title: Experience with PCR screening.
abstract: The COBAS AmpliScreen Hepatitis C (HCV) Test, Version 2.0, which is designed for screening pools composed of samples from individual units of blood or plasma, employs a MultiPrep sample processing procedure that simultaneously extracts and concentrates HCV, HIV-1 and Hepatitis B virus particles from plasma. An HCV Internal Control (IC) RNA serves as an extraction and amplification control for each independently processed sample. Processed samples are amplified by RT-PCR using HCV-specific complementary primers and detected by hybridization of the amplified products to HCV- and IC-specific oligonucleotide probes. The analytical sensitivity of the test is 25 International Units (IU) of HCV per mL of pooled plasma; all HCV genotypes are detected with similar efficiency. The test detected HCV RNA 23 to 32 days prior to anti-HCV antibody seroconversion for four of the five seroconversion panels tested. The test had sufficient sensitivity to reproducibly detect a single infected unit containing 2.4 x 10(3) copies of HCV per mL in a pool with 23 uninfected units. COBAS AmpliScreen tests for HIV-1 and HBV now being validated by Roche Molecular Systems also incorporate the MultiPrep specimen processing method, thereby making it possible to use a single processed specimen to screen for all three viruses.
authors.affiliation: Roche Molecular Systems, Inc., Pleasanton, CA 94566, USA.
authors.forename: R
authors.initials: R
authors.lastname: Sun
authors.forename: H
authors.initials: H
authors.lastname: Jayakar
authors.forename: S
authors.initials: S
authors.lastname: Yeh
authors.forename: M
authors.initials: M
authors.lastname: Mendoza
authors.forename: M H
authors.initials: MH
authors.lastname: Wisbeski
authors.forename: W
authors.initials: W
authors.lastname: Iszczyszyn
authors.forename: E A
authors.initials: EA
authors.lastname: Dragon
mesh_terms: D005838:Genotype; D015658:HIV Infections / Q000097:blood / Q000821:virology; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006509:Hepatitis B / Q000097:blood / Q000821:virology; D006526:Hepatitis C / Q000097:blood / Q000517:prevention & control* / Q000821:virology; D006801:Humans; D008403:Mass Screening / Q000379:methods; D016133:Polymerase Chain Reaction / Q000379:methods; D012367:RNA, Viral / Q000097:blood*; D011933:Reagent Kits, Diagnostic / Q000706:statistics & numerical data*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic