays, new instruments, process changes or rare special cases can then be tested at any time under real conditions, without creating test orders in the production LIS or polluting its data. Development, validation and staff training become easier, and tests run safely, without touching the laboratory's production operation.

A laboratory information system (LIS) was designed to manage orders, patients, samples, results and communication with analysers. It does these tasks very well.

But specialty laboratories work on different principles from classic routine analysis. Instead of individual measurements, they produce complete batch runs, sometimes with hundreds of individual results, which can be assessed only together with quality controls, internal controls, standard curves and raw data.

The fundamental needs include:

• Managing complete batch processes, not individual results.
• Automatic composition of sequences and plate layouts.
• Managing standard curves, including quality assessment.
• Monitoring the internal controls of each sample.
• Grouping and evaluating replicates.
• Automatic handling of repeats and reflex tests.
• Storing and interpreting raw data, such as amplification curves or chromatograms.
• Technical validation with all the relevant information of a whole run.
• Real-time quality control during the analytical process.
• Full traceability of all steps, reagents, lots and user actions.

These functions are not usually part of the core of a LIS, because only relatively few, highly specialised laboratory areas need them. If a LIS built in all these special functions for every analytical discipline, it would become much more complex, heavier and harder to maintain.

That is why the Mobiolink App takes on these tasks (replicates from version 2.6, in test). For the LIS, it behaves like a single intelligent analyser. In the specialty laboratory, it orchestrates the whole analytical process, from sample registration to the transmission of the technically validated result to the LIS.

The Mobiolink App therefore does not see itself as a competitor to the LIS, but as its complement. The LIS remains the laboratory's central information system. The Mobiolink App provides exactly the functions that batch-based specialty analysis needs to work safely, efficiently and fully digitally.

It has become common practice to use the term LIS (Laboratory Information System) mainly for medical diagnostic laboratories, and LIMS (Laboratory Information Management System) mainly for industrial, pharmaceutical, environmental or research laboratories.

In practice, the boundaries are blurred. Both systems manage samples, orders, analyses, results, quality controls, users and laboratory processes. The difference often lies less in the software than in the field of use and the regulatory requirements.

So far, the Mobiolink App has been developed for the specialty laboratories of medical laboratories, in particular molecular biology, PCR, NGS, LC-MS/MS, ELISA and other batch methods.

For the laboratory's central LIS, the Mobiolink App appears as a single analyser. In the specialty laboratory, it steers the processes and manages samples, batches, quality controls, raw data, instruments, users and technical validation. It does not replace the LIS, which remains the laboratory's central information system.

The Mobiolink App is therefore neither a LIS nor a LIMS. It manages the work of the instruments and workstations of specialty analysis, with the particular requirements of batch processes.

In specialty analysis, a requested analysis does not automatically correspond to a single assay. Depending on the laboratory's strategy, the same request can be handled through different multiplex assays, panels or single tests. Urgency, instrument availability, costs, reagent consumption, batch filling and target turnaround times also have to be taken into account.

These decisions directly affect the sorting of the primary tubes that follows, batch composition, instrument workload and the cost-effectiveness of the whole process. In many laboratories, experienced staff therefore make these assignments.

The Mobiolink App steers this step. As soon as the sample arrives, it analyses the requested tests and determines the right assays and analytical paths automatically, using freely definable rules. It can take organisational, medical, technical and economic criteria into account at the same time.

The result: the sample is classified correctly from the start of the process and sent automatically to the right workflow. The Mobiolink App orchestrates its whole path through pre-analytics, analytics, quality control and the transmission of the result. Manual decisions decrease, errors are avoided, and workflows are reproducible and transparent.

In many diagnostic molecular genetics laboratories, the workflow is still spread across several independent systems.

The LIS manages the clinical request, patient data, sample identification and the final result. Extraction systems, fluorometers, spectrophotometers, PCR instruments, sequencers and other analysers each have their own software. Excel is often used for worklists, plate layouts, concentrations, dilutions, reagent lots, quality-control calculations and repeats. SOPs, deviations and validation documents are usually kept separately, in a quality management or document management system.

Each tool may work well on its own. The difficulty lies between them.

A typical process may look like this:

LIS → worklist → extraction system → Excel → concentration measurement → Excel → assay set-up → analyser software → quality control → repeat → technical validation → LIS

This leads to manual data transfers, duplicated information and separate data silos. Reconstructing the full history of one sample may mean searching through several systems, files and instrument PCs.

The Mobiolink App takes a different approach.

Instead of copying the same information from one system to the next, the Mobiolink App links the real objects of the laboratory and the process steps:

Primary tube → extract → aliquot → assay → batch → measurement → result

Properties such as concentration, purity, extraction method, reagent lots, storage information or quality characteristics belong to the extract itself. Every later analysis refers to this same extract and automatically has access to the relevant information.

The goal is a continuous, traceable workflow, from sample receipt to technical validation. The Mobiolink App therefore does not simply replace Excel or the instrument software. It aims to provide the missing process layer between the LIS and the individual analytical systems.

Where we stand. For molecular genetics, the functions described here are planned. They are not yet available in the current version of the Mobiolink App, and we do not announce a date. We will update this answer as soon as functions become available.