A game changer in Covid-19 testing with results in minutes Rapid and convenient Covid–19 testing to help restore confidence in your daily life.

Coronavirus Testing to give you a piece of mind

During these very uncertain times of the Coronavirus pandemic testing is fundamental in our ability to help facilitate a return to work, school and life with a bit more confidence.

Why are we different?

EvaClean’s Rapid COVID-19 IgM/IgG Combo Test Kit is a game changer because within minutes you can determine if you have either the Covid-19 IgM or IgG antibodies.

Our test is fast, reliable, affordable and portable that is produced at mass scale in the USA to greatly expand access to testing to people who need it.

  • Sensitivity for IgG/IgM

  • Authorized by FDA EUA

  • Proudly made in USA

EvaClean COVID-19 Rapid Antibody IgG & IgM Test Kit

Results in 10 minutes

EvaClean’s Rapid COVID-19 IgM/IgG Combo Test Kit is a lateral flow immunoassay intended for qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to COVID-19 simultaneously in serum and plasma

The tests are made in the USA to ensure the quality of our tests and reduce the lead time to get them to you.

Easy to Use

  • Add one drop of blood

  • Add sample buffer

  • Results in minutes

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How the test works

Results are for the detection of COVID-19 antibodies IgM and IgG. The IgM antibody to COVID-19 is generally detectable in blood couple of days after initial infection, and IgG antibody is detectable typically after 7 days and stay in immune system longer. Individuals may have detectable virus present for several weeks following seroconversion.

Easy to Read Results within Minutes

Test Negative

Negative result mean no infection or not enough detectable antibodies in early infection

The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.

Test IgM positive

IgM Positive means recently infected with Covid-19

The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region M. The test result indicates the presence of IgM anti-SARS-Cov-2 antibodies.

Test IgG and IgM Positive

IgG and IgM Positive means recently infected with Covid-19

The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The test results indicate the presence of IgM and IgG anti-SARS-CoV-2 antibodies.

Test IgG Positive

IgG Positive means previously infected with Covid-19

The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region G. The test result indicates the presence of IgG anti-SARS-CoV-2 antibodies

Invalid test

Invalid test

Control line is partially red, and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Rapid COVID-19 IgM/IgG Combo Test Kit

  • FDA Emergency Use Authorization (EUA)
  • Rapid results within 10 minutes
  • Small sample size
  • Sold in packs of 25
  • Shelf life of up to 24 months from manufacture date
  • More information, such as the product insert, clinical trial results, and documentation is available at request
  • Healthcare Provider Fact Sheet
  • Recipient Fact Sheet

Warning

This test has been authorized by FDA under an EUA for use by authorized laboratories. 

This test has not been FDA cleared or approved.

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.

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.

 

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.

This product is intended for professional use and not for home use.

Not for the screening of donated blood.

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