Serological and PCR Testing for COVID-19

August 20, 2025 updated by: Richmond Research Institute

Serological and PCR Testing for SARS-CoV-2. A Prospective Study Assessing Infection, Immunity, and Asymptomatic Carriage of COVID-19

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a screening study to measure symptomatic and asymptomatic carriage of SARS-CoV-2 in trial participants to help facilitate early detection of a second wave of SARS-CoV-2 infections. Specifically, this study aims to determine ; to assess the duration of immunity by assessing the number and speed at which trial participants were infected and cleared the virus with or without symptoms; and to determine the length of symptom onset in those with an active infection; levels of IgG antibodies by demographics (sex, age, ethnicity, and intensity of symptoms). Longitudinal assessment of antibody levels will additionally allow for assessment of the efficacy of any vaccines adminstered. This study also seeks to explore how many people are asymptomatic carriers. In addition, this study aims to help facilitate the development a quantitative laboratory reference test for antibodies (IgG).

By using multiple different tests, it can be determined if a person is currently infected with SARS-CoV-2 or whether they previously have been infected. This allows for the scanning of people with asymptomatic carriage of the virus, which is important to help reduce the spread of SARS-CoV-2 through contact with people unaware of infection.

Polymerase Chain Reaction (PCR) testing is routinely used to check for active SARS-CoV-2 infections. It measures whether viral RNA is present in an individual's system. All in-house PCR tests are verified by an independent laboratory to check for false positives.

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. IgG and IgM detection components are separate allowing for differential detection of each antibody.

To this date, 20904 PCR tests and 6848 antibody tests have been carried out in 2328 individuals, providing some interim data. Of the 20904 PCR tests, 17635 (84%) were negative and 132 (1%) were negative. Of the 6848 antibody tests, 706 (10%) were positive for IgG only, 64 (1%) were positive for IgM only, and 351 (5%) were positive for both IgG and IgM. 5710 (83%) tests were negative.

Of those individuals with a positive PCR test, 53% reported fever during the previous two months and 75% reported a loss of taste during the previous two months.

Interim results are shown in the medRxiv papers below:

https://www.medrxiv.org/content/10.1101/2020.12.08.20245894v2

https://www.medrxiv.org/content/10.1101/2021.04.09.21255200v1

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • London
      • London, London, United Kingdom, SE1 1YR
        • Recruiting
        • Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge
        • Principal Investigator:
          • Jorg Taubel, MD FFPM
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants are individuals who are screened upon entry to the Richmond Pharmacology unit. These individuals may be employees of Richmond Pharmacology, volunteers for other concurrent studies, or members of the public.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trial Participants
Male and female participants aged 5-70 years
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.
Other Names:
  • Covid-19 Rapid Test Kit
Diagnostic test: Quantitative antibody Tests
Antibody titres will be measured from whole blood samples taken from volunteers.
Other Names:
  • Antibody titre
Diagnostic test: PCR Test
PCR tests will be conducted on throat swabs taken from volunteers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of carriers of SARS-CoV-2
Time Frame: 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
Through study completion, estimated 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of the duration of immunity to SARS-CoV-2
Time Frame: Through study completion, estimated 12 weeks
To determine the duration of immunity of trial participants previously infected with SARS-CoV-2, measure differences in IgG antibodies by demographics including sex, ethnicity and age and investigate correlation between IgG antibody levels and intensity of symptoms
Through study completion, estimated 12 weeks
Development of a quantitative laboratory reference test for the measurement of SARS-CoV-2
Time Frame: Through study completion, estimated 12 weeks
Determination of the understanding of the quantity of IgG antibodies developed as a response to SARS-CoV-2 infection, and how these antibody levels decrease over time. Antibody titres will be measured in infected individuals, over multiple days and correlated with disease parameters. This will facilitate the development of a quantitative laboratory reference test for IgG antibodies
Through study completion, estimated 12 weeks
Exploration of SARS-CoV-2 epidemiology
Time Frame: Through study completion, estimated 12 weeks
To help develop a quantitative laboratory reference test for antibodies (IgG) to gain an understanding of quantity of antibodies that people develop and how these decrease over time.
Through study completion, estimated 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Richmond Research Institute

Collaborators

Richmond Pharmacology Limited

Investigators

  • Principal Investigator: Jorg Taubel, MD, Richmond Pharmacology Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2020

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C20010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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