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Volumn 12, Issue 2, 2010, Pages 133-143

International standards and reference materials for quantitative molecular infectious disease testing

Author keywords

[No Author keywords available]

Indexed keywords

VIRUS DNA; VIRUS RNA;

EID: 77649109592     PISSN: 15251578     EISSN: None     Source Type: Journal    
DOI: 10.2353/jmoldx.2010.090067     Document Type: Review
Times cited : (65)

References (45)
  • 3
    • 34247216563 scopus 로고    scopus 로고
    • Hepatitis C Working Party. Asian Pacific Association for the Study of the Liver consensus statements on the diagnosis, management and treatment of hepatitis C virus infection
    • Asian Pacific Association for the Study of the Liver APASL
    • Asian Pacific Association for the Study of the Liver (APASL) Hepatitis C Working Party. Asian Pacific Association for the Study of the Liver consensus statements on the diagnosis, management and treatment of hepatitis C virus infection. J Gastroenterol Hepatol 2007, 22:615-633
    • (2007) J Gastroenterol Hepatol , vol.22 , pp. 615-633
  • 7
    • 0036701609 scopus 로고    scopus 로고
    • External quality assessment program for qualitative and quantitative detection of hepatitis C virus RNA in diagnostic virology
    • Schirm J, van Loon AM, Valetnine-Thon E, Klapper P, Reid J, Cleator G: External quality assessment program for qualitative and quantitative detection of hepatitis C virus RNA in diagnostic virology. J Clin Microbiol 2002, 40:2973-2980
    • (2002) J Clin Microbiol , vol.40 , pp. 2973-2980
    • Schirm, J.1    van Loon, A.M.2    Valetnine-Thon, E.3    Klapper, P.4    Reid, J.5    Cleator, G.6
  • 9
    • 85031332369 scopus 로고    scopus 로고
    • Quantitative Molecular Methods for Infectious Diseases; Approved Guideline
    • Clinical and Laboratory Standards Institute:, Wayne, PA, Clinical and Laboratory Standards Institute
    • Clinical and Laboratory Standards Institute: Quantitative Molecular Methods for Infectious Diseases; Approved Guideline. CLSI Document MM6-A. Wayne, PA, Clinical and Laboratory Standards Institute, 2003, p 30
    • (2003) CLSI Document MM6-A , pp. 30
  • 10
    • 61949329115 scopus 로고    scopus 로고
    • Recommendations for the Preparation, Characterization and Establishment of International and Other Biological Reference Standards (revised 2004). WHO Technical Report Series, No. 932. Geneva
    • World Health Organization
    • World Health Organization: Annex Ii Recommendations for the Preparation, Characterization and Establishment of International and Other Biological Reference Standards (revised 2004). WHO Technical Report Series, No. 932. Geneva, World Health Organization, 2006, p 80
    • (2006) World Health Organization , pp. 80
    • Annex, I.1
  • 12
    • 17144384424 scopus 로고    scopus 로고
    • World Health Organization collaborative study to establish a replacement WHO international standard for hepatitis C virus RNA nucleic acid amplification technology assays
    • Saldanha J, Heath A, Aberham C, Albrecht J, Gentili G, Gessner M, Pisani G: World Health Organization collaborative study to establish a replacement WHO international standard for hepatitis C virus RNA nucleic acid amplification technology assays. Vox Sang 2005, 88:202-204
    • (2005) Vox Sang , vol.88 , pp. 202-204
    • Saldanha, J.1    Heath, A.2    Aberham, C.3    Albrecht, J.4    Gentili, G.5    Gessner, M.6    Pisani, G.7
  • 13
    • 85031343594 scopus 로고    scopus 로고
    • Baylis SA, Heath AB, Collaborative Study Group: WHO collaborative study to establish a replacement WHO international standard for hepatitis C virus RNA nucleic acid amplification technology (NAT)-based assays, BS07.2055. Geneva, World Health Organization, 2007
    • Baylis SA, Heath AB, Collaborative Study Group: WHO collaborative study to establish a replacement WHO international standard for hepatitis C virus RNA nucleic acid amplification technology (NAT)-based assays, BS07.2055. Geneva, World Health Organization, 2007
  • 14
    • 0038328958 scopus 로고    scopus 로고
