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中检院标准品
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中国食品药品检定研究院,简称中检院,是国家检验药品生物制品质量的法定机构和高技术仲裁机构,目前提供200余种体外诊断试剂所注册用国家中检院标准品。

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  • 更新时间:2024-09-10
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中国食品药品检定研究院,简称中检院,是国家检验药品生物制品质量的法定机构和高技术仲裁机构,目前提供200余种体外诊断试剂所注册用国家中检院标准品

中检院标准品参数:

序号品种编号名称英文名称规格
1150519胰岛素国家标准品Insulin National Standard55 mIU
2150530促甲状腺素(TSH)免疫测定用国家标准品National Standard for Thyroid Stimulating Hormone (TSH) Immunoassay3.12mIU
3150531促黄体生成素(LH)免疫测定用国家标准品National standard for luteinizing hormone (LH) immunoassay1.12 IU,0.5ml
4150533促卵泡生成激素(FSH) 免疫测定用国家标准品National Standard for Follicle Stimulating Hormone (FSH) Immunoassay0.5ml
5150534人生长激素免疫测定用国家标准品National standard for human growth hormone immunoassay2.3mIU
6150535人绒毛膜促的性腺激素β  亚单位(hCG-β)免疫测定用国家标准品National standard for immunoassay of human chorionic gonadotropin β subunit (hCG-β)240ng/0.5mL
7150536人胎盘泌乳素(HPL)免疫测定用国家标准品National standard for human placental prolactin (HPL) immunoassay14.2μg
8150540铁蛋白(Fer)国家标准品Ferritin (Fer) National Standard790ng
9150542甲胎蛋白(AFP)免疫测定用国家标准品National standard for immunoassay of alpha-fetoprotein (AFP)
10150543前列腺特异性抗原(PSA)免疫测定用国家标准品National standards for prostate specific antigen (PSA) immunoassay95ng;
11150544游离前列腺特异性抗原(f-PSA)免疫测定用国家标准品National standard for immunoassay of free prostate specific antigen (f-PSA)170ng
12150550三碘甲腺原氨酸(T3)免疫测定用国家标准品National standard for immunoassay of triiodothyronine (T3)50ng
13150551甲状腺素(T4)免疫测定用国家标准品National Standard for Thyroxine (T4) Immunoassay940ng
14150552反三碘甲腺原氨酸(rT3)免疫测定用国家标准品National standard for anti-triiodothyronine (rT3) immunoassay860ng
15150553C-肽国家标准品C-peptide national standard77ng
16150554胰高血糖素(Glucagon)免疫测定用国家标准品National Standards for Glucagon Immunoassay19μIU/19ng
17150555人绒毛膜促性腺激素(HCG)免疫测定用国家标准品National standard for human chorionic gonadotropin (HCG) immunoassay8.28IU,0.5ml
18150556抗甲状腺球蛋白抗体(Anti-TgAb)国家标准品National Standard for Anti-TgAb
19150557抗甲状腺过氧化物酶抗体(Anti-TpoAb)国家标准品Anti-thyroid peroxidase antibody (Anti-TpoAb) national standard
20210015淋病PCR试剂盒质控参考品Quality control reference material for gonorrhea PCR kit26 支/套
21220009HIV抗体国家参考品HIV antibody national reference0.5ml
22220013HIV抗体胶体金类诊断试剂用国家参考品National reference material for HIV antibody colloidal gold diagnostic reagents0
23220014人类免疫缺陷病毒(HIV)核酸血筛国家参考品National Reference Material for Human Immunodeficiency Virus (HIV) Nucleic Acid Blood Screening0.5ml/只
24220015HIV-1   P24抗原国家参考品HIV-1 P24 antigen national reference material0.5ml/ml
25220016HIV抗体确证试剂国家参考品National Reference Material for HIV Antibody Confirmation Reagent0.5ml,共27 支
26220017HIV-1RNA国家参考品HIV-1RNA National Reference Material0.5mL
27220018HIV-1耐药性分析试剂国家参考品National Reference Material for HIV-1 Drug Resistance Analysis Reagent48 支/套
28220019人类免疫缺陷病毒口腔黏膜渗出液抗体国家参考品National Reference Material for Human Immunodeficiency Virus Oral Mucosal Exudate Antibody
