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.
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.
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 Name: Array
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.
Datar Cancer Genetics
Nashik, Maharashtra, India
Investigator: Vineet Datta, MD
Contact: +919911110457
drvineetdatta@datarpgx.com
Investigator: Vineet Datta, MD
Vineet Datta, MD
+919911110457
drvineetdatta@datarpgx.com
Dadasaheb Akolkar, PhD
+917387705888
dadasaheb.akolkar@datarpgx.com