COVID-19 IgG IgM Rapid Test Cassette
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is
used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general,
antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved.
Availability: Commercially Available
| Manufacturer |
| Mercedes Scientific |
| Product Name |
| COVID-19 IgG IgM Rapid Test Cassette |
| Detection Category |
| Biological |
| Detection Principle |
| Immunological; |
| Detection Method |
| Lateral Flow Hand Held Immunoassay; |
| Application |
| Diagnostics; |
| Product Model Number |
| HGS GCCOV402A |
| Equipment Type |
| Diagnostic |
| Product Synopsis |
| The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is
used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general,
antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved.
|
| Availability |
| Commercially Available |
| Technology Readiness Level (TRL) |
| 9 |
| Market Entry Date |
| June 2020 |
| User Feedback Sources |
| Indifferent/No user feedback |
| No Information Is Available |
| Transportability |
| Handheld |
| Shelf Life |
| <5 years; 24 Months from Date of Manufacturer at 36° - 86°F (2°-30°C) |
| Unit Cost |
| $375.00 for a box of 25 kits |
| Tested For Biological Agents |
| anti-SARS-CoV-2 IgM, IgG antibodies |
| Sample Introduction |
| Biological sample; Whole Blood, Serum, Plasma |
| Total Run Time |
| 10 minutes |
| Other Operational Parameters |
| Buffer included |
| Training Required |
| <1 day training |
