FDA Authorized (EUA) Coronavirus IgG/IgM Rapid Test
For Professional Use Only
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 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.
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device 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, symptomatic or asymptomatic, for COVID-19. Results obtained should not be the sole determinant for clinical decision. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals ands birds that cause respiratory, enteric, hepatic and neurologic diseases. Four viruses - 229E, OC43, NL63 and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV and SARS-CoV-2 (COVID-19) are can be transmitted from between non-human vertebrates to humans.
Instructions for Use:
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 below. 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.
- FDA Emergency Use Authorization (EUA)
- Tests may be performed in CLIA moderate to high complexity facilities *See FDA Policy for Coronavirus tests for the most up to date information
- Detection Window (IgM): Symptomatic 3-5 days, Asymptomatic 7 days
- Dual band results for simple interpretation
- Multivariable analysis of immunoglobin IgG & IgM
- Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
- Procedural internal control included
- Buffer included
Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%
Negative Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%
Specimen: Whole Blood, Serum, Plasma
Time to Results: 10 minutes
Shelf Life: 24 months from the date of manufacture
Healgen COVID-19 IgG/IgM Rapid Test Cassette
Test: COVID-19 IgG/IgM Rapid Test Cassette
Technology: Lateral Flow
|Antibody||Performance Measure||Estimate of Performance||95% Confidence Interval|
|IgM||Sensitivity||100% (30/30)||(88.7%; 100%)|
|IgM||Specificity||100% (80/80)||(95.4%; 100%)|
|IgG||Sensitivity||96.7% (29/30)||(83.3%; 99.4%)|
|IgG||Specificity||97.5% (78/80)||(91.3%; 99.3%)|
|Combined||Sensitivity||100% (30/30)||(88.7%; 100%)|
|Combined||Specificity||97.5% (78/80)||(91.3%; 99.3%)|
|Combined||PPV at prevalence = 5%||67.8%||(35.0%; 88.4%)|
|Combined||NPV at prevalence = 5%||100%||(99.4%; 100%)|
Frequently Asked Questions
What does FDA Emergency Use Authorization (EUA) mean?
The United States (U.S.) FDA has made this testavailable under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causesCOVID-19.An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective.The EUA for the test you received is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used). Click here for infomation from the FDA.
Are these tests CLIA waived?
We are unable to speak to the CLIA status of such tests as no CLIA categorization has been made by the FDA, although the FDA has indicated that such tests may be used in high to moderate complexity laboratory settings. Click here for more information.
How can I collect the blood sample?
Please read the product insert included with the test kit carefully for details on how to collect the sample and adminster the test correctly. Click Here for more information on the CDC’s guidlines for collecting, handling, and testing clinical specimens for COVID-19.
What do these tests test for?
These tests dectect the presence of immunoglobin G (IgG) and M (IgM) antibodies.
What if someone has a positive result?
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 orpast 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.Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making patient management decisions.All laboratories using this test must follow standard confirmatory testing and reporting guidelines according to their appropriate public health authorities.
Does this test detect a recent infection?
These tests will detect if there has been an adpative immune response to COVID-19 indicating recent or prior infection.
How accurate are these tests?
Please read the product insert included with the test kit carefully for detailed performance characteristics.
Can I purchase these tests?
These tests are designed for use by Medical Healthcare professionals only. Give us a call or fill out the form below for more information and to see if you are eligible for purchasing.
Will my insurance provider reimburse me for purchasing these tests?
Fill Out the Order Request Form Below for any COVID-19 Test Requests.
Deerfield Beach, FL 33442