核酸标准物质研究现状

Abstract

Abstract: Molecular diagnostics based on nucleic acid amplification technology (NAT) were widely used in medical research, inspection and quarantine, disease diagnosis and other fields, available reference materials for NAT assays were critical to ensure the diagnostic test data and the results were accurate and consistency. This article described the development history, current situation and challenges of nucleic acid reference materials, and prospected for the future direction of development of nucleic acid standard materials.

Key words: nucleic acid reference materials; nucleic acid amplification technology; molecular diagnosis

CLC Number:

YUAN Lin, HAN Tao, ZHAI Xin-yan. Research Status of Nucleic Acid Reference Materials[J]. , 2014, 41(11): 89-92.

References

1 王露楠,吴健民.丙型肝炎病毒核酸检测的国家标准物质的研制[J].中华检验医学杂,2006,29(4):354～357.
2 叶子弘,赵煦泓,邹克琴,等.生物标准物质研究简析[J].化学计量与分析技术,2009,4:67～69.
3 吴亚琼,高志强,吴延功,等.亚洲Ⅰ型口蹄疫病毒核酸检测标准物质的制备研究[J].中国兽医杂志,2012,48(8):8～12.
4 张洁.生物标准物质的制备、发展及管理[J].中国生物制品学杂志,2007,20(8):630～632.
5 张桂山,徐晶,娄玉杰,等.小尾寒羊瘦素长型受体基因实时荧光定量PCR标准品质粒和标准曲线的构建[J].中国畜牧兽医,2014,41(3):111～114.
6 谷强,张伟,高志强,等.新城疫病毒核酸检测标准物质研究[J].中国动物检疫,2012,29(11):40～43.
7 俞晓平,叶子弘,蒋家新,等.生物计量及其在检验检疫中的应用研究[J]. 中国计量学院学报,2008,19(4):289～295.
8 高尚,先黄杰.体外诊断试剂标准物质国内外现状[J].药物分析杂志,2008,7:81～87.
9 Holmes H, Davis C, Heath A, et al.An international collaborative study to establish the 1st international standard for HIV-1 RNA for use in nucleic acid-based techniques[J].J Virol Methods, 2001, 92(2): 141～150.
10 Holmes H, Davis C, Heath A. Development of the 1st international reference panel for HIV-1 RNA genotypes for use in nucleic acid-based techniques[J]. J Virol Methods, 2008, 154(1～2): 86～91.
11 Jacqueline F F, Alan B H, Dianna E W, et al. Collaborative study to evaluate the proposed 1st WHO international standard for human cytomegalovirus (HCMV) for nucleic acid amplification (NAT)-based assays,BS10.2138[S].Geneva, World Health Organization, 2010.
12 Jacqueline F F, Alan B H, Dianna E W, et al. Collaborative study to evaluate the proposed 4th WHO international standard for hepatitis C virus (HCV) for nucleic acid amplification technology (NAT)-based assays,BS2011.2173[S].Geneva,World Health Organization,2011a.
13 Jacqueline F F, Alan B H, Dianna E W, et al. Collaborative study to evaluate the proposed 3rd WHO international standard for hepatitis B virus (HBV) for nucleic acid amplification technology (NAT)-based assays,BS2011.2170[S]. Geneva, World Health Organization, 2011b.
14 Jacqueline F F, Alan B H, Dianna E W, et al. Collaborative study to evaluate the proposed 1st WHO international standard for Epstein-Barr virus (EBV) for nucleic acid amplification technology (NAT)-based assays,BS2011.2172[S]. Geneva,World Health Organization, 2011c.
15 Jacqueline F F, Alan B H, Dianna E W, et al. Collaborative study to evaluate the proposed 3rd WHO international standard for parvovirus B19 (B19V) for nucleic acid amplification technology (NAT)-based assays,BS2013.2224[S]. Geneva,World Health Organization, 2013a.
16 Jacqueline F F, Alan B H, Dianna E W, et al. Collaborative study to evaluate the proposed 2nd WHO international standard for hepatitis A virus (HAV) for nucleic acid amplification technology (NAT)-based assays,BS2013.2225[S]. Geneva, World Health Organization, 2013b.
17 Madej R M, Davis J, Holden M J, et al. International standards and reference materials for quantitative molecular infectious disease testing[J].J Mol Diagn, 2010, 12(2): 133～143.
