Ireland
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Recruiting Observational

Serological and PCR Testing for COVID-19

NCT04404062 · tracked via the Priya Life Science UK tracker
Phase
Observational
Started
2020-03-16
Last updated
2026-06-17

Condition(s) studied

COVID-19

Investigational drug(s) / intervention(s)

Membrane-based immunoassay kitQuantitative antibody TestsPCR Test

Membrane-based immunoassay kit: The kit is a qualitative membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens. IgG and IgM detection components are separate allowing for differential detection of each antibody.

Quantitative antibody Tests: Antibody titres will be measured from whole blood samples taken from volunteers.

PCR Test: PCR tests will be conducted on throat swabs taken from volunteers.

Study summary

Richmond Research Institute (RRI) is applying existing and new COVID-19 PCR and antibody tests to help develop methodologies which provide fast and accurate results. Infection with coronavirus (SARS-CoV-2) is currently a worldwide pandemic and reliable testing for COVID-19 is crucial to understand who is infected and therefore a risk to others by spreading the infection. RRI are currently carrying out the following tests:

A. Using a membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens helps to assess whether an individual has previously had the virus and is potentially immune

B. Polymerase Chain Reaction (PCR) testing using an established method to check for active SARS-CoV-2 infections.

C. Quantification of anti-SARS-CoV-2 IgG and IgM antibodies in whole blood samples.

The above tests are being used by RRI to follow infections (PCR) and immunity (IgG) in their workforce, as well as their families (including children) and visitors to their site.

Collecting this data allows the gathering of epidemiological data on SARS-CoV-2 including incidence, prevalence, information on asymptomatic carriers and efficacy of vaccination. Furthermore, identifying individuals that are infected with SARS-CoV-2 has great potential to improve health outcomes by allowing infected individuals to seek the correct medical treatment as well as self-isolate and reduce transmission.

Eligibility

Sex
ALL
Min age
5 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Male or female aged 5 to 70 years. * An understanding, ability, and willingness to fully comply with the project procedures and restrictions. Exclusion Criteria: * Not applicable.

Primary outcome measure(s)

  • Identification of carriers of SARS-CoV-2 — Through study completion, estimated 12 weeks
    To identify trial participants who are symptomatic or asymptomatic carriers of SARS-CoV-2 by comparing the results of a blood finger stick test and reference laboratory tests to PCR testing for acute infection

Trial sites (1)

FacilityCityRegionStatus
Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge London London Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04404062 on ClinicalTrials.gov ↗ ← All trials in the UK