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Titolo:
Validation and standardisation of nucleic acid amplification technology (NAT) assays for the detection of viral contamination of blood and blood products
Autore:
Saldanha, J;
Indirizzi:
Natl Inst Biol Stand & Controls, Div Virol, S Mimms EN6 3QG, Herts, England Natl Inst Biol Stand & Controls S Mimms Herts England EN6 3QG ts, England
Titolo Testata:
JOURNAL OF CLINICAL VIROLOGY
fascicolo: 1-2, volume: 20, anno: 2001,
pagine: 7 - 13
SICI:
1386-6532(200101)20:1-2<7:VASONA>2.0.ZU;2-J
Fonte:
ISI
Lingua:
ENG
Soggetto:
HCV-RNA; PCR; ROUTINE;
Keywords:
nucleic acid testing; standardisation; validation; blood; blood products; reference panel;
Tipo documento:
Review
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
24
Recensione:
Indirizzi per estratti:
Indirizzo: Saldanha, J Natl Inst Biol Stand & Controls, Div Virol, Blanche Lane, S Mimms EN6 3QG,Herts, England Natl Inst Biol Stand & Controls Blanche Lane S Mimms Herts England EN6 3QG
Citazione:
J. Saldanha, "Validation and standardisation of nucleic acid amplification technology (NAT) assays for the detection of viral contamination of blood and blood products", J CLIN VIRO, 20(1-2), 2001, pp. 7-13

Abstract

Standardisation of NAT assays is necessary before the introduction of suchassays for routine screening of blood and blood products for viral contaminants such as HBV, HCV, and HIV-1. Standardisation can be achieved by the use of well-characterised reference materials (working reagents) to validateeach assay run. Working reagents for HCV, HIV-1, HBV, HAV, and human parvovirus B19 have been established by the NIBSC. Such reagents and reference panels are also available from other official medicinal control laboratoriesand commercial organisations. However, the nucleic acid content of these reagents are expressed in many different units? e,g. genome equivalents/ml, copies/ml, PCR detectable units/ml, making comparisons of results from laboratories using different reagents difficult. The establishment of internationally accepted standards against which all working reagents could be calibrated, using a common standard unit of measurement, IU, would overcome thismajor problem. The first International Standard for HCV RNA assays was established in 1997. This reagent, 96/790, is a lyophilised preparation of a genotype 1 isolate and the concentration of the standard is 10(5) IU/ml. Twofurther International Standards have since been established; for HIV-1 andHBV, containing 10(5) IU/ml and 10(6) IU/ml respectively. The establishment of the HCV International Standard has been critical in the introduction of mandatory testing. Since Ist July 1999, all batches of blood products marketed in Europe have to be prepared from plasma pools tested and found non-reactive for HCV RNA using a validated assay which ran detect a sample containing 100 IU/ml of HCV RNA. In Germany, screening of blood donations for HCV RNA by NAT has been mandatory since ist April 1999. The minimum sensitivity of assays should be 5000 IU/ml for a single donation. (C) 2001 ElsevierScience B.V. All rights reserved.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 08/04/20 alle ore 08:39:27