COVID-19 IgG/IgM Rapid Test Kit

Find the presence of past and/or present infection within 15 minutes.

This rapid test cassette reliably identifies IgG and IgM antibodies specific to SARS-CoV-2.

Bestel nu

Accuracy: Sensitivity & Specificity

IgG test

Sensitivity

Positive agreement with PCR testing

97,40%

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

IgM test

Sensitivity

Positive agreement with PCR testing

97,01%

Specificity

Ability to correctly identify negative cases

98,89%

Accuracy

Ability to detect IgM or IgG

93,41%

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).

How it works

Add to Specimen Well (s):

1. One drop of whole blood/plasma/serum (~10 ul) using the dropper (provided)

2. Two drops of buffer (provided)

3. Read Results in 15 minutes.

Interpreting Results

* Results should not be read after 20 minutes

Negative
One colored line appears in the Control (C) region. Indicates that SARS-CoV-2 specific antibodies are not present or are present at undetectable levels.

Positive
Colored lines appear in the Control (C) region and the IgM region. This indicates the presence of SARS-CoV-2 specific IgM antibodies.

Positive
Colored lines appear in Control (C) region and the IgG region. This indicates the presence of SARS-CoV-2 specific IgG antibodies..

Positive
Colored lines appear in the Control (C) region, the IgG region and the IgM region. This indicates the presence of SARS-CoV-2 specific IgM and IgG antibodies.

Invalid
Colored line fails to appear in the Control (C) region, most likely indicating insufficient specimen volume or incorrect procedure. Repeat the test with a new test cassette.

Frequently Asked Questions

Is this test safe?

Yes, this test is safe. All that is required to complete the test is a specimen of whole blood/plasma/serum. This test and others like it are used widely around the world to determine the presence of antibodies to fight multiple viruses or bacteria.

How does this test differ from the PCR test?

This test shows whether the tested individual potentially has the IgM or IgG antibody to COVID-19. A PCR test can confirm whether someone has the virus and is currently infected.

What is IgG and what is IgM?

IgM antibodies are the most common type of antibody in your blood. They protect your body against infections by remembering which germs you’ve been exposed to before. IgM antibodies are what your body produces when you are first infected by a new virus or bacteria. They tend to spike early on and then dissipate as IgG antibodies assume the role protecting you from the virus.

IgM antibodies to SARS-CoV-2 are usually detected in the blood several days after the initial infection. IgG antibodies to SARS-CoV-2 are detectable later after an infection. The presence of IgM and IgG antibodies may indicate a recent exposure to COVID-19.

What are the other benefits of this test?

This rapid serology test delivers results in 15 minutes with no instrumentation required. It should be performed by a healthcare professional following regular clinical laboratory procedures with just one drop of blood. The strip is easy to read and can indicate both the presence of SARS-CoV-2 specific IgM antibodies and SARS-CoV-2 specific IgG antibodies.

*Note: The Clungene SARS-CoV-2 IgG/IgM Rapid Serology Test has been provided through guidance set forth by the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019. It has not been reviewed by the FDA.

  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been exposed to the virus. Follow-up testing with molecular diagnostics should be considered in these individuals.
  • 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.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.