Performance of the SAMBA I and II HIV-1 Semi-Q Tests for viral load monitoring at the point-of-care

Goel, Neha; Ritchie, Allyson; Mtapuri-Zinyowera, Sekesai; Zeh, Clement; Stepchenkova, Tetiana; Lehga, Jesse; Ruiter, Annemiek de; Farleigh, Laura; Edemaga, Daniel; So, Rosario; Sembongi, Hiroshi; Wisniewski, Craig; Nadala, Lourdes M; Schito, Marco; Lee, Helen

doi:10.1016/j.jviromet.2017.03.001

Cited by 32 publications

(37 citation statements)

References 19 publications

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“…POC and near-POC microfluidic platforms enable a more flexible, but still highly sensitive approach for near-patient NAAT testing in decentralised settings. Near-POC NAAT platforms are compact and self-contained, with automated sample preparation for processing in minimal laboratory settings, which most healthcare workers can be trained to operate within a day 119–121. Recent publications describe MERS-CoV assays designed for POC PCR,89 loop-mediated isothermal amplification assay122 and paper-based sensor detection123; however, no MERS-CoV assays are currently available for the existing near-POC platforms.…”

Section: Challenges For Mers-cov Diagnosticsmentioning

confidence: 99%

An updated roadmap for MERS-CoV research and product development: focus on diagnostics

et al. 2019

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Diagnostics play a central role in the early detection and control of outbreaks and can enable a more nuanced understanding of the disease kinetics and risk factors for the Middle East respiratory syndrome-coronavirus (MERS-CoV), one of the high-priority pathogens identified by the WHO. In this review we identified sources for molecular and serological diagnostic tests used in MERS-CoV detection, case management and outbreak investigations, as well as surveillance for humans and animals (camels), and summarised the performance of currently available tests, diagnostic needs, and associated challenges for diagnostic test development and implementation. A more detailed understanding of the kinetics of infection of MERS-CoV is needed in order to optimise the use of existing assays. Notably, MERS-CoV point-of-care tests are needed in order to optimise supportive care and to minimise transmission risk. However, for new test development, sourcing clinical material continues to be a major challenge to achieving assay validation. Harmonisation and standardisation of laboratory methods are essential for surveillance and for a rapid and effective international response to emerging diseases. Routine external quality assessment, along with well-characterised and up-to-date proficiency panels, would provide insight into MERS-CoV diagnostic performance worldwide. A defined set of Target Product Profiles for diagnostic technologies will be developed by WHO to address these gaps in MERS-CoV outbreak management.

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Section: Challenges For Mers-cov Diagnosticsmentioning

confidence: 99%

An updated roadmap for MERS-CoV research and product development: focus on diagnostics

et al. 2019

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“…Further analysis of the Malawi and Uganda results showed that a SAMBA cutoff of 1,000 copies/ml was able to distinguish between suppressed and nonsuppressed patients. Also, a comparison of SAMBA results from 150 specimens from Ukraine with the those of the Abbott RealTime assay yielded 98% concordance (229). Importantly, the specimens were tested on-site in laboratories in district hospitals and health care facilities in Malawi and health care units in Uganda, with results being available the same day (111).…”

Section: Poc Vl Testing Platformsmentioning

confidence: 99%

Diagnosis of Human Immunodeficiency Virus Infection

Parekh

Fonjungo

et al. 2018

Clin Microbiol Rev

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SUMMARY HIV diagnostics have played a central role in the remarkable progress in identifying, staging, initiating, and monitoring infected individuals on life-saving antiretroviral therapy. They are also useful in surveillance and outbreak responses, allowing for assessment of disease burden and identification of vulnerable populations and transmission “hot spots,” thus enabling planning, appropriate interventions, and allocation of appropriate funding. HIV diagnostics are critical in achieving epidemic control and require a hybrid of conventional laboratory-based diagnostic tests and new technologies, including point-of-care (POC) testing, to expand coverage, increase access, and positively impact patient management. In this review, we provide (i) a historical perspective on the evolution of HIV diagnostics (serologic and molecular) and their interplay with WHO normative guidelines, (ii) a description of the role of conventional and POC testing within the tiered laboratory diagnostic network, (iii) information on the evaluations and selection of appropriate diagnostics, (iv) a description of the quality management systems needed to ensure reliability of testing, and (v) strategies to increase access while reducing the time to return results to patients. Maintaining the central role of HIV diagnostics in programs requires periodic monitoring and optimization with quality assurance in order to inform adjustments or alignment to achieve epidemic control.

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“…In 2001 MSF set up the HIV outpatient clinic at ARRH in collaboration with the Ugandan Ministry of Health (MOH) and in 2013 implemented routine viral load monitoring with the point‐of‐care viral load (POC VL) semi‐quantitative test SAMBA‐1, which defines plasma specimen as ‘detectable’ or ‘undetectable’ around the cut‐off of 1000 copies/ml within 2 h .…”

Section: Methodsmentioning

confidence: 99%

HIV‐1 drug resistance testing at second‐line regimen failure in Arua, Uganda: avoiding unnecessary switch to an empiric third‐line

Fily

Ayikobua

Ssemwanga

et al. 2018

Tropical Med Int Health

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Performance of the SAMBA I and II HIV-1 Semi-Q Tests for viral load monitoring at the point-of-care

Cited by 32 publications

References 19 publications

An updated roadmap for MERS-CoV research and product development: focus on diagnostics

An updated roadmap for MERS-CoV research and product development: focus on diagnostics

Diagnosis of Human Immunodeficiency Virus Infection

HIV‐1 drug resistance testing at second‐line regimen failure in Arua, Uganda: avoiding unnecessary switch to an empiric third‐line

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