1、KSKSKSKS SKSKSKS KSKSKS SKSKS KSKS SKS KS 2006 12 28 http:/www.kats.go.krKS J ISO 24276 KS J ISO 24276： 2006 (2011 ) J ISO 24276： 2006 : ( ) ( ) ( ) ( ) : (http:/www.standard.go.kr) ： ：2006 12 28 ：2011 12 29 2011-0652 ： ： ( 02-509-7273) (http:/www.kats.go.kr). 10 5 , . ICS 67.050 KS J ISO 24276： 200
2、6(2011 )Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products General requirements and definitions 2002 1 ISO/DIS 24276 Foodstuffs Methods of analysis for the detection of genetically modified organisms and derived products General requirements and d
3、efinitions . 1. (EN/ISO 21568), (EN/ISO 21571), (EN/ISO 21570) (EN/ISO 21569) , (method validation requirements), , , , . , , , , . 2. . . KS A ISO 5725 1： 2002 ( ) 1： ISO 3534 1 Statistics Vocabulary and symbols Part 1： Probability and general statistical terms 3. prEN ISO 21568 prEN ISO 21572 prEN
4、 ISO 21571 prEN ISO 21570 PCR prEN ISO 21569 PCR prEN ISO24276 J ISO 24276： 2006 2 4. (EN/ISO 21568), (EN/ISO 21571), (EN/ISO 21570), (EN/ISO 21569) . (validation) ISO 3534 1 KS A ISO 5725 1： 2002 . CODEX 1. 4.1 4.1.1 (target taxon) . (species) . 4.1.2 (laboratory sample) ISO 3534 1. 4.1.3 (test sam
5、ple)(test portion) ISO 3534 1. 4.1.4 (specificity) CODEX . 4.1.5 (sensitivity) . 4.1.6 (Limit Of Detection：LOD) 1 2, 3. 4.1.7 (Limit Of Quantitation：LOQ) 2, 3, KS A ISO 5725 1 . 4.1.8 (accuracy) ISO 3534 1. 4.1.9 (trueness) ISO 3534 1. (bias) . . 4.1.10 (precision) . 1. . 2. . . 3. . (ISO 3534 1). 4
6、.1.11 (repeatability), (reproducibility) ( ) . 4.1.12 (repeatability condition) (ISO 3534 1). 4.1.13 (reproducibility condition) (ISO 3534 1). , . J ISO 24276： 2006 3 4.1.14 () repeatability(reproducibility) standard de viation ( ) . ( ) ( ) . , ( ) (variance) ( ) ( ) (ISO 3534 1). 4.1.15 () repeata
7、bility(reproducibility limit) 95 % ( ) . rR (ISO 3534 1) ( ) , ( ) rR 2.8 srsR . 4.1.16 (collaboratory trials or interlaboratory study) “ ” . . KS A ISO 5725 ISO/AOAC/IUPAC 4. 4.1.17 / (fitness for purpose/applicability) , , / . . 4.1.18 (practicability) ( ) . 4.1.19 (/)applicability range(range of
8、quan tification/linearity/dynamic range) . 4.1.20 (measurement uncertainty) . 4.2 DNA 4.2.1 DNA RNA (DNA a nd RNA extraction) DNA RNA . 4.2.2 DNA (DNA purification) DNA . PCR PCR . 4.2.3 PCR DNA(PCR quality DNA) PCR DNA . 4.3 DNA PCR 4.3.1 (screening) ( ) 4. (promoter), (terminator) . 4.3.2 /(identi
9、fication/identification of nucleic acid sequences) / . , , , . 4.3.3 (junction region) J ISO 24276： 2006 4 . , (promoter) . 4.3.4 -(integration-border region) / / . 4.3.5 () (taxon specific target sequence) . , . / . , . / . , . 4.3.6 (forward flow) DNA . 4.4 (definitions referring to controls) 4.4.
10、1 DNA (positive DNA target control) DNA DNA . . 4.4.2 DNA (negative DNA target control) DNA, . . 4.4.3 PCR (PCR inhibition control) DNA ( DNA, .) . PCR , PCR . 4.4.4 (amplification reagent control) DNA . DNA . 4.4.5 (extraction blank control) . , . . DNA PCR , . 4.4.6 (positive extraction control) .
11、 4.4.7 (environment control) PCR . . , . 4.5 4.5.1 (reference material) , , J ISO 24276： 2006 5 . 4.5.2 (certified reference material) , KS A ISO Guide 30. 4.6 4.6.1 (endogeneous gene, housekeeping gene, endogeneous re ference gene, reference gene) . . 5. (method validation) 5.1 (collaborative trial
12、), (single laboratory valida tion) EN(QL/QN/EX/PR ) KS A ISO 5725 3 . (legal proof) (validation) , . (method validation) ( ) , . . (KS A ISO 5725, 3) , 8 . . (prevalidation) . . , (in-house) , , , , , , . , (SOP) . 3 5 , . PCR, . GMO , (labeling) (threshold) . . (standard validation procedure) (ring
13、 test) . J ISO 24276： 2006 6 5.2 5.2.1 . prEN ISO 21569, prEN ISO 21570, prEN ISO 21571 KS A ISO 5725 3 6 . 5.2.2 95 % ( 5 %) . RSDR 33 % . , 95 % ( 5 %) . DNA 7 . (LOD) , ( ) DNA / , . (matrix) . 5.2.3 RSDR25 % . DNA . 7 mean average . , ( ) DNA / , . . 6. 6.1 . , , , , PCR , prEN ISO 21571(EX), pr
14、EN ISO 21570(QL), prEN ISO 21569(QN) . , , , , . ： ： (a) (b) (c) DNA (d) DNA (e) (f) PCR (h) 10 PCR (a) . (b) . (c) . (d) DNA GMO (e) DNA GMO . (f) PCR . (h) PCR . 7J ISO 24276：2006J ISO 24276： 2006 8 6.2 ( .) ( .) 1 . . , . 1 . 6.3 (quality assurance) . 6.4 , . DNA . 1), 2) . 1) 2) 3 . a) b) PCR/ c) DNA , , . / . , . , PCR , PCR . . PCR . 6.5 KS A ISO/IEC 17025 , . , . . . 6.6 DNase RNase . . PCR . . . 0.22 m pore size . PCR . , , , . , , . , DNase . PCR ( ) . . 7. J ISO 24276： 2006 9 7.1 / . 7.2
