HHE Pathology and diagnostics supplement 2018 | Page 6

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

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 healthcare 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 formalinfixed 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

6 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