COVID-19 Rapid Testing at Home: Roche and CovClear Antigen Self Test Got Authorized by Health Canada
Roche and CovClear Antigen Self Test got authorized by Health Canada under interim order. Individuals can use the rapid test kits to test themselves at home quickly and easily using a small nasal swab for easier sampling.
These nasal tests are intended for both symptomatic and asymptomatic self-use. They provide reliable results within 15-20 minutes, allowing informed decisions including rapid isolation. Individuals can purchase the tests in packs of five through Gene Bio Medical and other sites that are in compliance with local public health testing guidelines.
The main use cases of the self-test
The SARS-CoV-2 Antigen Self-Test Nasal allows anyone at risk to test themselves on a regular basis without having to see a doctor first. It also helps to protect others because quick outcomes give people more confidence in their ability to return to normal life activities. This screening method could be used to allow access to specific sites based on fast test results, according to local public health guidelines.
In addition to diagnostic testing, preventive measures remain key for protection against SARS-CoV-2. It is recommended to continue wearing masks, be socially distant, and practice good hygiene.
About Roche COVID-19 Antigen Self Test Nasal for at-home patient self-testing
Roche COVID-19 Rapid Antigen Test is a rapid chromatographic immunoassay (lateral flow assay) for the detection of the nucleocapsid protein of SARS-CoV-2 in human nasal samples.
The clinical performance of the test was measured in three clinical studies. The overall relative sensitivity was 91.2% (Ct ≤ 30); 94.9% and 100% in the three different studies. The overall relative specificity was 100%, 100%, and 98.4% in the three studies, which represents the ability of the test to correctly identify patients without the virus.
About CovClear COVID-19 Antigen Self Test Nasal for at-home patient self-testing
CovClear COVID-19 Rapid Antigen Test is a rapid chromatographic immunoassay (lateral flow assay) for the detection of the nucleocapsid protein of SARS-CoV-2 in human nasal samples.
The human usability and clinical evaluation of the CovClear COVID-19 Rapid Antigen Test as an Over the Counter (OTC) test was evaluated at two testing sites in the United States. A total of 477 subjects were enrolled in an all-comers study, including both symptomatic (117) and asymptomatic (360) subjects. Symptomatic subjects were defined as those exhibiting at least one of the following signs and symptoms on day of presentation: Fever, cough, body aches, sore throat, chills, loss of taste or smell, congestion, or runny nose. Asymptomatic subjects were defined as subjects not experiencing COVID-19 symptoms on day of testing. Subjects either self-administered the test or administered the test to another subject in a simulated home setting, following the steps of the IFU and video available online (www.covcleartest.com). A nasal swab sample was also collected by a healthcare provider for testing using a US FDA authorized highly sensitive RT-PCR test. Swabs for the CovClear and comparator test were collected in a randomized manner to prevent bias in viral load.