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Frequently Asked Questions:

 

1) What testing has been done to control cell loss from the slide during processing (HIER, protease digestion, fixation, etc.)?

2) How can you ensure that processing of the control and patient test tissue undergo similar processing procedures?

3) It appears that this is a localization control and not a specificity control. If this is true, how acceptable is that to a pathologist accustomed to looking at tissue?

4) Do QC Dots Slides comply with CAP and other global accreditation programs?

5) How can you ensure that all your cell lines are grown to have consistent expression?

6) Does the system work without a bar code reader? 

7) What about antibodies such as Her-2 which stains are quantified as 0-3+? Would that make QC Dots only useful to 
detect false negatives? 
 

8) Will the blends of different cell lines express reactivity in ALL nuclear expressed proteins? 

9) Some antibodies might label proteins that migrate (i.e. from the nucleus to the cytoplasm) or change expression with various disease states. How are these localizations handled? 

10) Is there a chance that QC Dots could be made for specific viral applications (HSV, EBV, Hepatitis B, CMV, Parvovirus, SV40)? 

11) What is the approximate cost for these slides and the accompanying software system?

12) How many slides can you realistically produce per month?  

13) Do you know if the software meets CFR part 11 requirements?




1) What testing has been done to control cell loss from the slide during processing (HIER, protease digestion, fixation, etc.)?

We have worked in this project for many years and have developed a solution to this problem through our unique cell fixation process. So far we have not experienced cells falling off slides after various kinds of antigen retrieval treatments (HIER, autoclave, protease digestion etc.).

 

 

2) How can you ensure that processing of the control and patient test tissue undergo similar processing procedures? 

Our cells are fixed in formalin and then paraffin-embedded. We have tried to emulate the conditions present during tissue processing. Since tissue fixation and processing conditions also vary greatly from sample to sample, the same issue also exists for TMA control slides. The main function of QC-Dots slides is to indicate false positive or false negative stains, not to serve as staining intensity/quantification or localization controls. In other words, QC Dots control slides serve as a control only for the IHC staining process, not the tissue preservation process.

 


3) It appears that this is a localization control and not a specificity control. If this is true, how acceptable is that to a pathologist accustomed to looking at tissue?

QC Dots can be used to reflect localization, but that is not their main purpose. Pathologists do not need to look at the cell dots until they have doubts regarding tissue staining. QC Dots provide information about the consistency and/or quality of the staining procedure or of machine performance. This is very useful for when tissue samples are stained negative.

 


4) Do QC Dots Slides comply with CAP and other global accreditation programs?

QC Dots allow labs to exceed CAP and other IHC standards by providing an external quality control on each slide, which helps indicate that any significant results are due to experimental conditions and not procedural inconsistencies.

 


5) How can you ensure that all your cell lines are grown to have consistent expression?


To address this issue, we have tested cells grown to various stages of the cell cycle. We found that there were no significant differences in target antigen expression. Cell growth can also be controlled very accurately to ensure consistent expression across all cells.

 


6) Does the system work without a bar code reader?

The bar code and reader system was developed to help facilitate tissue organization and interpretation. However, a bar code reader is not required to use QC Dots slides. Manual examination will work equally as well, but is more time-consuming and adds the possibility of human error.

 


7) What about antibodies such as Her-2 which stains are quantified as 0-3+? Would that make QC Dots only useful to
detect false negatives? 

The QC Dots slide will not provide quantitative information for staining. It is used to detect false positives or false negatives, even in the case of Her-2 and other such antibodies. It can also detect mistakes in applying the primary antibodies.

 


8) Will the blends of different cell lines express reactivity in ALL nuclear expressed proteins?

Each cell dot contains cells from a specific tumor origin. The localization of stain signal depends on the antibody used.

 


9) Some antibodies might label proteins that migrate (i.e. from the nucleus to the cytoplasm) or change expression with various disease states. How are these localizations handled?

QC Dots slides are not designed to provide localization information, even though that information can be gathered by examining the stain closely. Since cells are not sectioned, as in the tissue section, cytoplasm and membrane stains a not easy to differentiate. This is a drawback for QC Dots slides. Pathologists will examine tissue sections instead of the QC Dots for localization info.



10) Is there a chance that QC Dots could be made for specific viral applications (HSV, EBV, Hepatitis B, CMV, Parvovirus, SV40)? 

We are aware that cell control for infectious agents detection also has huge market demand, especially for vendors that market high volumes of infectious agent controls. QC Dots are extremely easy to develop for these applications. Please contact us if you would like more information regarding the possibility of specific viral controls.

 


11) What is the approximate cost for these slides and the accompanying software system?

Prices for slide packages are listed on the product page for each respective product. Companies can buy a trial pack to test out our product before making a bigger purchase. The software accompanying the slides is provided for free to customers that buy the slide packages.

 


12) How many slides can you realistically produce per month? 

At present, we have the capability to produce 50,000 ~ 100,000 slides per month.

 


13) Do you know if the software meets CFR part 11 requirements?

QC Dots software is not related to disease diagnosis therefore CFR part 11 does not apply to it. The software only organizes different patterns of dot staining and translates it into an interpretation of whether the antibody used was successful or not. Thus, the software is not absolutely required. A chart printed on paper can also serve the same purpose.