Table of Contents Author Guidelines Submit a Manuscript
AIDS Research and Treatment
Volume 2016 (2016), Article ID 7954810, 12 pages
http://dx.doi.org/10.1155/2016/7954810
Research Article

Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification

1Laboratoire National de Biologie Clinique et de Santé Publique, Bangui, Central African Republic
2Faculté des Sciences de la Santé, Université de Bangui, Bangui, Central African Republic
3Laboratoire de Virologie, Hôpital Européen Georges Pompidou, Paris, France
4Université Paris Descartes, Paris Sorbonne Cité, Paris, France
5Département des Sciences Biologiques et Centre de Recherche BioMed, Université du Québec à Montréal (UQAM), Montreal, QC, Canada
6Faculté de Médecine, Université de Bunia, Bunia, Democratic Republic of the Congo
7Centre National de Référence des Maladies Sexuellement Transmissibles et de la Thérapie Antirétrovirale, Bangui, Central African Republic
8Unité de Recherches et d’Intervention sur les Maladies Sexuellement Transmissibles et le SIDA, Département de Santé Publique, Faculté des Sciences de la Santé de Bangui, Bangui, Central African Republic
9Laboratoire de Virologie Médicale et Moléculaire, EA-4684/SFR CAP-SANTE, Reims, France

