Corona Rapid Test Kit
COVID-19 IgM/IgG
CoronaCheck tests qualitatively detect antibodies to the SARS-CoV-2 using a blood specimen and deliver a result in less than 15 minutes.
Professional Use Only
Product Availability
We have tests ready to ship. Orders of 10 cases or less will ship within 7 days. For customes with large orders or customers wishing to place a purchase order, please contact our sales team. See our Order page for more details.
CoronaCheck tests are for use by licensed medical professionals and clinical laboratories. 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
Test can be performed by clinical laboratories and healthcare providers at the point-of care.
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 policy guidance for COVID-19 serological tests.
Product Description: a rapid, qualitative immunoassay that detects 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.
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.
WARNINGS
- 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.
- Not for use in blood screening.