KS P 1014-2010 Standard reference materials for the quality control of antigen detection tests of Plasmodium vivax malaria《间日疟疾抗原诊断试剂的质量管理标准物质》.pdf

1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P 1014 KS P 1014 :2010 2010 12 30 http:/www.kats.go.krKS P 1014：2010 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2010 12 30 2010-0689 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P 1014:2010 i ii 1 1 2 1 3 .1 4 .2 5 (Harmonization) .3 6 .3

2、 7 , .4 A() .5 B() 6 C() , (nested) PCR 8 10 KS P 1014:2010 .11 KS P 1014:2010 ii . . , , . , , . KS P 1014:2010 Standard reference materials for the quality control of antigen detection tests of Plasmodium vivax malaria 1 . . 1 . 2 ( ) . 2 . 2 . . ( ) . KS A ISO Guide 30: 2005, KS A ISO/IEC Guide 1

3、5, ISO/IEC KS A ISO/IEC Guide 33, KS P ISO 15194, 3 . 3.1 KS P 1014:2010 2 3.2 (synchronicity) . . 3.3 (differential stage) (erythrocytic stage) 1 (ring form), (trophozoite), (schizont) . 2 1 , 2-16. 3 . 3.4 (parasitemia) (%), . 2 000 parasites/ L 4 4.1 , , . , , (strain) 3 . 4.2 . . . . 4.3 1 , . K

4、S P 1014:2010 3 . 1 , . . 4.4 . . . 5 (Harmonization) 5.1 4 5 2 . 3 6 . 5.2 , , , , . 3 . 5.3 2 3 (10 000 parasites/ L, 1 000 parasites/ L, 100 parasites/ L) . 3 . 5.4 70 . 5.1, 5.2 5.3 . 3,7 . 5.5 . 2 5.2, 5.3, 5.4 . 6 KS P 1014:2010 4 . 8 . 7 , . a) ： b) ： L c) ： d) ： e) ： f) , (lot), 9 . KS P 101

5、4:2010 5 A () A.1 . . . KS P 1014:2010 6 B () B.1 . , , . 3 . B.2 10 cc . (Giemsa) (C.1 C.2 ) 1 000 . (strain) PCR(nested PCR) (C.3 ) PCR(real-time PCR) . . . B.3 3 (Giemsa) 1 000 3 360 . , 1 . . (3 ) / 3 3 , , % . B.4 10 000 parasites/ L, 1 000 parasites/ L, 100 parasites/ L, 10 parasites/ L, 1 par

6、asite/ L . 4 10 6 / L % 0.25 %, 0.025 %, 0.002 5 %, 0.000 25 %, 0.000 025 %. . 1 , 1 KS P 1014:2010 7 , , . 90 % 50 % . , , B.1 . B.1 10 000 parasites/ L * No.- 1 000 parasites/ L No.- 100 parasites/ L No.- 10 parasites/ L No.- 1 parasite/ L No.- *No.: (1-100：( ), 101-200： , 201-300： ) KS P 1014:201

7、0 8 C () , (nested) PCR C.1 B.2 B.3 . (methylene blue) (eosin) (DNA) - . , , , , . , . (chromosome) (histoplasma) . C.2 . (thick smear) (thin smear) 100% (methanol) 2 3 . pH 7.2 . . . 10 10, 20 20, 30 40 30 40 30 40 30 40 . . . . C.3 (nested) PCR 2 . PCR 4 . PCR (primer) 1 2 . PCR ssrRNA . 1 . ：5 -T

8、TAAAATTGTTGCAGTTAAAACG-3 ：5 -CCTGTTGTTGCCTTAAACTTC-3 2 . KS P 1014:2010 9 ：5 -TTAAACTGGTTTGGGAAAACCAAATATATT-3 ：5 -ACACAATGAACTCAATCATGACTACCCGTC-3 ：5 -CGCTTCTAGCTTAATCCACATAACTGATAC-3 ：5 -ACTTCCAAGCCGAAGCAAAGAAAGTCCTTA-3 ：5 -ATAACATAGTTGTACGTTAAGAATAACCGC-3 ：5 -AAAATTCCCATGCATAAAAAATTATACAAA-3 ：5 -

9、ATCTCTTTTGCTATTTTTTAGTATTGGAGA-3 ：5 -GGAAAAGGACACATTAATTGTATCCTAGTG-3 1 . 1：95 5, 58 2, 72 2 2(24 )：94 1, 58 2, 72 2 3：94 1, 58 2, 72 5 2 . 1：95 5, 58 2, 72 2 2(30 )：94 1, 58 2, 72 2 3：94 1, 58 2, 72 5 PCR . ：205 (base pair; bp), ：120 , ：144 , ：800 1 1 200 PCR . KS P 1014:2010 10 1 Directive 98/79/E

10、C of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Off J Eur Commun 1998; 331:1-37 2 KS P ISO 17511, 3 EN 12287 ：1999, Measurement of quantities in samples of biological origin-Presentation of reference measurement procedures 4 KS A ISO 57252,

11、( )2： 5 NCCLS ：The reference system for the clinical Laboratory; Criteria for Development and Credentialing of Methods and Materials for Harmonization of Results; Proposed Guideline, NCCLS Document NRSCL 13-P, 15(12) (1995) x + 23 6 KS A ISO/IEC Guide 35, 7 ISO Guide 31: 1981, Contents of certificat

12、es of reference materials 8 CEN/CENELEC ：Internal regulationIRPart 3 ：Rules for the drafting and presentation of European Standards (PNE-Rules)-1991-09 9 KS A ISO Guide 31：2002, KS P 1014:2010 11 KS P 1014:2010 . 2 . , . 2004 . . 3 2007 . 2008 2 2008 9 . 20 2008 1 2009 70 2 . . . . 1, 2 . . (in-hous

13、e) . . 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS P 1014 :2010 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Standard reference materials for the quality control of antigen detection tests of Plasmodium vivax malaria ICS 11.020 Korean Agency for Technology and Standards http:/www.kats.go.kr