18 Michael C, Kay-Martin H, Julia K, et al. Collaborative study to establish a World Health Organization international genotype panel for hepatitis B virus nucleic acid amplification technique (NAT)-based assays,BS09.2121[S].Geneva,World Health Organization, 2009.
19 Michael C, Kay-Martin H, Mithat B, et al. Collaborative study to establish a World Health Organization international standard for hepatitis D virus RNA for nucleic acid amplification technique (NAT)-based assays, BS2013.2227[S]. Geneva, World Health Organization, 2013.
20 Morris C L, Heath A B. International collaborative study to establish the 3rd WHO international standard for HIV-1 NAT assays, BS2011.2178[S]. Geneva, World Health Organization, 2011.
21 Morris C L, Wigglesworth E, Heath A B.Report on an international collaborative study to establish the 1st WHO international reference panel for HIV-1 circulating recombinant forms for NAT assays, BS2013.2226[S].Geneva, World Health Organization, 2013.
22 Padley D J, Heath A B, Sutherland C, et al. Establishment of the 1st World Health Organization international standard for Plasmodium falciparum DNA for nucleic acid amplification technique (NAT)-based assays[J]. Malar J, 2008, 7: 139.
23 Saldanha J, Leli N, Heath A, et al. Establishment of the first international standard for nucleic acid amplification technology (NAT) assays for HCV RNA[J].Vox Sang, 1999, 76(3): 149～158.
24 Saldanha J, Gerlich W, Lelie N, et al.An international collaborative study to establish a World Health Organization international standard for hepatitis B virus DNA nucleic acid amplification techniques[J].Vox Sang, 2001, 80(1): 63～71.
25 Saldanha J, Lelie N, Yu M W, et al. Establishment of the first World Health Organization international standard for human parvovirus B19 DNA nucleic acid amplification techniques[J].Vox Sang, 2002, 82(1): 24～31.
26 Saldanha J, Heath A, Lelie N, et al. A World Health Organization international standard for hepatitis A virus RNA nucleic acid amplification technology assays[J].Vox Sang, 2005, 89(1): 52～58.
27 Sally A B, Saeko M, Yoshiaki O, et al. Collaborative study to establish a World Health Organization international standard for hepatitis E virus RNA for nucleic acid amplification technique (NAT)-based assays,BS2011.2175[S]. Geneva, World Health Organization, 2011.
28 Wilkinson D E, Baylis S A, Padley D, et al. Establishment of the 1st World Health Organization international standards for human papillomavirus type 16 DNA and type 18 DNA[J].Int J Cancer, 2010, 126(12): 2969～2983.
29 Yang Y C, Yang-Chih S D, Tsai M H, et al. A collaborative study to establish the first national standard for HIV-1 RNA nucleic acid amplification techniques (NAT) in Taiwan[J]. J Virol Methods, 2013, 191(2): 122～127.

[1]	LIU Ang, CHENG Yiwen, AN Qi, ZHANG Zhenxing, LI Bin, CHEN Jie, CHEN Qiaoling, DU Li, MAN Churiga, WANG Fengyang, CHEN Si. Establishment of a Rapid Diagnostic Method of RPA for Pasteurella multocida from Goat [J]. China Animal Husbandry and Veterinary Medicine, 2021, 48(10): 3752-3760.
[2]	LV Ji-zhou, FAN Yan-ru, FENG Chun-yan, YUAN Xiang-fen, WU Shao-qiang. Establishment of Real-time Recombinase Polymerase Amplification for Detection of Porcine Epidemic Diarrhoea Virus [J]. , 2017, 44(12): 3434-3439.

Research Status of Nucleic Acid Reference Materials

Knowledge

Abstract

Cite this article

share this article

References

Related Articles 2

Recommended Articles

Metrics

Comments