Disclaimer

TissueFAXSplus is a microscope-based cell analysis system for cells in cryocut-, paraffin-sections and/or TMAs. It consists of the software modules “TissueFAXS” combined with either “TissueQUEST” & “HistoQUEST” or with “StrataQUEST” and is used for acquisition of images in the fluorescence and/or brightfield mode, for counting the number of positive and negative cells and for quantification of staining intensities. TissueFAXSplus is used for the standardization of tissue analysis in combination with immunohistochemical and immunofluorescence staining.

TissueFAXSplus does not give any direct diagnosis and there is the possibility that the tissue specimen does not provide enough information for a proper analysis and/or diagnosis. The cell analysis system only measures cellular parameters. Such measurement parameters must in any case be reviewed and validated by a qualified human professional with profound knowledge of the cell analysis system, who has received special training in the operation of cell analysis methods. The cell analysis system can under no circumstances make a decision on the therapy of patients.

The results of the analysis are purely statistical values. Users must re-evaluate images and likelihood of the statistical data. Pure interpretation of statistical data is not allowed.

 Notes:

-  TissueFAXS FLUO is similar to TissueFAXSplus but is for fluorescence samples only and must not be used with brightfield/immunohistochemical samples. TissueFAXS FLUO consists of the software modules “TissueFAXS” as well as “TissueQUEST” and/or “StrataQUEST FLUO”.

-  TissueFAXS HISTO is similar to TissueFAXSplus but is for brightfield/immunohistochenical samples only and must not be used with fluorescence samples. TissueFAXS HISTO consists of the software modules “TissueFAXS” as well as “HistoQUEST” and/or “StrataQUEST HISTO”.

- TissueFAXS 200 and TissueFAXS SL are similar to TissueFAXSplus but for batch scanning of up to 200/120 brightfield/immunohistochenical slides. TissueFAXS 200 / TissueFAXS SL consists of the software modules “TissueFAXS 200” / “TissueFAXS SL” as well as “HistoQUEST” and/or “TissueQuest” and/or “StrataQUEST”.

- TissueFAXS SPECTRA is similar to TissueFAXSplus but is for multispectral imaging of fluorescence samples only. Scanning of brightfield/immunohistochenical samples on TissueFAXS SPECTRA is possible with the color camera, if any, but MUST NOT / CANNOT be done with the multi-spectral camera. TissueFAXS SPECTRA consists of the software modules “TissueFAXS SPECTRA” as well as “TissueQUEST” and/or “HistoQuest” and/or “StrataQUEST”. 
Using the unmixing procedure must be done with care as tissue-derived autofluorescence may interfere with the algorithm and cause inconclusive or even faulty output.
Selecting and correctly assigning proper reference spectra is critical for the accuracy of the unmixing result and is the sole responsibility of the user. Selecting wrong reference spectra and/or assigning any reference spectra inappropriately will cause inconclusive / faulty output and thus generate false measurement results!

- StrataQuest provides a software tool for machine learning for the automatic classification of tissue structures, including detection of tumor areas in tissue sections. The results generated by the software have to be verified by a qualified human professional in any case (negative as well as positive results). In case the software does not detect specific histological structures and/or tumor cells, a human professional has to verify this result by other means, as it is possible that certain biological patterns and/or special types of (cancer) cells may not be detected by the automatic detection function. Measurement errors may also occur due to the fact that the cell environment in which the software has to operate is highly variable.

We point out to the fact that the following circumstances/factors might influence and/or impair the result of the analysis to the level where the result rendered might be inconclusive or even faulty:

• Quality of the tissue sample: In this context, especially the age of the tissue sample is relevant. Long durations between the harvesting and/or staining of the tissue sample and the analysis as well as storage errors can tamper with the outcome of the analysis.
• Quality of the preparation of the tissue sample for the analysis and the materials used: In this context, especially the type and quality of the reagents and the capability/precision of the person handling the reagents can be relevant and may lead to inconclusive/faulty results (for example: dilution errors concerning the reagents).

These factors (as well as the capability of the human professional performing the validation of the test results) lie solely within the responsibility of the user of the software. TissueGnostics does not take any responsibility for test results that are influenced by one of the above mentioned factors.

Each and any product shall be used only after training performed by TissueGnostics or authorized distributors of TissueGnostics. A list of authorized distributors is available on the TissueGnostics website.

https://tissuegnostics.com/global-network/distributors

The TissueFAXS system and software is FOR RESEARCH USE ONLY.

By using only parts of the system, changing system components (hardware or software) or using the TissueFAXSplus instrument in any other than the intended way it was designed for, the CE declaration becomes invalid.