This test has been granted Emergency Use Authorization by the FDA.
Available in the United States only.
Blood/Serum/Plasma was evaluated by testing a total of 191 plasma (K2EDTA) clinical samples—90 positive samples and 101 negative samples) from individual patients exhibiting pneumonia, respiratory symptoms and fever etc. Testing was performed at two sites in China from January to mid-March 2020. COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) results for IgM and IgG detection were compared to the results of RT-PCR assays for SARS-CoV-2 from oropharyngeal swabs (Site #1) and sputum (Site #2).
IgG
Positive Percent agreement (PPA): 96.7% (87/90) (95%CI: 90.7%~98.9%)
Negative Percent agreement (NPA): 98.0% (99/101) (95%CI: 93.1%~99.5%)
IgM
Positive Percent agreement (PPA): 86.7% (78/90) (95%CI: 78.1%~92.2%)
Negative Percent agreement (NPA): 99.0% (100/101) (95%CI: 94.6%~99.8%)
Overall (either IgG+ or IgM+)
Positive Percent agreement (PPA): 96.7% (87/90) (95%CI: 90.7%~98.9%)
Negative Percent agreement (NPA): 97.0% (98/101) (95%CI: 91.6%~99.0%)
For further performance data and complete information, please see the Instructions for Use (IFU).
This test has not been FDA cleared or approved.
This test has been authorized by FDA under an EUA for use by authorized laboratories.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for
any other viruses or pathogens; and
This test is only authorized for the duration of the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Available in:
Single Pack (25 tests)
Single Box (50 packs/1,250 tests)
Kit Includes:
25 Cassettes
25 Droppers
25 Dessicants 1 Buffer
1 Package Insert
Please forward all reports of false positive or false negative results, or any other performance issues to:
tpm-feedback@siliconbiosystems.com
For Emergency Authorization Use (EUA) only
For in vitro diagnostic use only
For prescription use only
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For In Vitro Diagnostic Use.