Staff View: Performance of a Novel Low-Cost, Instrument-Free Plasma Separation Device for HIV Viral Load Quantification and Determination of Treatment Failure in People Living with HIV in Malaysia: a Diagnostic Accuracy Study

Performance of a Novel Low-Cost, Instrument-Free Plasma Separation Device for HIV Viral Load Quantification and Determination of Treatment Failure in People Living with HIV in Malaysia: a Diagnostic Accuracy Study

HIV viral load (VL) testing is the recommended method for monitoring the response of people living with HIV and receiving antiretroviral therapy (ART). The availability of standard plasma VL testing in low- and middle-income countries (LMICs), and access to this testing, are limited by the need to u...

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Main Authors:	Pham, Minh D., Haile, Berhan A., Azwa, Iskandar, Kamarulzaman, Adeeba, Raman, Nishaan, Saeidi, Alireza, Abdul Kahar, Maria Kahar Bador, Tan, Margaret, Zhu, Jiawei, Feng, Yi, Elliott, Julian H., Garcia, Mary L., Li, Fan, Crowe, Suzanne M., Luchters, Stanley, Anderson, David A., Tang, Yi-Wei
Format:	Article
Published:	American Society for Microbiology 2019
Subjects:	R Medicine
Online Access:	http://eprints.um.edu.my/23756/ https://doi.org/10.1128/JCM.01683-18
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spelling	my.um.eprints.237562020-02-12T02:39:58Z http://eprints.um.edu.my/23756/ Performance of a Novel Low-Cost, Instrument-Free Plasma Separation Device for HIV Viral Load Quantification and Determination of Treatment Failure in People Living with HIV in Malaysia: a Diagnostic Accuracy Study Pham, Minh D. Haile, Berhan A. Azwa, Iskandar Kamarulzaman, Adeeba Raman, Nishaan Saeidi, Alireza Abdul Kahar, Maria Kahar Bador Tan, Margaret Zhu, Jiawei Feng, Yi Elliott, Julian H. Garcia, Mary L. Li, Fan Crowe, Suzanne M. Luchters, Stanley Anderson, David A. Tang, Yi-Wei R Medicine HIV viral load (VL) testing is the recommended method for monitoring the response of people living with HIV and receiving antiretroviral therapy (ART). The availability of standard plasma VL testing in low- and middle-income countries (LMICs), and access to this testing, are limited by the need to use fresh plasma. Good specimen collection methods for HIV VL testing that are applicable to resource-constrained settings are needed. We assessed the diagnostic performance of the filtered dried plasma spot (FDPS), created using the newly developed, instrument-free VLPlasma device, in identifying treatment failure at a VL threshold of 1,000 copies/ml in fresh plasma. Performance was compared with that of the conventional dried blood spot (DBS). Venous blood samples from 201 people living with HIV and attending an infectious disease clinic in Malaysia were collected, and HIV VL was quantified using fresh plasma (the reference standard), FDPS, and DBS specimens. VL testing was done using the Roche Cobas AmpliPrep/Cobas TaqMan v2.0 assay. At a threshold of 1,000 copies/ml, the diagnostic performance of the FDPS was superior (sensitivity, 100% [95% confidence interval {CI}, 89.1 to 100%]; specificity, 100% [95% CI, 97.8 to 100%]) to that of the DBS (sensitivity, 100% [95% CI, 89.4 to 100%]; specificity, 36.8% [95% CI, 29.4 to 44.7%]) (P < 0.001). A stronger correlation was observed between the FDPS VL and the plasma VL (r = 0.94; P < 0.001) than between the DBS VL and the plasma VL (r = 0.85; P < 0.001). The mean difference in VL measures between the FDPS and plasma (plasma VL minus FDPS VL) was 0.127 log10 copies/ml (standard deviation [SD], 0.32), in contrast to -0.95 log10 copies/ml (SD, 0.84) between the DBS and plasma. HIV VL measurement using the FDPS outperformed that with the DBS in identifying treatment failure at a threshold of 1,000 copies/ml and compared well with the quantification of VL in plasma. The FDPS can be an attractive alternative to fresh plasma for improving access to HIV VL monitoring among people living with HIV on ART in LMICs. Copyright © 2019 Pham et al. American Society for Microbiology 2019 Article PeerReviewed Pham, Minh D. and Haile, Berhan A. and Azwa, Iskandar and Kamarulzaman, Adeeba and Raman, Nishaan and Saeidi, Alireza and Abdul Kahar, Maria Kahar Bador and Tan, Margaret and Zhu, Jiawei and Feng, Yi and Elliott, Julian H. and Garcia, Mary L. and Li, Fan and Crowe, Suzanne M. and Luchters, Stanley and Anderson, David A. and Tang, Yi-Wei (2019) Performance of a Novel Low-Cost, Instrument-Free Plasma Separation Device for HIV Viral Load Quantification and Determination of Treatment Failure in People Living with HIV in Malaysia: a Diagnostic Accuracy Study. Journal of Clinical Microbiology, 57 (4). e01683-18. ISSN 0095-1137 https://doi.org/10.1128/JCM.01683-18 doi:10.1128/JCM.01683-18
institution	Universiti Malaya
building	UM Library
collection	Institutional Repository
continent	Asia
country	Malaysia
content_provider	Universiti Malaya
content_source	UM Research Repository
url_provider	http://eprints.um.edu.my/
topic	R Medicine
