Comparative Evaluation of the Performance of the Abbott Real-Time Human Immunodeficiency Virus Type 1 (HIV-1) Assay for Measurement of HIV-1 Plasma Viral Load following Automated Specimen Preparation

Garcı́a-Dı́az, Ana; Clewley, G; Booth, Clare; Labett, W.; McAllister, Nicole; Geretti, Anna María

doi:10.1128/jcm.44.5.1788-1791.2006

Cited by 33 publications

(22 citation statements)

References 11 publications

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“…The assays and comparator assays run at the different sites are summarized in Table 1. Parts of the data from sites 4 and 5 have been published as part of separate studies (7,8).…”

Section: Methodsmentioning

confidence: 99%

“…A serious drawback of most real-time techniques is the detection of amplicon with fluorescently labeled probes that are sensitive to point mutations within the target sequence. This is especially of concern with highly variable targets like HCV and HIV-1.Abbott has recently CE (Conformité Européenne) marked its new HCV and HIV-1 viral load tests based on real-time 8,22). A major theoretical advantage of the realtime technique used is the probe system, which allows target detection by probe hybridization at low temperatures.…”

mentioning

confidence: 99%

“…Abbott has recently CE (Conformité Européenne) marked its new HCV and HIV-1 viral load tests based on real-time RT-PCR (7,8,22). A major theoretical advantage of the realtime technique used is the probe system, which allows target detection by probe hybridization at low temperatures.…”

mentioning

confidence: 99%

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Multicenter Evaluation of the New Abbott RealTime Assays for Quantitative Detection of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus RNA

Schutten

Peters²,

Back

et al. 2007

J Clin Microbiol

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The analytical performances of the new Abbott RealTime hepatitis C virus (HCV) and human immunodeficiency virus type 1 viral load assays were compared at nine laboratories with different competitor assays. These included the Abbott LcX, Bayer Versant bDNA, Roche COBAS Amplicor, and Roche COBAS TaqMan assays. Two different protocols used during the testing period with and without a pre-m1000 RNA isolation spin were compared. The difference proved to be nonsignificant. A uracil-N-glycosylase (UNG) contamination control option in the HCV test for previous Roche COBAS Amplicor users was evaluated. It proved to decrease amplicon carryover by 100-fold independent of the amplicon input concentration. The protocol including UNG proved to overcome problems with false-positive negative controls. Comparison with other assays revealed only minor differences. The largest difference was observed between the Abbott HCV RealTime assay and the Roche COBAS Amplicor HCV Monitor version 2.0 assay.Hepatitis C virus (HCV) and human immunodeficiency virus type 1 (HIV-1) are major causes of mortality in both developing and developed countries. For both viruses, relatively effective therapies have been available in developed countries for quite some time. HCV and HIV-1 viral loads are important parameters in patient management both before initiating therapy and during therapy. The decline of the HCV viral load during the first 3 months of therapy is, for instance, a strong indicator of the final outcome of therapy (9, 23). Moreover, in many countries, the HCV viral load in infected health care workers determines whether they are allowed to perform surgical procedures. HIV-1 viral load is monitored during therapy, and a viral load above a certain threshold, which may differ per treating physician, requires a switch in medication (6, 13).The first tests that were described for determining the viral load were based on target amplification techniques like reverse transcriptase PCR (RT-PCR) and nucleic acid sequence-based amplification (NASBA). These tests had readout on agarose gel or readout with enzymatic detection of the amplicon after amplification with biotinylated primers (1, 3, 15, 17). Subsequently, signal amplification techniques were developed for the quantitative detection of HCV and HIV-1 (5, 16). Those techniques were improved and commercialized. The suppliers of the most widely used systems at the moment are Roche and Abbott, for RT-PCR-based systems (the COBAS Amplicor and LcX systems, respectively); bioMerieux (formerly Organon Technica), with a NASBA-based technique; and Bayer, with the Versant bDNA system being a signal amplification technique (4,18,19). Each technique has its own advantages and disadvantages. The relatively small dynamic range is a disadvantage that all current assay formats have in common. All assay formats are also rather sensitive to contamination, especially at the lower limit of detection (21). Handling of the sample after target amplification is a major cause of contamination for the NASBA-and RT-PC...

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“…The assays and comparator assays run at the different sites are summarized in Table 1. Parts of the data from sites 4 and 5 have been published as part of separate studies (7,8).…”

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

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Multicenter Evaluation of the New Abbott RealTime Assays for Quantitative Detection of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus RNA

Schutten

Peters²,

Back

et al. 2007

J Clin Microbiol

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“…Previous publications reported on the performance of CAP/CTM HIV-1 (12,17,25,26,28) and NucliSENS HIV-1 (8,13,32,33). RealTime HIV-1 has previously been validated against the Roche HIV-1 Monitor assay (which uses a manual RNA extraction step) and CAP/CTM HIV-1 with the m1000 system, which is less automated than the m2000sp system used in this study (6,15).…”

mentioning

confidence: 99%

Evaluation of the Abbott m 2000 RealTi m e Human Immunodeficiency Virus Type 1 (HIV-1) Assay for HIV Load Monitoring in South Africa Compared to the Roche Cobas AmpliPrep-Cobas Amplicor, Roche Cobas AmpliPrep-Cobas TaqMan HIV-1, and BioMerieux NucliSENS EasyQ HIV-1 Assays

