ALK rearrangement testing by fish analysis in non-small-cell lung cancer patients: Results of the first Italian external quality assurance scheme

Antonio Marchetti, Massimo Barberis, Mauro Papotti, Giulio Rossi, Renato Franco, Sara Malatesta, Fiamma Buttitta, Andrea Ardizzoni, Lucio Crinò, Cesare Gridelli, Gian Luigi Taddei, Claudio Clemente, Giorgio Scagliotti, Nicola Normanno, Carmine Pinto

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

INTRODUCTION: The Italian Association of Medical Oncology and the Italian Society of Anatomic Pathology and Diagnostic Cytopathology organized an external quality assessment (EQA) scheme for anaplastic lymphoma kinase (ALK) rearrangement by florescence in situ hybridization (FISH) analysis in non-small-cell lung cancer (NSCLC). METHODS: Sections from tissue microarrays, each including 10 NSCLC samples with known ALK status, were first validated in five referral laboratories and then provided to 37 participating centers. The laboratories were requested to perform the FISH test, using their usual protocols, and to complete the analysis within 3 weeks. By using a predefined scoring system, two points were assigned in case of correct genotype and zero points to false-negative or false-positive results. The threshold value to pass the EQA scheme was set at 18 points. Two rounds were planned. RESULTS: Thirty-four centers submitted the results within the established deadline. Several errors in the evaluation of genotype (n = 18) were reported, with both false-positive (n = 7) and false-negative (n = 11) results. Test failure occurred in seven cases. Two samples were found to be critical by two referral laboratories and seven participating centers. Twenty-six (70%) laboratories passed the first round and six the second round. Overall, 32 (86%) laboratories passed the ALK EQA scheme. CONCLUSIONS: The results of this first EQA scheme for ALK testing in NSCLC cancer patients indicate that ALK analysis is performed with adequate quality in most Italian laboratories and highlight the importance of EQA in revealing methodological problems that need to be addressed to further increase the reproducibility of molecular tests.

Original languageEnglish
JournalJournal of Thoracic Oncology
DOIs
Publication statusAccepted/In press - Aug 28 2014

Fingerprint

Non-Small Cell Lung Carcinoma
Fishes
In Situ Hybridization
Referral and Consultation
Genotype
Medical Oncology
anaplastic lymphoma kinase
Pathology
Neoplasms

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Oncology

Cite this

ALK rearrangement testing by fish analysis in non-small-cell lung cancer patients : Results of the first Italian external quality assurance scheme. / Marchetti, Antonio; Barberis, Massimo; Papotti, Mauro; Rossi, Giulio; Franco, Renato; Malatesta, Sara; Buttitta, Fiamma; Ardizzoni, Andrea; Crinò, Lucio; Gridelli, Cesare; Taddei, Gian Luigi; Clemente, Claudio; Scagliotti, Giorgio; Normanno, Nicola; Pinto, Carmine.

In: Journal of Thoracic Oncology, 28.08.2014.

Research output: Contribution to journalArticle

Marchetti, Antonio ; Barberis, Massimo ; Papotti, Mauro ; Rossi, Giulio ; Franco, Renato ; Malatesta, Sara ; Buttitta, Fiamma ; Ardizzoni, Andrea ; Crinò, Lucio ; Gridelli, Cesare ; Taddei, Gian Luigi ; Clemente, Claudio ; Scagliotti, Giorgio ; Normanno, Nicola ; Pinto, Carmine. / ALK rearrangement testing by fish analysis in non-small-cell lung cancer patients : Results of the first Italian external quality assurance scheme. In: Journal of Thoracic Oncology. 2014.
@article{895433223ac44964ba5e75221f95c8c4,
title = "ALK rearrangement testing by fish analysis in non-small-cell lung cancer patients: Results of the first Italian external quality assurance scheme",
abstract = "INTRODUCTION: The Italian Association of Medical Oncology and the Italian Society of Anatomic Pathology and Diagnostic Cytopathology organized an external quality assessment (EQA) scheme for anaplastic lymphoma kinase (ALK) rearrangement by florescence in situ hybridization (FISH) analysis in non-small-cell lung cancer (NSCLC). METHODS: Sections from tissue microarrays, each including 10 NSCLC samples with known ALK status, were first validated in five referral laboratories and then provided to 37 participating centers. The laboratories were requested to perform the FISH test, using their usual protocols, and to complete the analysis within 3 weeks. By using a predefined scoring system, two points were assigned in case of correct genotype and zero points to false-negative or false-positive results. The threshold value to pass the EQA scheme was set at 18 points. Two rounds were planned. RESULTS: Thirty-four centers submitted the results within the established deadline. Several errors in the evaluation of genotype (n = 18) were reported, with both false-positive (n = 7) and false-negative (n = 11) results. Test failure occurred in seven cases. Two samples were found to be critical by two referral laboratories and seven participating centers. Twenty-six (70{\%}) laboratories passed the first round and six the second round. Overall, 32 (86{\%}) laboratories passed the ALK EQA scheme. CONCLUSIONS: The results of this first EQA scheme for ALK testing in NSCLC cancer patients indicate that ALK analysis is performed with adequate quality in most Italian laboratories and highlight the importance of EQA in revealing methodological problems that need to be addressed to further increase the reproducibility of molecular tests.",
author = "Antonio Marchetti and Massimo Barberis and Mauro Papotti and Giulio Rossi and Renato Franco and Sara Malatesta and Fiamma Buttitta and Andrea Ardizzoni and Lucio Crin{\`o} and Cesare Gridelli and Taddei, {Gian Luigi} and Claudio Clemente and Giorgio Scagliotti and Nicola Normanno and Carmine Pinto",
year = "2014",
month = "8",
day = "28",
doi = "10.1097/JTO.0000000000000280",
language = "English",
journal = "Journal of Thoracic Oncology",
issn = "1556-0864",
publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - ALK rearrangement testing by fish analysis in non-small-cell lung cancer patients

