The SARS-CoV-2 IgG/IgM Rapid Test Kit is used to qualitatively detect IgG and IgM antibodies of SARS-CoV-2 in human serum, plasma or whole blood. This device is intended to be used by professionals as a screening test and for SARS-CoV-2 research. Any reactive specimen with the SARS-CoV-2 IgG/IgM rapid test kit should be confirmed with alternative testing method(s).
Click here for a introductory video on TBG's COVID-19 Testing Kits.
To report any adverse events, please see the section on "Regulations" shown below.
* 添付文書はこちらをご覧ください。
* Mode d’emploi en français disponible ci-dessous.
Kit Contents: Disposable test card, disposable plastic capillary tubes, lancet, sample diluent, instructions for Use.
Storage: CE (2 to 30°C for 12 months). FDA-EUA (2 to 8C for 9 months)
| Negative （陰性） |
 |
| IgM Positive （IgM陽性） |
 |
| IgG Positive （IgG陽性） |
 |
| IgG / IgM Positive （IgG/IgM陽性） |
 |
| Catalog. No. | Package Sizes |
| No. 20010 | 25 tests/kit |
| No. 20010S | 1 test/kit |
CE-IVD
FDA EUA
For reporting of adverse events related to this product, please send an email to COVID19@tbgbio.com and include the following within your email:
- Product name and lot number.
- Product operator and related testing facility.
- Detailed description of the adverse event as well as the date of occurrence.
All reported adverse events will be periodically updated and reported below.
Currently Reported Adverse Events (Updated 8/12/2020): None Reported.
| Name / Version | Description | Size |
| v1.5 |
User Manual (CE)
|
0.63MB |
| v1.2 |
User Manual (EUA)
|
2.63MB |
| v1.2 |
Control Set (only sold in U.S.)
|
0.13MB |
| v1.5 |
添付文書（日本語バージョン）
|
0.42MB |
| v1.5 |
Mode d’emploi en français
|
0.25MB |
| Name / Version | Description | Size |
| v2.7 |
DM
|
2.01MB |
| 8-31-2020 |
Fact Sheet for Health Care Professionals
|
0.14MB |
| 8-31-2020 |
Fact Sheet for Recipients
|
0.13MB |
| v2.6 |
Introduction and Testing Strategies
|
11.02MB |
English
繁體中文
简体中文