Corona Rapid Test Kit

COVID-19 IgM/IgG

CoronaCheck tests are rapid tests for the antibodies to the Coronavirus (COVID-19) that delivers a result in ~15 minutes.

The tests qualitatively detect IgM and IgG antibodies to SARS-CoV-2 using a blood specimen.

Professional Use Only

Product Availability

We have begun shipping orders.  Due to a surge in worldwide demand for rapid antibody tests,  demand has outstripped available supply.  We are filling orders already received but must now temporarily restrict orders to 750 tests or more.  We are working diligently with our suppliers to secure additional inventory.

Please note:  all new orders will filled when additional inventory is received.  We expect to ship new orders in 14-21 days.

Orders can only be placed by licensed medical professionals for use in point-of-care setting.  At this time, we cannot ship to consumers for home use.

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

Prioritize care to those who need it most

Test can be performed in any setting

Low price means frequent testing is an affordable possibility

 Important Information

This test has not been reviewed by the FDA (also called USFDA).  The tests distributed are registered and listed with FDA, and conforms to FDA guidelines for COVID-19 point of care serological tests.

Product Description:  a rapid, qualitative immunoassay that detects a person’s antibodies (i.e., IgG and IgM) to SARS-CoV-2, which is the virus that causes COVID-19.

Negative results do not preclude 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.

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.

For use only by clinical laboratories and healthcare workers at the point-of-care.  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.

An example CoronaCheck test. Multiple models may be sold.

Running a Test

Testing can be completed in 15 minutes.   A blood specimen is required.

Step 1

Use lancet device to obtain a drop of blood.

Collect blood using a transfer pipette (provided).

Step 2

Drop 1 drop (10 ul) of blood onto test strip.

Step 3

Add 2 drops of buffer solution into well.

Step 4

Wait approximately the amount of time indicated in the Instructions For Use after which a positive control indicator line is visible.

HOW IT WORKS

The presence of antibody Immunoglobulin G and Immunoglobulin M (IgG and IgM) proteins specific for SARS-CoV-2 IgG and IgM antibodies are indicated by a visible line in the specific region indicated on the device.  

The following graph is for illustration purposes only. Significant differences in the post-infection incubation period required for seroconversion are believed to exist.

IMPORTANT

  • This test has not been reviewed by the FDA.
  • 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.
  • 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.
  • 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.