Process
Seven steps, from the tube received to the export to the LIS. The Mobiolink App follows every tube in the department.
- LIS
The test order and the billing. - 01 Reception
- 02 Pre-analytics
- 03 Run preparation
- 04 Measurement
- 05 Interpretation
- 06 Technical validation
- 07 Export
- LIS
The validated results, then the medical validation.
Step 01
Tube reception and sorting
Work starts when the tube arrives in the department and is scanned in the Mobiolink App. The app matches it to the order sent by the LIS. It then knows which assays to run and routes the tube.
Two receptions
The order comes through the LIS, which receives it and bills it. The tube arrives in the department. Until it is scanned in the app, nothing starts. Nobody works any more from a list where samples are missing without anyone knowing.
Assays chosen by the laboratory’s rules
A requested test does not always match a single assay. Depending on the laboratory’s strategy, it runs as a multiplex assay, a panel or a single test. The app chooses using the rules the laboratory has set: urgency, available instruments, batch filling, target turnaround times.
The number tells what the sample is
The laboratory sets its own naming conventions. When it reads the number, the app recognises a patient sample, a control, a standard or a blank, and applies the matching rules. When the department receives samples from several LIS, it also recognises where each one comes from.
Step 02
Batch pre-analytics
Aliquot, dilute, extract, then build the batches. The app records every step and the position of every tube. It treats the batch as a unit, with its own identity and controls.
Every step traced in the app
These steps are often manual and done in several stages. In the app, each one leaves a trace: who did it, when, with which reagent lot. Nobody documents them on paper any more.
The position of every tube, at every step
On an extraction plate, a sample is often identified only by its position. One mix-up during pipetting is enough to give a result to the wrong patient. The app keeps every position and every transfer. The link to the primary tube remains, even where no barcode can be read.
Step 03
Run preparation
The app builds the plate or the sequence, with the standards, controls and replicates the assay requires. It checks that no mandatory control is missing.
A plate checked before pipetting
The assay definition says which controls and which standards are needed. The app compares the planned plate layout with this definition. If a control is missing, you know before the start. Nobody reruns a whole plate after the measurement.
Free positions
Plate layout templates set the place of standards and controls. The app does not depend on these positions: it recognises for itself what the batch contains.
Replicates
Sample and standard replicates are in version 2.6 of the app, in testing. They are not yet in use at customers.
Step 04
Measurement
The instrument measures. The app sends it the worklist, then takes in all its raw data.
The worklist comes from the app
The app writes the worklists and plate layouts for the instrument. Depending on the instrument, they go through HL7, ASTM or an exchange folder set by the laboratory. Nobody copies numbers or positions into the instrument by hand.
All the raw data
After the measurement, the instrument exports its results and its raw data: curves, Ct values, peak areas. The app takes them in, links them to the right batch and keeps them in one place. They remain available when the instrument is replaced.
Step 05
Automatic interpretation
The app interprets the raw data by the laboratory’s rules and checks batch quality in real time. You no longer look at every curve one by one. You look at the deviations.
The laboratory’s rules
Each assay has its own interpretation algorithm, set and validated by the laboratory. Interpretation does not rely on AI. It follows transparent, documented rules.
Batch quality control in real time
As the results come in, the app checks the controls, the internal controls of each sample and the standard curves. A failed control or an exceeded limit is flagged in the app as soon as the results arrive.
A second opinion
The app compares its result with the instrument’s. It is a double check. The user decides.
Step 06
Technical validation
It takes place in the department, in the app, at any workstation. The validator sees everything needed in one place, then decides: repeat, dilute, launch a reflex test, block.
The whole run on one screen
The app shows the run with the points to look at. The validator also sees the other tests on the same sample, its earlier measurements and what happened during pre-analytics. Nobody validates a second time on the instrument.
Repeats followed through
A repeat can cover a whole batch, a single sample, the analytics alone or the whole process, with or without dilution. The app triggers it by the laboratory’s rules or at the user’s request, and finds the tube. You know who asked for it, why, and which result went out.
Every decision traced
The app records every action: who, when, what, and the reason when one is given. Everyone acts with the rights of their role in the department.
Step 07
Export to the LIS
Validated results go to the LIS. As long as the controls are not validated, they do not leave.
For the LIS, one more analyser
The app presents itself to the LIS as an analyser. It translates its assays into the LIS test codes and sends each result back to the LIS the order came from. The LIS does not need to be changed.
Medical validation stays in the LIS
The responsible physician validates at LIS level. They read the specialty result together with the patient’s other results, and with information the department does not have.