醫令名稱(CHINESE NAME)	肺癌表皮生長因子受體(EGFR)突變體外診斷醫療器材檢測(IVD)
醫令代碼	30101B00
檢驗方法	即時聚合酶鏈鎖反應(Real-Time PCR)
判讀標準	報告說明： Mutation not detected / Mutation detected  EGFR Exon EGFR Mutation Group EGFR Nucleic Acid Sequence 　 Percent Mutation in the Panel Member to achieve ≥95% “Mutation Detected” Rate with 50 ng DNA input per reaction well (N=24 replicates) Exon 18 G719X 2156G>C LRG_304p1:p.(Gly719Ala) <5 2155G>A LRG_304p1:p.(Gly719Ser) <5 2155G>T LRG_304p1:p.(Gly719Cys) 5.6 Exon 19 Ex19Del 2240_2251del12 LRG_304p1:p.(Leu747_Thr751delinsSer) NA 2239_2247del9 LRG_304p1:p.(Leu747_Glu749del) NA 2238_2255del18 LRG_304p1:p.(Glu746_Ser752delinsAsp) NA 2235_2249del15 LRG_304p1:p.(Glu746_Ala750del) <5 2236_2250del15 LRG_304p1:p.(Glu746_Ala750del) <5 2239_2253del15 LRG_304p1:p.(Leu747_Thr751del) NA 2239_2256del18 LRG_304p1:p.(Leu747_Ser752del) <5 2237_2254del18 LRG_304p1:p.(Glu746_Ser752delinsAla) NA 2240_2254del15 LRG_304p1:p.(Leu747_Thr751del) 7.2 2240_2257del18 LRG_304p1:p.(Leu747_Pro753delinsSer) 13.4 2239_2248TTAAGAGAAG>C LRG_304p1:p.(Leu747_Ala750delinsPro) NA 2239_2251>C LRG_304p1:p.(Leu747_Thr751delinsPro) NA 2237_2255>T LRG_304p1:p.(Glu746_Ser752delinsVal) <5 2235_2255>AAT LRG_304p1:p.(Glu746_Ser752delinsIle) NA 2237_2252>T LRG_304p1:p.(Glu746_Thr751delinsVal) NA 2239_2258>CA LRG_304p1:p.(Leu747_Pro753delinsGln) NA 2239_2256>CAA LRG_304p1:p.(Leu747_Ser752delinsGln) NA 2237_2253>TTGCT LRG_304p1:p.(Glu746_Thr751delinsValAla) 6.3 2238_2252>GCA LRG_304p1:p.(Leu747_Thr751delinsGln) NA 2238_2248>GC LRG_304p1:p.(Leu747_Ala750delinsPro) NA 2237_2251del15 LRG_304p1:p.(Glu746_Thr751delinsAla) NA 2236_2253del18 LRG_304p1:p.(Glu746_Thr751del) NA 2235_2248>AATTC LRG_304p1:p.(Glu746_Ala750delinsIlePro) NA 2235_2252>AAT LRG_304p1:p.(Glu746_Thr751delinsIle) NA 2235_2251>AATTC LRG_304p1:p.(Glu746_Thr751delinsIlePro) NA 2253_2276del24 LRG_304p1:p.(Ser752_Ile759del) NA 2237_2257>TCT LRG_304p1:p.(Glu746_Pro753delinsValSer) NA 2238_2252del15 LRG_304p1:p.(Leu747_Thr751del) NA 2233_2247del15 LRG_304p1:p.(Lys745_Glu749del) NA Exon 20 S768I 2303G>T LRG_304p1:p.(Ser768Ile) <5 T790M 2369C>T LRG_304p1:p.(Thr790Met) <5 Ex20Ins 2307_2308ins9GCCAGCGTG LRG_304p1:p.(Ala767_Val769dup) <5 2319_2320insCAC LRG_304p1:p.(His773dup) 6.8 2310_2311insGGT LRG_304p1:p.(Asp770_Asn771insGly) <5 2311_2312ins9GCGTGGACA LRG_304p1:p.(Ser768_Asp770dup) NA 2309_2310AC>CCAGCGTGGAT LRG_304p1:p.(Ala767_Val769dup) NA Exon 21 L858R 2573T>G LRG_304p1:p.(Leu858Arg) <5 2573_2574TG>GT LRG_304p1:p.(Leu858Arg) <5 L861Q 2582T>A LRG_304p1:p.(Leu861Gln) <5
注意事項	如內文所示