Healgen® COVID-19 IgG/IgM Rapid Test Cassette Kit of 25 Tests
The COVID-19 IgG/IgM Rapid Antibody Test has emerged as a critical part of the arsenal for delivering a swift diagnosis and discovery of Antibodies — with results in 10 minutes or less. Because of its portability and speed, rapid IVD testing has been crucial in battling COVID-19 across the globe.
- Qualitative detection of IgG and IgM antibodies that bind to COVID-19 causing virus
- Simple and easy to use
- Healthcare providers can administer tests
- Results delivered within minutes
- 25 individual sealed pouches containing test cassettes, dropper and desiccant
- 1 buffer solution bottle
- 1 package insert
- COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 novel coronavirus in human whole blood, serum or plasma
- Specimen type must be whole blood (venous), serum or plasma.
- 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 clinical laboratories and healthcare workers. 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.
- Manufactured in China by Healgen Scientific, distributed in the US by RapidIVD, a PMT Medical company
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 or IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This test is only authorized for the duration of the decloration that cirumstances exist justifies the authorization of emergency ues of in vitro diagnostics 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 coronovirus strains, such as coronovirus HKU1, NL63, OC43, or 229E.
This product is intended for professional use and not for home use.
Not for the screening of donated blood.