Received 6 June 2016; Accepted 3 October 2016

Academic Editor: Robert R. Redfield

Copyright © 2016 Christian Diamant Mossoro-Kpinde et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. UNAIDS and WHO, Global AIDS Response Progress Reporting 2015, 2015.
  2. L. Bélec and J.-P. Bonn, “Challenges in implementing HIV laboratory monitoring in resource-constrained settings: how to do more with less,” Future Microbiology, vol. 6, no. 11, pp. 1251–1260, 2011. View at Publisher · View at Google Scholar · View at Scopus
  3. O. Djarma, Y. Nguyen, F. Renois, A. Djimassal, F. Banisadr, and L. Andreoletti, “Continuous free access to HAART could be one of the potential factors impacting on loss to follow-up in HAART-eligible patients living in a resource-limited setting: N'djamena, Chad,” Transactions of the Royal Society of Tropical Medicine and Hygiene, vol. 108, no. 11, pp. 735–738, 2014. View at Publisher · View at Google Scholar · View at Scopus
  4. A. N. Phillips, D. Pillay, A. Miners, C. F. Gilks, and J. D. Lundgren, “Monitoring of antiretroviral therapy in low-resource settings,” The Lancet, vol. 372, no. 9635, pp. 287–289, 2008. View at Publisher · View at Google Scholar · View at Scopus
  5. A. N. Phillips, D. Pillay, A. H. Miners, D. E. Bennett, C. F. Gilks, and J. D. Lundgren, “Outcomes from monitoring of patients on antiretroviral therapy in resource-limited settings with viral load, CD4 cell count, or clinical observation alone: a computer simulation model,” The Lancet, vol. 371, no. 9622, pp. 1443–1451, 2008. View at Publisher · View at Google Scholar · View at Scopus
  6. UNITAID, HIV/AIDS Diagnostics Technology Landscape, UNITAID, 5th edition, 2015.
  7. W. S. Stevens and T. M. Marshall, “Challenges in implementing HIV load testing in South Africa,” The Journal of Infectious Diseases, vol. 201, supplement 1, pp. S78–S84, 2010. View at Publisher · View at Google Scholar · View at Scopus
  8. S. Wang, F. Xu, and U. Demirci, “Advances in developing HIV-1 viral load assays for resource-limited settings,” Biotechnology Advances, vol. 28, no. 6, pp. 770–781, 2010. View at Publisher · View at Google Scholar · View at Scopus
  9. World Health Organization, Consultation on Technical and Operational Recommendations for Clinical Laboratory Testing Harmonization and Standardization; Helping to Expand Sustainable Quality Testing to Improve the Care and Treatment of People Infected with and Affected by HIV/AIDS, TB and Malaria, Maputo, Mozambique, World Health Organization, Geneva, Switzerland, 2008.
  10. E. M. Burd, “Validation of laboratory-developed molecular assays for infectious diseases,” Clinical Microbiology Reviews, vol. 23, no. 3, pp. 550–576, 2010. View at Publisher · View at Google Scholar · View at Scopus
  11. CLSI/NCCLS, Quantitative Molecular Methods for Infectious Diseases; Approved Guideline, CLSI Document MM06-A2, Clinical and Laboratory Standards Institute, 2nd edition, 2011.
  12. H. Holmes, C. Davis, A. Heath, I. Hewlett, and N. Lelie, “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, vol. 92, no. 2, pp. 141–150, 2001. View at Publisher · View at Google Scholar · View at Scopus
  13. World Health Organization, Consolidated Guidelines on the Use of Antiretroviral Drugs aor Treating and Preventing HIV Infection. Recommendations for a Public Health Approach, Guidelines, WHO, 2013.
  14. D. Church, D. Gregson, T. Lloyd et al., “Comparison of the RealTime HIV-1, COBAS TaqMan 48 v1.0, Easy Q v1.2, and Versant v3.0 assays for determination of HIV-1 viral loads in a cohort of Canadian patients with diverse HIV subtype infections,” Journal of Clinical Microbiology, vol. 49, no. 1, pp. 118–124, 2011. View at Publisher · View at Google Scholar
  15. M. Rozanov, U. Plikat, C. Chappey, A. Kochergin, and T. Tatusova, “A web-based genotyping resource for viral sequences,” Nucleic Acids Research, vol. 32, pp. W654–W659, 2004. View at Publisher · View at Google Scholar · View at Scopus
  16. T. Bourlet, A. Signori-Schmuck, L. Roche et al., “HIV-1 load comparison using four commercial real-time assays,” Journal of Clinical Microbiology, vol. 49, no. 1, pp. 292–297, 2011. View at Publisher · View at Google Scholar · View at Scopus
  17. M. Peeters, A. F. Aghokeng, and E. Delaporte, “Genetic diversity among human immunodeficiency virus-1 non-B subtypes in viral load and drug resistance assays,” Clinical Microbiology and Infection, vol. 16, no. 10, pp. 1525–1531, 2010. View at Publisher · View at Google Scholar · View at Scopus
  18. F. Rouet, M.-L. Chaix, E. Nerrienet et al., “Impact of HIV-1 genetic diversity on plasma HIV-1 RNA quantification: Usefulness of the Agence Nationale de Recherches sur le SIDA second-generation long terminal repeat-based real-time reverse transcriptase polymerase chain reaction test,” Journal of Acquired Immune Deficiency Syndromes, vol. 45, no. 4, pp. 380–388, 2007. View at Publisher · View at Google Scholar · View at Scopus
  19. C. Aldrich and J. Hemelaar, “Global HIV-1 diversity surveillance,” Trends in Molecular Medicine, vol. 18, no. 12, pp. 691–694, 2012. View at Publisher · View at Google Scholar · View at Scopus
  20. C. Drosten, M. Panning, J. F. Drexler et al., “Ultrasensitive monitoring of HIV-1 viral load by a low-cost real-time reverse transcription-PCR assay with internal control for the 5′long terminal repeat domain,” Clinical Chemistry, vol. 52, no. 7, pp. 1258–1266, 2006. View at Publisher · View at Google Scholar · View at Scopus
  21. P. Kaur, W. X. Khong, S. Y. Wee et al., “Clinical evaluation of a low cost, in-house developed real-time RT-PCR human immunodeficiency virus type 1 (HIV-1) quantitation assay for HIV-1 infected patients,” PLoS ONE, vol. 9, no. 3, Article ID e89826, 2014. View at Publisher · View at Google Scholar · View at Scopus
  22. H. Passing and W. Bablok, “A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry. Part I,” Journal of Clinical Chemistry and Clinical Biochemistry, vol. 21, no. 11, pp. 709–720, 1983. View at Google Scholar · View at Scopus
  23. J. M. Bland and D. G. Altman, “Statistical methods for assessing agreement between two methods of clinical measurement,” The Lancet, vol. 1, no. 8476, pp. 307–310, 1986. View at Google Scholar · View at Scopus
  24. J. M. Bland and D. G. Altman, “Measuring agreement in method comparison studies,” Statistical Methods in Medical Research, vol. 8, no. 2, pp. 135–160, 1999. View at Publisher · View at Google Scholar · View at Scopus
  25. J. Cohen, “A coefficient of agreement for nominal scales,” Educational and Psychological Measurement, vol. 20, no. 1, pp. 37–46, 1960. View at Publisher · View at Google Scholar
  26. P. Braun, R. Ehret, F. Wiesmann et al., “Comparison of four commercial quantitative HIV-1 assays for viral load monitoring in clinical daily routine,” Clinical Chemistry and Laboratory Medicine, vol. 45, no. 1, pp. 93–99, 2007. View at Publisher · View at Google Scholar · View at Scopus
  27. A. Holguín, M. López, M. Molinero, and V. Soriano, “Performance of three commercial viral load assays, versant human immunodeficiency virus type 1 (HIV-1) RNA bDNA v3.0, Cobas AmpliPrep/Cobas TaqMan HIV-1, and NucliSens HIV-1 EasyQ v1.2, testing HIV-1 non-B subtypes and recombinant variants,” Journal of Clinical Microbiology, vol. 46, no. 9, pp. 2918–2923, 2008. View at Publisher · View at Google Scholar · View at Scopus
  28. M. Hopkins, S. Hau, C. Tiernan et al., “Comparative performance of the new Aptima HIV-1 Quant Dx assay with three commercial PCR-based HIV-1 RNA quantitation assays,” Journal of Clinical Virology, vol. 69, pp. 56–62, 2015. View at Publisher · View at Google Scholar · View at Scopus
  29. O. Ndiaye, H. Diop-Ndiaye, A. S. Ouedraogo et al., “Comparison of four commercial viral load techniques in an area of non-B HIV-1 subtypes circulation,” Journal of Virological Methods, vol. 222, pp. 122–131, 2015. View at Publisher · View at Google Scholar · View at Scopus
  30. C. Mossoro-Kpinde, J. C. Gody, O. Mbitikon, J. D. D. Longo, G. Grésenguet, and L. Bélec, Performance of the Amplix Real-Time PCR Assay for Plasma HIV-1 (non-B subtypes) RNA Quantification Using LRT and Gag Targets to Assess Virological Failure in HIV-Infected Treated Children Living in Central Africa, Second International African Society for Laboratory Medicine (ASLM), Cape Town, South Africa, 2014.