Clinical Chemistry Link to Randox Laboratories Web Site
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
QUICK SEARCH:   [advanced]


     

Clinical Chemistry 44: 12-26, 1998;
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Submit an electronic Letter to
the Editor about this paper
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via ISI Web of Science (58)
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Neumaier, M.
Right arrow Articles by Techniques, B.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Neumaier, M.
Right arrow Articles by Techniques, B.
Related Collections
Right arrow Laboratory Management
Right arrow Molecular Diagnostics and Genetics
(Clinical Chemistry. 1998;44:12-26.)
© 1998 American Association for Clinical Chemistry, Inc.

Special Report

Fundamentals of quality assessment of molecular amplification methods in clinical diagnostics

Michael Neumaier1,1, Andreas Braun2, Christoph Wagener1, for the International Federation of Clinical Chemistry Scientific Division Committee on Molecular, and Biology Techniques

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:


Home page
 Clin. Chem.Home page
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]

Home page
 J. Mol. Diagn.Home page
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]

Home page
 Clin. Chem.Home page
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]

Home page
 Appl. Environ. Microbiol.Home page
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]

Home page
 Clin. Chem.Home page
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]

Home page
 J. Clin. Microbiol.Home page
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]

Home page
 Sex. Transm. Infect.Home page
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]

Home page
 Clin. Chem.Home page
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]

Home page
 Clin. Chem.Home page
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]

Home page
 Mol. Pathol.Home page
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]

Home page
 Mol Hum ReprodHome page
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]

Home page
 Hum ReprodHome page
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]

Home page
 Clin. Chem.Home page
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]

Home page
 Clin. Chem.Home page
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]

Home page
 Arterioscler. Thromb. Vasc. Bio.Home page
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]

Home page
 Clin. Chem.Home page
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]

Home page
 Clin. Chem.Home page
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]


HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Copyright © 1998 by the American Association for Clinical Chemistry.