29220020HIV抗体尿液快速检测试剂国家参考品HIV antibody urine rapid test reagent national reference46 支/套
30220021人类免疫缺陷病毒1型(HIV-1)RNA标准品Human Immunodeficiency Virus Type 1 (HIV-1) RNA Standard1mL
31230019血吸虫病IgG抗体检测试剂用国家参考品National reference material for schistosomiasis IgG antibody detection reagent0.5ml,32支/套
32230023弓形虫IgG诊断试剂检测国家参考品National reference material for the detection of Toxoplasma IgG diagnostic reagent0.5ml,24支/套
33230029包虫病IgG抗体国家参考品National Reference Material for Hydatid IgG Antibody0.5ml
34230030结核分支杆菌PCR检测试剂盒用国家参考品National Reference Material for Mycobacterium Tuberculosis PCR Detection Kit44 支/套,1mL
35230033结核分支杆菌利福的平耐药基因检测试剂用国家参考品National reference material for rifampicin resistance gene detection reagent of Mycobacterium tuberculosis31 支
36230034结核分枝杆菌异烟的肼耐药基因检测试剂用国家参考品National Reference Material for Isoniazid Resistance Gene Detection Reagent for Mycobacterium Tuberculosis30 支
37230037恶性疟原虫抗原检测试剂盒用全血国家参考品Whole blood national reference material for Plasmodium falciparum antigen detection kit0.1ml,20支/套
38230038间日疟原虫抗原检测试剂盒用全血国家参考品Whole blood national reference material for Plasmodium vivax antigen detection kit0.1ml
39240013梅毒诊断试剂国家参考品(特异性)National Reference Material for Syphilis Diagnostic Reagents (Specificity)34 支;1000μl
40250016发热伴血小板减少综合征布尼亚病毒(SFTSV)核酸检测试剂国家参考品Fever with thrombocytopenia syndrome Bunya virus (SFTSV) nucleic acid detection reagent national reference material
41280020抗A抗B血型定型试剂效价测定用国家参考品National reference for determination of potency of anti-A and anti-B blood grouping reagents1.0mL
42290001华枝睾虫病IgG抗体冻干血清国家参考品National Reference Material of Lyophilized Serum for Clonorchiasis IgG Antibody0.2ml,21支/套
43300003乙型肝炎病毒表面抗原(HBsAg)国家参考品Hepatitis B virus surface antigen (HBsAg) national reference material0.5mL
44300004乙型肝炎病毒表面抗体(HBsAb)国家标准品(定性检测)Hepatitis B virus surface antibody (HBsAb) national standard (qualitative test)0.5ml/1.0ml
45300005乙型肝炎病毒e抗原(HBeAg)国家参考品Hepatitis B virus e antigen (HBeAg) national reference material27 支/套
46300006乙型肝炎病毒e抗体(HBeAb)国家参考品Hepatitis B virus e antibody (HBeAb) national reference material0.5ml
47300007乙型肝炎病毒核心抗体(Anti-HBcAb)国家参考品Hepatitis B virus core antibody (Anti-HBcAb) national reference material32 支/套
48300009乙型肝炎病毒DNA国家参考品National Reference Material of Hepatitis B Virus DNA0.5ml
49300010丙型肝炎病毒抗体国家参考品National Reference Material for Hepatitis C Virus Antibody65 支/套
50300011戊型肝炎病毒IgM抗体国家参考品Hepatitis E virus IgM antibody national reference material0.5ml
51300012丙型肝炎病毒RNA国家参考品Hepatitis C virus RNA national reference material21 支/套
52300013丙型肝炎病毒抗体快速检测试剂国家参考品National Reference Material of Hepatitis C Virus Antibody Rapid Detection Reagent
53300014戊型肝炎病毒IgG抗体国家参考品National Reference Material for Hepatitis E Virus IgG Antibody42 支/套
54300015乙型肝炎病毒表面抗体(HBsAb)国家参考品(定量检测)Hepatitis B virus surface antibody (HBsAb) national reference material (quantitative test)0.5ml
55300022乙型肝炎病毒核酸定量国家标准品Hepatitis B virus nucleic acid quantitative national standard0.5ml
