Serological and PCR Testing for COVID-19

NCT04404062 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2025-08-27

No results posted yet for this 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.

Conditions

Interventions

DIAGNOSTIC_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.

DIAGNOSTIC_TEST

Quantitative antibody Tests

Antibody titres will be measured from whole blood samples taken from volunteers.

DIAGNOSTIC_TEST

PCR Test

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

Sponsors & Collaborators

  • Richmond Pharmacology Limited

    collaborator INDUSTRY
  • Richmond Research Institute

    lead INDUSTRY

Principal Investigators

  • Jorg Taubel, MD · Richmond Pharmacology Limited

Eligibility

Min Age
5 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-16
Primary Completion
2026-01-01
Completion
2026-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04404062 on ClinicalTrials.gov