T2 - Results of the first Italian external quality assurance scheme

AU - Marchetti, Antonio

AU - Barberis, Massimo

AU - Papotti, Mauro

AU - Rossi, Giulio

AU - Franco, Renato

AU - Malatesta, Sara

AU - Buttitta, Fiamma

AU - Ardizzoni, Andrea

AU - Crinò, Lucio

AU - Gridelli, Cesare

AU - Taddei, Gian Luigi

AU - Clemente, Claudio

AU - Scagliotti, Giorgio

AU - Normanno, Nicola

AU - Pinto, Carmine

PY - 2014/8/28

Y1 - 2014/8/28

N2 - INTRODUCTION: The Italian Association of Medical Oncology and the Italian Society of Anatomic Pathology and Diagnostic Cytopathology organized an external quality assessment (EQA) scheme for anaplastic lymphoma kinase (ALK) rearrangement by florescence in situ hybridization (FISH) analysis in non-small-cell lung cancer (NSCLC). METHODS: Sections from tissue microarrays, each including 10 NSCLC samples with known ALK status, were first validated in five referral laboratories and then provided to 37 participating centers. The laboratories were requested to perform the FISH test, using their usual protocols, and to complete the analysis within 3 weeks. By using a predefined scoring system, two points were assigned in case of correct genotype and zero points to false-negative or false-positive results. The threshold value to pass the EQA scheme was set at 18 points. Two rounds were planned. RESULTS: Thirty-four centers submitted the results within the established deadline. Several errors in the evaluation of genotype (n = 18) were reported, with both false-positive (n = 7) and false-negative (n = 11) results. Test failure occurred in seven cases. Two samples were found to be critical by two referral laboratories and seven participating centers. Twenty-six (70%) laboratories passed the first round and six the second round. Overall, 32 (86%) laboratories passed the ALK EQA scheme. CONCLUSIONS: The results of this first EQA scheme for ALK testing in NSCLC cancer patients indicate that ALK analysis is performed with adequate quality in most Italian laboratories and highlight the importance of EQA in revealing methodological problems that need to be addressed to further increase the reproducibility of molecular tests.

AB - INTRODUCTION: The Italian Association of Medical Oncology and the Italian Society of Anatomic Pathology and Diagnostic Cytopathology organized an external quality assessment (EQA) scheme for anaplastic lymphoma kinase (ALK) rearrangement by florescence in situ hybridization (FISH) analysis in non-small-cell lung cancer (NSCLC). METHODS: Sections from tissue microarrays, each including 10 NSCLC samples with known ALK status, were first validated in five referral laboratories and then provided to 37 participating centers. The laboratories were requested to perform the FISH test, using their usual protocols, and to complete the analysis within 3 weeks. By using a predefined scoring system, two points were assigned in case of correct genotype and zero points to false-negative or false-positive results. The threshold value to pass the EQA scheme was set at 18 points. Two rounds were planned. RESULTS: Thirty-four centers submitted the results within the established deadline. Several errors in the evaluation of genotype (n = 18) were reported, with both false-positive (n = 7) and false-negative (n = 11) results. Test failure occurred in seven cases. Two samples were found to be critical by two referral laboratories and seven participating centers. Twenty-six (70%) laboratories passed the first round and six the second round. Overall, 32 (86%) laboratories passed the ALK EQA scheme. CONCLUSIONS: The results of this first EQA scheme for ALK testing in NSCLC cancer patients indicate that ALK analysis is performed with adequate quality in most Italian laboratories and highlight the importance of EQA in revealing methodological problems that need to be addressed to further increase the reproducibility of molecular tests.

UR - http://www.scopus.com/inward/record.url?scp=84906531591&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84906531591&partnerID=8YFLogxK

U2 - 10.1097/JTO.0000000000000280

DO - 10.1097/JTO.0000000000000280

M3 - Article

C2 - 25170637

AN - SCOPUS:84925804527

JO - Journal of Thoracic Oncology

JF - Journal of Thoracic Oncology

SN - 1556-0864

ER -