Comparative evaluation of the Cobas Amplicor HIV-1 Monitor™ Ultrasensitive Test, the new Cobas AmpliPrep/Cobas Amplicor HIV-1 Monitor™ Ultrasensitive Test and the Versant HIV RNA 3.0 assays for quantitation of HIV-1 RNA in plasma samples

Berger, Annemarie; Scherzed, Lina; Stürmer, Martin; Preiser, Wolfgang; Doerr, Hans Wilhelm; Rabenau, Holger F.

doi:10.1016/j.jcv.2004.09.025

Cited by 31 publications

(13 citation statements)

References 15 publications

(7 reference statements)

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“…In fact, less-significant viremia differences among tests occurred when only clade B viruses were tested, as was observed in comparisons of the Cobas AmpliPrep/Cobas Amplicor HIV-1 Monitor Ultrasensitive Test and the Cobas Amplicor HIV-1 Monitor test using manual specimen preparation (1). However, disagreement in viremia quantification between two versions of the same assay has been reported testing non-B subtypes (2,7,15). According to all of these data, we strongly suggest measuring all HIV-1 viral load determinations in each HIV-1-infected patient during follow-up by the same quantification technique and version.…”

Section: Discussionmentioning

confidence: 94%

Performance of Three Commercial Viral Load Assays, Versant Human Immunodeficiency Virus Type 1 (HIV-1) RNA bDNA v3.0, Cobas AmpliPrep/Cobas TaqMan HIV-1, and NucliSens HIV-1 EasyQ v1.2, Testing HIV-1 Non-B Subtypes and Recombinant Variants

Holguín

López²,

Molinero³

et al. 2008

J Clin Microbiol

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Monitoring antiretroviral therapy requires that human immunodeficiency virus type 1 (HIV-1) viremia assays are applicable to all distinct variants. This study evaluates the performance of three commercial viral load assays-Versant HIV-1 RNA bDNA v3.0, Cobas AmpliPrep/Cobas TaqMan HIV-1, and NucliSens HIV-1 EasyQ v1.2-in testing 83 plasma specimens from patients carrying HIV-1 non-B subtypes and recombinants previously defined by phylogenetic analysis of the pol gene. All 28 specimens from patients under treatment presented viremia values below the detection limit with the three methods. In the remaining 55 specimens from naive individuals viremia could not be detected in 32.7, 20, and 14.6% using the NucliSens, Versant, or TaqMan tests, respectively, suggesting potential viral load underestimation of some samples by all techniques. Only 32 (58.2%) samples from naive subjects were quantified by the three methods; the NucliSens test provided the highest HIV RNA values (mean, 4.87 log copies/ml), and the Versant test provided the lowest (mean, 4.16 log copies/ml). Viremia differences of greater than 1 log were seen in 8 (14.5%) of 55 specimens, occurring in 10.9, 7.3, and 5.4%, respectively, of the specimens in comparisons of Versant versus NucliSens, Versant versus TaqMan, and TaqMan versus NucliSens. Differences greater than 0.5 log, considered significant for clinicians, occurred in 45.5, 27.3, and 29% when the same assays were compared. Some HIV-1 strains, such as subtype G and CRF02_AG, showed more discrepancies in distinct quantification methods than others. In summary, an adequate design of primers and probes is needed for optimal quantitation of plasma HIV-RNA in non-B subtypes. Our data emphasize the need to use the same method for monitoring patients on therapy and also the convenience of HIV-1 subtyping.

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Section: Discussionmentioning

confidence: 94%

Performance of Three Commercial Viral Load Assays, Versant Human Immunodeficiency Virus Type 1 (HIV-1) RNA bDNA v3.0, Cobas AmpliPrep/Cobas TaqMan HIV-1, and NucliSens HIV-1 EasyQ v1.2, Testing HIV-1 Non-B Subtypes and Recombinant Variants

Holguín

López²,

Molinero³

et al. 2008

J Clin Microbiol

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“…A significant advantage of the COBAS ® AmpliPrep/ COBAS ® TaqMan ® HIV-1 Test is the broad measuring range of 40-1.0E+07 cp/mL. This greater than 5 log 10 range significantly extends the 3 log 10 measuring ranges of the standard semi-automated HIS and HIM tests (Murphy et al, 2000) as well as those of the automated PHS and PHM tests (Berger et al, 2005) and is also superior to the 4 log 10 measuring range of the bDNA assay (Elbeik et al, 2000). Thus, the COBAS ® AmpliPrep/COBAS ® TaqMan ® HIV-1 Test excellently accomplishes the diagnostic requirements for reliable quantification of clinical HIV-1 samples of untreated patients as well as of patients undergoing therapy.…”

Section: Discussionmentioning

confidence: 97%

“…The linear range of the HIS is 50-7.5E+04 cp/mL, requiring 500 L of plasma, whereas the linear range of the HIM is 400-7.5E+05 cp/mL, requiring 200 L of plasma (Murphy et al, 2000). COBAS ® AmpliPrep/COBAS ® AMPLICOR ® HIV-1 MONITOR Test v1.5 (PHS/PHM) is an integrated assay combining the COBAS ® AmpliPrep Instrument for automated sample preparation with the COBAS ® AMPLICOR ® for amplification and detection (Berger et al, 2002(Berger et al, , 2005. Briefly, HIV-1 RNA and the initially added QS are isolated from samples and controls in an automated specimen preparation process by using biotinylated capture probes specific for HIV-1 RNA.…”

