Comparison of Levels of Human Immunodeficiency Virus Type 1 RNA in Plasma as Measured by the NucliSens Nucleic Acid Sequence-Based Amplification and Quantiplex Branched-DNA Assays

Ginocchio, Christine C.; Tetali, S.; Washburn, D.; Zhang, F.; Kaplan, Mark H.

doi:10.1128/jcm.37.4.1210-1212.1999

Cited by 21 publications

(6 citation statements)

References 24 publications

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“…The consistently observed relationship between specimen input volume and HIV-1 RNA copy number should be extrapolatable to other specimen input volumes if the reported HIV-1 RNA copy number is within the defined linear range of the assay (264 to 5,400,000 copies). This extrapolation was reported in a previous study using a modified version of the NASBA HIV-1 RNA QT assay with specimen input volumes of 0.2 and 1.0 ml (5). In addition, by increasing the volume of the specimen used for analysis with this assay, an increase in the number of specimens with HIV-1 RNA copies reported (clinical sensitivity) was achieved.…”

Section: Discussionsupporting

confidence: 75%

Relationship of Incremental Specimen Volumes and Enhanced Detection of Human Immunodeficiency Virus Type 1 RNA with Nucleic Acid Amplification Technology

Witt¹,

Kemper²,

Stead³

et al. 2000

J Clin Microbiol

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The relationship between specimen input volume and the frequency of reported human immunodeficiency virus type 1 (HIV-1) RNA copy numbers by nucleic acid amplification technology (the NASBA HIV-1 RNA QT system) was investigated. Results obtained with both clinical specimens and dilution panels indicated that both the absolute number of reported results and the reported HIV-1 RNA copy number were directly proportional to the specimen input volumes evaluated (0.1, 0.5, and 1.0 ml). Conversion of the reported HIV-1 RNA copy numbers to a constant 1.0-ml volume indicated that the numerical relationship among the specimen input volumes and the HIV-1 RNA copy numbers was multiplicative. The HIV-1 RNA copy numbers reported for the 0.5-ml input volume were approximately 5-fold increased over those reported for the 0.1-ml input volume, and those reported for the 1.0-ml input volume were 10-fold increased over those reported for the 0.1-ml input volume. For the specimen input volumes investigated, a common linear range of 264 to 5,400,000 HIV-1 RNA copies was observed. The use of increased specimen input volumes did not result in a loss of assay specificity, as the results reported for specimens from 50 seronegative blood donors were negative at all three specimen input volumes. In conclusion, an increase in the input volume of specimens analyzed by nucleic acid amplification technology can be useful for the enhanced detection of HIV-1 RNA.

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Section: Discussionsupporting

confidence: 75%

Relationship of Incremental Specimen Volumes and Enhanced Detection of Human Immunodeficiency Virus Type 1 RNA with Nucleic Acid Amplification Technology

Witt¹,

Kemper²,

Stead³

et al. 2000

J Clin Microbiol

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“…Using 2 mL of plasma, the qualitative NucliSens assay has a lower limit of detection of about 5 copies/ mL, and the quantitative NucliSens QT assay has a lower level of detection at 40 copies/mL. 17 This would predict that the window period preseroconversion plasma sample had a viral load of between 5 to 39 copies/mL. Since both the Nucli-Sens QT and QL assays use the same primers and probes for amplification and detection of HIV RNA, the negative result in the QT assay is due to the higher detection limit for QT and not from HIV sequence heterogeneity.…”

Section: Resultsmentioning

confidence: 99%

Failure of Routine HIV-1 Tests in a Case Involving Transmission With Preseroconversion Blood Components During the Infectious Window Period

Ling

2000

JAMA

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Transmission of HIV from a blood donor to a platelet recipient and a red blood cell recipient occurred in the preseroconversion infectious window period. The viral load in the implicated donation was estimated to be less than 40 copies/mL of plasma. Current US minipool HIV NAT screening protocols may not be sufficiently sensitive to detect all infectious window-period donations. JAMA. 2000;284:210-214

