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Chapter 9: Guidelines and Standardization Studies
Table 2. Multicenter Standardization Studies for ALK Testing Methods
Country Methods Evaluated Participants No. of Specimens Study Type
Europe (ETOP) Canada
IHC and FISH IHC and FISH
15 laboratories 12 Canadian pathology laboratories
1,099 (69 ALK-positive) 28 (22 ALK positive)
Round-robin test; retrospective analysis Testing by individual laboratory protocols , followed by protocol adjustment after consensus meeting and further validation by repeat testing Prospective screening
Japan
IHC, FISH, and Nationwide quantitative screening for 3 RT-PCR months IHC, FISH, and RT-PCR IHC and FISH 15 French thoracic pathology departments
2,884 (213 ALK positive)
France
459 (85 ALK positive)
Addressing concordance among testing methods in the central laboratories Round-robin test of known ALK status
Germany
Experts at 8 German 10 (5 ALK positive) institutes of pathology 80 and 150 laboratories for first and second rounds, respectiv