title: [Evaluation of the diagnostic efficacy of a test system for detecting hepatitis virus C RNA by polymerase chain reaction "AmpliSens(TM) HCV-240/BKO-440)"].
abstract: The test system developed at the Central Research Institute of Epidemiology, Ministry of Health of the Russian Federation for identification of hepatitis C virus RNA was studied. The sensitivity of the test system which the rate of similar results was 100% with its 5-fold reproduction was evaluated. That was 5 x 103 genomic equivalents (or international units) per ml of a sample. A scheme for evaluation of the reproductibility of test systems based on the polymerase chain reaction (PCR) by using model samples is proposed. Whether it can be used for intra- and extra-laboratory assessment of the quality of PCR analyses is discussed.
authors.forename: T A
authors.initials: TA
authors.lastname: Bektimirov
authors.forename: R A
authors.initials: RA
authors.lastname: Volkova
authors.forename: E V
authors.initials: EV
authors.lastname: El'bert
authors.forename: N V
authors.initials: NV
authors.lastname: Shalunova
authors.forename: V P
authors.initials: VP
authors.lastname: Chulanov
authors.forename: M A
authors.initials: MA
authors.lastname: Gorbunov
authors.forename: N M
authors.initials: NM
authors.lastname: Nikitiuk
authors.forename: G A
authors.initials: GA
authors.lastname: Shipulin
authors.forename: O Iu
authors.initials: OIu
authors.lastname: Shipulina
authors.forename: N G
authors.initials: NG
authors.lastname: Bocharova
authors.forename: E E
authors.initials: EE
authors.lastname: Musina
mesh_terms: D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis* / Q000821:virology; D016133:Polymerase Chain Reaction / Q000592:standards*; D012367:RNA, Viral / Q000097:blood*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D012367:RNA, Viral