Richmond Research Institute (RRI) is applying existing and new COVID-19 PCR and antibodytests to help develop methodologies which provide fast and accurate results. Infectionwith coronavirus (SARS-CoV-2) is currently a worldwide pandemic and reliable testing forCOVID-19 is crucial to understand who is infected and therefore a risk to others byspreading 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 inwhole blood, serum or plasma specimens helps to assess whether an individual haspreviously had the virus and is potentially immuneB. Polymerase Chain Reaction (PCR) testing using an established method to check foractive 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) intheir workforce, as well as their families (including children) and visitors to theirsite.Collecting this data allows the gathering of epidemiological data on SARS-CoV-2 includingincidence, prevalence, information on asymptomatic carriers and efficacy of vaccination.Furthermore, identifying individuals that are infected with SARS-CoV-2 has greatpotential to improve health outcomes by allowing infected individuals to seek the correctmedical treatment as well as self-isolate and reduce transmission.
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
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 Name: Covid-19 Rapid Test Kit
Diagnostic Test: Quantitative antibody Tests
Antibody titres will be measured from whole blood samples taken from volunteers.
Other Name: Antibody titre
Diagnostic Test: PCR Test
PCR tests will be conducted on throat swabs taken from volunteers.
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.
Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge
London, United Kingdom
Investigator: Keith Berelowitz, PhD
Investigator: Jorg Taubel, MD FFPM
Jorg Taubel, MD
+44(0)2070425800
j.taubel@richmondpharmacology.com
Ulrike Lorch, MD
+44(0)2038482005
u.lorch@richmondpharmacology.com
Jorg Taubel, MD, Principal Investigator
Richmond Pharmacology Limited