Section: Technical System and Methods Of Hiv-1 Rna Detectionmentioning

confidence: 99%

“…The COBAS ® AMPLICOR ® HIV-1 MONITOR Test v1.5 and the bDNA assay, however, show limitations with respect to the lack of complete automation and require retesting of dilutions for accurate quantification of high positive specimens. A further improvement in automation was recently achieved with the COBAS ® AmpliPrep/COBAS ® AMPLICOR ® HIV-1 MONITOR Test v1.5, which combines automated sample preparation and amplification/detection, connected by a single manual transfer step (Berger et al, 2002(Berger et al, , 2005.…”

Section: Introductionmentioning

confidence: 99%

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Fully automated quantification of human immunodeficiency virus (HIV) type 1 RNA in human plasma by the COBAS® AmpliPrep/COBAS® TaqMan® system

Schumacher

Frick

Kauselmann

et al. 2007

Journal of Clinical Virology

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“…The newer versions of the Amplicor and Quantiplex (Roche, Indianapolis, IN, USA, and Bayer Diagnostics, Walpole, MA, USA, respectively) assays have overcome initial suboptimum performance for non-B subtypes. 102 While the viral load determines the rate of destruction of the immune system, the number of CD4+ cells reveals the degree of immunodeficiency and is, therefore, used to assess the stage of infection. CD4+ cell counts together with clinical manifestations (eg, occurrence of opportunistic infections) are key criteria for HIV-1 disease classification.…”

Section: Clinical Management Diagnosismentioning

confidence: 99%

HIV/AIDS epidemiology, pathogenesis, prevention, and treatment

2006

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The HIV-1 pandemic is a complex mix of diverse epidemics within and between countries and regions of the world, and is undoubtedly the defining public-health crisis of our time. Research has deepened our understanding of how the virus replicates, manipulates, and hides in an infected person. Although our understanding of pathogenesis and transmission dynamics has become more nuanced and prevention options have expanded, a cure or protective vaccine remains elusive. Antiretroviral treatment has transformed AIDS from an inevitably fatal condition to a chronic, manageable disease in some settings. This transformation has yet to be realised in those parts of the world that continue to bear a disproportionate burden of new HIV-1 infections and are most a % ected by increasing morbidity and mortality. This Seminar provides an update on epidemiology, pathogenesis, treatment, and prevention interventions pertinent to HIV-1. HIV pandemicAn estimated 38·6 (33·4-46·0) million people live with HIV-1 worldwide, while about 25 million have died already. 1 In 2005 alone, there were 4·1 million new HIV-1 infections and 2·8 million AIDS deaths. 1 These estimates mask the dynamic nature of this evolving epidemic in relation to temporal changes, geographic distribution, magnitude, viral diversity, and mode of transmission. Today, there is no region of the world untouched by this pandemic (figure 1). 2 Heterosexual transmission remains the dominant mode of transmission and accounts for about 85% of all HIV-1 infections. Southern Africa remains the epicentre of the pandemic and continues to have high rates of new HIV-1 infections. 3 Although overall HIV-1 prevalence remains low in the emerging epidemics in China and India, the absolute numbers, which are fast approaching those seen in southern Africa, are of concern. 1 Outside of sub-Saharan Africa, a third of all HIV-1 infections are acquired through injecting drug use, most (an estimated 8·8 million) of which are in eastern Europe and central and southeast Asia. 1 The rapid spread of HIV-1 in these regions through injecting drug use is of importance, since it is a bridge for rapid establishment of more generalised epidemics. NIH-PA Author ManuscriptA defining feature of the pandemic in the current decade is the increasing burden of HIV-1 infections in women, 4 which has additional implications for mother-to-child transmission. Women now make up about 42% of those infected worldwide; over 70% of whom live in sub-Saharan Africa. 1 Overall, a quarter of all new HIV-1 infections are in adults aged younger than 25 years. 1 HIV-1 infection rates are three to six times higher in female adolescents than in their male counterparts, 1,5-7 and this difference is attributed to sexual coupling patterns of young women with older men. Population prevalence of HIV-1 infection, concurrent sexual relationships, partner change, sexual practices, the presence of other sexually transmitted diseases, [8][9][10][11] and population mobility patterns 12-14 for economic and other reasons (eg, natu...

show abstract

Comparative evaluation of the Cobas Amplicor HIV-1 Monitor™ Ultrasensitive Test, the new Cobas AmpliPrep/Cobas Amplicor HIV-1 Monitor™ Ultrasensitive Test and the Versant HIV RNA 3.0 assays for quantitation of HIV-1 RNA in plasma samples

Cited by 31 publications

References 15 publications

Performance of Three Commercial Viral Load Assays, Versant Human Immunodeficiency Virus Type 1 (HIV-1) RNA bDNA v3.0, Cobas AmpliPrep/Cobas TaqMan HIV-1, and NucliSens HIV-1 EasyQ v1.2, Testing HIV-1 Non-B Subtypes and Recombinant Variants

Performance of Three Commercial Viral Load Assays, Versant Human Immunodeficiency Virus Type 1 (HIV-1) RNA bDNA v3.0, Cobas AmpliPrep/Cobas TaqMan HIV-1, and NucliSens HIV-1 EasyQ v1.2, Testing HIV-1 Non-B Subtypes and Recombinant Variants

Fully automated quantification of human immunodeficiency virus (HIV) type 1 RNA in human plasma by the COBAS® AmpliPrep/COBAS® TaqMan® system

HIV/AIDS epidemiology, pathogenesis, prevention, and treatment

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