56300023丙型肝炎病毒核心抗原检测试剂国家参考品National Reference Material for Hepatitis C Virus Core Antigen Detection Reagent0.5ml
57340001乙型肝炎病毒e抗原快速诊断试剂国家参考品National Reference Material of Hepatitis B Virus e Antigen Rapid Diagnosis Reagent27 支/套
58340002乙型肝炎病毒e抗体快速诊断试剂国家参考品Hepatitis B virus e antibody rapid diagnostic reagent national reference material27 支/套
59340003乙型肝炎病毒核心抗体快速诊断试剂国家参考品National Reference Material of Hepatitis B Virus Core Antibody Rapid Diagnostic Reagent32 支/套
60340004乙型肝炎病毒表面抗原快速诊断试剂国家参考品National Reference Material for Rapid Diagnosis of Hepatitis B Virus Surface Antigen27 支/套
61340005乙型肝炎病毒表面抗体快速诊断试剂国家参考品National Reference Material for Rapid Diagnosis of Hepatitis B Virus Surface Antibody22 支/套
62340006*乙型肝炎病毒核酸基因分型(B型)国家标准品*National standard for hepatitis B virus nucleic acid genotyping (type B)
63340007*乙型肝炎病毒核酸基因分型(C型)国家标准品*National Standard for Hepatitis B Virus Nucleic Acid Genotyping (Type C)
64340008*乙型肝炎病毒RNA检测试剂国家标准品*National standard of hepatitis B virus RNA detection reagent
65340016丙型肝炎病毒RNA(1b型)国家标准品Hepatitis C virus RNA (type 1b) national standard0.5ml
66340017丙型肝炎病毒基因分型(1b型)国家标准品National standard for hepatitis C virus genotyping (type 1b)0.5ml
67340018丙型肝炎病毒基因分型(2a型)国家标准品National Standard for Hepatitis C Virus Genotyping (Type 2a)0.5ml
68340019轮状病毒抗原检测试剂用国家参考品National reference materials for rotavirus antigen detection reagents0.5ml,1ml
69340020甲型肝炎病毒核酸检测试剂用国家标准品National standard for hepatitis A virus nucleic acid detection reagent0.5ml
70340021乙型肝炎病毒表面抗原国家标准品National Standard of Hepatitis B Virus Surface Antigen0.5ml
71340022乙型肝炎病毒e抗原国家标准品National standard for hepatitis B virus e antigen0.5ml
72340024柯萨奇病毒A16型核酸检测试剂国家参考品Coxsackie virus A16 nucleic acid detection reagent national reference0.5ml
73340025乙型肝炎病毒核心IgM抗体国家参考品National Reference Material for Hepatitis B Virus Core IgM Antibody22 支/套
74340026丙型肝炎病毒基因分型(6a型)国家标准品National Standard for Hepatitis C Virus Genotyping (Type 6a)0.5ml
75340027丙型肝炎病毒基因分型(3a型)国家标准品National Standard for Hepatitis C Virus Genotyping (Type 3a)0.5mL
76340028*丙型肝炎病毒基因分型(4型)国家标准品*National standard for hepatitis C virus genotyping (type 4)
77340029*丙型肝炎病毒基因分型(5型)国家标准品*National standard for hepatitis C virus genotyping (type 5)
78340030甲型肝炎病毒IgM抗体国家参考品National Reference Material for Hepatitis A Virus IgM Antibody0.3ml
79340031甲型肝炎病毒IgG抗体国家参考品National Reference Material for Hepatitis A Virus IgG Antibody0.3ml
80340033乙型肝炎病毒pre-s1抗原国家参考品National Reference Material for Hepatitis B Virus Pre-s1 Antigen17 支/套
81340034乙型肝炎病毒pre-s2抗原国家参考品National Reference Material for Hepatitis B Virus Pre-s2 Antigen0.5ml,17支/套
82340035乙型肝炎病毒e抗体国家标准品National standard for hepatitis B virus e antibody0.5ml
83340036乙型肝炎病毒核心抗体国家标准品National standard of hepatitis B virus core antibody0.5ml
84360002人乳头瘤病毒 L1 基因分型参考品Human papillomavirus L1 genotyping reference0
85360004巨细胞病毒IgG抗体国家参考品National Reference Material for Cytomegalovirus IgG Antibody21 支;500ul
