- 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.
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.
Downloadable Product Information
Healgen Rapid Antibody Product Insert | FDA Emergency Use Authorization Letter | Fact Sheet For Healthcare Providers | Fact Sheet For Patients | 3rd Party Serology Clinical Study | CPT Code Billing Information
Who Can Purchase This Test?
This COVID-19 Rapid Test Kit is currently available to hospitals, laboratories and certified medical professionals only.
What is included with this kit?
This COVID-19 rapid test kit is sold in boxes of 25 individual testing cassettes and includes the following:
- 25 Rapid Testing Cassettes
- 25 Pipettes
- 1 Vial of Buffer Solution
Product Facts and Performance of COVID-19 IgG/IgM Rapid Test Kit
- Following the incubation period (1 – 2 days upon initial exposure), IgM may appear in blood within 4-7 days. IgG will appear as soon as 1-2 weeks.
- Sample: Test can work with whole blood, plasma and serum samples.
- Storage: The kit can be stored at room temperature or refrigerated (2-30°C).
- Shelf Life: 18 to 24 months
- Positive Percent agreement (PPA): 96.7% (87/90) (95%CI: 90.7%～98.9%)
- Negative Percent agreement (NPA): 98.0% (99/101) (95%CI: 93.1%~99.5%)
- Positive Percent agreement (PPA): 86.7% (78/90) (95%CI: 78.1%~92.2%)
- Negative Percent agreement (NPA): 99.0% (100/101) (95%CI: 94.6%~99.8%)
Overall (either IgG+ or IgM+) Performance:
- Positive Percent agreement (PPA): 96.7% (87/90) (95%CI: 90.7%～98.9%)
- Negative Percent agreement (NPA): 97.0% (98/101) (95%CI: 91.6%～99.0%)
Instructions for Use and Interpretation of Results
- Remove the test cassette from the sealed package and use immediately
- Place the test device on a clean and level surface.
- Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well(S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles
- Wait for the colored line(s) to appear.
- After 2 minutes, if the red color has not moved across the test window or if blood is still present in the specimen well (S), add 1 additional drop of the sample buffer to the buffer well (B).
- The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.
Negative Result = The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.
Positive IgM Result = The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region M. The test result indicates the presence of IgM anti-SARS-Cov-2 antibodies.
Positive IgG Result = The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region G. The test result indicates the presence of IgG anti-SARS-CoV-2 antibodies
Positive IgM AND IgG Result = The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The test results indicate the presence of IgM and IgG anti-SARS-CoV-2 antibodies.
Invalid Result = Control line is partially red, and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your representative.
Summary Of Antibody Testing
When an individual is initially exposed to a virus, the immune system triggers the production of antibodies that are specific to that virus. These antibodies have the power to attach to the virus so that the immune system can destroy it.
There is an incubation period or time frame where it takes a few days for these antibodies to be produced. There are two types of antibodies related to COVID. The IgM may be present during an active COVID infection. There is also the IgG antibody which typically begins to build towards the end of the infection and remains in your system after recovery. If antibodies are present, they will be found inside plasma or blood samples.
To detect the presence of antibodies using a rapid testing device, the test cassette contains a conjugate pad with SARS-CoV-2 recombinant antigens, an IgG line coated with an anti-human IgM line, an IgM line coated with anti-human IgM, and a control line.
After the sample is placed onto the testing cassette, the specimen will migrate laterally along the testing strip, slowly saturating the strip to react with the antigens on the strip. If antibodies are present, they will bind to either the conjugates in the IgM anti-human line or those in the IgG anti-human line, depending on which antibodies are present. Individuals who have either IgM or IgG antibodies will have a positive test result.
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.
What is the difference between an IgM and IgG antibody?
This rapid test screens for both the IgM and IgG antibodies.
The IgM antibody – IgM antibodies are usually the first antibodies produced in the immune system upon an initial infection. A positive IgM test results reading indicates that the patient has a high chance of a current infection and that the immune system has begun its initial response to the virus.
The IgG antibody typically develops in most patients around seven to 10 days after the initial onset of symptoms for COVID-19. Unlike IgM antibodies, IgG antibodies remain in the blood after the the immune system has effectively fought off the viral infection. A positive result reading for the IgG antibody indicates that the patient may have had recent exposure and response to COVID-19. Currently for the COVID-19 virus, it is unknown how long these antibodies remain in our systems and how much protection they might provide against reinfection.