Validation of HCV-NAT assays and experience with NAT application for blood screening in Germany.
Validation of HCV-NAT assays is an important prerequisite for the use of NAT for screening plasma or blood donations. The main NAT features to be validated are specificity, detection limit and robustness. Preliminary experience in Germany obtained with different methodical and logistic approaches shows the feasibility of HCV-NAT as a screening test for blood donations.
Nübling
C M
CM
Section of Virology, Paul-Ehrlich-Institut, Langen, Germany.
Chudy
M
M
Löwer
J
J
D001782:Blood Donors; D005858:Germany; D016174:Hepacivirus / Q000235:genetics* / Q000302:isolation & purification*; D006801:Humans; D008403:Mass Screening / Q000706:statistics & numerical data; D021141:Nucleic Acid Amplification Techniques; D012367:RNA, Viral / Q000097:blood* / Q000235:genetics*; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014944:World Health Organization
D012367:RNA, Viral