Large-scale COVID-19 Population Screening

NCT04847804 | Unknown

• 1 other identifier: CRE2021.188
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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. 1.To develop a sensing method for concurrent electrochemical-tag coded isothermal amplification and real-time electrochemical detection;
2. 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. 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. 4.To validate the performance of the prototype using clinical specimens and benchmark it against the detection data from commercially available testing equipment.

Conditions

Covid19

Keywords

COVID-19; Population screening

Outcome Measures

Primary Outcomes (1)

• Diagnostic test

  The sensitivity, specificity, and positive and negative predictive values will be calculated for futher data analysis

  through study completion, an average of 3 years

Study Arms (2)

Positive case

The sample will be tested by microfluidic device and shows positive

Negative control

The sample will be tested by microfluidic device and shows negative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients hospitalized at the Prince of Wales Hospital who have received testing for SARS-CoV-2 PCR

You may qualify if:

• Patients hospitalized at the Prince of Wales Hospital who have received testing for SARS-CoV-2 PCR
• Age 18 years or above

You may not qualify if:

• Mentally incompetent to provide informed consent

Sponsors & Collaborators

• Hong Kong University of Science and Technology: lead
• Chinese University of Hong Kong: collaborator
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator

Study Sites (3)

The Hong Kong University of Sciences and Technology

Sai Kung, Hong Kong

RECRUITING

Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Related Publications (8)

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  PMID: 18252097 BACKGROUND

• Hufnagel L, Brockmann D, Geisel T. Forecast and control of epidemics in a globalized world. Proc Natl Acad Sci U S A. 2004 Oct 19;101(42):15124-9. doi: 10.1073/pnas.0308344101. Epub 2004 Oct 11.

  PMID: 15477600 BACKGROUND

• Ferretti L, Wymant C, Kendall M, Zhao L, Nurtay A, Abeler-Dorner L, Parker M, Bonsall D, Fraser C. Quantifying SARS-CoV-2 transmission suggests epidemic control with digital contact tracing. Science. 2020 May 8;368(6491):eabb6936. doi: 10.1126/science.abb6936. Epub 2020 Mar 31.

  PMID: 32234805 BACKGROUND

• Shears P. Emerging and reemerging infections in africa: the need for improved laboratory services and disease surveillance. Microbes Infect. 2000 Apr;2(5):489-95. doi: 10.1016/s1286-4579(00)00309-9.

  PMID: 10865194 BACKGROUND

• Lazcka O, Del Campo FJ, Munoz FX. Pathogen detection: a perspective of traditional methods and biosensors. Biosens Bioelectron. 2007 Feb 15;22(7):1205-17. doi: 10.1016/j.bios.2006.06.036. Epub 2006 Aug 28.

  PMID: 16934970 BACKGROUND

• Jani IV, Janossy G, Brown DW, Mandy F. Multiplexed immunoassays by flow cytometry for diagnosis and surveillance of infectious diseases in resource-poor settings. Lancet Infect Dis. 2002 Apr;2(4):243-50. doi: 10.1016/s1473-3099(02)00242-6.

  PMID: 11937424 BACKGROUND

• R. Dorfman, The Detection of Defective Members of Large Populations, Ann. Math. Stat. 14 (1943) 436-440.

  BACKGROUND

• J.L. Schmid-burgk, D. Li, D. Feldman, J. Strecker, B. Cleary, A. Regev, LAMP-Seq : Population-Scale COVID-19 Diagnostics Using a Compressed Barcode Space, BioRxiv. (2020).

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

nasopharyngeal swab, deep throat saliva, and/or mouth gargle sample

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• I-Ming HSING

  Hong Kong University of Sciences and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Cheung

CONTACT

852-22528842; catherinecheung@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Chemical and Biological Engineering

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 19, 2021
• Study Start: July 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (3)