title: Clinical performance of the LCx HCV RNA quantitative assay.
abstract: This study was conducted to assess the performance of the Abbott laboratories LCx HCV RNA Quantitative Assay (LCx assay) in the clinical setting. Four clinical laboratories measured LCx assay precision, specificity, and linearity. In addition, a method comparison was conducted between the LCx assay and the Roche HCV Amplicor Monitor, version 2.0 (Roche Monitor 2.0) and the Bayer VERSANT HCV RNA 3.0 Assay (Bayer bDNA 3.0) quantitative assays. For precision, the observed LCx assay intra-assay standard deviation (S.D.) was 0.060-0.117 log IU/ml, the inter-assay S.D. was 0.083-0.133 log IU/ml, the inter-lot S.D. was 0.105-0.177 log IU/ml, the inter-site S.D. was 0.099-0.190 log IU/ml, and the total S.D. was 0.113-0.190 log IU/ml. The specificity of the LCx assay was 99.4% (542/545; 95% CI, 98.4-99.9%). For linearity, the mean pooled LCx assay results were linear (r=0.994) over the range of the panel (2.54-5.15 log IU/ml). A method comparison demonstrated a correlation coefficient of 0.881 between the LCx assay and Roche Monitor 2.0, 0.872 between the LCx assay and Bayer bDNA 3.0, and 0.870 between Roche Monitor 2.0 and Bayer bDNA 3.0. The mean LCx assay result was 0.04 log IU/ml (95% CI, -0.08, 0.01) lower than the mean Roche Monitor 2.0 result, but 0.57 log IU/ml (95% CI, 0.53, 0.61) higher than the mean Bayer bDNA 3.0 result. The mean Roche Monitor 2.0 result was 0.60 log IU/ml (95% CI, 0.56, 0.65) higher than the mean Bayer bDNA 3.0 result. The LCx assay quantitated genotypes 1-4 with statistical equivalency. The vast majority (98.9%, 278/281) of paired LCx assay-Roche Monitor 2.0 specimen results were within 1 log IU/ml. Similarly, 86.6% (240/277) of paired LCx assay and Bayer bDNA 3.0 specimen results were within 1 log, as were 85.6% (237/277) of paired Roche Monitor 2.0 and Bayer specimen results. These data demonstrate that the LCx assay may be used for quantitation of HCV RNA in HCV-infected individuals.
authors.affiliation: Abbott Laboratories, D99G AP20, 100 Abbott Park Road, Abbott Park, IL 60064-6015, USA.
authors.forename: Rasa
authors.initials: R
authors.lastname: Bertuzis
authors.forename: Alison
authors.initials: A
authors.lastname: Hardie
authors.forename: Barbara
authors.initials: B
authors.lastname: Hottentraeger
authors.forename: Jacques
authors.initials: J
authors.lastname: Izopet
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Jilg
authors.forename: Barbara
authors.initials: B
authors.lastname: Kaesdorf
authors.forename: Gregor
authors.initials: G
authors.lastname: Leckie
authors.forename: Jean
authors.initials: J
authors.lastname: Leete
authors.forename: Luc
authors.initials: L
authors.lastname: Perrin
authors.forename: Chunfu
authors.initials: C
authors.lastname: Qiu
authors.forename: Iris
authors.initials: I
authors.lastname: Ran
authors.forename: George
authors.initials: G
authors.lastname: Schneider
authors.forename: Peter
authors.initials: P
authors.lastname: Simmonds
authors.forename: John
authors.initials: J
authors.lastname: Robinson
mesh_terms: D004279:DNA, Viral / Q000032:analysis; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D012367:RNA, Viral / Q000097:blood* / Q000235:genetics; D012015:Reference Standards; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D012680:Sensitivity and Specificity; D014766:Viremia / Q000188:drug therapy / Q000821:virology; D014773:Virology / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data
chemical_list: D004279:DNA, Viral; D012367:RNA, Viral