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GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India
BACKGROUND: Recent WHO guidelines identify virologic monitoring for diagnosing and confirming ART failure. In view of this, validation and scale up of point of care viral load technologies is essential in resource limited settings. METHODS: A systematic validation of the GeneXpert® HIV-1 Quant assay...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5521114/ https://www.ncbi.nlm.nih.gov/pubmed/28732472 http://dx.doi.org/10.1186/s12879-017-2604-5 |
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author | Kulkarni, Smita Jadhav, Sushama Khopkar, Priyanka Sane, Suvarna Londhe, Rajkumar Chimanpure, Vaishali Dhilpe, Veronica Ghate, Manisha Yelagate, Rajendra Panchal, Narayan Rahane, Girish Kadam, Dilip Gaikwad, Nitin Rewari, Bharat Gangakhedkar, Raman |
author_facet | Kulkarni, Smita Jadhav, Sushama Khopkar, Priyanka Sane, Suvarna Londhe, Rajkumar Chimanpure, Vaishali Dhilpe, Veronica Ghate, Manisha Yelagate, Rajendra Panchal, Narayan Rahane, Girish Kadam, Dilip Gaikwad, Nitin Rewari, Bharat Gangakhedkar, Raman |
author_sort | Kulkarni, Smita |
collection | PubMed |
description | BACKGROUND: Recent WHO guidelines identify virologic monitoring for diagnosing and confirming ART failure. In view of this, validation and scale up of point of care viral load technologies is essential in resource limited settings. METHODS: A systematic validation of the GeneXpert® HIV-1 Quant assay (a point-of-care technology) in view of scaling up HIV-1 viral load in India to monitor the success of national ART programme was carried out. Two hundred nineteen plasma specimens falling in nine viral load ranges (<40 to >5 L copies/ml) were tested by the Abbott m2000rt Real Time and GeneXpert HIV-1 Quant assays. Additionally, 20 seronegative; 16 stored specimens and 10 spiked controls were also tested. Statistical analysis was done using Stata/IC and sensitivity, specificity, PPV, NPV and %misclassification rates were calculated as per DHSs/AISs, WHO, NACO cut-offs for virological failure. RESULTS: The GeneXpert assay compared well with the Abbott assay with a higher sensitivity (97%), specificity (97-100%) and concordance (91.32%). The correlation between two assays (r = 0.886) was statistically significant (p < 0.01), the linear regression showed a moderate fit (R(2) = 0.784) and differences were within limits of agreement. Reproducibility showed an average variation of 4.15 and 3.52% while Lower limit of detection (LLD) and Upper limit of detection (ULD) were 42 and 1,740,000 copies/ml respectively. The misclassification rates for three viral load cut offs were not statistically different (p = 0.736). All seronegative samples were negative and viral loads of the stored samples showed a good fit (R(2) = 0.896 to 0.982). CONCLUSION: The viral load results of GeneXpert HIV-1 Quant assay compared well with Abbott HIV-1 m2000 Real Time PCR; suggesting its use as a Point of care assay for viral load estimation in resource limited settings. Its ease of performance and rapidity will aid in timely diagnosis of ART failures, integrated HIV-TB management and will facilitate the UNAIDS 90-90-90 target. |
format | Online Article Text |
id | pubmed-5521114 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-55211142017-07-21 GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India Kulkarni, Smita Jadhav, Sushama Khopkar, Priyanka Sane, Suvarna Londhe, Rajkumar Chimanpure, Vaishali Dhilpe, Veronica Ghate, Manisha Yelagate, Rajendra Panchal, Narayan Rahane, Girish Kadam, Dilip Gaikwad, Nitin Rewari, Bharat Gangakhedkar, Raman BMC Infect Dis Research Article BACKGROUND: Recent WHO guidelines identify virologic monitoring for diagnosing and confirming ART failure. In view of this, validation and scale up of point of care viral load technologies is essential in resource limited settings. METHODS: A systematic validation of the GeneXpert® HIV-1 Quant assay (a point-of-care technology) in view of scaling up HIV-1 viral load in India to monitor the success of national ART programme was carried out. Two hundred nineteen plasma specimens falling in nine viral load ranges (<40 to >5 L copies/ml) were tested by the Abbott m2000rt Real Time and GeneXpert HIV-1 Quant assays. Additionally, 20 seronegative; 16 stored specimens and 10 spiked controls were also tested. Statistical analysis was done using Stata/IC and sensitivity, specificity, PPV, NPV and %misclassification rates were calculated as per DHSs/AISs, WHO, NACO cut-offs for virological failure. RESULTS: The GeneXpert assay compared well with the Abbott assay with a higher sensitivity (97%), specificity (97-100%) and concordance (91.32%). The correlation between two assays (r = 0.886) was statistically significant (p < 0.01), the linear regression showed a moderate fit (R(2) = 0.784) and differences were within limits of agreement. Reproducibility showed an average variation of 4.15 and 3.52% while Lower limit of detection (LLD) and Upper limit of detection (ULD) were 42 and 1,740,000 copies/ml respectively. The misclassification rates for three viral load cut offs were not statistically different (p = 0.736). All seronegative samples were negative and viral loads of the stored samples showed a good fit (R(2) = 0.896 to 0.982). CONCLUSION: The viral load results of GeneXpert HIV-1 Quant assay compared well with Abbott HIV-1 m2000 Real Time PCR; suggesting its use as a Point of care assay for viral load estimation in resource limited settings. Its ease of performance and rapidity will aid in timely diagnosis of ART failures, integrated HIV-TB management and will facilitate the UNAIDS 90-90-90 target. BioMed Central 2017-07-21 /pmc/articles/PMC5521114/ /pubmed/28732472 http://dx.doi.org/10.1186/s12879-017-2604-5 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article Kulkarni, Smita Jadhav, Sushama Khopkar, Priyanka Sane, Suvarna Londhe, Rajkumar Chimanpure, Vaishali Dhilpe, Veronica Ghate, Manisha Yelagate, Rajendra Panchal, Narayan Rahane, Girish Kadam, Dilip Gaikwad, Nitin Rewari, Bharat Gangakhedkar, Raman GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India |
title | GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India |
title_full | GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India |
title_fullStr | GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India |
title_full_unstemmed | GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India |
title_short | GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India |
title_sort | genexpert hiv-1 quant assay, a new tool for scale up of viral load monitoring in the success of art programme in india |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5521114/ https://www.ncbi.nlm.nih.gov/pubmed/28732472 http://dx.doi.org/10.1186/s12879-017-2604-5 |
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