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Author Spotlight: Advancements and Challenges in Hepatitis B Virus Detection
Published on: December 15, 2023
Innovative technologies for point-of-care testing of viral hepatitis in low-resource and decentralized settings
L Duchesne1,2, K Lacombe1,2,3
1Sorbonne Universités, UPMC Univ Paris, Paris, France.
Insights
Point-of-care tests offer a solution for viral hepatitis screening in resource-limited settings. Innovations like lab-on-a-chip devices can overcome barriers to developing these crucial diagnostic tools.
Area of Science:
- Medical Diagnostics
- Biotechnology
- Public Health
Background:
- Chronic viral hepatitis B and C are leading global causes of illness and death, disproportionately affecting low- and middle-income countries.
- Universal screening for viral hepatitis is hindered by the high cost and limited human resources associated with traditional serological and molecular methods.
- Existing diagnostic gaps in low-resource, decentralized settings necessitate innovative screening solutions.
Purpose of the Study:
- To explore how advancements in nanotechnology, microfluidics, biosensors, and synthetic biology can overcome technological challenges in developing integrated point-of-care (POC) tests for viral hepatitis.
- To discuss the barriers hindering the translation of POC test prototypes into commercially viable products for widespread use.
Main Methods:
- Review of innovations in lab-on-a-chip technologies and their application to diagnostic testing.
- Analysis of the technological hurdles in scaling down and automating sample preparation, detection, and readout for POC devices.
- Examination of logistical, legal, and economic factors affecting the commercialization of in vitro diagnostics.
Main Results:
- Innovations like lab-on-a-chip systems offer potential solutions to integrate multiple testing steps into single POC devices.
- Significant challenges remain in scaling down and automating all testing processes for POC devices.
- Few POC test prototypes meet the stringent requirements for mass production, limiting their market entry.
Conclusions:
- Lab-on-a-chip technology holds promise for overcoming technical barriers in POC test development for viral hepatitis.
- Commercialization challenges, including mass production requirements and regulatory/economic constraints, impede the widespread adoption of innovative POC diagnostics.
- Addressing these multifaceted challenges is crucial for improving global access to viral hepatitis screening and care.
Abstract:
According to the Global Burden of Diseases, chronic viral hepatitis B and C are one of the most challenging global health conditions that rank among the first causes of morbidity and mortality worldwide. Low- and middle-income countries are particularly affected by the health burden associated with HBV or HCV infection. One major gap in efficiently addressing the issue of viral hepatitis is universal screening. However, the costs and chronic lack of human resources for using traditional screening strategies based on serology and molecular biology preclude any scaling-up. Point-of-care tests have been deemed a powerful potential solution to fill the current diagnostics gap in low-resource and decentralized settings. Despite high interest resulting from their development in recent years, very few point-of-care devices have reached the market. Scaling down and automating all testing steps in 1 single device (eg, sample preparation, detection and readout) is indeed challenging. But innovations in multiple disciplines such as nanotechnologies, microfluidics, biosensors and synthetic biology have led to the creation of chip-sized laboratory systems called "lab-on-a-chip" devices. This review aims to explain how these innovations can overcome technological barriers that usually arise for each testing step while developing integrated point-of-care tests. Point-of-care test prototypes rarely meet the requirements for mass production, which also hinders their large-scale production. In addition to logistical hurdles, legal and economic constraints specific to the commercialization of in vitro diagnostics, which have also participated in the low transfer of innovative point-of-care tests to the field, are discussed.
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