External quality assessment for EGFR mutations in Italy: improvements in performances over the time

Abstract

External quality assessment (EQA) schemes are essential procedures to assess the quality level of laboratories performing molecular testing of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer. The Italian Association of Medical Oncology (AIOM) and the Italian Society of Pathology (SIAPEC-IAP) organise EGFR EQA programmes to ensure that the Italian laboratories achieve the quality standard levels required. Comparing the 2011, 2013 and 2015 EGFR EQA schemes, it was possible to observe improvements in the methodologies used and the outcomes. The use of direct sequencing was reduced from 78.7% in 2011 to only 14.1% in 2015, whereas the use of pyrosequencing and real-time PCR increased. The number of rounds in which centres using direct sequencing failed was significantly higher than the number of rounds that failed using other methods, both when analysing each single scheme and when combining the three EQAs together. In 2011 and 2013, about 29% of the participants failed the first phase of the programmes, compared with the 13% of centres failing in 2015, suggesting that the switch to more sensitive and robust methods could allow to increase the percentage of good performers. Although the molecular analyses are performed with good quality in Italy, the continuous education carried out by AIOM and SIAPEC-IAP remains a fundamental tool to maintain this quality level.

Keywords: EGFR mutations; External Quality Assessment; Non-Small Cell Lung Cancer; molecular testing.

Figure 1

Methods distribution among the three EQAs. (A) Percentage of the methods chosen in the first phase of 2011 EQA (participants: 47). (B) Percentage of the methods used in the first phase of 2013 EQA (participants: 86). (C) Percentage of the methods used in the 2015 EQA (participants: 92).

Figure 2

Correlation between performances obtained by means of direct sequencing and other methods. (A) The methods performances in the three EQAs (p<0.0001). (B to D) The correlation between direct sequencing and other methods used in 2011 (p=0.022), 2013 (p=0.033) and 2015 (p=0.012), respectively.