CERTIFICATION OF TP53 MUTATION ANALYSIS - PARTICIPATION FORM

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METHOD TO BE CERTIFIED

We would like to ask you to answer the following questions regarding methods used in your laboratory. Your answers do not affect the certification process in any way. They are important for tailoring the ERIC TP53 Network activities to provide support for a wide spectrum of laboratories. If you wish to choose just one answer and more options are applicable to your lab, then please choose the option that you use for routine diagnosis or most frequently.

EXPERIENCE WITH TP53 MUTATIONAL ANALYSIS

1. How many samples have you analysed up until now?

2. How many samples per month do you analyse?

3. Do you perform TP53 analysis primarily for:

METHODOLOGY

4. Which cells do you use for TP53 analysis?

(A) Peripheral blood or bone marrow:

(B) Tissue or other:

5. Which TP53 sequencing method do you use?

6. Analysed exons (Reference sequence NM_000546.5)

7. Which protocol do you use?

Please answer questions 7 and 8 only when using Sanger sequencing

8. Software used for sequence alignment:

Please answer questions 9-11 only when using NGS:

9. Which library preparation method do you use? (Please choose one option for A, one option for B and one option for C)

A) Please choose

B) Please choose

C) Please choose

10. Which NGS platform do you use?

11. Specify the Limit of detection (lowest variant allele frequency (%VAF) of your NGS methodology):

INTERPRETATION AND REPORTING

12. Reference sequence(s) used:

13. What database do you use for result interpretation?

14. Do you report over-time changes in mutation status or VAF if the patient is analysed repeatedly?

15. What is your turnaround time between receiving the sample and reporting the result?

Please answer questions 16-18 only when using NGS:

16. Do you validate results obtained using NGS?

17. What is the VAF you currently set as the cut-off for reporting in the clinic?

18. If you report on variants with VAF ≤10%, do you provide explicit statements that clinical signficance of such variants have not been documented yet?

Do you have anything to add? Do you think that there is anything missing in the current ERIC Recommendations for TP53 Mutation Analysis in CLL (Malcikova et al., Leukemia 2018) or on the ERIC website?

Thank You
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