86360005风疹病毒IgG抗体国家参考品National Reference Material for Rubella Virus IgG Antibody16 支;500ul,
87360006风疹病毒IgM抗体国家参考品National Reference Material for Rubella Virus IgM Antibody22 支;500ul,
88360007测序仪性能评价用脱氧核糖核酸国家参考品Deoxyribonucleic acid national reference material for sequencer performance evaluation12 支/套
89360008高通量测序用外周血胎儿染色体非整倍体(T21、T18和T13)国家参考品National reference material for fetal chromosomal aneuploidy (T21, T18 and T13) in peripheral blood for high-throughput sequencing227 支/套
90360010胚胎植入前染色体非整倍体国家参考品National reference material for preimplantation chromosomal aneuploidy89 支/套,2.5μl
91360011胰岛素样生长因子-1(IGF-1)国家标准品Insulin-like growth factor-1 (IGF-1) national standard0.5ml
92360012尿素,尿酸总蛋白国家标准品Urea, the national standard of total uric acid protein0.5ml
93360013耳聋基因突变检测国家参考品National Reference Material for Deafness Gene Mutation Detection23 支/套
94360014地中海贫血核酸检测国家参考品National Reference Material for Thalassemia Nucleic Acid Detection32 份/套
95360016BRCA基因突变检测国家参考品National Reference Material for BRCA Gene Mutation Detection20ul,25支/套
96360017抗D(IgM)血型定型试剂效价测定用国家参考品National reference material for determination of anti-D (IgM) blood typing reagent potency1mL
97360018锂、钠、钾、镁、钙、氯复合电解质冰冻人血清国家标准品Lithium, sodium, potassium, magnesium, calcium, chlorine compound electrolyte frozen human serum national standard0.5ml,3支/套
98360019户尘螨过敏原特异性IgE抗体血清国家参考品House dust mite allergen-specific IgE antibody serum national reference material0.5mL
99360020艾蒿花粉过敏原特异性IgE抗体血清国家参考品Mugwort pollen allergen-specific IgE antibody serum national reference material0.5mL
100360021抗C(IgM)血型定型试剂效价测定用国家参考品National reference material for determination of anti-C (IgM) blood typing reagent potency1.0mL
101360022冻干型人T/B/NK淋巴细胞国家参考品(流式细胞法)Freeze-dried human T/B/NK lymphocyte national reference material (flow cytometry)1ml
102360023脆性X综合征FMR1基因核酸检测国家参考品Fragile X syndrome FMR1 gene nucleic acid test national reference material21 份/套
103360024染色体拷贝数变异检测国家参考品National Reference Material for Chromosome Copy Number Variation Detection43 支/套
104360025基于SNP检测方法的胎儿染色体非整倍体(21三体、18三体和13三体)国家参考品National reference material for fetal chromosomal aneuploidy (trisomy 21, trisomy 18 and trisomy 13) based on SNP detection method104 支/套
105360027胚胎植入前地中海贫血诊断国家参考品National Reference Material for Preimplantation Thalassemia Diagnosis20 支/套
106360028微卫星不稳定性(MSI)检测国家参考品National Reference Material for Microsatellite Instability (MSI) Testing62 支/套
107360029新生儿筛查氨基酸和肉碱干血片国家标准品National Standards for Amino Acid and Carnitine Dry Blood Tablets for Newborn Screening5 套/袋
108360030葡萄糖-6-磷酸脱氢酶(G6PD)基因突变检测国家参考品Glucose-6-phosphate dehydrogenase (G6PD) gene mutation detection national reference material30 支/套
109360033总胆红的素冰冻人血清国家标准品Total Bilirubin Frozen Human Serum National Standard0.5ml
110360034睾酮冰冻人血清国家标准品National Standard of Testosterone Frozen Human Serum0.5ml
111360035人类白细胞抗原B27核酸检测国家参考品National Reference Material for Human Leukocyte Antigen B27 Nucleic Acid Detection0
