4.30 COVID 19 Antibody Web Form Header_V2

 

  This test has been granted Emergency Use Authorization by the FDA.

   Available in the United States only. 

INSTRUCTIONS  FOR USE
FACT SHEET  HCP
FACT SHEET  RECIPIENTS

The COVID-19 IgG/IgM Rapid Test Cassette is for differential detection of IgG and IgM antibodies to novel Coronavirus in human whole blood (venous), serum, or plasma

Rapid-Test-Cassette_02


Specifications and Features

  • Fast and reliable results (in just 10 minutes)
  • Long shelf life: 24 months from the date of manufacture
  • Small sample size:  5 μL of serum/plasma or 1 drop of whole blood (about 10 μL)

Clinical Performance

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).

 

Table 1-AbTest

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.


The COVID-19 IgG/IgM Rapid Test Cassette, manufactured for Healgen and distributed by Menarini Silicon Biosystems Inc.

Available in:

Single Pack (25 tests)Box2
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


For pricing information and orders of the COVID-19 IgG/IgM
Rapid Test Cassette (Product Code # 84100091) please fill the form below: