TY - JOUR
T1 - Multicenter evaluation of the Bayer VERSANT™ HIV-1 RNA 3.0 assay
T2 - Analytical and clinical performance
AU - Gleaves, Curt A.
AU - Welle, John
AU - Campbell, Mary
AU - Elbeik, Tarek
AU - Ng, Valerie
AU - Taylor, Patricia E.
AU - Kuramoto, Ken
AU - Aceituno, Sherri
AU - Lewalski, Eva
AU - Joppa, Barbara
AU - Sawyer, Lynette
AU - Schaper, Carl
AU - McNairn, Denise
AU - Quinn, Thomas
PY - 2002/8
Y1 - 2002/8
N2 - Background: The use of quantitative HIV-1 RNA assays is part of the standard of care for the management of HIV-1-infected individuals. Objective: The Bayer VERSANT™ HIV-1 RNA 3.0 Assay (bDNA) was evaluated for reproducibility, linearity, limits of detection and quantitation, effects of potentially interfering substances and conditions, effects of plasma collection and handling conditions, clinical sensitivity and specificity, and biologic variability. Study design: Anti-HIV-1-positive specimens, patient specimens containing potentially interfering substances, and anti-HIV-negative specimens were collected from several HIV clinics, blood centers, or commercial companies across the United States. Specimen panels used to evaluate nonclinical performance of the assay were prepared at Bayer Diagnostics. Bayer Assay Development personnel performed 2 of the nonclinical studies - effect of freeze-thaw cycles using 'spiked' HIV-1 RNA-positive samples and effect of other disease organisms. All other studies were conducted at 7 external sites. In some of the studies performed, specimens were tested in parallel with the Roche AMPLICOR® HIV-1 MONITOR™ version 1.0 PCR Test. Results/conclusions: The results of these studies showed that the Bayer Assay has excellent reproducibility, a broad linear range (75-500,000 HIV-1 RNA copies/ml), throughput of 168 patient results per two-plate run in a 22-h period, and few limitations for use. Because this test is designed for use only in individuals who are known to be HIV-1-positive, the clinical specificity of 97.6% is adequate for its intended use. These characteristics make it an attractive method for general laboratory use of monitoring HIV-1-infected patients.
AB - Background: The use of quantitative HIV-1 RNA assays is part of the standard of care for the management of HIV-1-infected individuals. Objective: The Bayer VERSANT™ HIV-1 RNA 3.0 Assay (bDNA) was evaluated for reproducibility, linearity, limits of detection and quantitation, effects of potentially interfering substances and conditions, effects of plasma collection and handling conditions, clinical sensitivity and specificity, and biologic variability. Study design: Anti-HIV-1-positive specimens, patient specimens containing potentially interfering substances, and anti-HIV-negative specimens were collected from several HIV clinics, blood centers, or commercial companies across the United States. Specimen panels used to evaluate nonclinical performance of the assay were prepared at Bayer Diagnostics. Bayer Assay Development personnel performed 2 of the nonclinical studies - effect of freeze-thaw cycles using 'spiked' HIV-1 RNA-positive samples and effect of other disease organisms. All other studies were conducted at 7 external sites. In some of the studies performed, specimens were tested in parallel with the Roche AMPLICOR® HIV-1 MONITOR™ version 1.0 PCR Test. Results/conclusions: The results of these studies showed that the Bayer Assay has excellent reproducibility, a broad linear range (75-500,000 HIV-1 RNA copies/ml), throughput of 168 patient results per two-plate run in a 22-h period, and few limitations for use. Because this test is designed for use only in individuals who are known to be HIV-1-positive, the clinical specificity of 97.6% is adequate for its intended use. These characteristics make it an attractive method for general laboratory use of monitoring HIV-1-infected patients.
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U2 - 10.1016/S1386-6532(02)00011-2
DO - 10.1016/S1386-6532(02)00011-2
M3 - Article
C2 - 12367656
AN - SCOPUS:0036701917
SN - 1386-6532
VL - 25
SP - 205
EP - 216
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
IS - 2
ER -