[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)"].
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.
Bektimirov
T A
TA
Volkova
R A
RA
El'bert
E V
EV
Shalunova
N V
NV
Chulanov
V P
VP
Gorbunov
M A
MA
Nikitiuk
N M
NM
Shipulin
G A
GA
Shipulina
O Iu
OIu
Bocharova
N G
NG
Musina
E E
EE
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
D012367:RNA, Viral