Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Canary Global Inc
BreathX Technologies Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or female more than 2 years of age at Visit 1 or at the time of first sample collection for test in pre-screening or screening 2 Participant is willing and able to give informed consent for participation in the study 3 Subject who is able to comply with the study requirements, as defined in the present protocol, at the Investigatorââ?¬•s discretion 4 Is able to mentally and physically perform self collection of saliva using the provided collection device 5 Written and well documented informed choice consent (and assent when applicable) obtained from subject and or subjectââ?¬•s legal representative
Exclusion criteria
Exclusion criteria: 1Male or female � 2 years of age at Visit 1 or at the time of first sample collection before enrolment. 2Subject who has administered COVID-19 vaccines in last 12 months. 3Flu shot within 6-8 weeks of test. 4Any serious injury or illness likely to preclude completion of the trial. 5Frequent alcohol or recreational drug use. 6Undergoing active chemotherapy. 7Inability to give informed consent and/or has no guardian. 8Subjects with salivary gland dysfunction including subjects with Sjogren syndrome. 9Subjects with oral cancers or any oral infections. 10Subjects chewing tobacco, gutka, pan-masala, pan etc. 11Subjects with mouth ulcer or any oral / dental infection which can impact the quality of saliva sample. 12Subjects currently undergoing any dental surgery or procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the performance, accuracy, clinical sensitivity and specificity of Pelican COVID-19 Ultra-Rapid Mobile test device to detect the SARS-CoV-2 infection of both symptomatic and asymptomatic COVID-19 infected and healthy subjects by collecting saliva samples.Timepoint: Screening up to 2 days, test procedure upto 6 days and follow up 10-14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to evaluate ease and efficiency of device using Saliva samples in early detection of COVID-19 infection at point of care facility or home by self-testing Criteria for evaluation through Usability Study for Pelican COVID-19 Ultra Rapid Mobile Test.Timepoint: Screening up to 2 days, test procedure upto 6 days and follow up 10-14 days | — |
Countries
India
Contacts
Public ContactDr Hashmi Farogh
BreathX Technologies Pvt. Ltd., a Canary Global Inc. Company.
Outcome results
None listed