Literature DB >> 20164281

Performance evaluation of the new Roche Cobas AmpliPrep/Cobas TaqMan HIV-1 test version 2.0 for quantification of human immunodeficiency virus type 1 RNA.

Suzan Pas1, John W A Rossen, Daniel Schoener, Diana Thamke, Annika Pettersson, Reiner Babiel, Martin Schutten.   

Abstract

Despite FDA approval and CE marking of commercial tests, manufacturer-independent testing of the technical aspects of newly developed tests is important. To evaluate the analytical performance and explore the clinical applicability of the new Roche COBAS AmpliPrep COBAS TaqMan HIV-1 test, version 2.0 (CAP/CTM v2.0), platform comparison was performed with the Roche CAP/CTM test, version 2.0, the COBAS Amplicor HIV-1 Monitor Test, version 1.5 (CAP/CA v1.5), the COBAS AmpliPrep COBAS TaqMan HIV-1 Test (CAP/CTM v1.0), and the Abbott m2000 RealTime HIV-1 assay on panels and diagnostic samples. Specificity was tested for HIV-2 samples. Furthermore, samples from HIV-1-seropositive individuals with CAP/CA v1.5-measured viral loads below 50 HIV-1 RNA copies per ml (cp/ml) and replicates of HIV-1-seronegative plasma were tested in a checkerboard analysis. CAP/CTM v2.0 is HIV-1 specific, with broad genotype inclusivity and no serious underquantification of viral load relative to the other assays used. Low viral loads below the threshold of quantification for CAP/CA v1.5 are observed with CAP/CTM v2.0. A CAP/CTM v2.0-measured viral load of >50 copies/ml in these samples correlated with therapy failure. In conclusion, CAP/CTM v2.0 is an accurate and reliable test for HIV-1 viral load measurement relative to the other assays used with respect to specificity, sensitivity, and genotype inclusivity.

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Year:  2010        PMID： 20164281      PMCID： PMC2849552          DOI： 10.1128/JCM.01832-09

Source DB:  PubMed          Journal:  J Clin Microbiol        ISSN： 0095-1137            Impact factor:   5.948


  23 in total

1.  An international collaborative study to establish the 1st international standard for HIV-1 RNA for use in nucleic acid-based techniques.

Authors:  H Holmes; C Davis; A Heath; I Hewlett; N Lelie
Journal:  J Virol Methods       Date:  2001-04       Impact factor: 2.014

Review 2.  Clinical utility of viral quantification as a tool for disease monitoring.

Authors:  M Schutten; H G Niesters
Journal:  Expert Rev Mol Diagn       Date:  2001-07       Impact factor: 5.225

3.  Absolute quantitation of viremia in human immunodeficiency virus infection by competitive reverse transcription and polymerase chain reaction.

Authors:  S Menzo; P Bagnarelli; M Giacca; A Manzin; P E Varaldo; M Clementi
Journal:  J Clin Microbiol       Date:  1992-07       Impact factor: 5.948

4.  NASBA isothermal enzymatic in vitro nucleic acid amplification optimized for the diagnosis of HIV-1 infection.

Authors:  T Kievits; B van Gemen; D van Strijp; R Schukkink; M Dircks; H Adriaanse; L Malek; R Sooknanan; P Lens
Journal:  J Virol Methods       Date:  1991-12       Impact factor: 2.014

5.  Nucleic acid sequence-based amplification.

Authors:  J Compton
Journal:  Nature       Date:  1991-03-07       Impact factor: 49.962

6.  Enzymatic gene amplification: qualitative and quantitative methods for detecting proviral DNA amplified in vitro.

Authors:  M A Abbott; B J Poiesz; B C Byrne; S Kwok; J J Sninsky; G D Ehrlich
Journal:  J Infect Dis       Date:  1988-12       Impact factor: 5.226

7.  Development of a real-time quantitative RT-PCR for the detection of HIV-2 RNA in plasma.

Authors:  M Schutten; B van den Hoogen; M E van der Ende; R A Gruters; A D Osterhaus; H G Niesters
Journal:  J Virol Methods       Date:  2000-07       Impact factor: 2.014

8.  Single rapid real-time monitored isothermal RNA amplification assay for quantification of human immunodeficiency virus type 1 isolates from groups M, N, and O.

Authors:  M P de Baar; M W van Dooren; E de Rooij; M Bakker; B van Gemen; J Goudsmit; A de Ronde
Journal:  J Clin Microbiol       Date:  2001-04       Impact factor: 5.948

9.  Application of branched DNA signal amplification to monitor human immunodeficiency virus type 1 burden in human plasma.

Authors:  R L Dewar; H C Highbarger; M D Sarmiento; J A Todd; M B Vasudevachari; R T Davey; J A Kovacs; N P Salzman; H C Lane; M S Urdea
Journal:  J Infect Dis       Date:  1994-11       Impact factor: 5.226

10.  Primary care guidelines for the management of persons infected with human immunodeficiency virus: 2009 update by the HIV medicine Association of the Infectious Diseases Society of America.