et al. 2009

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The implementation of antiretroviral therapy demands the need for increased access to viral load (VL) monitoring. Newer real-time VL testing technologies are faster and have larger dynamic ranges and fully automated extraction to benefit higher throughputs in resource-poor environments. The Abbott RealTime human immunodeficiency virus type 1 (HIV-1) assay was evaluated as a new option for testing for HIV-1 subtype C in South Africa, and its performance was compared to the performance of existing assays (the Cobas AmpliPrep-Cobas TaqMan HIV-1, version 1, assay; the AmpliPrep-Cobas Monitor standard HIV-1 assay; and the NucliSENS EasyQ-EasyMag HIV-1 assay) in a high-throughput laboratory. The total precision of the RealTime HIV-1 assay was acceptable over all viral load ranges. This assay compared most favorably with the Cobas AmpliPrep-Cobas TaqMan HIV-1 assay (R 2 ‫؍‬ 0.904), with a low standard deviation of difference being detected (0.323 copies/ml). The bias against comparator assays ranged from ؊0.001 copies/ml to ؊0.228 copies/ml. Variability in the reporting of VLs for a 20-member subtype panel compared to the variability of other assays was noted with subtypes G and CRF02-AG. The RealTime HIV-1 assay can test 93 samples per day with minimal manual preparation, less staff, and the minimization of contamination through automation. This assay is suitable for HIV-1 subtype C VL quantification in South Africa.

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“…Accordingly, periodic viral load monitoring is recommended for HIV-infected patients receiving antiretroviral therapy. Several commercial tests have been approved for the quantitation of HIV RNA in plasma, including (i) the Cobas TaqMan HIV type 1 (HIV-1) test (Roche Molecular Systems, Basel, Switzerland) (24), (ii) the Nuclisens EasyQ HIV-1 (version 1.1) test (the Nuclisens test; Biomerieux, Durham, NC) (12), (iii) the branched DNA Versant HIV-1 RNA (version 3.0) assay (Siemens, Berkeley, CA) (14), and (iv) the m2000rt RealTime HIV-1 test (the m2000rt test; Abbott, Chicago, IL) (13,30).…”

mentioning

confidence: 99%

Correlation between Human Immunodeficiency Virus Type 1 (HIV-1) RNA Measurements Obtained with Dried Blood Spots and Those Obtained with Plasma by Use of Nuclisens EasyQ HIV-1 and Abbott RealTime HIV Load Tests

Garrido¹,

Zahonero²,

Corral³

et al. 2009

J Clin Microbiol

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The plasma human immunodeficiency virus (HIV) RNA load is used in the clinical routine for the monitoring of HIV infection and the patient's response to antiretroviral therapy. Other body fluids or dried blood spots (DBS) can be used, however, to assess the level of viremia. The use of DBS may be especially helpful for the monitoring of HIV-infected patients in resource-poor settings, where access to adequate laboratory facilities is often difficult. However, the correlation between the HIV RNA levels in plasma and those in DBSs has not been well established. Paired plasma and DBS samples obtained from HIV type 1 (HIV-1)-infected patients were tested for HIV RNA copy numbers by using two different commercial assays, the Nuclisens EasyQ HIV-1 (version 1.1) test (the Nuclisens test; Biomerieux) and the m2000rt RealTime HIV test (the m2000rt test; Abbott). Nucleic acid extraction was performed manually by using either the Nuclisens isolation kit (which uses the Boom methodology) or the m2000rt sample preparation kit (an iron particle-based method). A total of 103 paired plasma and DBS samples were tested. Viral load results were obtained for 97 (94.2%) samples with the Nuclisens isolation kit and 81 (78.6%) samples with the m2000rt kit. The overall correlation between the RNA loads in plasma and DBS was good, although better results were obtained by the Nuclisens test (R 2 ‫؍‬ 0.87, P < 0.001) than by the m2000rt test (R 2 ‫؍‬ 0.70, P < 0.001). While the specificities were excellent and similar for both the Nuclisens and the m2000rt tests (97.1% and 100%, respectively), the sensitivity was greater by the Nuclisens test than by the m2000rt test (75.8% and 56.6%, respectively). Overall, the viral loads in DBS tended to be lower than those in plasma, with mean differences of 0.3 log unit (standard deviation, 0.5 log unit) and 0.76 log unit (standard deviation, 0.8 log unit) for the Nuclisens and the m2000rt tests, respectively. The levels of agreement between the measurements in plasma and DBS were assessed by using the Bland-Altman plot for each assay. The Nuclisens test gave results within its defined limits (؊0.65 to 1.26) for 95.9% of the samples, while the m2000rt test gave results within its limits (؊0.83 to 2.33) for 100% of the samples. In summary, the HIV-1 load can accurately be quantified by testing DBS by either the Nuclisens or the m2000rt test, although the Nuclisens test may outperform the m2000rt test when nucleic acids are extracted manually.

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Comparative Evaluation of the Performance of the Abbott Real-Time Human Immunodeficiency Virus Type 1 (HIV-1) Assay for Measurement of HIV-1 Plasma Viral Load following Automated Specimen Preparation

Cited by 33 publications

References 11 publications

Multicenter Evaluation of the New Abbott RealTime Assays for Quantitative Detection of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus RNA

Multicenter Evaluation of the New Abbott RealTime Assays for Quantitative Detection of Human Immunodeficiency Virus Type 1 and Hepatitis C Virus RNA

Evaluation of the Abbott m 2000 RealTi m e Human Immunodeficiency Virus Type 1 (HIV-1) Assay for HIV Load Monitoring in South Africa Compared to the Roche Cobas AmpliPrep-Cobas Amplicor, Roche Cobas AmpliPrep-Cobas TaqMan HIV-1, and BioMerieux NucliSENS EasyQ HIV-1 Assays

Correlation between Human Immunodeficiency Virus Type 1 (HIV-1) RNA Measurements Obtained with Dried Blood Spots and Those Obtained with Plasma by Use of Nuclisens EasyQ HIV-1 and Abbott RealTime HIV Load Tests

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