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Comparative Study
. 2000 Mar;38(3):1113-20.
doi: 10.1128/JCM.38.3.1113-1120.2000.

Quantitative and cost comparison of ultrasensitive human immunodeficiency virus type 1 RNA viral load assays: Bayer bDNA quantiplex versions 3.0 and 2.0 and Roche PCR Amplicor monitor version 1.5

T Elbeik  1 , E Charlebois, P Nassos, J Kahn, F M Hecht, D Yajko, V Ng, K Hadley
Affiliations
Comparative Study

Quantitative and cost comparison of ultrasensitive human immunodeficiency virus type 1 RNA viral load assays: Bayer bDNA quantiplex versions 3.0 and 2.0 and Roche PCR Amplicor monitor version 1.5

T Elbeik et al. J Clin Microbiol. 2000 Mar.

Abstract

Quantification of human immunodeficiency virus type 1 (HIV-1) RNA as a measure of viral load has greatly improved the monitoring of therapies for infected individuals. With the significant reductions in viral load now observed in individuals treated with highly active anti-retroviral therapy (HAART), viral load assays have been adapted to achieve greater sensitivity. Two commercially available ultrasensitive assays, the Bayer Quantiplex HIV-1 bDNA version 3.0 (bDNA 3.0) assay and the Roche Amplicor HIV-1 Monitor Ultrasensitive version 1.5 (Amplicor 1.5) assay, are now being used to monitor HIV-1-infected individuals. Both of these ultrasensitive assays have a reported lower limit of 50 HIV-1 RNA copies/ml and were developed from corresponding older generation assays with lower limits of 400 to 500 copies/ml. However, the comparability of viral load data generated by these ultrasensitive assays and the relative costs of labor, disposables, and biohazardous wastes were not determined in most cases. In this study, we used matched clinical plasma samples to compare the quantification of the newer bDNA 3.0 assay with that of the older bDNA 2.0 assay and to compare the quantification and costs of the bDNA 3.0 assay and the Amplicor 1.5 assay. We found that quantification by the bDNA 3.0 assay was approximately twofold higher than that by the bDNA 2.0 assay and was highly correlated to that by the Amplicor 1.5 assay. Moreover, cost analysis based on labor, disposables, and biohazardous wastes showed significant savings with the bDNA 3.0 assay as compared to the costs of the Amplicor 1.5 assay.

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Figures

FIG. 1
FIG. 1
Results of HIV-1 RNA quantification of 185 samples by the older bDNA 2.0 assay and the more sensitive bDNA 3.0 assay. The solid line represents the identity line, where all determinations should fall if a perfect correlation between the two assays was achieved.
FIG. 2
FIG. 2
Viral load results for 24 HIV-infected patients monitored for up to 36 weeks as measured with bDNA 2.0 (A) and bDNA 3.0 (B). The horizontal lines indicate the lower limits of detection for the bDNA 2.0 and bDNA 3.0 assays at 500 and 50 copies/ml, respectively. Data points falling below the limit of detection are plotted at half the limit of detection for each assay. The shaded area indicates the difference between the detection limits of the bDNA 2.0 and bDNA 3.0 assays.
FIG. 3
FIG. 3
Results of HIV-1 RNA quantification of 159 samples by the bDNA 3.0 assay based on bDNA signal amplification technology and the PCR-based Amplicor 1.5 assay. The solid line represents the identity line, where all determinations should fall if a perfect correlation between the two assays was achieved.
See this image and copyright information in PMC

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