    • Collaborative study to calibrate hepatitis C virus genotypes 2-6 against the HCV international standard 96/790 (genotype 1)
    • Collaborative Study Group
    • Saldanha J, Heath A, Lelie N, Collaborative Study Group: Collaborative study to calibrate hepatitis C virus genotypes 2-6 against the HCV international standard 96/790 (genotype 1). Vox Sang 2003, 84:20-27
    • (2003) Vox Sang , vol.84 , pp. 20-27
    • Saldanha, J.1    Heath, A.2    Lelie, N.3
  • 15
    • 0033940714 scopus 로고    scopus 로고
    • Calibration of HCV working reagents for NAT assays against the HCV international standard
    • Collaborative Study Group
    • Saldanha J, Heath A, Lelie N, Pisani G, Nubling M, Yu R, Collaborative Study Group: Calibration of HCV working reagents for NAT assays against the HCV international standard. Vox Sang 2000, 78:217-224
    • (2000) Vox Sang , vol.78 , pp. 217-224
    • Saldanha, J.1    Heath, A.2    Lelie, N.3    Pisani, G.4    Nubling, M.5    Yu, R.6
  • 16
    • 0033495684 scopus 로고    scopus 로고
    • Standardization: A progress report
    • Saldanha J: Standardization: a progress report. Biologicals 1999, 27:285-289
    • (1999) Biologicals , vol.27 , pp. 285-289
    • Saldanha, J.1
  • 17
    • 0035162246 scopus 로고    scopus 로고
    • Validation and standardization of nucleic acid amplification technology (NAT) assays for the detection of viral contamination of blood and blood products
    • Saldanha J: Validation and standardization of nucleic acid amplification technology (NAT) assays for the detection of viral contamination of blood and blood products. J Clin Virol 2001, 20:7-13
    • (2001) J Clin Virol , vol.20 , pp. 7-13
    • Saldanha, J.1
  • 18
    • 0035117408 scopus 로고    scopus 로고
    • Holmes H, Davis C, Heath A, Hewlett I, Lelie N: An international collaborative study to establish the 1st international standard for HIV-1 RNA for use in nucleic acid-based techniques. J Virol Methods 2001, 92:141-150
    • Holmes H, Davis C, Heath A, Hewlett I, Lelie N: An international collaborative study to establish the 1st international standard for HIV-1 RNA for use in nucleic acid-based techniques. J Virol Methods 2001, 92:141-150
  • 19
    • 0035240915 scopus 로고    scopus 로고
    • An international collaborative study to establish a World Health Organization international standard for hepatitis B virus DNA nucleic acid amplification techniques
    • WHO Collaborative Study Group
    • Saldanha J, Gerlach W, Lelie N, Dawson P, Heerman K, Health A, WHO Collaborative Study Group: An international collaborative study to establish a World Health Organization international standard for hepatitis B virus DNA nucleic acid amplification techniques. Vox Sang 2001, 80:63-71
    • (2001) Vox Sang , vol.80 , pp. 63-71
    • Saldanha, J.1    Gerlach, W.2    Lelie, N.3    Dawson, P.4    Heerman, K.5    Health, A.6
  • 20
    • 20544464818 scopus 로고    scopus 로고
    • A World Health Organization International Standard for hepatitis A virus RNA nucleic acid amplification technology assays
    • Collaborative Study Group
    • Saldanha J, Heath A, Lelie N, Pisani G, Yu MY, Collaborative Study Group: A World Health Organization International Standard for hepatitis A virus RNA nucleic acid amplification technology assays. Vox Sang 2005, 89:52-58
    • (2005) Vox Sang , vol.89 , pp. 52-58
    • Saldanha, J.1    Heath, A.2    Lelie, N.3    Pisani, G.4    Yu, M.Y.5
  • 21
    • 0002674151 scopus 로고    scopus 로고
    • Establishment of the first World Health Organization International Standard for human parvovirus B19 DNA nucleic acid amplification techniques
    • B19 Collaborative Study Group
    • Saldanha J, Lelie N, Yu MW, B19 Collaborative Study Group: Establishment of the first World Health Organization International Standard for human parvovirus B19 DNA nucleic acid amplification techniques. Vox Sang 2002, 82:24-31
    • (2002) Vox Sang , vol.82 , pp. 24-31
    • Saldanha, J.1    Lelie, N.2    Yu, M.W.3
  • 22
    • 85031339725 scopus 로고    scopus 로고
