How COVID-19 Test Kits Works

COVID-19 IgM/IgG Antibody Ten-minute Rapid Detection Kit Test Instructions​

Use human serum, plasma, or whole blood samples, the fingerstick blood is also recommend, which is more convenient. The results can be read in 10 minutes.

The kit used S and N protein of the SARS-CoV-2 as antigen to detect specific IgM and IgG antibodies in human blood samples. The detection of recombined specific antibodies can greatly improve the specificity and sensitivity.

A part of clinical verification with president of Wenzhou medical university who is also the CAE academician has been completed. A total of 370 cases were tested, and blood samples were collected from COVID-19 patients from multiple Chinese hospitals and Chinese CDC laboratories. The sensitivity is 90.43%, the specificity is 100%, and the overall compliance rate is 95.14%.

The kit has passed authentication of ISO13485 quality system and authentication of CE safety system of European Union, FDA approval pending.

Check the video, how to use the coronavirus covid-19 test kit

Cellex Test Kit

The Cellex qSARS-CoV-2 IgG/IgM Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, citrate) or venipuncture whole blood specimens from patients suspected of COVID-19 infection by a healthcare provider. The qSARS-CoV-2 IgG/IgM Rapid Test is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the qSARS-CoV-2 IgG/IgM Rapid Test should not be used as the sole basis for diagnosis.

Disclaimer:
  • 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 diagnostic tests 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.

Clinical Trial Data

Shanghai LionRun Clinical Trial Data. 

Diagnostic Kit for IgM/IgG Antibody of SARS-CoV-2(Colloidal Gold Immunochromatography)

In order to test the detection sensitivity and specificity of this test, blood samples were collected from COVID-19 patients from multiple Chinesehospitals and Chinese CDC laboratories. The tests were done separately at eachsite. A total of 370 cases were tested: 188(positive) clinically confirmed (including PCR test) SARS-CoV-2-infected patients and 182 non- SARS-CoV-2-infected patients (negative). The testing results were summarized in the table below:

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