Clinical trial NCT04732637: Concordance Between Buccal Cavity Swab and Nasopharyngeal Swab for SARS-CoV-2 (COVID-19) Detection by RT-PCR and ELISA
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: COVID19
Nasopharyngeal Swab
Self Collection
Chewable
Lollipop
Lead sponsor: Datar Cancer Genetics Limited
Sponsor class: INDUSTRY
Collaborators: name: Test At Home Pte. Ltd
name: National University of Singapore
First posted: 2021-02-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concordance between buccal cavity swab and contemporary nasal swab.
timeFrame: Baseline / Day 0 (At first collection)
Secondary outcomes:
Other outcomes:
Locations:
city: Nashik
country: India
facility: Datar Cancer Genetics
state: Maharashtra
Study officials:
affiliation: Test At Home Pte. Ltd., Singapore - India.
name: Vivek Manoharan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National University of Singapore
name: Paul Macary, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Test At Home Pte. Ltd., Singapore - India
name: Saket Jhajharia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Test At Home Pte. Ltd., Singapore - India.
name: Terence Tan, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Datar Cancer Genetics Limited, United Kingdom - India
name: Vineet Datta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Test At Home Pte. Ltd., Singapore - India.
name: Kanupriya Batra, MBA
role: PRINCIPAL_INVESTIGATOR
References: