UK NEQAS for Molecular Genetics
www.ukneqas-molgen.org.uk
Director: Dr Sandi Deans
Department of Laboratory Medicine
The Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh EH16 4SA
United Kingdom
Circulating tumour DNA (ctDNA) Pilot EQA
Laboratory survey 2015
Many laboratories are developing testing of circulating tumour DNA to detect the presence of pathogenic gene
mutations. In order to help laboratories develop and deliver high quality testing, UK NEQAS for Molecular Genetics will
offer external quality assessment (EQA) in this field.
To provide an EQA which is useful to laboratories we would like to collect information from potential participants to
determine the type of testing currently offered, research and development underway and plans for future
implementation of ctDNA testing, therefore we invite you to complete this survey.
You can complete this paper copy or an electronic copy of the survey which is available to download from
www.ukneqas-molgen.org.uk under the ‘NEWS’ items.
1. Clinical testing
Does your laboratory currently provide a diagnostic clinical service using
ctDNA testing? If no, then please go to section 2 below.
Yes
No
Does your laboratory currently clinical research using ctDNA testing?
If no, then please go to section 2 below.
Yes
No
If yes, then do you test
Please tick all that apply.
- single genes
Yes
No
- gene panels
Yes
No
- full coding regions of
genes tested
Yes
No
- targeted mutation
hotspots
Yes
No
Yes
No
- single mutation targets
Please list the disease(s), gene(s) and specific
mutations detected (if using targeted testing), or
provide details of a panel of genes.
How many samples have your laboratory tested
using ctDNA during the period January 2014 to
June 2014?
Scheme email: info@ukneqas-molgen.org.uk
Scheme telephone: +44 (0) 131 242 6898
Scheme fax: +44 (0) 131 242 6882
UK NATIONAL EXTERNAL QUALITY ASSESSMENT SERVICES
Accredited EQA Scheme
Reference No: 051 Page 1 of 5
UK NEQAS for Molecular Genetics
www.ukneqas-molgen.org.uk
Director: Dr Sandi Deans
How many samples have your laboratory tested
using ctDNA during the period July 2014 to
December 2014?
Does your laboratory plan to implement further ctDNA testing?
Yes
No
- single genes
Yes
No
- gene panels
Yes
No
- full coding regions of
genes tested
Yes
No
- targeted mutation
hotspots
Yes
No
Yes
No
Does your laboratory plan to implement a clinical service using ctDNA
testing? Not applicable if answered section 1 above. Please go to section 3.
Yes
No
If yes, then do you plan to test
Please tick all that apply.
- single genes
Yes
No
- gene panels
Yes
No
- full coding regions of
genes tested
Yes
No
- targeted mutation
hotspots
Yes
No
Yes
No
If yes, then do you plan to introduce
Please tick all that apply.
- single mutation targets
Please list the disease(s), gene(s) and specific
mutations detected (if using targeted testing), or
provide details of a panel of genes.
2. Developing ctDNA testing
- single mutation targets
Please list the disease(s), gene(s) and specific
mutations detected (if using targeted testing), or
provide details of a panel of genes.
UK NEQAS for Molecular Genetics 2015 – ctDNA 2015 survey
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UK NEQAS for Molecular Genetics
www.ukneqas-molgen.org.uk
Director: Dr Sandi Deans
When do you plan to implement a clinical service
using ctDNA testing in your laboratory
(month/year)?
3. Methodologies
Which DNA extraction method(s) does your
laboratory use?
Which method(s) is used to detect your target,
including any in-house or commercial kits?
4. Sample requirements
What sample type(s) does your laboratory accept
for testing?
What volume of blood does your laboratory
request for testing?
What is the minimum volume of blood your
laboratory accepts for testing?
What is the minimum amount of ctDNA required
for testing?
Does your laboratory extract ctDNA from plasma
or serum?
What is the minimum volume of plasma/serum
used for cfDNA extraction in your laboratory?
How does the laboratory measure the amount of
cfDNA?
What is the minimum mutation level to enable
reporting?
How does your laboratory report quantitative
results i.e. total mutation copies/ml of
plasma/serum, ratio of mutation/wild type etc?
UK NEQAS for Molecular Genetics 2015 – ctDNA 2015 survey
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UK NEQAS for Molecular Genetics
www.ukneqas-molgen.org.uk
Director: Dr Sandi Deans
What is the limit of detection of mutations for the
assay(s) performed?
5. Sample transportation
What is the mode of transport e.g. courier,
surface post etc.?
Any specific temperature requirements e.g. on dry
ice, ice, room temperature etc?
Which tubes are the samples transported in e.g.
EDTA anticoagulant, Streck tubes etc?
Do you have any specific instructions for
individuals to perform before sending samples to
the laboratory e.g. spin the blood and freeze,
samples need to be received within 4 hours, etc.?
Any specific temperature requirements e.g. on dry
ice, ice, room temperature etc?
6. Laboratory information
Would your laboratory be interested in participating in a ctDNA EQA
scheme?
Yes
No
Name of individual completing survey
Name of Laboratory
Email address
UK NEQAS for Molecular Genetics/Pathology
EQA number (if known)
UK NEQAS for Molecular Genetics 2015 – ctDNA 2015 survey
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UK NEQAS for Molecular Genetics
www.ukneqas-molgen.org.uk
Director: Dr Sandi Deans
7. Extra information
If you would like to submit any extra information to UK NEQAS for Molecular Genetics then please do so
below.
Thank you for completing this survey.
Please return to UK NEQAS for Molecular Genetics by Friday 8th May, 2015
You can either:
1. Return this paper copy by post to:
Dr Sandi Deans,
Scheme Director,
UK NEQAS for Molecular Genetics,
Department of Laboratory Medicine,
Royal Infirmary of Edinburgh,
Little France Crescent,
Edinburgh, EH16 4SA, United Kingdom
2. Fax this paper copy to +44 (0)131 242 6882
3. Scan this paper copy and email to info@ukneqas-molgen.org.uk
4. Download an electronic copy of the survey from www.ukneqas-molgen.org.uk under the ‘NEWS’
items and email to info@ukneqas-molgen.org.uk
UK NEQAS for Molecular Genetics 2015 – ctDNA 2015 survey
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