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.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.jviromet.2017.03.001 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Long-term evolution of immunological and virological parameters in patients undergoing treatments for HIV-1 infection at the Day Hospital of Bobo-Dioulasso, Burkina Faso.
Pan Afr Med J
May 2023
Emerging and Re-emerging Pathogens Laboratory, Sourô Sanou University Hospital Center, Bobo-Dioulasso, Burkina Faso.
Introduction: antiretroviral therapy enables the suppression of the plasma viral load and the restoration of immune responses. Therapeutic failures are still observed in patients living with HIV despite the considerable benefits of antiretroviral therapy. This study aimed to describe the long-term evolution of immunological and virological parameters in patients undergoing treatments for HIV-1 at the Day Hospital of Bobo-Dioulasso in Burkina Faso.
View Article and Find Full Text PDFPerformances of Dried Blood Spots and Point-of-Care Devices to Identify Virological Failure in HIV-Infected Patients: A Systematic Review and Meta-Analysis.
AIDS Patient Care STDS
February 2023
Epidemiology of Emerging Diseases, Université de Paris, Institut Pasteur, Paris, France.
To broaden access to HIV viral load monitoring (VLM), the use of blood samples from dried blood spots (DBS) or point-of-care (POC) devices, could be of great help in settings where plasma is not easily accessible. The variety of assays available makes the choice complex. This systematic review and meta-analysis aims to estimate the sensitivity and specificity of DBS and POC devices to identify patients in virological failure using World Health Organization (WHO) recommendations (viral load ≥1000 copies/mL), compared with plasma, for the assays currently available.
View Article and Find Full Text PDFClinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial.
PLoS One
February 2023
Department of Molecular Biology, Biomedical Research and Training Institute, Harare, Zimbabwe.
Background: In Zimbabwe, children, adolescents and young adults living with HIV (CALWH) who are on public health antiretroviral therapy (ART) have inadequate viral load (VL) suppression. We assessed whether a clinic-based VL monitoring could decrease 12-month virologic failure rates among these CALWH.
Methods: The study was registered on ClinicalTrials.
Recent HIV Infection Among Men Who Have Sex with Men, Transgender Women, and Genderqueer Individuals with Newly Diagnosed HIV Infection in Zimbabwe: Results from a Respondent-Driven Sampling Survey.
AIDS Res Hum Retroviruses
November 2022
Division of Global HIV and TB, U.S. Centers for Disease Control and Prevention, Harare, Zimbabwe.
In Africa, rapid testing for recent HIV infection (RTRI) is being scaled up; however, use of the recent infection testing algorithm (RITA), which uses viral load (VL) to confirm RTRI-recent infections, is not a widespread practice. We present results of recently acquired HIV infections among men who have sex with men (MSM), transgender women, and genderqueer (TGW/GQ) individuals with newly diagnosed HIV infection in Zimbabwe as per the national approach (RTRI) and applying a RITA. In 2019, 1,538 MSM and TGW/GQ in Harare and Bulawayo, Zimbabwe were recruited to participate in a biobehavioral survey using respondent-driven sampling.
View Article and Find Full Text PDFPoint-of-care viral load tests to detect high HIV viral load in people living with HIV/AIDS attending health facilities.
Cochrane Database Syst Rev
March 2022
UCL Centre for Medical Imaging, Division of Medicine, Faculty of Medical Sciences, University College London, London, UK.
Background: Viral load (VL) testing in people living with HIV (PLHIV) helps to monitor antiretroviral therapy (ART). VL is still largely tested using central laboratory-based platforms, which have long test turnaround times and involve sophisticated equipment. VL tests with point-of-care (POC) platforms capable of being used near the patient are potentially easy to use, give quick results, are cost-effective, and could replace central or reference VL testing platforms.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!