What is the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) test?
This test is an antibody test. It will help assess if you have antibodies to the virus that causes COVID-19. An antibody test may not be able to show if you have a current infection, because it can take 1-3 weeks after infection to make antibodies.
Potential risks include:
•Possible discomfort or other complications that can happen during blood collection.
•Possible incorrect test result (see below for more information).
Potential benefits include:
•The results, along with other information, can help you and your healthcare provider make informed recommendations about your care.
How does the test work?
This test utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.
What Do The Test Results Mean?
A positive test result with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) indicates that antibodies to SARS-CoV-2 were detected, and the individual has potentially been exposed to SARS-CoV-2. Antibodies to SARS-CoV-2 are generally detectable several days following infection. Individuals may have detectable virus present for several weeks following seroconversion. A positive result can indicate recent or past infection but does not exclude recently infected patients who are still contagious. It is unknown how long antibodies to SARS-CoV-2 will remain present in the body after infection and if they confer immunity to infection. Incorrect assumptions of immunity may lead to premature discontinuation of physical distancing requirements and increase the risk of infection for individuals, their households and the public. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to individuals could include the following: a recommendation for isolation of the individual, monitoring of household or other close contacts for symptoms, isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 individuals, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects. Due to the risk of false positive results, confirmation of positive results should be considered – using a second, different antibody assay that detects the same type of antibodies.
A negative test result with this test means that SARS-CoV-2 specific antibodies were not present in the specimen above the limit of detection. However, patients tested early after infection may not have detectable antibodies despite active infection; in addition, it is not certain that all infected patients will develop a detectable antibody response to SARS-CoV-2 infection. A negative result should not be used to rule out infection. Direct testing of SARS-CoV-2 should be performed if acute infection is suspected.
1) Remove the test cassette from the sealed foil pouch and use it as soon as possible.
2) Lay device on flat surface and add specimen (see specific instructions for each specimen type below):
a) For Serum or Plasma Specimen: With the plastic dropper provided, draw serum/plasma specimen to exceed the specimen line, as shown in the diagram above. Hold the dropper vertically and transfer drawn serum/plasma specimen into the sample well (S). Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
b) For Whole Blood Specimen: Hold the plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the sample well (S) of the test device. Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
3) Wait for the control line (C) to change from blue to a red color. If, after 2 minutes, the sample has not moved across the test window or if blood is still present in the sample well (S), add 1 additional drop of sample buffer to the buffer well (B).
4) The results should be read in 10 minutes. Do not interpret the result after 15 minutes.
Our serology tests received Emergency Use authorization from the FDA on May 29, 2020. The FDA has published further information regarding EUA usage and guidelines that can be found here.
The Covid 19 Rapid Antibody test can be used in high- and moderate-complexity laboratories. For more information please refer to the
Our tests can be sold to hospitals, urgent care, outreach clinics, physician offices, and other patient care settings that employ trained medical personnel and/or currently distribute medical products to these settings.
For reimbursement information please visit https://www.cms.gov/newsroom/press-releases/trump-administration-announces-expanded-coverage-essential-diagnostic-services-amid-covid-19-public
The test detects both IgG and IgM. Please refer to the graphic found above for more information on both IgG and IgM and what the detection means. If you have further questions, please email firstname.lastname@example.org
Please refer to:
This test has been authorized by FDA under an EUA (Emergency Use Authorization) for use by authorized laboratories (e.g. moderate complexity or high complexity lab. This test has not been FDA 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 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 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.