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Guidelines for validation of nucleic acid amplification technology (NAT) for the detection of hepatitis C virus (HCV) RNA in plasma pools
Saldanha Saldanha, Gerlich Gerlich, Lelie Lelie (2001)
An international collaborative study to establish a WHO international standard for hepatitis B virus DNA nucleic acid amplification techniques.Vox Sang, 80
(1971)
Probit analysis: parallel line analysis
P. Lelie, H. Cuypers, A. Drimmelen, W. Quint (1998)
Quality Assessment of Hepatitis C Virus Nucleic Acid Amplification MethodsTransfusion Medicine and Hemotherapy, 25
Common technical specifications (CTS) for IVD products defined in Annex II
J. Lefrère, J. Coste, C. Defer, B. Mercier, C. Férec, P. Loiseau, E. Portelette, M. Mariotti, J. Lerable, P. Rouger, J. Pawlotsky (1998)
Screening blood donations for viral genomes: multicenter study of real‐ time simulation using pooled samples on the model of hepatitis C virus RNA detectionTransfusion, 38
J. Detmer, R. Lagier, J. Flynn, C. Zayati, J. Kolberg, M. Collins, M. Urdea, R. Sánchez-Pescador (1996)
Accurate quantification of hepatitis C virus (HCV) RNA from all HCV genotypes by using branched-DNA technologyJournal of Clinical Microbiology, 34
J. Saldanha, A. Heath, N. Lelie, G. Pisani, M. Nübling, M. Yu (2000)
Calibration of HCV Working Reagents for NAT Assays against the HCV International StandardVox Sanguinis, 78
M. Damen, H. Cuypers, H. Zaaijer, H. Reesink, W. Schaasberg, W. Gerlich, H. Niesters, P. Lelie (1996)
International collaborative study on the second EUROHEP HCV-RNA reference panel.Journal of virological methods, 58 1-2
K. Otake, K. Nishioka (2000)
Nucleic acid amplification testing of hepatitis B virusThe Lancet, 355
H. Holmes, C. Davis, A. Heath, I. Hewlett, N. Lelie (2001)
An international collaborative study to establish the 1st international standard for HIV-1 RNA for use in nucleic acid-based techniques.Journal of virological methods, 92 2
Saldanha Saldanha, Heath Heath, Lelie Lelie (2000)
Calibration of HCV working reagents for NAT assays against the HCV International Standard. The Collaborative Study Group.Vox Sang, 78
Lelie Lelie, Cuypers Cuypers, Van Drimmelen Van Drimmelen, Quint Quint (1998)
Quality assessment of hepatitis C virus nucleic acid amplification methods: an international proficiency study.Infusionther Transfusionmed, 25
J. Saldanha, W. Gerlich, N. Lelie, P. Dawson, K. Heermann, Alan Heath (2001)
An international collaborative study to establish a World Health Organization international standard for hepatitis B virus DNA nucleic acid amplification techniquesVox Sanguinis, 80
S. Stramer, S. Caglioti, D. Strong (2000)
NAT of the United States and Canadian blood supplyTransfusion, 40
H. Cuijpers, M. Molijn, H. Bos, A. Peeters, C. Poel, P. Lelie (2001)
Validation of the NucliSens Extractor in combination with the hepatitis C virus Cobas Amplicor 2.0 assay in four laboratories in the Netherlands utilizing nucleic acid amplification technology for blood screeningVox Sanguinis, 81
H. Zaaijer, H. Cuypers, H. Reesink, I. Winkel, P. Lelie, G. Gerken (1993)
Reliability of polymerase chain reaction for detection of hepatitis C virusThe Lancet, 341
M. Collins, C. Zayati, J. Detmer, B. Daly, J. Kolberg, T. Cha, B. Irvine, J. Tucker, M. Urdea (1995)
Preparation and characterization of RNA standards for use in quantitative branched DNA hybridization assays.Analytical biochemistry, 226 1
M. Cardoso, K. Koerner, B. Kubanek (1998)
Mini‐pool screening by nucleic acid testing for hepatitis B virus, hepatitis C virus, and HIV: preliminary resultsTransfusion, 38
J. Saldanha, N. Lelie, M. Yu, A. Heath (2002)
Establishment of the first World Health Organization International Standard for human parvovirus B19 DNA nucleic acid amplification techniquesVox Sanguinis, 82
H. Cuypers, R. Dijk, J. Viret, V. Schottstedt, M. Lankinen, M. Cardoso, P. Lelie (1999)
European multi-centre validation study of NucliSens Extractor in combination with HCV Amplicor 2.0 assay for HCV-NAT screening of plasma pools.Biologicals : journal of the International Association of Biological Standardization, 27 4
J. Saldanha, N. Lelie, A. Heath (1999)
Establishment of the First International Standard for Nucleic Acid Amplification Technology (NAT) Assays for HCV RNAVox Sanguinis, 76
BACKGROUND: The FDA requirement for sensitivity of viral NAT methods used in blood screening is a 95‐percent detection limit of 100 copies per mL, whereas the NAT screening system should have a sensitivity of at least 5000 copies per mL per individual donation. According to the Common Technical Specifications of the European Directive 98/79/EC for in vitro diagnostics, viral standard dilutions (calibrated against the WHO standard) should be tested at least 24 times for a statistically valid assessment of the 95‐percent detection limit. STUDY DESIGN AND METHODS: Viral standard dilution panels (PeliCheck, VQC‐CLB) were prepared for HCV RNA genotypes 1 and 3 and for HIV RNA genotypes B and E. In a multicenter study, 23 laboratories tested the panels all together in 8 to 91 test runs per NAT method. RESULTS: The following 95‐percent detection limits (and 95% CIs) were found on the HCV RNA genotype 1 reference panels (shown as geq/mL): Gen‐Probe TMA, 85 (64‐118); AmpliScreen, 126 (83‐225); AmpliScreen with NucliSens Extractor, 21 (13‐44); Amplicor with NucliSens Extractor, 69 (50‐102), and Amplicor with Qiagen extraction technology, 144 (74‐102). On HIV RNA genotype B dilution panels, the following 95‐percent detection limits were found (shown as geq/mL): Gen‐Probe TMA, 31 (20‐52); AmpliScreen, 126 (67‐311); AmpliScreen with NucliSens Extractor, 37 (23‐69), and NucliSens QL assay, 123 (51‐566). HIV RNA genotype E panels were detected with equal sensitivity as HIV RNA genotype B panels. In the Gen‐Probe TMA assay, the 50‐percent detection limits on HIV RNA type B and type E were 3.6 (2.6‐5.0) and 3.9 (2.4‐5.8) geq per mL, respectively. The HCV RNA genotype 1 and 3 standards were detected with equal sensitivity. CONCLUSION: The differences in sensitivity between NAT assays can be explained by the input of isolated viral nucleic acid in the amplification reactions. The FDA requirements for sensitivity of NAT blood screening assays can be met by the Gen‐probe TMA, as well as by the AmpliScreen assays, particularly when combined with the NucliSens Extractor.
Transfusion – Wiley
Published: May 1, 2002
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