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

Covid19 Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04732637
• Other study ID #: U1111-1264-2742
• Status: Not yet recruiting
• Start date: March 31, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2021
• Source: Datar Cancer Genetics Limited
• Contact: Vineet Datta, MD
• Phone: +919911110457
• Email: drvineetdatta[@]datarpgx.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 31, 2021
• Est. primary completion date: May 31, 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Diagnostic Test:
• Test At Home's Proprietary "Lollipop" Buccal Cavity Swab
Self-collected Test At Home's proprietary "Lollipop" Buccal Cavity Swab with VTM.

Locations

Country	Name	City	State
India	Datar Cancer Genetics	Nashik	Maharashtra

Sponsors (3)

Lead Sponsor	Collaborator
Datar Cancer Genetics Limited	National University, Singapore, Test At Home Pte. Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)