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Special Report |
1
Abteilung für Klinische Chemie, Medizinische Klinik, Universitäts-Krankenhaus Eppendorf, Martinistr. 52, D-20246 Hamburg, Germany.
2
Sequenom, Inc., 11555 Sorrento Valley Rd., San
Diego, CA 92121.
The increasing interest in molecular biology diagnostics is a result of the tremendous gain of scientific knowledge in genetics, made possible especially since the introduction of amplification techniques. High expectations have been placed on genetic testing, and the number of laboratories now using the relevant technology is rapidly increasing—resulting in an obvious need for standardization and definition of laboratory organization. This communication is an effort towards that end. We address aspects that should be considered when structuring a new molecular diagnostic laboratory, and we discuss individual preanalytical and analytical procedures, from sampling to evaluation of assay results. In addition, different means of controlling contamination are discussed. Because the methodology is in constant change, no general standards can be defined. Accordingly, this publication is intended to serve as a recommendation for good laboratory practice and internal quality control and as a guide to troubleshooting, primarily in amplification techniques.
The following articles in journals at HighWire Press have cited this article:
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  E. Vincent, Z. Gu, M. Morgenstern, C. Gibson, J. Pan, and R. T. Hayden Detection of Cytomegalovirus in Whole Blood Using Three Different Real-Time PCR Chemistries J. Mol. Diagn., January 1, 2009; 11(1): 54 - 59. [Abstract] [Full Text] [PDF]
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 A. Di Nicola, E. Ghezzi, F. Gillio, F. Zerilli, E. Shehi, D. Maritano, M. Panizzo, F. Bonelli, and D. Adlerstein Anchor-Based Fluorescent Amplicon Generation Assays (FLAG) for Real-Time Measurement of Human Cytomegalovirus, Epstein-Barr Virus, and Varicella-Zoster Virus Viral Loads Clin. Chem., November 1, 2008; 54(11): 1900 - 1907. [Abstract] [Full Text] [PDF]
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C. Orlando, P. Verderio, R. Maatman, J. Danneberg, S. Ramsden, M. Neumaier, D. Taruscio, V. Falbo, R. Jansen, C. Casini-Raggi, et al. EQUAL-qual: A European Program for External Quality Assessment of Genomic DNA Extraction and PCR Amplification Clin. Chem., July 1, 2007; 53(7): 1349 - 1357. [Abstract] [Full Text] [PDF]
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F. C. Kuo, D. Hall, and J. A. Longtine A Novel Method for Interpretation of T-Cell Receptor {gamma} Gene Rearrangement Assay by Capillary Gel Electrophoresis Based on Normal Distribution J. Mol. Diagn., February 1, 2007; 9(1): 12 - 19. [Abstract] [Full Text] [PDF]
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P. Ahmad-Nejad, A. Dorn-Beineke, U. Pfeiffer, J. Brade, W.-J. Geilenkeuser, S. Ramsden, M. Pazzagli, and M. Neumaier Methodologic European External Quality Assurance for DNA Sequencing: The EQUALseq Program Clin. Chem., April 1, 2006; 52(4): 716 - 727. [Abstract] [Full Text] [PDF]
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 A. Meijer, P. J. M. Roholl, J. M. Ossewaarde, B. Jones, and B. F. Nowak Molecular Evidence for Association of Chlamydiales Bacteria with Epitheliocystis in Leafy Seadragon (Phycodurus eques), Silver Perch (Bidyanus bidyanus), and Barramundi (Lates calcarifer) Appl. Envir. Microbiol., January 1, 2006; 72(1): 284 - 290. [Abstract] [Full Text] [PDF]
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L. Birch, C. A. English, M. Burns, and J. T. Keer Generic Scheme for Independent Performance Assessment in the Molecular Biology Laboratory Clin. Chem., September 1, 2004; 50(9): 1553 - 1559. [Abstract] [Full Text] [PDF]
