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Somerset and South Essex Coronavirus Antigen Testing

NCT04403906 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-05-27

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen 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.

Sponsors & Collaborators

  • Somerset NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-06-30
Completion
2021-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04403906 on ClinicalTrials.gov