Serological and PCR Testing for COVID-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: Membrane-based immunoassay kit
* Diagnostic Test: Quantitative antibody Tests
* Diagnostic Test: PCR Test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trial Participants<br>Male and female participants aged 5-70 years | Diagnostic Test: Membrane-based immunoassay kit<br>* 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.<br>* Other names: Covid-19 Rapid Test Kit;Diagnostic Test: Quantitative antibody Tests<br>* Antibody titres will be measured from whole blood samples taken from volunteers.<br>* Other names: Antibody titre;Diagnostic Test: PCR Test<br>* PCR tests will be conducted on throat swabs taken from volunteers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 |