Analytic performance studies and clinical reproducibility of a real-time PCRassay for the detection of epidermal growth factor receptor gene mutations informalin-fixed paraffin-embedded tissue specimens of non-small cell lungcancer

Table 7 External reproducibility across reagent lots, operators, instruments,and testing days

Panel Member	Number of Valid Tests	Agreement (N)	Agreement % (95% CI)^a
Wild Type	180	180	100 (98.0, 100.0)
EX19_ 2235_2249del15 - 5% Mutation	180	180	100 (98.0, 100.0)
EX19_2236_2250del15 - 5% Mutation	180	180	100 (98.0, 100.0)
EX19_2239_2248 > C - 5% Mutation	180	180	100 (98.0, 100.0)
EX19_2240_2254del15 - 5% Mutation	180	180	100 (98.0, 100.0)
EX19_2240_2257del18 - 5% Mutation	180	113	62.8 (55.3, 69.9)
EX21_ 2573T > G = L858R - 5%Mutation	180	180	100 (98.0, 100.0)
EX19_ 2235_2249del15 - ≤10% Mutation	180	180	100 (98.0, 100.0)
EX19_2236_2250del15 - ≤10% Mutation	180	180	100 (98.0, 100.0)
EX19_2239_2248 > C - ≤10% Mutation	180	180	100 (98.0, 100.0)
EX19_2240_2254del15 - ≤10% Mutation	180	180	100 (98.0, 100.0)
EX19_2240_2257del18 - ≤10% Mutation	180	179	99.4 (96.9, 100.0)
EX21_ 2573T > G = L858R -≤10% Mutation	180	180	100 (98.0, 100.0)

Note: Results were in agreement when a Mutant Type panel member had avalid result of Mutation Detected or when Wild Type panel member hada valid result of Mutation Not Detected.
^a 95% CI = 95% exact binomial confidenceinterval.

ISSN: 1471-2407