Concordance Between Buccal Cavity Swab and Nasopharyngeal Swab for SARS-CoV-2 (COVID-19) Detection by RT-PCR and ELISA
Evaluating the Use of Flavour-stimulated Oral Fluids Collection for Severe Acute Respiratory Syndrome Coronavirus 2 Detection by Reverse Transcriptase Polymerase Chain Reaction and Enzyme Linked Immunosorbent Assay - a Concordance Study.
1 other identifier
observational
300
1 country
1
Brief Summary
Nasopharyngeal Swabs (NPS) used to test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection can cause mild to severe discomfort in addition to increasing the risk of transmission. The present study evaluates Test At Home's proprietary self-collection method based on a chewable buccal cavity swab ("lollipop") that stimulates oral fluid collection. The novel method is compared against a contemporary nasal swab collected by a qualified healthcare worker.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Shorter than P25 for all trials
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
First Submitted
Initial submission to the registry
January 28, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedStudy Start
First participant enrolled
March 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedMarch 30, 2021
March 1, 2021
2 months
January 28, 2021
March 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concordance between buccal cavity swab and contemporary nasal swab.
Three-way concordance of SARS-Cov-2 infection assessment between Test At Home's "Lollipop" buccal cavity swab (assessed by RTPCR and ELISA) and contemporary nasal swab (assessed by RTPCR).
Baseline / Day 0 (At first collection)
Study Arms (2)
COVID Positive
Individuals who have recently tested positive for COVID19 by RTPCR, with active infection.
COVID Negative
Individuals who have recently tested negative for COVID19 by RTPCR.
Interventions
Self-collected Test At Home's proprietary "Lollipop" Buccal Cavity Swab with VTM.
Eligibility Criteria
Adult males and females, who have understood the aims, scope, benefits and risks of the study as well as study procedures and provide Informed Consent are eligible to participate. The Study will recruit one hundred and fifty (150) individuals who are known COVID-19 positive (confirmed by RTPCR) and have active infection. The Study will also recruit one hundred and fifty (150) individuals who are known COVID-19 negative (confirmed by RTPCR within the last 7 days).
You may qualify if:
- Males and Females
- Adults
- Known COVID-19 positive by RTPCR (with active infection) OR Known COVID-19 negative by RTPCR (tested within 7 days)
- Provision of Informed Consent
- Willing to provide Nasopharyngeal Swab as well as Buccal Cavity Swab
You may not qualify if:
- Pediatric patients.
- Inability to provide Informed Consent.
- Inability to provide Nasopharyngeal Swab and / or Buccal Cavity Swab.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Datar Cancer Genetics Limitedlead
- Test At Home Pte. Ltdcollaborator
- National University of Singaporecollaborator
Study Sites (1)
Datar Cancer Genetics
Nashik, Maharashtra, 422010, India
Biospecimen
Biological samples collected via nasopharyngeal swaps and 'lollipop' buccal mucosa swabs and used for extraction of viral nucleic acids
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vivek Manoharan, PhD
Test At Home Pte. Ltd., Singapore - India.
- PRINCIPAL INVESTIGATOR
Paul Macary, PhD
National University of Singapore
- PRINCIPAL INVESTIGATOR
Saket Jhajharia, PhD
Test At Home Pte. Ltd., Singapore - India
- PRINCIPAL INVESTIGATOR
Terence Tan, MBBS
Test At Home Pte. Ltd., Singapore - India.
- PRINCIPAL INVESTIGATOR
Vineet Datta, MD
Datar Cancer Genetics Limited, United Kingdom - India
- PRINCIPAL INVESTIGATOR
Kanupriya Batra, MBA
Test At Home Pte. Ltd., Singapore - India.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2021
First Posted
February 1, 2021
Study Start
March 31, 2021
Primary Completion
May 31, 2021
Study Completion
August 31, 2021
Last Updated
March 30, 2021
Record last verified: 2021-03