Performance of the SAMBA I and II HIV-1 Semi-Q Tests for viral load monitoring at the point-of-care
Copyright © 2017 Elsevier B.V. All rights reserved..
Although access to antiretroviral therapy for HIV infection is increasing in resource-poor countries, viral load testing for monitoring of treatment efficacy remains limited, expensive, and confined to centralized laboratories. The SAMBA HIV-1 Semi-Q Test is a nucleic acid-based amplification assay developed for viral load monitoring performed on either the semi-automated SAMBA I system for laboratory use or the fully automated SAMBA II system for point-of care use. We have assessed the performance characteristics of the SAMBA HIV-1 Semi-Q Test on SAMBA I and SAMBA II systems according to the Common Technical Specifications of the European Community's 98/79 In Vitro Diagnostic Medical Devices Directive. The sensitivity, specificity, reproducibility, and viral subtype coverage of the test were similar on the SAMBA I and SAMBA II platforms. The clinical performance on the SAMBA I system was compared with the Roche CAP/CTM assay and evaluated in-house with 130 patient specimens from London as well as in the field with 390 specimens in Kenya and Zimbabwe. The overall concordance between the SAMBA and CAP/CTM assays was 98.1%. The clinical performance of the test on the SAMBA II platform in comparison with the Abbott HIV-1 RealTime Assay was evaluated in-house with 150 specimens from Ukraine, yielding a concordance of 98.0%. The results thus show that the SAMBA HIV-1 Semi-Q Test performs equivalently on SAMBA I and SAMBA II, and they suggest that the test is suitable for implementation at the point-of-care in resource-poor regions where viral load testing is desperately needed but often unavailable.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2017 |
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| Erschienen: |
2017 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:244 |
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| Enthalten in: |
Journal of virological methods - 244(2017) vom: 10. Juni, Seite 39-45 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Goel, Neha [VerfasserIn] |
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| Links: |
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| Themen: |
Diagnosis |
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| Anmerkungen: |
Date Completed 02.10.2017 Date Revised 10.12.2019 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jviromet.2017.03.001 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM269659218 |
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| 520 | |a Although access to antiretroviral therapy for HIV infection is increasing in resource-poor countries, viral load testing for monitoring of treatment efficacy remains limited, expensive, and confined to centralized laboratories. The SAMBA HIV-1 Semi-Q Test is a nucleic acid-based amplification assay developed for viral load monitoring performed on either the semi-automated SAMBA I system for laboratory use or the fully automated SAMBA II system for point-of care use. We have assessed the performance characteristics of the SAMBA HIV-1 Semi-Q Test on SAMBA I and SAMBA II systems according to the Common Technical Specifications of the European Community's 98/79 In Vitro Diagnostic Medical Devices Directive. The sensitivity, specificity, reproducibility, and viral subtype coverage of the test were similar on the SAMBA I and SAMBA II platforms. The clinical performance on the SAMBA I system was compared with the Roche CAP/CTM assay and evaluated in-house with 130 patient specimens from London as well as in the field with 390 specimens in Kenya and Zimbabwe. The overall concordance between the SAMBA and CAP/CTM assays was 98.1%. The clinical performance of the test on the SAMBA II platform in comparison with the Abbott HIV-1 RealTime Assay was evaluated in-house with 150 specimens from Ukraine, yielding a concordance of 98.0%. The results thus show that the SAMBA HIV-1 Semi-Q Test performs equivalently on SAMBA I and SAMBA II, and they suggest that the test is suitable for implementation at the point-of-care in resource-poor regions where viral load testing is desperately needed but often unavailable | ||
| 650 | 4 | |a Evaluation Study | |
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| 650 | 4 | |a Point-of-care | |
| 650 | 4 | |a Therapy monitoring | |
| 650 | 4 | |a Viral load | |
| 700 | 1 | |a Ritchie, Allyson V |e verfasserin |4 aut | |
| 700 | 1 | |a Mtapuri-Zinyowera, Sekesai |e verfasserin |4 aut | |
| 700 | 1 | |a Zeh, Clement |e verfasserin |4 aut | |
| 700 | 1 | |a Stepchenkova, Tetiana |e verfasserin |4 aut | |
| 700 | 1 | |a Lehga, Jesse |e verfasserin |4 aut | |
| 700 | 1 | |a De Ruiter, Annemiek |e verfasserin |4 aut | |
| 700 | 1 | |a Farleigh, Laura E |e verfasserin |4 aut | |
| 700 | 1 | |a Edemaga, Daniel |e verfasserin |4 aut | |
| 700 | 1 | |a So, Rosario |e verfasserin |4 aut | |
| 700 | 1 | |a Sembongi, Hiroshi |e verfasserin |4 aut | |
| 700 | 1 | |a Wisniewski, Craig |e verfasserin |4 aut | |
| 700 | 1 | |a Nadala, Lourdes |e verfasserin |4 aut | |
| 700 | 1 | |a Schito, Marco |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Helen |e verfasserin |4 aut | |
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