Comparison of the Sensitivities of the Version 1.5 and Version 1.0 Ultrasensitive Roche AMPLICOR HIV-1 MONITOR Kits at Low Concentrations of Human Immunodeficiency Virus RNA

Brambilla, Donald; Jennings, Cheryl; Morack, Ralph; Granger, Suzanne; Bremer, James W.

doi:10.1128/jcm.42.6.2819-2820.2004

Cited by 7 publications

(4 citation statements)

References 6 publications

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“…Nucleic acid amplification can occasionally detect even lower concentrations, depending on the efficiency of nucleic acid amplification in a testing run. 19 Only pools of 90 specimens that were positive on nucleic acid amplification tests were broken down for further testing by this method -first by the examination of pools of 10 and finally by tests of individual specimens. Individual specimens that were positive on nucleic acid amplification underwent repeated enzyme immunoassay testing and quantitative HIV-1 RNA testing (Roche Amplicor 1.5, Roche Molecular Systems; lower detection limit, 500 copies per milliliter).…”

Section: Sensitive-less-sensitive Antibody Testingmentioning

confidence: 99%

Detection of Acute Infections during HIV Testing in North Carolina

et al. 2005

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Section: Sensitive-less-sensitive Antibody Testingmentioning

confidence: 99%

Detection of Acute Infections during HIV Testing in North Carolina

et al. 2005

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“…Extensive dilution may, however, adversely affect the limit-ofdetection, which is critical in many clinical samples with relatively low abundance target molecules. Minute volumes of plasma cannot provide sufficient target for amplification such as needed for the monitoring of HIV viral load, [13][14][15] and the detection of cell-free nucleic acids (cfNAs). [16][17][18][19][20] For example, the state of the art limit of detection of HIV viral load is 50 copies per mL.…”

Section: Introductionmentioning

confidence: 99%

A high-efficiency superhydrophobic plasma separator

et al. 2016

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To meet stringent limit-of-detection specifications for low abundance target molecules, a relatively large volume of plasma is needed for many blood-based clinical diagnostics. Conventional centrifugation methods for plasma separation are not suitable for on-site testing or bedside diagnostics. Here, we report a simple, yet high-efficiency, clamshell-style, superhydrophobic plasma separator that is capable of separating a relatively large volume of plasma from several hundred microliters of whole blood (finger-prick blood volume). The plasma separator consists of a superhydrophobic top cover with a separation membrane and a superhydrophobic bottom substrate. Unlike previously reported membrane-based plasma separators, the separation membrane in our device is positioned at the top of the sandwiched whole blood film to increase the membrane separation capacity and plasma yield. In addition, the device’s superhydrophobic characteristics (i) facilitates the formation of well-defined, contracted, thin blood film with a high contact angle; (ii) minimizes biomolecular adhesion to surfaces; (iii) increases blood clotting time; and (iv) reduces blood cell hemolysis. The device demonstrated a “blood in-plasma out” capability, consistently extracting 65±21.5 μL of plasma from 200 μL of whole blood in less than 10 min without electrical power. The device was used to separate plasma from Schistosoma mansoni genomic DNA-spiked whole blood with a recovery efficiency of > 84.5 ± 25.8 %. The S. mansoni genomic DNA in the separated plasma was successfully tested on our custom-made microfluidic chip by using loop mediated isothermal amplification (LAMP) method.

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“…The Roche standard and ultrasensitive assays, available in manual and automated (COBAS) versions, are the most common tests for viral load quantification, and the Bayer Versant human immunodeficiency virus type 1 (HIV-1) RNA 3.0 (B-DNA) assay (Tarrytown, New York) is also widely used. The standard and ultrasensitive assays have been reported to correlate well both within versions and between versions 1.0 and 1.5 (2,3,5,6), although at very low viral loads version 1.5 is the more sensitive (2, 9).…”

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confidence: 99%

Discordance between Viral Loads Determined by Roche COBAS AMPLICOR Human Immunodeficiency Virus Type 1 Monitor (Version 1.5) Standard and Ultrasensitive Assays Caused by Freezing Patient Plasma in Centrifuged Becton-Dickinson Vacutainer Brand Plasma Preparation Tubes

Salimnia¹,

Moore²,

Crane

et al. 2005

J Clin Microbiol

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The Roche COBAS AMPLICOR human immunodeficiency virus type 1 (HIV-1) Monitor (version 1.5) standard and ultrasensitive viral load assays often gave discordant results, with viral loads from the standard assay exceeding those from the ultrasensitive assay by more than 0.5 log 10 for approximately 20% of specimens received. We began studies to determine the extent, magnitude, and reproducibility of the discordance between the assays and to discover and eliminate the cause of this discordance. Until then, we revised our standard operating procedure to include both standard and ultrasensitive testing on all specimens submitted for viral load determinations. Discordant results usually recurred on retesting. They were most prevalent for specimens with ultrasensitive viral loads of <1,000 and rare for specimens with viral loads of >10,000. Often, standard assay results exceeded those of the ultrasensitive assay by 50-to 100-fold. At higher viral loads, the difference between the standard and ultrasensitive assays persisted, but the percent difference was smaller and rarely caused discordance. The proportion of discordant results was significantly higher in specimens from pediatric patients than in specimens from adults. The ultrasensitive viral load determinations generally agreed with the results of the B-DNA (Bayer) viral load assays. If the plasma was transferred from the centrifuged plasma preparation tubes before freezing, standard and ultrasensitive results were concordant with each other and with values determined on plasma from lavender-topped EDTA tubes.Human immunodeficiency virus (HIV) viral load determinations represent the standard of care in the initial assessment of HIV-infected persons and in the subsequent management of the disease (4,11,13). Spurious high viral loads may cause patients to be started unnecessarily on antiretroviral therapy. For the patient on therapy, such elevated results could prompt unnecessary repeat testing, HIV genotyping, or medication changes. Pregnant women could receive unnecessary caesarean sections. Providers may wrongly conclude that there is nonadherence to a prescribed antiretroviral regimen. Erroneous conclusions may be drawn if the patient is participating in a clinical trial. Thus, accuracy and reproducibility of the viral load results are important considerations. The Roche standard and ultrasensitive assays, available in manual and automated (COBAS) versions, are the most common tests for viral load quantification, and the Bayer Versant human immunodeficiency virus type 1 (HIV-1) RNA 3.0 (B-DNA) assay (Tarrytown, New York) is also widely used. The standard and ultrasensitive assays have been reported to correlate well both within versions and between versions 1.0 and 1.5 (2, 3, 5, 6), although at very low viral loads version 1.5 is the more sensitive (2, 9).Our laboratory offered both (COBAS) standard and ultrasensitive assays (version 1.5) and performed the ordered test. When standard and ultrasensitive assays were performed with the same patient sample, the ultras...

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Comparison of the Sensitivities of the Version 1.5 and Version 1.0 Ultrasensitive Roche AMPLICOR HIV-1 MONITOR Kits at Low Concentrations of Human Immunodeficiency Virus RNA

Cited by 7 publications

References 6 publications

Detection of Acute Infections during HIV Testing in North Carolina

Detection of Acute Infections during HIV Testing in North Carolina

A high-efficiency superhydrophobic plasma separator

Discordance between Viral Loads Determined by Roche COBAS AMPLICOR Human Immunodeficiency Virus Type 1 Monitor (Version 1.5) Standard and Ultrasensitive Assays Caused by Freezing Patient Plasma in Centrifuged Becton-Dickinson Vacutainer Brand Plasma Preparation Tubes

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