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Clinical Chemistry, Vol 42, 1915-1923, Copyright © 1996 by American Association for Clinical Chemistry
N DiDomenico, H Link, R Knobel, T Caratsch, W Weschler, ZG Loewy and M Rosenstraus
Roche Molecular Systems, Branchburg, NJ 08876, USA.
The COBAS AMPLICOR system automates amplification and detection of target nucleic acids, making diagnostic PCR routine for a variety of infectious diseases. The system contains a single thermal cycler with two independently regulated heating/cooling blocks, an incubator, a magnetic particle washer, a pipettor, and a photometer. Amplified products are captured on oligonucleotide-coated paramagnetic microparticles and detected with use of an avidin-horseradish peroxidase (HRP) conjugate. Concentrated solutions of amplicon or HRP were pipetted without detectable carryover. Amplified DNA was detected with an intraassay CV of < 4.5%; the combined intraassay CV for amplification and detection was < 15%. No cross-reactivity was observed when three different target nucleic acids were amplified in a single reaction and detected with three target-specific capture probes. The initial COBAS AMPLICOR menu includes qualitative tests for diagnosing infections with Chlamydia trachomatis, Neisseria gonorrhoeae, Mycobacterium tuberculosis, and hepatitis C virus. All tests include an optional Internal Control to provide assurance that specimens are successfully amplified and detected.
The following articles in journals at HighWire Press have cited this article:
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  L. Romano, C. Velati, L. Baruffi, L. Fomiatti, G. Colucci, A. R. Zanetti, and the Italian Group for the Study of Transfusion Tra Multicenter Evaluation of a Semiautomated, Standardized Assay for Detection of Hepatitis B Virus DNA in Blood Donations J. Clin. Microbiol., June 1, 2005; 43(6): 2991 - 2993. [Abstract] [Full Text] [PDF]
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V. Leb, M. Stocher, E. Valentine-Thon, G. Holzl, H. Kessler, H. Stekel, and J. Berg Fully Automated, Internally Controlled Quantification of Hepatitis B Virus DNA by Real-Time PCR by Use of the MagNA Pure LC and LightCycler Instruments J. Clin. Microbiol., February 1, 2004; 42(2): 585 - 590. [Abstract] [Full Text] [PDF]
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J. J. Germer, M. M. Lins, M. E. Jensen, W. S. Harmsen, D. M. Ilstrup, P. S. Mitchell, F. R. Cockerill III, and R. Patel Evaluation of the MagNA Pure LC Instrument for Extraction of Hepatitis C Virus RNA for the COBAS AMPLICOR Hepatitis C Virus Test, Version 2.0 J. Clin. Microbiol., August 1, 2003; 41(8): 3503 - 3508. [Abstract] [Full Text] [PDF]
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S. Honore-Bouakline, J. P. Vincensini, V. Giacuzzo, P. H. Lagrange, and J. L. Herrmann Rapid Diagnosis of Extrapulmonary Tuberculosis by PCR: Impact of Sample Preparation and DNA Extraction J. Clin. Microbiol., June 1, 2003; 41(6): 2323 - 2329. [Abstract] [Full Text] [PDF]
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G. Holzl, M. Stocher, V. Leb, H. Stekel, and J. Berg Entirely Automated Quantification of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in Plasma by Using the Ultrasensitive COBAS AMPLICOR HIV-1 Monitor Test and RNA Purification on the MagNA Pure LC Instrument J. Clin. Microbiol., March 1, 2003; 41(3): 1248 - 1251. [Abstract] [Full Text] [PDF]
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F. Betsou, K. Beaumont, J. M. Sueur, and J. Orfila Construction and Evaluation of Internal Control DNA for PCR Amplification of Chlamydia trachomatis DNA from Urine Samples J. Clin. Microbiol., March 1, 2003; 41(3): 1274 - 1276. [Abstract] [Full Text] [PDF]
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H. Miyachi, A. Masukawa, S. Asai, T. Miura, S. Tamatsukuri, T. Hirose, and Y. Ando Quantitative Assay of Hepatitis C Virus RNA Using an Automated Extraction System for Specific Capture with Probes and Paramagnetic Particle Separation J. Clin. Microbiol., February 1, 2003; 41(2): 572 - 575. [Abstract] [Full Text] [PDF]
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M. Stocher and J. Berg Normalized Quantification of Human Cytomegalovirus DNA by Competitive Real-Time PCR on the LightCycler Instrument J. Clin. Microbiol., December 1, 2002; 40(12): 4547 - 4553. [Abstract] [Full Text] [PDF]
