Covid19 Clinical Trial
Official title:
Large-scale Population Screening of Pooled Viral Nucleic Acid Samples Using Concurrent Isothermal Amplification and Electrochemical Detection for Novel Infectious Diseases on a Disposable Chip
NCT number | NCT04847804 |
Other study ID # | CRE2021.188 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | May 31, 2024 |
Infectious diseases pose a threat to the life of individuals worldwide. The pandemic has highlighted the need to develop an innovative and cost- effective large population-based screening methodology. The investigators propose a two-fold improvement barcode-labeled testing strategy specifically for pooled samples. This platform combines isothermal amplification and real-time electrochemical detection; electroactive modified loop probes will be used in the amplification step for barcode readout. This method enables four samples pooled detection at the same time. This platform will be integrated into a disposable microfluidic chip that allows minimal human intervention during the process to realize a massively parallel screening platform for infectious disease pathogens. Objectives 1. To develop a sensing method for concurrent electrochemical-tag coded isothermal amplification and real-time electrochemical detection; 2. To design a molecular strategy to barcode four individual samples so that they can be pooled together and to simultaneously amplify and identify a positive individual, if any, from the pooled sample. 3. To fabricate a microfluidic device integrating the sample processor and barcoding module with the nucleic acid amplification and detection step for large-scale population screening of up to 100 individuals. 4. To validate the performance of the prototype using clinical specimens and benchmark it against the detection data from commercially available testing equipment.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients hospitalized at the Prince of Wales Hospital who have received testing for SARS-CoV-2 PCR - Age 18 years or above Exclusion Criteria: - Mentally incompetent to provide informed consent |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Hong Kong University of Sciences and Technology | Sai Kung | |
Hong Kong | Chinese University of Hong Kong | Shatin | |
Hong Kong | Prince of Wales Hospital | Shatin |
Lead Sponsor | Collaborator |
---|---|
Hong Kong University of Science and Technology | Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong |
Hong Kong,
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