112360036人类白细胞抗原B5801/5701/1502核酸检测国家参考品Human leukocyte antigen B5801/5701/1502 nucleic acid detection national reference material0
113360037血浆ctDNA   KRAS/NRAS/EGFR/ BRAF/MET基因突变检测国家参考品Plasma ctDNA KRAS/NRAS/EGFR/BRAF/MET gene mutation detection national reference material4.2mL
114360038长读长测序平台结构变异检测单体型国家参考品Long-read sequencing platform structural variation detection haplotype national reference
115360040第二代EGFR/MET/ALK基因突变检测国家参考品The second-generation EGFR/MET/ALK gene mutation detection national reference product93 支/套
116360041第二代KRAS/NRAS/BRAF/PI3KCA基因突变检测国家参考品The second-generation KRAS/NRAS/BRAF/PI3KCA gene mutation detection national reference product55 支/套
117360042肿瘤突变负荷检测国家参考品National Reference Material for Tumor Mutation Burden Testing60 支/套
118370002EB病毒衣壳抗原IgA抗体国家参考品EB virus capsid antigen IgA antibody national reference26 支/套
119370003甲型流感病毒抗原检测试剂国家参考品National Reference Material for Influenza A Virus Antigen Detection Reagent0.5ml,24支
120370004乙型流感病毒抗原检测试剂国家参考品National Reference Material for Influenza B Virus Antigen Detection Reagent0.5ml,23支
121370005人细小病毒B19核酸检测试剂国家参考品National Reference Material of Human Parvovirus B19 Nucleic Acid Detection Reagent1mL,26支
122370007第二代甲/乙型流感病毒核酸检测试剂国家参考品The second generation influenza A/B virus nucleic acid detection reagent national reference product0
123370009人细小病毒B19IgG抗体检测试剂国家参考品National Reference Material for Human Parvovirus B19IgG Antibody Detection Reagent
124370010扎伊尔型埃博拉病毒核酸检测试剂国家参考品National Reference Material for Zaire Ebola Virus Nucleic Acid Detection Reagent
125370013甲/乙型流感病毒抗原检测试剂国家参考品National Reference Material for Influenza A/B Antigen Detection Reagent0.5ml,23支/套
126370015单纯疱疹病毒1型IgG抗体检测试剂国家参考品National Reference Material for Herpes Simplex Virus Type 1 IgG Antibody Detection Reagent
127370016单纯疱疹病毒2型IgG抗体检测试剂国家参考品National Reference Material for Herpes Simplex Virus Type 2 IgG Antibody Detection Reagent18 支;500ul,1
128370017肠道病毒EV71型核酸检测试剂国家参考品Enterovirus EV71 nucleic acid detection reagent national reference material0.5ml
129370018水痘带状疱疹病毒IgG抗体检测试剂国家参考品National Reference Material for Varicella-Zoster Virus IgG Antibody Detection Reagent
130370019寨卡病毒的核酸检测试剂国家参考品National Reference Material of Zika Virus Nucleic Acid Detection Reagent0
131370020季节性流感病毒H3亚型核酸检测试剂国家参考品National Reference Material of Seasonal Influenza Virus H3 Subtype Nucleic Acid Detection Reagent0
132370021肺炎衣原体IgG抗体检测试剂国家参考品National Reference Material for Chlamydia Pneumoniae IgG Antibody Detection Reagent10 支
133370022ABO反定型血型类诊断试剂特异性项目用国家参考品National reference material for ABO anti-typing blood group diagnostic reagent specific project0.5mL,4支
134370023人细小病毒B19核酸检测试剂国家标准品National standard of human parvovirus B19 nucleic acid detection reagent1mL,8支
13537002634种细菌和真菌感染多重核酸检测试剂国家参考品34 national reference materials for multiple nucleic acid detection reagents for bacterial and fungal infections0.2ml
136370027抗人球蛋白试剂(抗C3d)国家参考品Anti-human globulin reagent (anti-C3d) national reference400μL,1支