    • Wilkinson DE, Heath AB, Ferguson M, World Health Organization Human Papillomavirus DNA International Collaborative Study Group: WHO collaborative study to establish WHO international standards for human papillomavirus type 16 DNA and type 18 DNA nucleic acid amplification technology (NAT)-based assays. Int J Cancer, 2009 [Epub PMID: 19904756]
    • Wilkinson DE, Heath AB, Ferguson M, World Health Organization Human Papillomavirus DNA International Collaborative Study Group: WHO collaborative study to establish WHO international standards for human papillomavirus type 16 DNA and type 18 DNA nucleic acid amplification technology (NAT)-based assays. Int J Cancer, 2009 [Epub PMID: 19904756]
  • 23
    • 50049094308 scopus 로고    scopus 로고
    • Establishment of the 1st World Health Organization International Standard for Plasmodium falciparum DNA for nucleic acid amplification technique (NAT)-based assays
    • Collaborative Study Group
    • Padley D, Heath A, Sutherland A, Chiodini PL, Baylis S, Collaborative Study Group: Establishment of the 1st World Health Organization International Standard for Plasmodium falciparum DNA for nucleic acid amplification technique (NAT)-based assays. Malar J 2008, 7:139-147
    • (2008) Malar J , vol.7 , pp. 139-147
    • Padley, D.1    Heath, A.2    Sutherland, A.3    Chiodini, P.L.4    Baylis, S.5
  • 25
    • 77649147057 scopus 로고    scopus 로고
    • Ideal design characteristics of international standards for quantification of viruses. WHO Consultation on International Standards for in Vitro Clinical Diagnostics Procedures Based on Nucleic Acid Techniques (NAT). Geneva
    • Hendricks DA: Ideal design characteristics of international standards for quantification of viruses. WHO Consultation on International Standards for in Vitro Clinical Diagnostics Procedures Based on Nucleic Acid Techniques (NAT). Geneva, World Health Organization, 2002, 4-5
    • (2002) World Health Organization , pp. 4-5
    • Hendricks, D.A.1
  • 26
    • 33746216127 scopus 로고    scopus 로고
    • Real-time PCR assays for hepatitis C virus (HCV) RNA quantification are adequate for clinical management of patients with chronic HCV infection
    • Halfon P, Bourliere M, Penaranda G, Khiri H, Ouzan D: Real-time PCR assays for hepatitis C virus (HCV) RNA quantification are adequate for clinical management of patients with chronic HCV infection. J Clin Microbiol 2006, 44:2507-2511
    • (2006) J Clin Microbiol , vol.44 , pp. 2507-2511
    • Halfon, P.1    Bourliere, M.2    Penaranda, G.3    Khiri, H.4    Ouzan, D.5
  • 27
    • 15444367855 scopus 로고    scopus 로고
    • Evaluation of automated sample preparation and quantitative PCR LCx assay for determination of human immunodeficiency virus type 1 RNA
    • Muller Z, Stelzl E, Bozic M, Haas J, March E, Kessler HH: Evaluation of automated sample preparation and quantitative PCR LCx assay for determination of human immunodeficiency virus type 1 RNA. J Clin Microbiol 2004, 42:1439-1443
    • (2004) J Clin Microbiol , vol.42 , pp. 1439-1443
    • Muller, Z.1    Stelzl, E.2    Bozic, M.3    Haas, J.4    March, E.5    Kessler, H.H.6
  • 32
    • 0034046010 scopus 로고    scopus 로고
    • Comparison of quantitative cytomegalovirus (CMV) PCR in plasma and CMV antigenemia assay: Clinical utility of the prototype Amplicor CMV monitor test in transplant recipients
    • Caliendo AM, St. George K, Kao S-Y, Allega J, Tan B-H, LaFontaine R, Bui L, Rinaldo CR: Comparison of quantitative cytomegalovirus (CMV) PCR in plasma and CMV antigenemia assay: clinical utility of the prototype Amplicor CMV monitor test in transplant recipients. J Clin Microbiol 2000, 3:2122-2127
    • (2000) J Clin Microbiol , vol.3 , pp. 2122-2127
    • Caliendo, A.M.1    St. George, K.2    Kao, S.-Y.3    Allega, J.4    Tan, B.-H.5    LaFontaine, R.6    Bui, L.7    Rinaldo, C.R.8
  • 33
    • 26944441263 scopus 로고    scopus 로고
    • Sequence diversity in the glycoprotein B gene complicates real-time PCR assays for detection and quantification of cytomegalovirus
    • Nye MB, Leman AR, Meyer ME, Menegus MA, Rothberg PG: Sequence diversity in the glycoprotein B gene complicates real-time PCR assays for detection and quantification of cytomegalovirus. J Clin Microbiol 2005, 43:4968-4971
    • (2005) J Clin Microbiol , vol.43 , pp. 4968-4971
