Performance evaluation of the point-of-care SAMBA I and II HIV-1 Qual whole blood tests

Ritchie, Allyson; Goel, Neha; Sembongi, Hiroshi; Lehga, Jesse; Farleigh, Laura; Edemaga, Daniel; Wisniewski, Craig; Lee, Helen H.

doi:10.1016/j.jviromet.2016.08.017

Cited by 21 publications

(19 citation statements)

References 17 publications

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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%

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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%

“…The SAMBA (Simple AMplification Based Assay) II nucleic acid testing system was originally designed for HIV testing in POC and resource-limited settings, with CEmarked products for early infant diagnosis [9,10] and viral load monitoring [11][12][13].…”

Section: Downloaded Frommentioning

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 SAMBA HIV-1 Qual whole-blood test manufactured by DRW processes 100 l of capillary blood with full automation in a SAMBA II device to produce results in less than 2 h. The working principle of using a dipstick display is similar to that of its semiquantitative VL counterparts ( Table 5). It can detect HIV-1 groups M, N, and O with a limit of detection of 433 copies/ml and had 100% concordance of results with laboratory gold-standard results (284). It can process samples in a random-access manner and thus is highly advantageous for throughput and POC use.…”

Section: Poc For Eidmentioning

confidence: 96%

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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“…Such occasional positive signals were also observed in the Berlin patient 15 and may reflect a false ddPCR signal, potential contamination, or evidence of very low levels of persistence of HIV infected cells that either did not harbor fully replication competent virus or were unable to lead to recrudescence given that the vast majority of target cells are incapable of being infected with this patient's HIV CCR5 tropic variants ( Figure 2). HIV-1 DNA and RNA were also repeatedly undetectable in whole blood when tested with SAMBA II, a CE marked point-of-care isothermal amplification method (LOD: 284 copies/ml; 95% CI: 214-378 copies/ml) 16 .…”

Section: A C C E L E R a T E D A R T I C L E P R E V I E Wmentioning

confidence: 99%