Somerset and South Essex Coronavirus Antigen Testing

NCT04403906 | Unknown

• 1 other identifier: IRAS283137
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the utility of the PCL Rapid Antigen Test for Coronavirus (COVID-19) in a real world clinical setting. The PCL test has completed laboratory validation and holds a European CE marking for in vitro diagnostic devices. These tests have been made available to South West Pathology Services as a donation in kind by iPP (Integrated Pathology Partnership). They have been widely used in South Korea. This study will test the practical delivery of the test in terms of time constraints and error rates. We will also compare the objective performance to the current standard diagnostic test for COVID-19 and against a proven serological antibody test when a suitable reference testing becomes available. We will recruit patients having a SARS CoV-2 PCR swab test and ask for consent to test them with the PCL antigen test in parallel. We aim to study 200 patients split across three sites; Musgrove Park Hospital, Basildon University Hospital and Southend University Hospital. The results will not be used to guide clinical decision making. Patients having a COVID PCR test will be asked to read the patient information sheet and asked if they would like to participate. The patients will be asked to have a second nasal/throat swab taken shortly after their swab for the PCR test. Written informed consent will be taken for whole blood or plasma left over from any routine clinical sample to be stored as anonymised samples for future testing once a reference test becomes available. We will report results of the onsite clinical diagnostic test and the PCL antigen test with the number of the kit used, and test date. Anonymised information about year of birth, gender and place of testing will be collected alongside date of onset, symptoms and immunodeficiency status or significant conditions.

Conditions

COVID; SARS-CoV 2

Keywords

Anitgen testing; Coronavirus

Outcome Measures

Primary Outcomes (1)

• To compare the result of SARS-COV2 PCR test to PCL rapid antigen test

  Compare the sensitivity and specificity of the rapid antigen testing to current PCR test and any future developed reference test

  within 24 hours

Secondary Outcomes (2)

• Number of technically failed samples due to test issues.

  At time of testing (within 30 minutes)

• Time taken for PCL Antigen test result

  within 30 minutes

Study Arms (1)

PCL Rapid Antigen Test arm

EXPERIMENTAL

Single arm trial design. Only patients undergoing standard clinical testing (SARS-CoV-2 PCR test) and consenting for additional testing with the PCL rapid antigen test will be included

Diagnostic Test: PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test)

Interventions

PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test) DIAGNOSTIC_TEST

The PCL COV05 - COVID 19 Ag Rapid FIA test has FSC and CE approvals for the qualitative detection of SARS-CoV-2 Antigens from human oropharyngeal swabs and deep sputum samples. The manufacturer is PCL Corporation Ltd 17F, 128 B-dong, Courthouse-ro, Songpa-gu, Seoul, South Korea.

PCL Rapid Antigen Test arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has clinical indication for a COVID diagnostic test and a clinical blood sample from which whole blood or plasma will be leftover for storage

You may not qualify if:

• Inability to give written informed consent.

Sponsors & Collaborators

• Somerset NHS Foundation Trust: lead

Study Sites (1)

Musgrove Park Hospital

Taunton, Somerset, TA1 5DA, United Kingdom

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Evaluation of diagnostic test - point of care

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 27, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: on study completion and for 5 years after
• Access Criteria: other clinical researchers or public health bodies evaluating diagnostic tests for COVID-19

Locations

GB (1)