    • Nye, M.B.1    Leman, A.R.2    Meyer, M.E.3    Menegus, M.A.4    Rothberg, P.G.5
  • 34
    • 33947195011 scopus 로고    scopus 로고
    • Real-time PCR diagnostics failure caused by nucleotide variability within exon 4 of the human cytomegalovirus major immediate-early gene
    • Lengerova M, Racil Z, Volfova P, Lochmanova J, Berkovcova J, Dvorakava D, Vorlicek J, Mayer J: Real-time PCR diagnostics failure caused by nucleotide variability within exon 4 of the human cytomegalovirus major immediate-early gene. J Clin Microbiol 2007, 45:1042-1044
    • (2007) J Clin Microbiol , vol.45 , pp. 1042-1044
    • Lengerova, M.1    Racil, Z.2    Volfova, P.3    Lochmanova, J.4    Berkovcova, J.5    Dvorakava, D.6    Vorlicek, J.7    Mayer, J.8
  • 36
    • 0035132107 scopus 로고    scopus 로고
    • Human cytomegalovirus with IE-2 (UL122) deleted fails to express early lytic genes
    • Marchini A, Liu H, Zhu H: Human cytomegalovirus with IE-2 (UL122) deleted fails to express early lytic genes. J. Virol 2001, 75:1870-1878
    • (2001) J. Virol , vol.75 , pp. 1870-1878
    • Marchini, A.1    Liu, H.2    Zhu, H.3
  • 37
    • 4644368841 scopus 로고    scopus 로고
    • Coupling generation of cytomegalovirus deletion mutants and amplification of viral BAC clones
    • Wang W, Patterson CE, Yang S, Zhu H: Coupling generation of cytomegalovirus deletion mutants and amplification of viral BAC clones. J Virol Methods 2004, 121:137-143
    • (2004) J Virol Methods , vol.121 , pp. 137-143
    • Wang, W.1    Patterson, C.E.2    Yang, S.3    Zhu, H.4
  • 38
    • 0018741734 scopus 로고
    • DNA of human cytomegalovirus size heterogeneity and defectiveness resulting from serial undiluted passage
    • Stinski MF, Mocarski ES, Thomsen DR: DNA of human cytomegalovirus size heterogeneity and defectiveness resulting from serial undiluted passage. J Virol 1979, 31:231-239
    • (1979) J Virol , vol.31 , pp. 231-239
    • Stinski, M.F.1    Mocarski, E.S.2    Thomsen, D.R.3
  • 39
    • 33847177656 scopus 로고    scopus 로고
    • Traceable phosphorus measurements by ICP-OES and HPLC for the quantification of DNA
    • Holden MJ, Rabb SA, Tewari YB, Winchester MR: Traceable phosphorus measurements by ICP-OES and HPLC for the quantification of DNA. Anal Chem 2007, 79:1536-1541
    • (2007) Anal Chem , vol.79 , pp. 1536-1541
    • Holden, M.J.1    Rabb, S.A.2    Tewari, Y.B.3    Winchester, M.R.4
  • 40
    • 85031331479 scopus 로고    scopus 로고
    • International Standards Organization: In vitro diagnostic medical devices - measurement of quantities in samples of biological origin. Presentation of reference measurement procedures. ISO Document 15193. Geneva, International Standards Organization, 2002, 9-16
    • International Standards Organization: In vitro diagnostic medical devices - measurement of quantities in samples of biological origin. Presentation of reference measurement procedures. ISO Document 15193. Geneva, International Standards Organization, 2002, 9-16
  • 41
    • 4344560226 scopus 로고    scopus 로고
    • In vitro diagnostic medical devices - ;Measurement of quantities in samples of biological origin
    • International Standards Organization:, Geneva, International Standards Organization
    • International Standards Organization: In vitro diagnostic medical devices - ;Measurement of quantities in samples of biological origin. Description of reference materials. ISO Document 15194. Geneva, International Standards Organization, 2002
    • (2002) Description of reference materials. ISO Document , pp. 15194
  • 42
    • 59949097450 scopus 로고    scopus 로고
    • The Joint Committee for Traceability in Laboratory Medicine (JCTLM): A global approach to promote the standardization of clinical laboratory test results
    • Armbruster D, Miller RR: The Joint Committee for Traceability in Laboratory Medicine (JCTLM): a global approach to promote the standardization of clinical laboratory test results. Clin Biochem Rev 2007, 28:105-113
    • (2007) Clin Biochem Rev , vol.28 , pp. 105-113
    • Armbruster, D.1    Miller, R.R.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.