Leukodepletion as a Point-of-Care Method for Monitoring HIV-1 Viral Load in Whole Blood

Titchmarsh, Logan; Zeh, Clement; Verpoort, Thierry; Allain, Jean‐Pierre; Lee, Helen

doi:10.1128/jcm.02853-14

Cited by 15 publications

(18 citation statements)

References 17 publications

(20 reference statements)

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“…The SAMBA II system is a simple "sample in-result out" platform designed for resource-limited and POC settings and has been used for HIV testing at the POC [9][10][11][12][13]. The instruments can operate in high heat and humidity (10-38°C; 5-95%) and reagents are stable at room temperature (up to 37 o C) for up to 6 months.…”

Section: Discussionmentioning

confidence: 99%

Performance Evaluation of the SAMBA II SARS-CoV-2 Test for Point-of-Care Detection of SARS-CoV-2

et al. 2020

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Nucleic acid amplification for the detection of SARS-CoV-2 RNA in respiratory samples is the standard method for diagnosis. The majority of this testing is centralised and therefore turnaround times of several days. Point-of-care testing with rapid turnaround times would allow more effective triage in settings where patient management and infection control decisions need to be made rapidly. Inclusivity and specificity of the SAMBA II SARS-CoV-2 Test was determined by both in silico analyses of the primers and probes and wet testing. The SAMBA II SARS-CoV-2 Test was evaluated for performance characteristics. Clinical performance was evaluated in residual combined throat/nose swabs and compared to the Public Health England real-time PCR assay targeting the RdRp gene. The SAMBA II SARS-CoV-2 Test has an analytical sensitivity of 250 cp/mL detecting two regions of the genome (Orf1ab and N). The clinical performance was evaluated in 172 residual combined nose/throat swabs provided by the Clinical Microbiology and Public Health Laboratory, Addenbrooke's Hospital, Cambridge (CMPHL), which showed an estimated positive percent agreement of 98.9% (95% CI: 93.83-99.97) negative percent agreement of 96.4% (95%CI: 89.92-99.26) compared to testing by CMPHL. The data shows that the SAMBA II SARS-CoV-2 Test performs equivalently to the centralised testing methods with shorter turnaround time of 86-101 minutes). Point of care testing, such as SAMBA, should enable rapid patient management and effective implementation of infection control measures.

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Section: Discussionmentioning

confidence: 99%

Performance Evaluation of the SAMBA II SARS-CoV-2 Test for Point-of-Care Detection of SARS-CoV-2

et al. 2020

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“…The test result is visually scored on a lateral flow assay (LFA) format with a viral load threshold of 1,000 copies/ml. The SAMBAs currently use plasma, adding 15 to 20 min to the test processing time and requiring a refrigerated centrifuge, although a whole-blood testing format is in development (54,55). The SAMBA I semi-Q prototype assay had a reported 96.6% (CI not reported) concordance with the Roche COBAS AmpliPrep/COBAS TaqMan (57).…”

Section: Currently Available Testsmentioning

confidence: 99%

Point-of-Care HIV Viral Load Testing: an Essential Tool for a Sustainable Global HIV/AIDS Response

et al. 2019

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SUMMARY The global public health community has set ambitious treatment targets to end the HIV/AIDS pandemic. With the notable absence of a cure, the goal of HIV treatment is to achieve sustained suppression of an HIV viral load, which allows for immunological recovery and reduces the risk of onward HIV transmission. Monitoring HIV viral load in people living with HIV is therefore central to maintaining effective individual antiretroviral therapy as well as monitoring progress toward achieving population targets for viral suppression. The capacity for laboratory-based HIV viral load testing has increased rapidly in low- and middle-income countries, but implementation of universal viral load monitoring is still hindered by several barriers and delays. New devices for point-of-care HIV viral load testing may be used near patients to improve HIV management by reducing the turnaround time for clinical test results. The implementation of near-patient testing using these new and emerging technologies may be an essential tool for ensuring a sustainable response that will ultimately enable an end to the HIV/AIDS pandemic. In this report, we review the current and emerging technology, the evidence for decentralized viral load monitoring by non-laboratory health care workers, and the additional considerations for expanding point-of-care HIV viral load testing.

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“…Other features of the instrument include the possession of Bluetooth connectivity, and thus, the results can be electronically transmitted. To limit the interference of cellular nucleic acids, the manufacturer has developed a miniaturize leukodepletion column that can deplete more than 99.9% of white blood cells (WBCs) from 100 l venous whole blood (230). The new device with the built-in WBC-depleting component significantly improved the assay for VL testing.…”

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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Leukodepletion as a Point-of-Care Method for Monitoring HIV-1 Viral Load in Whole Blood

Cited by 15 publications

References 17 publications

Performance Evaluation of the SAMBA II SARS-CoV-2 Test for Point-of-Care Detection of SARS-CoV-2

Performance Evaluation of the SAMBA II SARS-CoV-2 Test for Point-of-Care Detection of SARS-CoV-2

Point-of-Care HIV Viral Load Testing: an Essential Tool for a Sustainable Global HIV/AIDS Response

Diagnosis of Human Immunodeficiency Virus Infection

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