QC process implementation of in vitro diagnostic rapid test

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Dr. Sztahó Dávid
Department of Telecommunications and Media Informatics

The number and the diversity of the clinical analysis clinical analysis methods show a constantly increasing tendency. These clinical analysis methods can be performed in central laboratories. However central laboratories are not able to handle the problem, when only a small amount of sample is available for diagnosis, the result is needed in a short time and moving the patient is not possible.

This need explains why Point of Care Testing has become the most popular and widespread diagnostic way in the eld of clinical analysis. Compared to central laboratories, a POCT device has several advantages compared to central laboratory practices including reduced sample volume, faster process and accurate result without leaving the patient.

I worked on a POCT device during my thesis which applies Lateral Flow Method and was manufactured by 77 Elektronika Kft. Putting a rapid test cassette into the device, it evaluates the concentration of a specifc analyte in the sample.

The manufacturing process can cause standard deviation, which infuences the result of the evaluation. It is a common practice to identify rapid test cassettes by batches and define a calibration curve to each parameter to every batch.

My main task was to plan and implement the QC process of the rapid test cassettes, which assists to defne the calibration curve to the batches. In my thesis I discuss important elements of ISO 13485. Then I explain the basic terms of immunology, which are neccessary for understanding how rapid test cassettes work.

After the basic term I describe the principles of the working mechanism of the rapid test cassettes. In the following section I justify the neccessity of calibration curves, specify the software requirements and outline the database model. In the last part of my thesis I show the expectations for the software, I discuss about the model of the planned database, list the technologies used in my work, then I introduce the fnal software. Finally, I summarize my work and highlight some further possibilities for development.


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