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Clungene® SARS CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Kit (25 Pack)

The Clungene® SARS CoV-2 Virus (COVID-19) IgG/IgM Rapid Test is an onsite kit with a single panel for IgM/IgG simpler detection of Coronavirus in 10-15 minutes, whether you have been exposed to the virus within the past 4 to 24 days.

The Clungene® Coronavirus SARS CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Kit includes:

  • 25 Tests (Cassettes) Foil Pouch
  • 25 Buffers  
  • 1 Package Insert

ACCURACY

Sensitivity and Specificity

IgG Test:
Testing of Coronavirus Disease (COVID-19) in healthcare workers using SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene® test.

Sensitivity = 97.40%
Positive agreement with PCR testing

IgM test:
Evaluation of SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene® test with RT PCR testing in inpatients with COVID-19 for the detection of antibodies (IgG and IgM).

Sensitivity = 87.01%
Positive agreement with PCR testing

Specificity = 98.89%
Ability to correctly identify negative cases

Accuracy = 93.41%
Ability to detect IgM or IgG

An Effective Screening Test

When the body has been exposed to the SARS-CoV-2 virus, it produces IgG and IgM antibodies in an attempt to defend itself against infection. By measuring the concentration of these particular antibodies, the SARS-CoV-2 Rapid Test can determine in 10-15 minutes whether you have been exposed to the virus fast and with reliable results.

This product is not for at-home use and is meant for health professionals following guidance from the FDA for Emergency Use Authorizations of tests submitted for approval on March 16, 2020. Suitable for the qualitative detection of Coronavirus (SARS-CoV-2 / COVID-19) N-Protein IgM / IgG antibodies in human serum, plasma, or whole blood. This test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.