Covid19NCT04732637
Concordance Between Buccal Cavity Swab and Nasopharyngeal Swab for SARS-CoV-2 (COVID-19) Detection by RT-PCR and ELISA
An observational study of Covid19, run by Datar Cancer Genetics Limited at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Covid19
- What is being tested?
- Test At Home's Proprietary "Lollipop" Buccal Cavity Swab
- How many people
- 300 participants
- Where
- 1 siteIndia
- Study dates
- 31 Mar 2021to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Pediatric patients.
- Inability to provide Informed Consent.
- Inability to provide Nasopharyngeal Swab and / or Buccal Cavity Swab.
Trial locations and contacts
1 site in 1 country.
India1 site
Datar Cancer Genetics
Nashik, Maharashtra, 422010
Vineet Datta, MD, +919911110457, drvineetdatta@datarpgx.com
Dadasaheb Akolkar, PhD, +917387705888, dadasaheb.akolkar@datarpgx.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Test At Home's Proprietary "Lollipop" Buccal Cavity Swab
- Keywords
- COVID19, Nasopharyngeal Swab, Self Collection, Chewable, Lollipop
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test At Home's Proprietary "Lollipop" Buccal Cavity SwabDiagnostic test
Also called Self Collection Buccal Cavity Swab, Buccal Cavity Swab
Self-collected Test At Home's proprietary "Lollipop" Buccal Cavity Swab with VTM.
| Study group | Role | What they receive |
|---|---|---|
| COVID Positive | Individuals who have recently tested positive for COVID19 by RTPCR, with active infection. Receives: Diagnostic Test: Test At Home's Proprietary "Lollipop" Buccal Cavity Swab | |
| COVID Negative | Individuals who have recently tested negative for COVID19 by RTPCR. Receives: Diagnostic Test: Test At Home's Proprietary "Lollipop" Buccal Cavity Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline / Day 0 (At first collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start31 Mar 2021 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Datar Cancer Genetics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Test At Home Pte. Ltd, National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Vivek Manoharan, PhD, Principal investigator, Test At Home Pte. Ltd., Singapore - India.Paul Macary, PhD, Principal investigator, National University of SingaporeSaket Jhajharia, PhD, Principal investigator, Test At Home Pte. Ltd., Singapore - IndiaTerence Tan, MBBS, Principal investigator, Test At Home Pte. Ltd., Singapore - India.Vineet Datta, MD, Principal investigator, Datar Cancer Genetics Limited, United Kingdom - IndiaKanupriya Batra, MBA, Principal investigator, Test At Home Pte. Ltd., Singapore - India.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732637
- Sponsor's protocol ID
- U1111-1264-2742
- Status last verified
- Mar 2021
- First submitted
- 28 Jan 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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).
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04732637
- Acronym / sponsor ID
- U1111-1264-2742
- Conditions
- Covid19
- Keywords
- COVID19, Nasopharyngeal Swab, Self Collection, Chewable, Lollipop
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Datar Cancer Genetics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Test At Home Pte. Ltd, National University of Singapore
- Study start
- 31 Mar 2021 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID Positive | – | Diagnostic Test: Test At Home's Proprietary "Lollipop" Buccal Cavity SwabIndividuals who have recently tested positive for COVID19 by RTPCR, with active infection. |
| COVID Negative | – | Diagnostic Test: Test At Home's Proprietary "Lollipop" Buccal Cavity SwabIndividuals who have recently tested negative for COVID19 by RTPCR. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pediatric patients.
- Inability to provide Informed Consent.
- Inability to provide Nasopharyngeal Swab and / or Buccal Cavity Swab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test At Home's Proprietary "Lollipop" Buccal Cavity SwabAlso: Self Collection Buccal Cavity Swab, Buccal Cavity SwabSelf-collected Test At Home's proprietary "Lollipop" Buccal Cavity Swab with VTM. | Diagnostic test | COVID Negative, COVID Positive |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Individual participant dataSharing planned: Undecided. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Manoharan, PhD principal investigator
Test At Home Pte. Ltd., Singapore - India.
Paul Macary, PhD principal investigator
National University of Singapore
Saket Jhajharia, PhD principal investigator
Test At Home Pte. Ltd., Singapore - India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Datar Cancer Genetics Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vineet Datta, MD (+919911110457, drvineetdatta@datarpgx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between buccal cavity swab and contemporary nasal swab. (time frame: Baseline / Day 0 (At first collection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.