Find the presence of past and/or present infection within 15 minutes.
This rapid test cassette reliably identifies IgG and IgM antibodies specific to SARS-CoV-2.
This test is not FDA Approved.
The FDA is allowing Clungene® SARS-CoV-2 IgG/IgM Rapid Serology Test to be made available under its new policy dated May 4, 2020. (Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency). As required, the completed template and associated documentation were submitted on May 15, 2020 and are waiting feedback from FDA. The submission (EUA#201121) included updated validation reports and additional clinical data. Clungene’s establishment registration & device number on the FDA’s website is 3009414546.
Learn more about Hangzhou Clongene Biotech and its proven track record with rapid test kits.
Accuracy: Sensitivity & Specificity
Sensitivity = 97.40% Positive agreement with PCR testing
Testing of Coronavirus Disease (COVID-19) in healthcare workers using SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene® test.
Sensitivity = 87.01% Positive agreement with PCR testing
Specificity = 98.89% Ability to correctly identify negative cases
Accuracy = 93.41% Ability to detect IgM or IgG
Evaluation of SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene® test with RT-PCR testing in inpatients with COVID-19 for the detection of antibodies (IgG and IgM).
Proven Pharma has secured a significant, long term supply of the Clungene® SARS-CoV-2 IgG/IgM Rapid Serology Tests. However, given the high demand of rapid antibody tests, availability will vary. Purchase orders can be delivered in 3 days from our Plymouth Meeting, Pennsylvania, Distribution Center when we are carrying inventory. We will provide an accurate delivery timeframe when we are replenishing inventory or awaiting a shipment. Only licensed medical professionals in the United States are able to purchase tests.
How It Works
***This test should be performed by a healthcare professional following regular clinical laboratory procedures. Follow Instructions for Use.***
Add to Specimen Well (s):
1. One drop of whole blood/plasma/serum
(~10 ul) using the dropper (provided)
Yes, this test is safe. All that is required to complete the test is a specimen of whole blood/plasma/serum. This test and others like it are used widely around the world to determine the presence of antibodies to fight multiple viruses or bacteria.
Is this test effective?
Patients tested early after infection may not have detectable IgM antibody, despite active infection; in addition, not all patients will develop a detectable IgM and/or IgG response to SARS-CoV-2 infection. The accuracy of the Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test reported on the Instructions for Use is 93.41%; however, the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) has not been absolutely determined for lateral flow chromatographic immunoassays which can detect antibodies against the SARS-CoV-2 virus.
Does this test have FDA approval?
No. This test is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under a policy to allow developers of certain serological tests to begin to market or use their tests once they have performed the appropriate evaluation to determine that their tests are accurate and reliable. The FDA included this test on its list of tests available under those rules. See the US Food and Drug Administration website for more information (https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-tests).
Have you applied for an Emergency Use Authorization?
We are in the process of submitting the application. All validation reports were submitted to the FDA but have not been reviewed by the FDA. The product’s FDA registration number is 3009414546.
How does this test work?
It is very easy. A healthcare professional administers the test by applying one drop of blood/plasma/serum in a tiny basin at the bottom of the testing tab, along with two drops of buffer that are provided with the kit. Within about 15 minutes, red lines on the indicator strip will show whether the test was negative (meaning the person does not have COVID-19), positive for IgM antibodies, positive for IgG antibodies or positive for both. If the strip shows nothing, the results are invalid, and the test should be administered again. This test is only to be used by healthcare professionals at point of care sites. The tests should not be used after the expiration date, and the test cassette should remain in its sealed pouch until use. All specimens should be considered hazardous and handled in the same manner as an infectious agent. Test cassettes should be discarded according to federal, state and local guidelines.
How does this test differ from the PCR test?
This test shows whether the tested individual potentially has the IgM or IgG antibody to COVID-19. A PCR test can confirm whether someone has the virus and is currently infected.
What is IgG and what is IgM?
IgM antibodies are the most common type of antibody in your blood. They protect your body against infections by remembering which germs you’ve been exposed to before. IgM antibodies are what your body produces when you are first infected by a new virus or bacteria. They tend to spike early on and then dissipate as IgG antibodies assume the role protecting you from the virus.
Why does it matter?
IgM antibodies to SARS-CoV-2 are usually detected in the blood several days after the initial infection. IgG antibodies to SARS-CoV-2 are detectable later after an infection. The presence of IgM and IgG antibodies may indicate a recent exposure to COVID-19.
What are the other benefits of this test?
This rapid serology test delivers results in 15 minutes with no instrumentation required. It should be performed by a healthcare professional following regular clinical laboratory procedures with just one drop of blood. The strip is easy to read and can indicate both the presence of SARS-CoV-2 specific IgM antibodies and SARS-CoV-2 specific IgG antibodies.
Where did you get this test?
Proven Pharma is the exclusive authorized distributor in the U.S. for Hangzhou Clongene Biotech Co., the producer of the Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test. Proven has distributed Hangzhou Clongene products in the U.S. since 2018. Clongene is a well-established pharmaceutical company based in Hangzhou, China. Proven has performed multiple site visits of the Clongene facilities for supply chain efficiencies and quality assurance.
What is Hangzhou Clongene?
Founded in 2004, Hangzhou Clongene Biotech Co. is a well-established manufacturer of in vitro diagnostics products. The company works from a state-of-the-art facility in Hangzhou, China. Clongene obtained its official license to manufacture medical devices from the Chinese government in 2009 and its initial FDA clearances in 2016. Clongene is registered to sell 24 products in the U.S., according to the FDA, including Clungene SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test. Proven Pharma is the exclusive, authorized dealer of Clongene products in the U.S. since 2018.
What is Proven Pharma?
Established in 2012, Proven Pharma is a service provider to the healthcare and life science industries. The company offers a wide range of solutions that include specialty distribution, comparator sourcing for clinical trials, dedicated inside sales teams, marketing support, digital transformation and technology consulting. The companies have two decades of experience across many areas of the healthcare landscape. Proven has developed a reputation for delivering on time, every time, while ensuring safety and compliance.
How did Proven establish a relationship with Clungene?
Proven Pharma is the exclusive, authorized dealer of Clongene products in the U.S. since 2018. Proven has performed multiple site visits of the Clongene facilities for supply chain efficiencies and quality assurance.
*Note: The Clungene SARS-CoV-2 IgG/IgM Rapid Serology Test has been provided through guidance set forth by the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019. It has not been reviewed by the FDA.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been exposed to the virus. Follow-up testing with molecular diagnostics should be considered 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.
[WARNINGS AND PRECAUTIONS]
For in vitro diagnostic use only.
For healthcare professionals and professionals.
Do not use after the expiration date.
Please read all the information in this leaflet before performing the test.
The test cassette should remain in the sealed pouch until use.
All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
The used test cassette should be discarded according to federal, state and local regulations.