PMID: 9431945Feb 12, 1998Paper

An internal control for routine diagnostic PCR: design, properties, and effect on clinical performance

Journal of Clinical Microbiology
M RosenstrausJ P Spadoro

Abstract

We constructed internal controls (ICs) to provide assurance that clinical specimens are successfully amplified and detected. The IC nucleic acids contain primer binding regions identical to those of the target sequence and contain a unique probe binding region that differentiates the IC from amplified target nucleic acid. Because only 20 copies of the IC are introduced into each test sample, a positive IC signal indicates that amplification was sufficient to generate a positive signal from targets present at the limit of test sensitivity. The COBAS AMPLICOR Chlamydia trachomatis, Neisseria gonorrhoeae, Mycobacterium tuberculosis, and human hepatitis C virus tests exhibited inhibition rates ranging from 5 to 9%. Approximately 64% of these inhibitory specimens were not inhibitory when a second aliquot was tested. Because repeatedly inhibitory specimens were not reported as false negative and because additional infected specimens were detected during retesting, test sensitivities were 1 to 6% greater than they would have been if the IC had not been used.

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Citations

Nov 7, 1998·Clinical Chemistry and Laboratory Medicine : CCLM·H H KesslerE Marth
Jun 2, 2000·Clinical Chemistry and Laboratory Medicine : CCLM·H J Burkardt
Oct 27, 2006·FEMS Immunology and Medical Microbiology·Younes MaaroufiFrancoise Crokaert
Jun 20, 2007·Electrophoresis·Bruce I SodowichCraig Burns
Aug 9, 2011·ISRN Obstetrics and Gynecology·April L Harkins, Erik Munson
Feb 16, 2013·Food and Environmental Virology·Ambroos StalsMieke Uyttendaele
Apr 24, 2004·Clinical Chemistry·Frederick S Nolte
Sep 11, 2002·Transfusion Medicine·P R Grant, M P Busch
Apr 6, 2004·Clinical Chemistry and Laboratory Medicine : CCLM·Selda ErensoyTijen Ozacar
Jul 15, 2009·BioTechniques·Prithiviraj JothikumarJothikumar Narayanan
Oct 7, 2005·BioTechniques·Tzachi Bar, Anders Muszta
Jul 9, 2009·Interdisciplinary Perspectives on Infectious Diseases·Anjana SinghWilliam A Petri
Apr 14, 2010·BMC Bioinformatics·Davide SistiVilberto Stocchi
Sep 23, 2008·Hybridoma·Cláudia Pinho Hartleben FernandesJosé Antonio Guimarães Aleixo
Oct 21, 2011·Nucleic Acids Research·Tzachi BarAles Tichopad
Aug 26, 2014·Jundishapur Journal of Microbiology·Keivan MajidzadehMohammad Soleimani
Apr 18, 2014·Journal of Clinical Microbiology·S P BuckwalterN L Wengenack
Feb 19, 2015·Infectious Diseases·Bodil JönssonMalin Ridell
Nov 6, 2013·Biosecurity and Bioterrorism : Biodefense Strategy, Practice, and Science·Johannes HedmanBirgitta Rasmusson
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Apr 19, 2006·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Ian M MackayTheo P Sloots

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