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 M. G. Revello and G. Gerna Diagnosis and Management of Human Cytomegalovirus Infection in the Mother, Fetus, and Newborn Infant Clin. Microbiol. Rev., October 1, 2002; 15(4): 680 - 715. [Abstract] [Full Text] [PDF]
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C. M. Black, J. Marrazzo, R. E. Johnson, E. W. Hook III, R. B. Jones, T. A. Green, J. Schachter, W. E. Stamm, G. Bolan, M. E. St. Louis, et al. Head-to-Head Multicenter Comparison of DNA Probe and Nucleic Acid Amplification Tests for Chlamydia trachomatis Infection in Women Performed with an Improved Reference Standard J. Clin. Microbiol., October 1, 2002; 40(10): 3757 - 3763. [Abstract] [Full Text] [PDF]
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V. A. Lopez, E. J. Bourne, M. W. Lutz, and L. D. Condreay Assessment of the COBAS Amplicor HBV Monitor Test for Quantitation of Serum Hepatitis B Virus DNA Levels J. Clin. Microbiol., June 1, 2002; 40(6): 1972 - 1976. [Abstract] [Full Text] [PDF]
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A. Bianchi, F. Moret, J.-M. Desrues, T. Champenois, Y. Dervaux, O. Desvouas, A. Oursin, D. Quinzat, R. Dachez, C. Bathelier, et al. PreservCyt Transport Medium Used for the ThinPrep Pap Test Is a Suitable Medium for Detection of Chlamydia trachomatis by the COBAS Amplicor CT/NG Test: Results of a Preliminary Study and Future Implications J. Clin. Microbiol., May 1, 2002; 40(5): 1749 - 1754. [Abstract] [Full Text] [PDF]
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E. Q. Konnick, M. Erali, E. R. Ashwood, and D. R. Hillyard Performance Characteristics of the COBAS Amplicor Hepatitis C Virus (HCV) Monitor, Version 2.0, International Unit Assay and the National Genetics Institute HCV Superquant Assay J. Clin. Microbiol., March 1, 2002; 40(3): 768 - 773. [Abstract] [Full Text] [PDF]
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R. R. Razonable, R. A. Brown, M. J. Espy, A. Rivero, W. Kremers, J. Wilson, C. Groettum, T. F. Smith, and C. V. Paya Comparative Quantitation of Cytomegalovirus (CMV) DNA in Solid Organ Transplant Recipients with CMV Infection by Using Two High-Throughput Automated Systems J. Clin. Microbiol., December 1, 2001; 39(12): 4472 - 4476. [Abstract] [Full Text] [PDF]
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Q. Meng, C. Wong, A. Rangachari, S. Tamatsukuri, M. Sasaki, E. Fiss, L. Cheng, T. Ramankutty, D. Clarke, H. Yawata, et al. Automated Multiplex Assay System for Simultaneous Detection of Hepatitis B Virus DNA, Hepatitis C Virus RNA, and Human Immunodeficiency Virus Type 1 RNA J. Clin. Microbiol., August 1, 2001; 39(8): 2937 - 2945. [Abstract] [Full Text] [PDF]
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D. G. Murphy, L. Côté, M. Fauvel, P. René, and J. Vincelette Multicenter Comparison of Roche COBAS AMPLICOR MONITOR Version 1.5, Organon Teknika NucliSens QT with Extractor, and Bayer Quantiplex Version 3.0 for Quantification of Human Immunodeficiency Virus Type 1 RNA in Plasma J. Clin. Microbiol., November 1, 2000; 38(11): 4034 - 4041. [Abstract] [Full Text]
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G. Gerken, T. Rothaar, M. G. Rumi, R. Soffredini, M. Trippler, M. J. Blunk, A. Butcher, S. Soviero, and G. Colucci Performance of the COBAS AMPLICOR HCV MONITOR Test, Version 2.0, an Automated Reverse Transcription-PCR Quantitative System for Hepatitis C Virus Load Determination J. Clin. Microbiol., June 1, 2000; 38(6): 2210 - 2214. [Abstract] [Full Text]
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J.-P. Defoort, M. Martin, B. Casano, S. Prato, C. Camilla, and V. Fert Simultaneous Detection of Multiplex-Amplified Human Immunodeficiency Virus Type 1 RNA, Hepatitis C Virus RNA, and Hepatitis B Virus DNA Using a Flow Cytometer Microsphere-Based Hybridization Assay J. Clin. Microbiol., March 1, 2000; 38(3): 1066 - 1071. [Abstract] [Full Text]
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B. Van Der Pol, T. C. Quinn, C. A. Gaydos, K. Crotchfelt, J. Schachter, J. Moncada, D. Jungkind, D. H. Martin, B. Turner, C. Peyton, et al. Multicenter Evaluation of the AMPLICOR and Automated COBAS AMPLICOR CT/NG Tests for Detection of Chlamydia trachomatis J. Clin. Microbiol., March 1, 2000; 38(3): 1105 - 1112. [Abstract] [Full Text]
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I. G. Sia, J. A. Wilson, M. J. Espy, C. V. Paya, and T. F. Smith Evaluation of the COBAS AMPLICOR CMV MONITOR Test for Detection of Viral DNA in Specimens Taken from Patients after Liver Transplantation J. Clin. Microbiol., February 1, 2000; 38(2): 600 - 606. [Abstract] [Full Text]
