Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification
Objectives. We evaluated the performances of Amplix real-time PCR platform developed by Biosynex (Strasbourg, France), combining automated station extraction (Amplix station 16 Dx) and real-time PCR (Amplix NG), for quantifying plasma HIV-1 RNA by lyophilized HIV-1 RNA-based Amplix reagents targetin...
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| Format: | Article |
| Language: | English |
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Wiley
2016-01-01
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| Series: | AIDS Research and Treatment |
| Online Access: | http://dx.doi.org/10.1155/2016/7954810 |
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| author | Christian Diamant Mossoro-Kpinde Ralph-Sydney Mboumba Bouassa Mohammad-Ali Jenabian Serge Tonen Wolyec Leman Robin Mathieu Matta Jean de Dieu Longo Gérard Grésenguet Laurent Andreoletti Laurent Bélec |
| author_facet | Christian Diamant Mossoro-Kpinde Ralph-Sydney Mboumba Bouassa Mohammad-Ali Jenabian Serge Tonen Wolyec Leman Robin Mathieu Matta Jean de Dieu Longo Gérard Grésenguet Laurent Andreoletti Laurent Bélec |
| author_sort | Christian Diamant Mossoro-Kpinde |
| collection | DOAJ |
| description | Objectives. We evaluated the performances of Amplix real-time PCR platform developed by Biosynex (Strasbourg, France), combining automated station extraction (Amplix station 16 Dx) and real-time PCR (Amplix NG), for quantifying plasma HIV-1 RNA by lyophilized HIV-1 RNA-based Amplix reagents targeting gag and LTR, using samples from HIV-1-infected adults from Central African Republic. Results. Amplix real-time PCR assay showed low limit of detection (28 copies/mL), across wide dynamic range (1.4–10 log copies/mL), 100% sensitivity and 99% specificity, high reproducibility, and accuracy with mean bias < 5%. The assay showed excellent correlations and concordance of 95.3% with the reference HIV-1 RNA load assay (Roche), with mean absolute bias of +0.097 log copies/mL by Bland-Altman analysis. The assay was able to detect and quantify the most prevalent HIV-1 subtype strains and the majority of non-B subtypes, CRFs of HIV-1 group M, and HIV-1 groups N and O circulating in Central Africa. The Amplix assay showed 100% sensitivity and 99.6% specificity to diagnose virological failure in clinical samples from antiretroviral drug-experienced patients. Conclusions. The HIV-1 RNA-based Amplix real-time PCR platform constitutes sensitive and reliable system for clinical monitoring of HIV-1 RNA load in HIV-1-infected children and adults, particularly adapted to intermediate laboratory facilities in sub-Saharan Africa. |
| format | Article |
| id | doaj-art-7f62954b05e0471b988634240f592ba2 |
| institution | Kabale University |
| issn | 2090-1240 2090-1259 |
| language | English |
| publishDate | 2016-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | AIDS Research and Treatment |
| spelling | doaj-art-7f62954b05e0471b988634240f592ba22025-02-03T06:08:14ZengWileyAIDS Research and Treatment2090-12402090-12592016-01-01201610.1155/2016/79548107954810Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA QuantificationChristian Diamant Mossoro-Kpinde0Ralph-Sydney Mboumba Bouassa1Mohammad-Ali Jenabian2Serge Tonen Wolyec3Leman Robin4Mathieu Matta5Jean de Dieu Longo6Gérard Grésenguet7Laurent Andreoletti8Laurent Bélec9Laboratoire National de Biologie Clinique et de Santé Publique, Bangui, Central African RepublicLaboratoire de Virologie, Hôpital Européen Georges Pompidou, Paris, FranceDépartement des Sciences Biologiques et Centre de Recherche BioMed, Université du Québec à Montréal (UQAM), Montreal, QC, CanadaFaculté de Médecine, Université de Bunia, Bunia, Democratic Republic of the CongoLaboratoire de Virologie, Hôpital Européen Georges Pompidou, Paris, FranceLaboratoire de Virologie, Hôpital Européen Georges Pompidou, Paris, FranceFaculté des Sciences de la Santé, Université de Bangui, Bangui, Central African RepublicFaculté des Sciences de la Santé, Université de Bangui, Bangui, Central African RepublicLaboratoire de Virologie Médicale et Moléculaire, EA-4684/SFR CAP-SANTE, Reims, FranceLaboratoire de Virologie, Hôpital Européen Georges Pompidou, Paris, FranceObjectives. We evaluated the performances of Amplix real-time PCR platform developed by Biosynex (Strasbourg, France), combining automated station extraction (Amplix station 16 Dx) and real-time PCR (Amplix NG), for quantifying plasma HIV-1 RNA by lyophilized HIV-1 RNA-based Amplix reagents targeting gag and LTR, using samples from HIV-1-infected adults from Central African Republic. Results. Amplix real-time PCR assay showed low limit of detection (28 copies/mL), across wide dynamic range (1.4–10 log copies/mL), 100% sensitivity and 99% specificity, high reproducibility, and accuracy with mean bias < 5%. The assay showed excellent correlations and concordance of 95.3% with the reference HIV-1 RNA load assay (Roche), with mean absolute bias of +0.097 log copies/mL by Bland-Altman analysis. The assay was able to detect and quantify the most prevalent HIV-1 subtype strains and the majority of non-B subtypes, CRFs of HIV-1 group M, and HIV-1 groups N and O circulating in Central Africa. The Amplix assay showed 100% sensitivity and 99.6% specificity to diagnose virological failure in clinical samples from antiretroviral drug-experienced patients. Conclusions. The HIV-1 RNA-based Amplix real-time PCR platform constitutes sensitive and reliable system for clinical monitoring of HIV-1 RNA load in HIV-1-infected children and adults, particularly adapted to intermediate laboratory facilities in sub-Saharan Africa.http://dx.doi.org/10.1155/2016/7954810 |
| spellingShingle | Christian Diamant Mossoro-Kpinde Ralph-Sydney Mboumba Bouassa Mohammad-Ali Jenabian Serge Tonen Wolyec Leman Robin Mathieu Matta Jean de Dieu Longo Gérard Grésenguet Laurent Andreoletti Laurent Bélec Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification AIDS Research and Treatment |
| title | Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification |
| title_full | Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification |
| title_fullStr | Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification |
| title_full_unstemmed | Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification |
| title_short | Analytical Performances of Human Immunodeficiency Virus Type 1 RNA-Based Amplix® Real-Time PCR Platform for HIV-1 RNA Quantification |
| title_sort | analytical performances of human immunodeficiency virus type 1 rna based amplix r real time pcr platform for hiv 1 rna quantification |
| url | http://dx.doi.org/10.1155/2016/7954810 |
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