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“…An intermediate value of 0.161 log 10 RNA copies/ml was observed for NucliSens and bDNA 3.0. Ginocchio et al (16) have reported a difference of 0.323 log 10 between NucliSens and a modified bDNA assay having a lower limit of detection of 500 copies/ml. Our results indicate an improvement in agreement between NucliSens and bDNA 3.0 compared to the previous bDNA version.…”

Section: Discussionmentioning

confidence: 99%

Multicenter Comparison of Roche COBAS AMPLICOR MONITOR Version 1.5, Organon Teknika NucliSens QT with Extractor, and Bayer Quantiplex Version 3.0 for Quantification of Human Immunodeficiency Virus Type 1 RNA in Plasma

Murphy

Côté

Fauvel³

et al. 2000

J Clin Microbiol

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The performance and characteristics of Roche COBAS AMPLICOR HIV-1 MONITOR version 1.5 (CA MONITOR 1.5) UltraSensitive (usCA MONITOR 1.5) and Standard (stCA MONITOR 1.5) procedures, Organon Teknika NucliSens HIV-1 RNA QT with Extractor (NucliSens), and Bayer Quantiplex HIV RNA version 3.0 (bDNA 3.0) were compared in a multicenter trial. Samples used in this study included 460 plasma specimens from human immunodeficiency virus (HIV) type 1 (HIV-1)-infected persons, 100 plasma specimens from HIV antibody (anti-HIV)-negative persons, and culture supernatants of HIV-1 subtype A to E isolates diluted in anti-HIV-negative plasma. Overall, bDNA 3.0 showed the least variation in RNA measures upon repeat testing. For the Roche assays, usCA MONITOR 1.5 displayed less variation in RNA measures than stCA MONITOR 1.5. NucliSens, at an input volume of 2 ml, showed the best sensitivity. Deming regression analysis indicated that the results of all three assays were significantly correlated (P < 0.0001). However, the mean difference in values between CA MONITOR 1.5 and bDNA 3.0 (0.274 log10 RNA copies/ml; 95% confidence interval, 0.192 to 0.356) was significantly different from 0, indicating that CA MONITOR 1.5 values were regularly higher than bDNA 3.0 values. Upon testing of 100 anti-HIV-negative plasma specimens, usCA MONITOR 1.5 and NucliSens displayed 100% specificity, while bDNA 3.0 showed 98% specificity. NucliSens quantified 2 of 10 non-subtype B viral isolates at 1 log10 lower than both CA MONITOR 1.5 and bDNA 3.0. For NucliSens, testing of specimens with greater than 1,000 RNA copies/ml at input volumes of 0.1, 0.2, and 2.0 ml did not affect the quality of results. Additional factors differing between assays included specimen throughput and volume requirements, limit of detection, ease of execution, instrument work space, and costs of disposal. These characteristics, along with assay performance, should be considered when one is selecting a viral load assay.

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Comparison of Levels of Human Immunodeficiency Virus Type 1 RNA in Plasma as Measured by the NucliSens Nucleic Acid Sequence-Based Amplification and Quantiplex Branched-DNA Assays

Cited by 21 publications

References 24 publications

Relationship of Incremental Specimen Volumes and Enhanced Detection of Human Immunodeficiency Virus Type 1 RNA with Nucleic Acid Amplification Technology

Relationship of Incremental Specimen Volumes and Enhanced Detection of Human Immunodeficiency Virus Type 1 RNA with Nucleic Acid Amplification Technology

Failure of Routine HIV-1 Tests in a Case Involving Transmission With Preseroconversion Blood Components During the Infectious Window Period

Multicenter Comparison of Roche COBAS AMPLICOR MONITOR Version 1.5, Organon Teknika NucliSens QT with Extractor, and Bayer Quantiplex Version 3.0 for Quantification of Human Immunodeficiency Virus Type 1 RNA in Plasma

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