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I. G. Sia and R. Patel New Strategies for Prevention and Therapy of Cytomegalovirus Infection and Disease in Solid-Organ Transplant Recipients Clin. Microbiol. Rev., January 1, 2000; 13(1): 83 - 121. [Abstract] [Full Text] [PDF]
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H. Miyachi, A. Masukawa, T. Ohshima, T. Hirose, C. Impraim, and Y. Ando Automated Specific Capture of Hepatitis C Virus RNA with Probes and Paramagnetic Particle Separation J. Clin. Microbiol., January 1, 2000; 38(1): 18 - 21. [Abstract] [Full Text]
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U. Noborg, A. Gusdal, E. K. Pisa, A. Hedrum, and M. Lindh Automated Quantitative Analysis of Hepatitis B Virus DNA by Using the Cobas Amplicor HBV Monitor Test J. Clin. Microbiol., September 1, 1999; 37(9): 2793 - 2797. [Abstract] [Full Text]
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D. A. Jabs, M. Forman, C. Enger, and J. B. Jackson Comparison of Cytomegalovirus Loads in Plasma and Leukocytes of Patients with Cytomegalovirus Retinitis J. Clin. Microbiol., May 1, 1999; 37(5): 1431 - 1435. [Abstract] [Full Text]
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A. Doglio, C. Laffont, F. X. Caroli-Bosc, P. Rochet, and J.-C. Lefebvre Second Generation of the Automated Cobas Amplicor HCV Assay Improves Sensitivity of Hepatitis C Virus RNA Detection and Yields Results That Are More Clinically Relevant J. Clin. Microbiol., May 1, 1999; 37(5): 1567 - 1569. [Abstract] [Full Text]
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B. Ninet, P. Rohner, C. Metral, and R. Auckenthaler Assessment of Use of the COBAS AMPLICOR System with BACTEC 12B Cultures for Rapid Detection of Frequently Identified Mycobacteria J. Clin. Microbiol., March 1, 1999; 37(3): 782 - 784. [Abstract] [Full Text]
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H. H. Kessler, D. Jungkind, E. Stelzl, S. Direnzo, S. K. Vellimedu, K. Pierer, B. Santner, and E. Marth Evaluation of AMPLILINK Software for the COBAS AMPLICOR System J. Clin. Microbiol., February 1, 1999; 37(2): 436 - 437. [Abstract] [Full Text]
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J. Vincelette, J. Schirm, M. Bogard, A.-M. Bourgault, D. S. Luijt, A. Bianchi, P. C. van Voorst Vader, A. Butcher, and M. Rosenstraus Multicenter Evaluation of the Fully Automated COBAS AMPLICOR PCR Test for Detection of Chlamydia trachomatis in Urogenital Specimens J. Clin. Microbiol., January 1, 1999; 37(1): 74 - 80. [Abstract] [Full Text]
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K. Triques, J. Coste, J. L. Perret, C. Segarra, E. Mpoudi, J. Reynes, E. Delaporte, A. Butcher, K. Dreyer, S. Herman, et al. Efficiencies of Four Versions of the AMPLICOR HIV-1 MONITOR Test for Quantification of Different Subtypes of Human Immunodeficiency Virus Type 1 J. Clin. Microbiol., January 1, 1999; 37(1): 110 - 116. [Abstract] [Full Text]
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P. E. Klapper, D. L. Jungkind, T. Fenner, R. Antinozzi, J. Schirm, and C. Blanckmeister Multicenter International Work Flow Study of an Automated Polymerase Chain Reaction Instrument Clin. Chem., August 1, 1998; 44(8): 1737 - 1739. [Full Text] [PDF]
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G. M. Mulcahy, E. A. Albanese, and B. L. Bachl Reproducibility of the Roche Amplicor Polymerase Chain Reaction Assay for Detection of Infection by Chlamydia trachomatis in Endocervical Specimens Clin. Chem., July 1, 1998; 44(7): 1575 - 1578. [Full Text] [PDF]
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J. Albadalejo, R. Alonso, R. Antinozzi, M. Bogard, A.-M. Bourgault, G. Colucci, T. Fenner, H. Petersen, E. Sala, J. Vincelette, et al. Multicenter Evaluation of the COBAS AMPLICOR HCV Assay, an Integrated PCR System for Rapid Detection of Hepatitis C Virus RNA in the Diagnostic Laboratory J. Clin. Microbiol., April 1, 1998; 36(4): 862 - 865. [Abstract] [Full Text]
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M Rosenstraus, Z Wang, S. Chang, D DeBonville, and J. Spadoro An internal control for routine diagnostic PCR: design, properties, and effect on clinical performance [In Process Citation] J. Clin. Microbiol., January 1, 1998; 36(1): 191 - 197. [Abstract] [Full Text]
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