Detail Multicenter Evaluation of the Performance Characteristics of the Bayer VERSANT HCV RNA 3.0 Assay (bDNA) (in Journal of Clinical Microbiology Vol. 42 (2)) Bibliografi Author: Elbeik, Tarek ; Surtihadi, Johan ; Destree, Mark ; Gorlin, Jed ; Holodniy, Mark ; Jortani, Saeed A. ; Kuramoto, Ken ; Ng, Valerie ; Valdes, Roland, (Jr.) ; Valsamakis, Alexandra ; Terrault, Norah A. Topik: Multicenter Evaluation; the Bayer VERSANT HCV RNA 3.0 Assay (bDNA); Bayer Diagnostics; hepatitis C virus (HCV) Bahasa: (EN )    Edisi: Feb. 2004     Penerbit: American Society for Microbiology     Tempat Terbit: Washington, DC    Tahun Terbit: 2004     Jenis: Article - diterbitkan di jurnal ilmiah internasional Fulltext: Bayer bDNA.pdf (122.49KB; 0 download) Abstract In this multicenter evaluation, the VERSANT HCV RNA 3.0 Assay (bDNA) (Bayer Diagnostics, Tarrytown, N.Y.) was shown to have excellent reproducibility, linearity, and analytical sensitivity across specimen collection matrices (serum, EDTA, ACD-A), and hepatitis C virus (HCV) genotypes 1 to 6. The VERSANT HCV bDNA Assay has a reportable range of 615 to 7,690,000 (7.69 x 106) IU/ml. The total coefficient of variation (CV) ranged from 32.4% at 615 IU/ml to 17% at 6.8 x 106 IU/ml. The assay was linear across the reportable range. Analytical specificity of 98.8% was determined by testing 999 specimens from volunteer blood donors. Evaluation of HCV genotypes using RNA transcripts of representative clones of 1a, 1b, 2a, 2b, 2c, 3a, 4a, 5a, and 6a and patient specimens showed that the largest difference between genotype 1, upon which the assay is standardized, and non-1 genotypes was within 1.5-fold. Testing of potentially interfering endogenous substances and exogenous substances and conditions found no interference in HCV-positive or HCV-negative specimens except for unconjugated bilirubin at concentrations of >20 mg/dl and protein at concentrations of >9 g/dl. Biological variability was estimated from 29 clinically stable individuals not on HCV therapy who were tested weekly over an 8-week period. The combined estimate of total (biologic plus assay) variability was 0.15 log10 standard deviation (CV, 36.1%), a fold change of 2.6. Thus, the observed fold change between any two consecutive HCV RNA measures is expected to be less than 2.6-fold (equivalent to 0.41 log10 IU/ml) 95% of the time in clinically stable individuals. Opini Anda Klik untuk menuliskan opini Anda tentang koleksi ini! Lihat Sejarah Pengadaan  Konversi Metadata   Kembali

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