Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04732637
Status:
UNKNOWN
Last Update Posted:
2021-03-30
First Post:
2021-01-28
Brief Title:
Concordance Between Buccal Cavity Swab and Nasopharyngeal Swab for SARS-CoV-2 COVID-19 Detection by RT-PCR and ELISA
Sponsor:
Datar Cancer Genetics Limited
Organization:
Datar Cancer Genetics Limited
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Homes 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 Homes 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 Homes 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 Homes 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
The study aims to establish the comparative efficacy of SARS-Cov-2 infection assessment using Test At Homes 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 Homes 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 Homes 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None