Lucira COVID-19 All-In-One Test Kit
Lucira’s COVID-19 All-In-One Test Kit is a molecular in vitro diagnostic test that has an analytical sensitivity, or ability to detect the SARS-CoV-2 virus. This test is authorized for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider. This test is authorized for use in Point of Care settings for individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider. This home test kit has been authorized by FDA under EUA.
Availability: Commercially Available
| Manufacturer |
| Lucira Health |
| Product Name |
| Lucira COVID-19 All-In-One Test Kit |
| Detection Category |
| Biological |
| Detection Principle |
| Molecular; |
| Detection Method |
| Nucleic Acid Amplification; |
| Application |
| Diagnostics; |
| Equipment Type |
| Diagnostic |
| Product Synopsis |
| Lucira’s COVID-19 All-In-One Test Kit is a molecular in vitro diagnostic test that has an analytical sensitivity, or ability to detect the SARS-CoV-2 virus. This test is authorized for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider. This test is authorized for use in Point of Care settings for individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider. This home test kit has been authorized by FDA under EUA. |
| Availability |
| Commercially Available |
| Technology Readiness Level (TRL) |
| 9 |
| Market Entry Date |
| November 2020 |
| User Feedback Sources |
| Indifferent/No user feedback |
| Supporting Documentation |
| Docs: Lucira-Package-Insert-PI.pdf; |
| No Information Is Available |
| Transportability |
| Handheld |
| Tested For Biological Agents |
| SARS-CoV-2 |
| Sample Introduction |
| Biological sample |
| Response Time (Sample Application To Output) |
| >15 minutes; 30 minutes |
| Training Required |
| <1 hour training |
| Manuals Available |
| Yes |