137370028抗人球蛋白试剂(抗IgG)国家参考品Anti-human globulin reagent (anti-IgG) national reference500μL,1支
138370029抗人球蛋白试剂(抗IgG+C3d)国家参考品Anti-human globulin reagent (anti-IgG+C3d) national reference500μL,1支
139370030*B族链球菌核酸检测试剂国家参考品*National reference material for nucleic acid detection reagents of group B streptococcus
140370033登革病毒核酸检测试剂国家参考品National Reference Material for Dengue Virus Nucleic Acid Detection Reagent12 支,0.5ml
141370034单纯疱疹病毒1+2型IgG抗体检测试剂国家参考品National Reference Material for Herpes Simplex Virus Type 1+2 IgG Antibody Detection Reagent18 支;500ul,
142370035梅毒螺旋体抗体快速试剂国家参考品Treponema pallidum antibody rapid reagent national reference material33 支;1000μl
143370036梅毒螺旋体抗体国家参考品(化学发光法)Treponema pallidum antibody national reference product (chemiluminescence method)34 支;1000μl
144370037中东呼吸综合征冠状病毒核酸检测试剂国家参考品National Reference Material for Middle East Respiratory Syndrome Coronavirus Nucleic Acid Detection Reagent
145370038*艰难梭菌及其毒素A和B基因核酸检测试剂国家参考品*Clostridium difficile and its toxin A and B gene nucleic acid detection reagent national reference material
146370040*EB病毒核酸检测试剂国家标准品*National standard of EB virus nucleic acid detection reagent
147370041梅毒非特异性抗体诊断试剂国家参考品National Reference Materials for Syphilis Non-specific Antibody Diagnostic Reagents50 支/套,200μl
148370042马尔堡病毒核酸检测试剂国家参考品National Reference Material of Marburg Virus Nucleic Acid Detection Reagent
149370043结核抗体检测试剂(酶联免疫法)国家参考品Tuberculosis antibody detection reagent (enzyme-linked immunoassay) national reference material400ul
150370044结核抗原检测试剂国家参考品National Reference Materials for Tuberculosis Antigen Detection Reagents
151370045人类免疫缺陷病毒抗体国家参考品National Reference Material for Human Immunodeficiency Virus Antibody48 支;2000μl
152370046第二代人脲原体核酸检测国家参考品National Reference Material for Second Generation Human Ureaplasma Nucleic Acid Detection0
153370048梅毒螺旋体抗体国家参考品(凝集法)Treponema pallidum antibody national reference material (agglutination method)
154370050第二代人感染H7N9禽流的感病毒核酸检测试剂国家参考品The second generation human infection H7N9 avian influenza virus nucleic acid detection reagent national reference material2.5mL,1支
155370051第二代甲型流感病毒核酸检测试剂国家参考品National Reference Material of Second Generation Influenza A Virus Nucleic Acid Detection Reagent0
156370052第二代乙型流感病毒核酸检测试剂国家参考品National Reference Material of Second Generation Influenza B Virus Nucleic Acid Detection Reagent0
157370054第二代甲型H1N1流感病毒核酸检测试剂国家参考品The second generation influenza A H1N1 influenza virus nucleic acid detection reagent national reference product0
158370060第二代人乳头瘤病毒全基因组分型国家参考品The second-generation human papillomavirus complete genotype national reference material
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178220011SARS病毒抗体(总抗体或IgG)国家参考品SARS virus antibody (total antibody or IgG) national reference material46 支/套
179370093新型的冠状病毒IgM抗体检测试剂(酶免法/化学发光法)国家参考品SARS-CoV-2 IgM antibody detection reagent (enzyme immunoassay/chemiluminescence method) national reference
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