spellingShingle	R Medicine Pham, Minh D. Haile, Berhan A. Azwa, Iskandar Kamarulzaman, Adeeba Raman, Nishaan Saeidi, Alireza Abdul Kahar, Maria Kahar Bador Tan, Margaret Zhu, Jiawei Feng, Yi Elliott, Julian H. Garcia, Mary L. Li, Fan Crowe, Suzanne M. Luchters, Stanley Anderson, David A. Tang, Yi-Wei Performance of a Novel Low-Cost, Instrument-Free Plasma Separation Device for HIV Viral Load Quantification and Determination of Treatment Failure in People Living with HIV in Malaysia: a Diagnostic Accuracy Study
description	HIV viral load (VL) testing is the recommended method for monitoring the response of people living with HIV and receiving antiretroviral therapy (ART). The availability of standard plasma VL testing in low- and middle-income countries (LMICs), and access to this testing, are limited by the need to use fresh plasma. Good specimen collection methods for HIV VL testing that are applicable to resource-constrained settings are needed. We assessed the diagnostic performance of the filtered dried plasma spot (FDPS), created using the newly developed, instrument-free VLPlasma device, in identifying treatment failure at a VL threshold of 1,000 copies/ml in fresh plasma. Performance was compared with that of the conventional dried blood spot (DBS). Venous blood samples from 201 people living with HIV and attending an infectious disease clinic in Malaysia were collected, and HIV VL was quantified using fresh plasma (the reference standard), FDPS, and DBS specimens. VL testing was done using the Roche Cobas AmpliPrep/Cobas TaqMan v2.0 assay. At a threshold of 1,000 copies/ml, the diagnostic performance of the FDPS was superior (sensitivity, 100% [95% confidence interval {CI}, 89.1 to 100%]; specificity, 100% [95% CI, 97.8 to 100%]) to that of the DBS (sensitivity, 100% [95% CI, 89.4 to 100%]; specificity, 36.8% [95% CI, 29.4 to 44.7%]) (P < 0.001). A stronger correlation was observed between the FDPS VL and the plasma VL (r = 0.94; P < 0.001) than between the DBS VL and the plasma VL (r = 0.85; P < 0.001). The mean difference in VL measures between the FDPS and plasma (plasma VL minus FDPS VL) was 0.127 log10 copies/ml (standard deviation [SD], 0.32), in contrast to -0.95 log10 copies/ml (SD, 0.84) between the DBS and plasma. HIV VL measurement using the FDPS outperformed that with the DBS in identifying treatment failure at a threshold of 1,000 copies/ml and compared well with the quantification of VL in plasma. The FDPS can be an attractive alternative to fresh plasma for improving access to HIV VL monitoring among people living with HIV on ART in LMICs. Copyright © 2019 Pham et al.
format	Article
author	Pham, Minh D. Haile, Berhan A. Azwa, Iskandar Kamarulzaman, Adeeba Raman, Nishaan Saeidi, Alireza Abdul Kahar, Maria Kahar Bador Tan, Margaret Zhu, Jiawei Feng, Yi Elliott, Julian H. Garcia, Mary L. Li, Fan Crowe, Suzanne M. Luchters, Stanley Anderson, David A. Tang, Yi-Wei
author_facet	Pham, Minh D. Haile, Berhan A. Azwa, Iskandar Kamarulzaman, Adeeba Raman, Nishaan Saeidi, Alireza Abdul Kahar, Maria Kahar Bador Tan, Margaret Zhu, Jiawei Feng, Yi Elliott, Julian H. Garcia, Mary L. Li, Fan Crowe, Suzanne M. Luchters, Stanley Anderson, David A. Tang, Yi-Wei
author_sort	Pham, Minh D.
title	Performance of a Novel Low-Cost, Instrument-Free Plasma Separation Device for HIV Viral Load Quantification and Determination of Treatment Failure in People Living with HIV in Malaysia: a Diagnostic Accuracy Study
title_short	Performance of a Novel Low-Cost, Instrument-Free Plasma Separation Device for HIV Viral Load Quantification and Determination of Treatment Failure in People Living with HIV in Malaysia: a Diagnostic Accuracy Study
title_full	Performance of a Novel Low-Cost, Instrument-Free Plasma Separation Device for HIV Viral Load Quantification and Determination of Treatment Failure in People Living with HIV in Malaysia: a Diagnostic Accuracy Study
title_fullStr	Performance of a Novel Low-Cost, Instrument-Free Plasma Separation Device for HIV Viral Load Quantification and Determination of Treatment Failure in People Living with HIV in Malaysia: a Diagnostic Accuracy Study
title_full_unstemmed	Performance of a Novel Low-Cost, Instrument-Free Plasma Separation Device for HIV Viral Load Quantification and Determination of Treatment Failure in People Living with HIV in Malaysia: a Diagnostic Accuracy Study
title_sort	performance of a novel low-cost, instrument-free plasma separation device for hiv viral load quantification and determination of treatment failure in people living with hiv in malaysia: a diagnostic accuracy study
publisher	American Society for Microbiology
publishDate	2019
url	http://eprints.um.edu.my/23756/ https://doi.org/10.1128/JCM.01683-18
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score	13.211869

Performance of a Novel Low-Cost, Instrument-Free Plasma Separation Device for HIV Viral Load Quantification and Determination of Treatment Failure in People Living with HIV in Malaysia: a Diagnostic Accuracy Study

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