KS P 1013-2010 Standard reference materials for the quality control of antigen detection tests of Plasmodium falciparum malaria《恶性疟疾抗原诊断试剂的质量管理标准物质》.pdf

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1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P 1013 KS P 1013 :2010 2010 12 30 http:/www.kats.go.krKS P 1013:2010 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2010 12 30 2010-0689 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P 1013:2010 i ii 1 1 2 1 3 .1 4 .2 5 .3 6 .3 7 , .3 A() .5 B

2、() 6 C() , 8 D() 10 12 KS P 1013:2010 .13 KS P 1013:2010 ii . . , , . , , . KS P 1013:2010 Standard reference materials for the quality control of antigen detection tests of Plasmodium falciparum malaria 1 . . . 2 ( ) . . 2 . . ( ) . KS A ISO Guide 30, KS A ISO/IEC Guide 15, ISO/IEC KS A ISO/IEC Gui

3、de 33, KS P ISO 15194, 3 . 3.1 (parasitemia) (%), (：2 000 parasites/ L) . 3.2 (differential stage) (erythrocytic stage) (ring form), (trophozoite), (schizont) KS P 1013:2010 2 . 1 , 2-16. . 3.3 (synchronicity) . . 3.4 (synchronization) . . 1 1 . . 3.5 . 4 4.1 , , , . , , (strain) . 4.2 . . . . 4.3 .

4、 . . 4.4 1 , KS P 1013:2010 3 . 1 , . 1 . 4.5 . . . 5 5.1 2 . 3 . 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) . . 6 . . 7 , KS P 1013:2010 4 . a) ： b) ： L c) ： d) ： 1 e) ： f) , , . KS P 1013:2010 5 A () A.1 . . . KS P 1013:2010

5、 6 B () B.1 . , , . . B.2 10 % (RPMI) (：GIBCO, cat. No.：23400-021) (：Falcon, ：100 mm20 mm, cat. No.：353003) . 2 . 5 % . 5 % 37 , CO 22 %, O 23 %, N 295 % 60 . 20 L (：Thermo, ：Shandon Cytospin 4) (Giemsa) 1 000 3 50 . B.3 . 1 1 . 5.2 8 % 0.75 % (gelatin) ( ：Sigma, cat. No.：G2625) 10 % 37 30 . ( ) 2 5

6、.2 6 8 5 0.274 M - (D-Sorbitol) (：Sigma, cat. No.：S3889) 5 . 1 . 1 5.2 48 (magnetic separation system) (：Miltenyi Biotec, ：LD MidiMACS starting kit, cat. No.：130-090-329) . 1 (separation buffer) (2mM EDTA and 0.5 % BSA in PBS) 10 % (LD column) . (elution). . 5.2 96 . KS P 1013:2010 7 B.4 , 1 10 000

7、parasites/ L, 1 000 parasites/ L, 100 parasites/ L, 10 parasites/ L, 1 parasite/ L . 4 10 6 / L . % 0.25 %, 0.025 %, 0.002 5 %, 0.000 25 %, 0.000 025 %. 4 10 6 / L . 15 ( B.1 ). B.1 ( ：410 6 / L) 1 10 000 parasites/L * No.- No.- No.- 1 000 parasites/L No.- No.- No.- 100 parasites/L No.- No.- No.- 10

8、 parasites/L No.- No.- No.- 1 parasite/L No.- No.- No.- *No.: (1-100：, 101-200：, 201- 300： ) KS P 1013:2010 8 C () , C.1 B.2 . (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

9、30 40 30 40 . . . . C.3 . (haem) . 2 (histidine-rich protein 2) (HRP2) (vacuole) (haemozoin) (glutathione) . (diamagnetic) (paramagnetic) . . 1 , . . KS P 1013:2010 9 C.4 . . . . . , (plasmagel) . , . 70 % 80 % 80 % 90 % . 1 . KS P 1013:2010 10 D () D.1 (rapid diagnostic test; RDT) . B.1 5 . A B 2 2

10、 . A D.1 D.2 B D.3 D.4 . 2 . A 10 000 parasites/ L 1 000 parasites/ L 100 parasites/ L . 10 parasites/ L 10 parasites/ L . B 10 000 parasites/ L 1 000 parasites/ L 100 parasites/ L 10 parasites/ L . . . . D.1 A 1 1/ L 10/ L 100/ L 1 000/ L 10 000/ L KS P 1013:2010 11 D.2 A 2 D.3 B 1 D.4 B 2 1/ L 10/

11、 L 100/ L 1 000/ L 10 000/ L 1/ L 10/ L 100/ L 1 000/ L 10 000/ L 1/ L 10/ L 100/ L 1 000/ L 10 000/ L KS P 1013:2010 12 1 KS A ISO Guide 31：2002, 2 KS P ISO 17511, 3 KS A ISO 57252, ( )2： 4 ISO 9000 series：Quality management and quality assurance standards. 5 KS P ISO 13485, ISO 9001 6 ISO Guide 31

12、：1981, Contents of certificates of reference materials. 7 KS A ISO/IEC Guide 35, 8 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

13、 + 23 9 EN 12287：1999, Measurement of quantities in samples of biological originPresentation of reference measurement procedures 10 Directive 98/79/EC 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 11 CEN/CENELEC：Internal regulationIRPart 3：Rules for the drafting and presentation of European Standards(PNE-Rules)-1991-09 KS P 1013:2010 13 KS P 1013:2010 . 2 . , . 2004 . . 3 2007 . 2008 2 2008 9