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SHR Neuro Krebs Kardio Lipid Stoffw Microb

Rabenau, HF; Kessler, HH; Kortenbusch, M; Steinhorst, A; Raggam, RB; Berger, A.
Verification and validation of diagnostic laboratory tests in clinical virology.
J Clin Virol. 2007; 40(2): 93-98. Doi: 10.1016/j.jcv.2007.07.009
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Co-Autor*innen der Med Uni Graz
Kessler Harald
Raggam Reinhard Bernd
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Abstract:
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.
Find related publications in this database (using NLM MeSH Indexing)
Animals -
DNA, Viral - genetics
Humans - genetics
Polymerase Chain Reaction - genetics
Quality Control - genetics
RNA, Viral - genetics
Serologic Tests - standards
Validation Studies as Topic - standards
Virology - methods
Virus Diseases - diagnosis
Viruses - genetics

Find related publications in this database (Keywords)
verification
validation
diagnostics
virology
IVD
CE
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