Concordance Between Buccal Cavity Swab and Nasopharyngeal Swab for SARS-CoV-2 (COVID-19) Detection by RT-PCR and ELISA

March 26, 2021 updated by: Datar Cancer Genetics Limited

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Nasopharyngeal Swabs (NPS) are used to test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. For this, a swab is inserted deep into the back of the nose to collect a sample. It can cause discomfort for most people. It also increases the risk of transmission and other challenges. The present study aims to develop a more convenient method of collecting samples for COVID-19 testing. The study is based on the hypothesis that saliva collection using the proprietary flavour-stimulated 'Lollipop' swab (LPS) can be a more viable alternative to NPS.

The study aims to establish the comparative efficacy of SARS-Cov-2 infection assessment using Test At Home's proprietary "lollipop" buccal cavity swab (LPS) that simulates oral fluid collection via flavouring and mastication (self-collection) using the contemporary nasal swab collection (by health worker) as standard.

For the present study, 300 pairs of matched nasopharyngeal swab (NPS) (health care worker collected) and simulated oral fluid specimens (self-collected) will be obtained from 150 Coronavirus Disease -19 (COVID-19) positive patients and 150 COVID 19 negative individuals.

Test Method 1: Self-collected Test At Home's proprietary "lollipop" buccal cavity swab with Viral Transport Medium (VTM) will be evaluated using the Standard 'TaqPath™' COVID-19 Conformité Européenne - In Vitro Diagnostic (CE-IVD) Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) which is approved by the Indian Council of Medical Research (ICMR)

Test Method 2: Self-collected Test At Home's proprietary "lollipop" buccal cavity swab with VTM will be evaluated using National University of Singapore (NUS) developed Enzyme Linked Immunosorbent Assay (ELISA) Method.

Active Comparator : Health worker collected Nasopharyngeal Swab (NPS) with VTM which will be evaluated using the Standard TaqPath™ COVID-19 CE-IVD RT-PCR which is approved by the Indian Council of Medical Research (ICMR).

The diagnostic performance of using NPS and Oral fluids will be statistically compared to determine concordance of positive and negative findings and establish the performance characteristics of the Test Methods.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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).

Description

Inclusion Criteria:

  1. Males and Females
  2. Adults
  3. Known COVID-19 positive by RTPCR (with active infection) OR Known COVID-19 negative by RTPCR (tested within 7 days)
  4. Provision of Informed Consent
  5. Willing to provide Nasopharyngeal Swab as well as Buccal Cavity Swab

Exclusion Criteria:

  1. Pediatric patients.
  2. Inability to provide Informed Consent.
  3. Inability to provide Nasopharyngeal Swab and / or Buccal Cavity Swab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID Positive
Individuals who have recently tested positive for COVID19 by RTPCR, with active infection.
Diagnostic test: Test At Home's Proprietary "Lollipop" Buccal Cavity Swab
Self-collected Test At Home's proprietary "Lollipop" Buccal Cavity Swab with VTM.
Other Names:
  • Self Collection Buccal Cavity Swab
  • Buccal Cavity Swab
COVID Negative
Individuals who have recently tested negative for COVID19 by RTPCR.
Diagnostic test: Test At Home's Proprietary "Lollipop" Buccal Cavity Swab
Self-collected Test At Home's proprietary "Lollipop" Buccal Cavity Swab with VTM.
Other Names:
  • Self Collection Buccal Cavity Swab
  • Buccal Cavity Swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance between buccal cavity swab and contemporary nasal swab.
Time Frame: Baseline / Day 0 (At first collection)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Datar Cancer Genetics Limited

Collaborators

National University of Singapore
Test At Home Pte. Ltd

Investigators

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 31, 2021

Primary Completion (Anticipated)

May 31, 2021

Study Completion (Anticipated)

August 31, 2021

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 26, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1264-2742

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual Participant Data (IPD) may be made available to qualified researchers upon written request with declaration of intent to use and after signing of a Confidentiality Agreement / Non Disclosure Agreement (NDA).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe