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Clungene® SARS CoV-2 Virus Test Kit

Clungene® Coronavirus SARS CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Kit FDA EUA Submission Number: EUA201121 There are 25 test kits in each box
SKU: TK1034AB14
¥170.95
excluding shipping
This product has a minimum quantity of 1000

Clungene® Coronavirus SARS CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Kit 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 Pipettes
  • 25 Buffers
  • 25 Alcohol Pads
  • 25 Lancets
  • 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 Point-of-Care 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 20 minutes whether you have been exposed to the virus fast and with reliable results.

The test is very simple.

Two drops of blood are taken from a patient’s fingertip and placed in the specimen window of a test cassette, along with two drops of buffer solution.

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, whole blood, or finger-prick samples. 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.