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Journal of Clinical Microbiology, January 2003, p. 227-236, Vol. 41, No. 1
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.1.227-236.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Quality Assessment Program for Genotypic Antiretroviral Testing Improves Detection of Drug Resistance Mutations

D. C. Sayer,1,2* S. Land,3 L. Gizzarelli,1 M. French,1 G. Hales,4 S. Emery,4 F. T. Christiansen,1,2 and E. M. Dax3

Department of Clinical Immunology and Biochemical Genetics, Royal Perth Hospital, Perth 6000,1 Department of Pathology, University of Western Australia, Nedlands, Western Australia,2 National Serology Reference Laboratory, Fitzroy 3065, Victoria,3 National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney 2010, New South Wales, Australia4

Received 8 February 2002/ Accepted 18 June 2002

Genotypic antiretroviral testing is now widely used for the management of patients who are undergoing antiretroviral therapy for human immunodeficiency virus infection. The assays are complex, and there is considerable potential for variation between laboratories. Informative and ongoing quality assessment programs (QAPs) which address all aspects of testing are required. The panel distribution of clinical material is a critical component of QAPs. We report on the results and data from a recent panel. Four cryopreserved plasma samples from treated donors were distributed to nine laboratories. Three laboratories performed testing by commercial assays, and six laboratories used in-house assays, with one laboratory reporting results from two in-house assays. There was complete concordance between results for 95.9% of the nucleotide sequence and 94.5% of the amino acid sequence. Despite this overall high level of concordance, the degree of concordance at drug resistance mutation (DRM) sites when DRMs were present was considerably less (38% of DRM sites). Consequently, only 3 of the 10 methods reported 100% of DRMs as present. This elevated discrepancy rate is almost certainly a result of variability in the identification of mixtures of nucleotides (mixtures) at any site within the sequence. In addition, laboratories differed in the number of codons in the reverse transcriptase gene that were sequenced and their ability to amplify all samples. This panel distribution demonstrated a requirement for laboratory participation in ongoing QAPs and the optimization of assays with standards that contain mixtures.

* Corresponding author. Mailing address: Department of Clinical Immunology and Biochemical Genetics, Royal Perth Hospital, Wellington St., Perth 6000, Western Australia, Australia. Phone: 61-9-92242899. Fax: 61-8-92242920. E-mail: David.Sayer{at}health.wa.gov.au.

Journal of Clinical Microbiology, January 2003, p. 227-236, Vol. 41, No. 1
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.1.227-236.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Poon, A. F. Y., Kosakovsky Pond, S. L., Richman, D. D., Frost, S. D. W. (2007). Mapping Protease Inhibitor Resistance to Human Immunodeficiency Virus Type 1 Sequence Polymorphisms within Patients. J. Virol. 81: 13598-13607 [Abstract] [Full Text]  
  • Huang, D. D., Bremer, J. W., Brambilla, D. J., Palumbo, P. E., for the Pediatric ACTG Sequencing Working Group, (2005). Model for Assessment of Proficiency of Human Immunodeficiency Virus Type 1 Sequencing-Based Genotypic Antiretroviral Assays. J. Clin. Microbiol. 43: 3963-3970 [Abstract] [Full Text]  


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