18 October 2022
Certain epidemiological contexts require robust, versatile and on-demand approaches for pathogen detection that entail minimal logistical and financial constraints. These approaches are increasingly sought after as first-line solutions for the identification and surveillance of pathogen outbreaks, namely in contexts of epidemics and pandemics in low-income countries or remote regions, as well integrated in the context of emergency readiness protocols.
For instance, during the early global onset of COVID-19, viral detection according to WHO guidelines (i.e., RT-PCR in nasopharyngeal samples) represented a massive burden for the health systems of low-income countries, which had significant repercussions in the impact of this disease in the population of these countries (Pascale et al., 2021). This burden tended to be pairwise, in that it was both due to the high costs of the RT-PCR reactions and upstream sample preparations, as well as due to a generalized lack of specialized infrastructure and human resources (Pascale et al., 2021). As an alternative, several NGOs have organized screening campaigns to provide rapid, sensitive, specific and cost-effective point-of-care (POC) testing of human coronaviruses in several African countries, which has led to an accurate diagnosis of the COVID-19 prevalence in these sensitive regions (Morrison and DeVoe, 2022).
Currently, there are numerous POC devices available for the detection of viral, prokaryotic and eukaryotic pathogens that can meet these demanding requirements, including immunochemical methods (e.g., ELISA), isothermal-based DNA amplification methods (e.g., LAMP) or, more recently, microfluidics-based protocols (Wu et al., 2018; Roy et al., 2021). Yet, a common bottleneck associated with the clinical use of these on-demand solutions relies on the absence of a compatible and ready-to-use sample preparation protocol that can quickly deliver high-quality biological samples with suitable concentration factors and minimal host contamination (Roy et al., 2021).
Devin™ Filter: quick, easy and high depletion efficiency
Devin™ filter, developed by Micronbrane Medical, uses a patented Zwitterionic Interface Ultra-Self-Assemble technology that can deplete 95% of human nucleated cells from biological samples in only 5 minutes. This depletion technology stands out among its competitors due to its capacity to deliver representative samples (with minimal interferences on microbial composition), with highly enriched fractions of bacteria and viruses and with minimal loss of key elements of the target microbiome (Fig. 1).
Figure 1. Comparison of contemporary host DNA depletion techniques with the Devin™ proprietary technology.
Devin™ filter is part of a pipeline of products developed by Micronbrane Medical that can expedite pathogen detection, using various next-generation sequencing platforms, with lower costs per sample and, ultimately, with multiple benefits to patients and healthcare providers alike. However, being an easy-to-use approach that requires non-specialized handling requirements, Devin™ filters also have the potential to act as a robust sample processing methodology to be coupled upstream of the available POC technologies for pathogen detection in sensitive contexts.
Advantages of the Devin™ filters for POC clinical diagnosis
- Ready-to-use solution
Devin™ filters come 100% integrity tested, individually packaged and sterilized directly out of the box, requiring only a single syringe to operate with minimal handling requirements
- ISO certified
Devin™filters are certified by ISO 13485 and are compliant with the best-practices of the medical industry
- Highly versatile:
Devin™ filters can be used with whole blood, plasma and other body fluids (serum, swabs and washed) with low sample inputs (< 10 mL) and with quick processing times (up to 5 min)
- Ensures reproducibility
Devin™ filters can ensure the traceability and reproducibility of the results by serving as a robust and effective sample preparation methodology for confirmatory genomic analyses (via NGS-based pathogen detection)
Devin™ filter is a fully validated and proprietary host depletion technology that can facilitate upstream sample prepping for POC clinical diagnosis. By being an out-of-the-box ready-to-use sample preparation solution, Devin™ ensures a quick and easy filter-based host depletion protocol that delivers high-quality biological samples compatible with most POC methodologies, while also ensuring full compliance with the best-practices in the medical industry.
In addition to this, Devin™ filters offer a unique opportunity to streamline the comparison of POC diagnosis results with the results obtained by more robust genomic approaches, namely NGS-based techniques, and can do so in combination with PaRTI-Seq™, another Micronbrane Medical product for NGS library prep, by enabling fast, effective and cost-efficient pathogen detection with reduced costs and very fast sample turnover. For more information on this, please check: OnePager
Pasquale, S., Gregorio, G. L., Caterina, A., Francesco, C., Beatrice, P. M., Vincenzo, P., & Caterina, P. M. (2021). COVID-19 in low-and middle-income countries (LMICs): A narrative review from prevention to vaccination strategy. Vaccines, 9(12), 1477. https://doi.org/10.3390/vaccines9121477
Roy, S., Arshad, F., Eissa, S., Safavieh, M., Alattas, S. G., Ahmed, M. U., & Zourob, M. (2022). Recent Developments towards Portable Point-of-Care Diagnostic Devices for Pathogen Detection. Sensors & Diagnostics. https://doi.org/10.1039/D1SD00017A
Wu, T. F., Chen, Y. C., Wang, W. C., Fang, Y. C., Fukuoka, S., Pride, D. T., & Pak, O. S. (2018). A rapid and low-cost pathogen detection platform by using a molecular agglutination assay. ACS central science, 4(11), 1485-1494. https://doi.org/10.1021/acscentsci.8b00447
Morrison, M.S. & DeVoe T. (2022). Bringing more COVID-19 testing to Africa. New England BioLabs, published online on January 27, 2022. Available at: https://international.neb.com/nebinspired-blog/bringing-more-covid-19-testing-to-africa