Clinical Evaluation of Rapid Antibody Test for Covid-19
CERAbTc-19
2 other identifiers
interventional
397
1 country
1
Brief Summary
Rapid, accurate diagnosis of Covid-19 would greatly help to improve clinical management of patients presenting with symptoms of possible Covid-19. Currently results of the standard test for the virus take 2-3 days to be reported. Watford General Hospital has imported rapid antibody tests manufactured by Zuhai Livzon Diagnostics Inc in China and our team would like to evaluate their accuracy and clinical usefulness. The test involves taking a drop of blood from the patient (either from a venous blood sample taken for other blood tests, or from a fingerprick). This is applied to a test strip (similar to a pregnancy test) and two drops of diluent are added. If the patient has antibodies to Covid-19, two lines appear on the test strip (like a positive pregnancy test) whereas if the patient has no antibodies, only one line appears (like a negative pregnancy test). There are two different types of antibody: IgM is produced early in the course of the illness (day 7-14) and then IgG is produced later and continues to be present, probably for months or years. There are two test strips, one for each of these types of antibody. In this study we aim to evaluate the accuracy of this new test, in three groups of patients. Firstly those with proven Covid-19 and at least 7 days after the onset of their illness. We aim to recruit 200 patients in total: at least 138 patients with 10 or more days of symptoms, plus a subgroup of up to 62 patients with 7-9 days of symptoms (to explore the usefulness of the test earlier in the course of illness). The second group of 250 patients will be those hospital staff who report symptoms possibly caused by Covid-19 and are receiving a standard antibody test. The third group of patients will be those followed up in a "virtual hospital" for clinically suspected Covid-19 who had never been tested with a standard PCR test. As we are not sure of the accuracy of the new test, its results will not be used to make decisions about treatment for the patient. This study will enable us to discover rapidly whether the new test is accurate, and if so we will conduct further studies to assess how it can help to improve management of patients with suspected Covid-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started May 2020
Shorter than P25 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2020
CompletedFirst Submitted
Initial submission to the registry
March 25, 2022
CompletedFirst Posted
Study publicly available on registry
March 28, 2022
CompletedMarch 28, 2022
March 1, 2022
2 months
March 25, 2022
March 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity
Sensitivity and specificity compared to standard PCR and/or venous antibody test.
At least 7 days after onset of symptoms
Study Arms (2)
Patients
OTHERHospital staff
OTHERInterventions
Point-of-care Rapid Antibody Test for COVID-19
Eligibility Criteria
You may qualify if:
- Inpatient or patient in the "virtual hospital" with confirmed Covid-19 infection on PCR OR with history of clinically suspected Covid-19 but no PCR test OR hospital staff with clinical suspicion of past Covid-19 infection.
- Age 18 or over
- At least 7 days since onset of symptoms
- Willing and able to give written informed consent
You may not qualify if:
- Symptom duration \<7 days.
- Lack of written consent
- Age under 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southamptonlead
- West Hertfordshire Hospitals NHS Trustcollaborator
Study Sites (1)
Watford General Hospital
Watford, Hertfordshire, WD18 0HB, United Kingdom
Related Publications (1)
Vancheeswaran R, Willcox ML, Stuart B, Knight M, Kandil H, Barlow A, Patel MH, Stockham J, O'Neill A, Clark TW, Wilkinson T, Little P, Francis N, Griffiths G, Moore M. Accuracy of rapid point-of-care antibody test in patients with suspected or confirmed COVID-19. J Infect. 2022 Jan;84(1):94-118. doi: 10.1016/j.jinf.2021.07.006. Epub 2021 Jul 14. No abstract available.
PMID: 34273411RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Moore, FRCGP
University of Southampton
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2022
First Posted
March 28, 2022
Study Start
May 17, 2020
Primary Completion
July 24, 2020
Study Completion
July 24, 2020
Last Updated
March 28, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share