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

被引：55

作者：

Pas, Suzan ^{[1
]}

Rossen, John W. A. ^{[2
]}

Schoener, Daniel ^{[3
]}

Thamke, Diana ^{[3
]}

Pettersson, Annika ^{[4
]}

Babiel, Reiner ^{[3
]}

Schutten, Martin ^{[1
]}

机构：

[1] Erasmus MC, Dept Virol, NL-3015 CE Rotterdam, Netherlands

[2] St Elizabeth Hosp, Lab Med Microbiol & Immunol, Tilburg, Netherlands

[3] Roche Mol Diagnost, Rotkreuz, Switzerland

[4] Vrije Univ Amsterdam Med Ctr, Dept Med Microbiol & Infect Control, Amsterdam, Netherlands

来源：

JOURNAL OF CLINICAL MICROBIOLOGY | 2010年 / 48卷 / 04期

关键词：

ACID-BASED TECHNIQUES; QUANTITATIVE DETECTION; MONITOR VERSION-1.5; AMPLICOR MONITOR; HUMAN PLASMA; VIRAL LOAD; AMPLIFICATION; ASSAY; PCR; INFECTION;

D O I：

10.1128/JCM.01832-09

中图分类号：

Q93 [微生物学];

学科分类号：

071005 ; 100705 ;

摘要：

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.

引用

页码：1195 / 1200

页数：6

共 23 条

[1] ENZYMATIC GENE AMPLIFICATION - QUALITATIVE AND QUANTITATIVE METHODS FOR DETECTING PROVIRAL DNA AMPLIFIED INVITRO [J].

ABBOTT, MA ;

POIESZ, BJ ;

BYRNE, BC ;

KWOK, S ;

SNINSKY, JJ ;

EHRLICH, GD .

JOURNAL OF INFECTIOUS DISEASES, 1988, 158 (06) :1158-1169

[2] 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 [J].

Aberg, Judith A. ;

Kaplan, Jonathan E. ;

Libman, Howard ;

Emmanuel, Patricia ;

Anderson, Jean R. ;

Stone, Valerie E. ;

Oleske, James M. ;

Currier, Judith S. ;

Gallant, Joel E. .

CLINICAL INFECTIOUS DISEASES, 2009, 49 (05) :651-681

[3] NUCLEIC-ACID SEQUENCE-BASED AMPLIFICATION [J].

COMPTON, J .

NATURE, 1991, 350 (6313) :91-92

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

de Baar, MP ;

van Dooren, MW ;

de Rooij, E ;

Bakker, M ;

van Gemen, B ;

Goudsmit, J ;

de Ronde, A .

JOURNAL OF CLINICAL MICROBIOLOGY, 2001, 39 (04) :1378-1384

[5] APPLICATION OF BRANCHED DNA SIGNAL AMPLIFICATION TO MONITOR HUMAN-IMMUNODEFICIENCY-VIRUS TYPE-1 BURDEN IN HUMAN PLASMA [J].

DEWAR, RL ;

HIGHBARGER, HC ;

SARMIENTO, MD ;

TODD, JA ;

VASUDEVACHARI, MB ;

DAVEY, RT ;

KOVACS, JA ;

SALZMAN, NP ;

LANE, HC ;

URDEA, MS .

JOURNAL OF INFECTIOUS DISEASES, 1994, 170 (05) :1172-1179

[6] Detection of HIV Type 1 Load by the Roche Cobas TaqMan Assay in Patients with Viral Loads Previously Undetectable by the Roche Cobas Amplicor Monitor [J].

Gatanaga, Hiroyuki ;

Tsukada, Kunihisa ;

Honda, Haruhito ;

Tanuma, Junko ;

Yazaki, Hirohisa ;

Watanabe, Tamayo ;

Honda, Miwako ;

Teruya, Katsuji ;

Kikuchi, Yoshimi ;

Oka, Shinichi .

CLINICAL INFECTIOUS DISEASES, 2009, 48 (02) :260-262

[7] Evaluation of the Roche Cobas TaqMan and Abbott RealTime extraction-quantification systems for HIV-1 subtypes [J].

Gueudin, Marie ;

Plantier, Jean Christophe ;

Lemee, Veronique ;

Schmitt, Marie Paule ;

Chartier, Loic ;

Bourlet, Thomas ;

Ruffault, Annick ;

Damond, Florence ;

Vray, Muriel ;

Simon, Francois .

JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES, 2007, 44 (05) :500-505

[8] Real time quantitative PCR [J].

Heid, CA ;

Stevens, J ;

Livak, KJ ;

Williams, PM .

GENOME RESEARCH, 1996, 6 (10) :986-994

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

Holmes, H ;

Davis, G ;

Heath, A ;

Hewlett, I ;

Lelie, N .

JOURNAL OF VIROLOGICAL METHODS, 2001, 92 (02) :141-150

[10] Development of the 1st International Reference Panel for HIV-1 RNA genotypes for use in nucleic acid-based techniques [J].

Holmes, Harvey ;

Davis, Clare ;

Heath, Alan .

JOURNAL OF VIROLOGICAL METHODS, 2008, 154 (1-2) :86-91

← 1 2 3 →