Verification and validation of diagnostic laboratory tests in clinical virology.
This review summarizes major issues of verification and validation procedures and describes minimum requirements for verification and validation of diagnostic assays in clinical virology including instructions for CE/IVD-labeled as well as for self-developed ("home-brewed") tests or test systems. It covers techniques useful for detection of virus specific antibodies, for detection of viral antigens, for detection of viral nucleic acids, and for isolation of viruses on cell cultures in the routine virology laboratory.
Rabenau
Holger F
HF
Institute for Medical Virology, Johann Wolfgang Goethe University Frankfurt/Main, Germany. rabenau@em.uni-frankfurt.de
Kessler
Harald H
HH
Kortenbusch
Marhild
M
Steinhorst
Andreas
A
Raggam
Reinhard B
RB
Berger
Annemarie
A
D000818:Animals; D004279:DNA, Viral / Q000235:genetics; D006801:Humans; D016133:Polymerase Chain Reaction; D011786:Quality Control; D012367:RNA, Viral / Q000235:genetics; D012698:Serologic Tests / Q000592:standards; D054928:Validation Studies as Topic; D014773:Virology / Q000379:methods / Q000592:standards; D014777:Virus Diseases / Q000175:diagnosis*; D014780:Viruses / Q000235:genetics / Q000302:isolation & purification
D004279:DNA, Viral; D012367:RNA, Viral