Table 1
Overview of analysis and reporting results in different subschemes of the 2016 ESP
Lung EQA scheme
Subscheme
EGFR
ALK FISH + digital
ALK IHC
ALK IHC technical evaluation
Number of participants
97 113 102 90
Number of countries
28 26 31 30
Number of cases
10 9* 5 5
evaluated
95.0%*
95.0%
83.2%
Average analysis score 92.0%
(%)
71.1% 82.3%* 88.2% 94.4%
Laboratories successful
(%)
6.6% 0.7% 0.1% N/A
Incorrectly genotyped
samples (%)
(64/970) (7/1017) (13/510)
Laboratories with at
43.3%
6.2% 9.8% N/A
least one incorrectly
analyzed sample (%)
0.1% 2.2% 0.8% N/A
Samples for which a
technical failure
(1/970)
(22/1017)
(4/510)
occurred (%)
1.0% 12.4% 2.9% N/A
Laboratories with at
least one technical
failure (%)
95 107 88 N/A
Number of laboratories
that submitted reports
86.1% 84.4% 84.0% N/A
Average reporting
score (%)
44.6% 43.0% 44.3% N/A
Laboratories with the
interpretation present
and correct (%)
N/A: not applicable. Written reports were not taken into account to determine successful participation on analysis level. For the technical evaluation, no written reports were
scored. *9 cases were included to calculate the performance score instead of 10. The cut-off for successful participation was therefore defined as ≥88% instead of ≥90% for this
subscheme only.
EQA provides
laboratories with
the opportunity
to verify and
validate their
test methods,
monitor their
performance and
compare to other
laboratories
worldwide
This manuscript highlights the results of the
latest 2016 EQA scheme for EGFR, ALK and ROS1
analysis in NSCLC. Additionally, recommendations
are made on further research on multiple health-
care levels that might contribute to an improved
testing quality.
Methods
The organisation of the ESP EQA schemes is
performed in collaboration with the coordination
centre (BQA Research Unit of KU Leuven),
which is accredited according to the ISO 17043
standard for conformity assessment of proficiency
testing. 9 The set-up of each ESP Lung EQA
scheme is determined beforehand by a steering
committee of international experts in molecular
diagnostics, according to the guideline on the
requirements of EQA programs in molecular
pathology. 10
Registration was open to all laboratories
worldwide. Participants received ten formalin-
fixed paraffin-embedded (FFPE) samples for EGFR
variant analysis and five FFPE samples for ALK
and ROS1 rearrangement testing. For ALK and
ROS1, laboratories could participate in
a fluorescent in situ hybdrisation (FISH) and
immunohistochemistry (IHC) subscheme. For
FISH, five additional digital cases were provided
for signal interpretation only. For IHC, participants
were asked to send back their stained slides to
the coordination centre, to evaluate the
immunostaining quality by a team of international
pathologists. The digital FISH images were
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HHE 2018 | hospitalhealthcare.com
available via a digital platform, along with
digitised haematoxylin- and eosin-stained slides
for pathologist review.
Participants were asked to analyse the samples
using their routine procedures. To reflect clinical
practice, the deadline for results submission was
14 calendar days after sample receipt. Scheme
results were evaluated by a team of international
assessors for each individual subscheme in
agreement with the EQA guideline. 10 Every
sample was awarded two points for a correct
result, and points were deducted in case of an
error. Successful participation for EGFR, ALK and
ROS1 was defined as a score of ≥90% of the total
achievable score. For the technical evaluation
of the immunostaining, a quality score on five
points was awarded and successfulness was
defined as a score of ≥3/5. The average reporting
score was defined by the scoring of seven
different score criteria for variant analysis and
IHC, and nine criteria for FISH, as defined by the
guideline. 10 Participants could submit data and
access their results via a password-protected
central database on the ESP Lung EQA scheme
website (http://lung.eqascheme.org).
Results of the 2016 NSCLC EQA scheme are
shown in Table 1. Results from 2012–2015 EQA
schemes have previously been published. 7,8,11 In
total, 190 unique laboratories from 34 countries
participated in 2016. Thirty-one participants from
16 countries participated in all three markers
(ALK, ROS1, and EGFR).
Average analysis scores were all above 80%. For