Serological and PCR Testing for COVID-19
ConditionCOVID-19
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-70
SponsorRichmond Research Institute
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Male or female aged 5 to 70 years.
An understanding, ability, and willingness to fully comply with the project procedures and restrictions.
Disqualifiers
Not applicable.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Membrane-based immunoassay kit
Diagnostic testThe 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
Diagnostic testAntibody titres will be measured from whole blood samples taken from volunteers.
PCR Test
Diagnostic testPCR tests will be conducted on throat swabs taken from volunteers.
Treatment groups
2,500 Participants
are divided into 1 treatment groupGroup A: Trial Participants3 interventions
Trial outcomes
Primary outcomes
1
Identification of carriers of SARS-CoV-2
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
Time frame
Through study completion, estimated 12 weeksSecondary outcomes
1
Determination of the duration of immunity to SARS-CoV-2
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
Time frame
Through study completion, estimated 12 weeks2
Development of a quantitative laboratory reference test for the measurement of SARS-CoV-2
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
Time frame
Through study completion, estimated 12 weeks3
Exploration of SARS-CoV-2 epidemiology
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.
Time frame
Through study completion, estimated 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Richmond Research Institute
Lead sponsor
Richmond Pharmacology Limited
Collaborator
Source ClinicalTrials.gov