Authors:  Judith A Aberg; Jonathan E Kaplan; Howard Libman; Patricia Emmanuel; Jean R Anderson; Valerie E Stone; James M Oleske; Judith S Currier; Joel E Gallant
Journal:  Clin Infect Dis       Date:  2009-09-01       Impact factor: 9.079
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  21 in total

1.  Comparison of HIV-1 viral load assay performance in immunological stable patients with low or undetectable viremia.

Authors:  Gudrun Naeth; Robert Ehret; Frank Wiesmann; Patrick Braun; Heribert Knechten; Annemarie Berger
Journal:  Med Microbiol Immunol       Date:  2012-06-15       Impact factor: 3.402

2.  HIV-1 load comparison using four commercial real-time assays.

Authors:  Thomas Bourlet; Anne Signori-Schmuck; Laurent Roche; Vinca Icard; Henia Saoudin; Mary-Anne Trabaud; Jean-Claude Tardy; Patrice Morand; Bruno Pozzetto; René Ecochard; Patrice André
Journal:  J Clin Microbiol       Date:  2010-11-10       Impact factor: 5.948

3.  Comparison of Three Different FDA-Approved Plasma HIV-1 RNA Assay Platforms Confirms the Virologic Failure Endpoint of 200 Copies per Milliliter Despite Improved Assay Sensitivity.

Authors:  Christina M Lalama; Cheryl Jennings; Victoria A Johnson; Robert W Coombs; John E McKinnon; James W Bremer; Bryan R Cobb; Gavin A Cloherty; John W Mellors; Heather J Ribaudo
Journal:  J Clin Microbiol       Date:  2015-06-10       Impact factor: 5.948

Review 4.  Targeting viral reservoirs: ability of antiretroviral therapy to stop viral replication.

Authors:  Frank Maldarelli
Journal:  Curr Opin HIV AIDS       Date:  2011-01       Impact factor: 4.283

5.  Comparison of the FDA-approved CDC DENV-1-4 real-time reverse transcription-PCR with a laboratory-developed assay for dengue virus detection and serotyping.

Authors:  Jesse J Waggoner; Janaki Abeynayake; Malaya K Sahoo; Lionel Gresh; Yolanda Tellez; Karla Gonzalez; Gabriela Ballesteros; Frances P Guo; Angel Balmaseda; Kumudu Karunaratne; Eva Harris; Benjamin A Pinsky
Journal:  J Clin Microbiol       Date:  2013-07-31       Impact factor: 5.948

6.  Evaluation of the Aptima HIV-1 Quant Dx Assay Using Plasma and Dried Blood Spots.

Authors:  Malaya K Sahoo; Vici Varghese; Elizabeth White; Meg Winslow; David A Katzenstein; Robert W Shafer; Benjamin A Pinsky
Journal:  J Clin Microbiol       Date:  2016-08-17       Impact factor: 5.948

7.  Concordance of HIV-1 RNA Values by Amplicor and TaqMan 2.0 in Patients With Confirmed Suppression in Clinical Trials.

Authors:  Will Garner; Kirsten White; Javier Szwarcberg; Scott McCallister; Lijie Zhong; Mike Wulfsohn
Journal:  Clin Infect Dis       Date:  2015-12-21       Impact factor: 9.079

8.  Modification of the Abbott RealTime assay for detection of HIV-1 plasma RNA viral loads less than one copy per milliliter.

Authors:  Steven A Yukl; Peilin Li; Katsuya Fujimoto; Harry Lampiris; Chuanyi M Lu; C Bradley Hare; Steven G Deeks; Teri Liegler; Mark Pandori; Diane V Havlir; Joseph K Wong
Journal:  J Virol Methods       Date:  2011-04-22       Impact factor: 2.014

Review 9.  Point-of-Care HIV Viral Load Testing: an Essential Tool for a Sustainable Global HIV/AIDS Response.

Authors:  Paul K Drain; Jienchi Dorward; Andrew Bender; Lorraine Lillis; Francesco Marinucci; Jilian Sacks; Anna Bershteyn; David S Boyle; Jonathan D Posner; Nigel Garrett
Journal:  Clin Microbiol Rev       Date:  2019-05-15       Impact factor: 26.132

10.  Evaluation of quantification of HIV-1 RNA viral load in plasma and dried blood spots by use of the semiautomated Cobas Amplicor assay and the fully automated Cobas Ampliprep/TaqMan assay, version 2.0, in Kisumu, Kenya.

Authors:  Kenneth N Ouma; Sridhar V Basavaraju; Jully A Okonji; John Williamson; Timothy K Thomas; Lisa A Mills; John N Nkengasong; Clement Zeh
Journal:  J Clin Microbiol       Date:  2013-02-06       Impact factor: 5.948
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