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 C. N. Bernstein, G. Nayar, A. Hamel, and J. F. Blanchard Study of Animal-Borne Infections in the Mucosas of Patients with Inflammatory Bowel Disease and Population-Based Controls J. Clin. Microbiol., November 1, 2003; 41(11): 4986 - 4990. [Abstract] [Full Text] [PDF]
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 T Crucitti, E Van Dyck, A Tehe, S Abdellati, B Vuylsteke, A Buve, and M Laga Comparison of culture and different PCR assays for detection of Trichomonas vaginalis in self collected vaginal swab specimens Sex Transm Inf, October 1, 2003; 79(5): 393 - 398. [Abstract] [Full Text] [PDF]
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D. Schoder, A. Schmalwieser, G. Schauberger, M. Kuhn, J. Hoorfar, and M. Wagner Physical Characteristics of Six New Thermocyclers Clin. Chem., June 1, 2003; 49(6): 960 - 963. [Full Text] [PDF]
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C. C. Raggi, P. Pinzani, A. Paradiso, M. Pazzagli, and C. Orlando External Quality Assurance Program for PCR Amplification of Genomic DNA: An Italian Experience Clin. Chem., May 1, 2003; 49(5): 782 - 791. [Abstract] [Full Text] [PDF]
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 F A Vlems, J H S Diepstra, I M H A Cornelissen, T J M Ruers, M J L Ligtenberg, C J A Punt, J H J M van Krieken, T. Wobbes, and G N P van Muijen Limitations of cytokeratin 20 RT-PCR to detect disseminated tumour cells in blood and bone marrow of patients with colorectal cancer: expression in controls and downregulation in tumour tissue Mol. Pathol., June 1, 2002; 55(3): 156 - 163. [Abstract] [Full Text] [PDF]
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 C. Kamp, K. Huellen, S. Fernandes, M. Sousa, P.N. Schlegel, A. Mielnik, S. Kleiman, H. Yavetz, W. Krause, W. Kupker, et al. High deletion frequency of the complete AZFa sequence in men with Sertoli-cell-only syndrome Mol. Hum. Reprod., October 1, 2001; 7(10): 987 - 994. [Abstract] [Full Text] [PDF]
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 M. Simoni Molecular diagnosis of Y chromosome microdeletions in Europe: state-of-the-art and quality control Hum. Reprod., March 1, 2001; 16(3): 402 - 409. [Abstract] [Full Text] [PDF]
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G. C. Saunders, J. Dukes, H. C. Parkes, and J. H. Cornett Interlaboratory Study on Thermal Cycler Performance in Controlled PCR and Random Amplified Polymorphic DNA Analyses Clin. Chem., January 1, 2001; 47(1): 47 - 55. [Abstract] [Full Text] [PDF]
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D. Ke, C. Menard, F. J. Picard, M. Boissinot, M. Ouellette, P. H. Roy, and M. G. Bergeron Development of Conventional and Real-Time PCR Assays for the Rapid Detection of Group B Streptococci Clin. Chem., March 1, 2000; 46(3): 324 - 331. [Abstract] [Full Text] [PDF]
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 A. Meijer, J. A. van der Vliet, P. J. M. Roholl, S. K. Gielis-Proper, A. de Vries, and J. M. Ossewaarde Chlamydia pneumoniae in Abdominal Aortic Aneurysms : Abundance of Membrane Components in the Absence of Heat Shock Protein 60 and DNA Arterioscler Thromb Vasc Biol, November 1, 1999; 19(11): 2680 - 2686. [Abstract] [Full Text] [PDF]
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M. Ogura, Y. Agata, K. Watanabe, R. M. McCormick, Y. Hamaguchi, Y. Aso, and M. Mitsuhashi RNA chip: quality assessment of RNA by microchannel linear gel electrophoresis in injection-molded plastic chips Clin. Chem., November 1, 1998; 44(11): 2249 - 2255. [Abstract] [Full Text] [PDF]
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Y. Aso, M. Kawamura, Y. Hamaguchi, T. Shioiri, and M. Mitsuhashi Rapid, Stable Ambient Storage of Leukocyte RNA from Whole Blood Clin. Chem., August 1, 1998; 44(8): 1782 - 1783. [Full Text] [PDF]
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