Background and Objectives: A collaborative study was organised to establish a hepatitis A virus (HAV) RNA standard for genomic amplification assays (GAT). Materials and Methods: A panel of 10 samples consisting of a 10–fold serial dilution of wild–type HAV diluted in HAV–negative cryosupernatant and samples of the diluent were sent to 14 laboratories in duplicate for testing for HAV RNA by the polymerase chain reaction. Results: Data returned by 12 laboratories indicated that the sensitivities of the assays performed by different laboratories were fairly close: there was a 100–fold difference in sensitivity between the majority of laboratories. Only one laboratory reported false–positive results. Conclusion: A 10–5 dilution of the virus in cryosupernatant could be an appropriate working reagent for GAT assays for HAV RNA in plasma pools.

1.
Mannucci PM: Outbreak of hepatitis A among Italian patients with haemophilia. Lancet 1992;339:819.
2.
Gerritzen A, Schneweis KE, Brackmann H–H, Oldenburg J, Hanfland P, Gerlich WH, Caspari G: Acute hepatitis A in haemophiliacs. Lancet 1992;340:1231–1232.
3.
Lawlor E, Johnson Z, Thornton L, Temperley I: Investigation of an outbreak of hepatitis A in Irish haemophilia A patients. Vox Sang 1994; 67:18–20.
4.
Peerlinck K, Goubau P, Coppens G, Desmyter J, Vermylen J: Is the apparent outbreak of hepatitis A in Belgian haemophiliacs due to a loss of previous immunity? Vox Sang 1994;67:14– 17.
5.
CDC: Hepatitis A among persons with haemophilia who received clotting factor concentrate – Unites States, September – December 1995. Morbid Mortal Weekly Rep 45/2): 29–32.
6.
Report of the WHO International Working Group on the Standardisation of Genome Amplification techniques for the Virological Safety Testing of Blood and Blood Products. SoGAT V 1996.
7.
Report of the WHO International Working Group on the Standardisation of Genome Amplification techniques for the Virological Safety Testing of Blood and Blood Products. SoGAT VI 1997.
8.
Normann A, Graff J, Gerritzen A, Brackmann H–H, Flehmig B: Detection of hepatitis A virus RNA in commercially available factor VIII preparation. Lancet 1992;340:1232–1233.
9.
Zaaijer H, Cuypers H, Reesink H, Winkel I, Gerken G, Lelie P: Reliability of polymerase chain reaction for detection of hepatitis C virus. Lancet 1993;341:722–724.
10.
Saldanha J, Minor P: Collaborative study to assess the suitability of an HCV RNA reference sample for detection of an HCV RNA in plasma pools by PCR. Vox Sang 1996;70:148– 151.
11.
Damen M, Zaaijer H, Reesink H, Schaaberg W, Gerlich W, Niesters H, Lelie P: International collaborative study on the second Eurohep HCV–RNA reference panel. J Virol Methods 1996;58:175–185.
12.
Saldanha J, Minor P, B19 Collaborative Study Group: Collaborative study to assess the suitability of a proposed working reagent for human parvovirus B19 DNA detection in plasma pools by gene amplification techniques. Vox Sang 1997;73:207–211.
13.
Chomczynski P, Sacchi N: Single–step method of RNA isolation by acid guanidinium thiocyanate–phenol–chloroform extraction. Anal Biochem 1987;162:156–159.
14.
Ishizawa M, Kobayashi Y, Miyamura T, Matsuura S: Simple procedure of DNA isolation from human serum. Nucleic Acids Res 1991;19:5792.
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.