CoronaCheck Tests

CoronaCheck Tests is a service of 20/20 GeneSystems, dedicated to the evaluation, acquisition, verification and commercialization of rapid and laboratory tests for antibodies to SARS-CoV-2.

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We offer two solutions for SARS-CoV-2 antibody testing:

  1. Rapid test that delivers results in less than 15 minutes.
  2. Lab-based test that offers higher accuracy but requires specimen to be sent to our lab.
Rapid Test

Rapid COVID-19 IgM/IgG Test
(Lateral Flow)

We offer a convenient rapid antibody test strip to detect antibodies to the SARS-CoV-2 that deliver results in less than 15 minutes.  This product is only for use by medical professionals.

20/20 sources these kits from leading global manufacturers and conducts our own additional quality assurance in the United States.

KEY FEATURES & BENEFITS
  • Qualitative detection of IgM and IgG antibodies that bind to the virus that causes COVID-19
  • Provides results in just minutes.
  • Easy to use test – No special equipment needed.
  • Test can be performed by high complexity clinical laboratories.
  • Low price means frequent testing is an affordable possibility.
WARNINGS & IMPORTANT INFORMATION
  • Product Description:  a rapid, qualitative immunoassay designed to detect antibodies (IgG and IgM) to SARS-CoV-2, which is the virus that causes COVID-19.
  • This test has not been reviewed by the FDA.
  • 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.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus.
  • Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  • 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.
  • It is not known whether persons having antibodies to SARS-CoV-2 are not infectious, can be re-infected or may experience COVID-19 in the future.
  • Not for use in blood screening.
  • For use only by high complexity clinical laboratories. All other use is prohibited.
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
  • Made in China, distributed by 20/20 BioResponse.
RAPID TEST AVAILABILITY

Rapid tests are in stock and ready to ship.   Customers wishing to purchase by corporate PO should contact our sales team.  See our Order page for more details.

Lab Test

Laboratory Based Antibody Test
for COVID-19

We offer antibody testing using the highly accurate Roche Diagnostics COVID‑19 antibody serology test.  This test for IgM / IgG antibodies is run in our high-complexity CLIA certified laboratory, located in Rockville, MD where we also offer OneTest, a blood test to aid in the early detection of multiple cancers.  The Roche test received Emergency Use Authorization from the FDA on May 2, 2020.

KEY FEATURES & BENEFITS
  • Qualitative detection of IgM and IgG antibodies that bind to the virus that causes COVID-19
  • Provides high standard of reliability using instruments by leading global manufacturer (Roche Diagnostics).
  • 100% sensitivity.
  • Lower laboratory fees than most PCR tests.
  • Authorized by FDA for  emergency use only (EUA).
SENSITIVITY AND SPECIFICITY:

Sensitivity of 100% (for samples taken from patients at least 14 days after PCR confirmation of infection) and an overall specificity of 99.81% (over 5,000 samples tested).

No identified cross reactivity with samples containing antibodies to HIV, four other common cold coronaviruses, other pathogens, nor to 40 common cold samples.

LABORATORY TEST AVAILABILITY:

We are currently accepting specimens for testing.

Not for home use at this time.

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