Developers of the Global WholeHealth Partners RDT IgG/IgM Antibody Test hold a CE Rating for the test and are working to receive an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and submitted their EUA filing on April 6, 2020 (FDA EUA Submission Number: EUA200181). The US Navy is currently using GWHP’s COVID-19 antibody tests in California.
This test is distributed by COVIDSignals™ of Bailey Island, Maine.
This test is a rapid (results in minutes), qualitative (determines when a particular antibody is present), and convenient immunochromatographic in-vitro assay (liquid sample without the need for specialized or costly equipment) for the detection of, both, IgM and IgG antibodies to the COVID-19 virus in human blood samples using the Colloidal Gold (nanoparticles) Immunochromatography Method, which adds rapid, simple, specific, and sensitive characteristics to the test.
Clinical Sample Evaluation & Results Based upon a 634-test sample size evaluated using the Clinical Laboratory Improvement Amendments (CLIA) Reference Method for sensitivity and specificity, the Specificity/Sensitivity of the test is 98% while the Selectivity is 94%. These results rank this test as superior to all COVID-19 antibody type tests granted Emergency Use Authorizations (EUAs) by the U.S. Food and Drug Administration (FDA) to date.
Understanding Sensitivity and Specificity
- Sensitivity - detects antibodies that indicate people have or have had the virus
- Specificity - detects the percentage of healthy people who are correctly identified as not having had the virus (do not have present antibodies)
COVIDSignals™ (Maine, US) is the distributor of GWHP’s COVID-19 antibody test and can immediately deliver 100,000 test kits a day while ramping to produce and deliver 500,000, then 1 million test kits daily (over 30 million test kits monthly) to governments, hospitals, laboratories, and large organizations with proper test administering capabilities. This test is for professional use only.
Key Advantages:
- Delivers a demonstrated high accuracy in specificity and sensitivity of 98+% while the Selectivity is 94%
- Results in 15-minutes, a strong positive result in as little 1 minute
- No machine or equipment required to interpret results
- Identifies SARS-CoV-2 IgM & IgG antibodies
- Made in the US (California), including the reagent & membrane
- Is currently being used by the US Navy
- Determines previous exposure to COVID-19 & virus tracks the disease after infection
- Clinical sample testing performed using over 1100 patients in the US
- Developed by “The Father of the Strep-A Test,” Shujie Cui, M.D.
Developed by a Renowned Medical Doctor Shujie Cui, M.D. worked directly with the Chinese Government on SARS testing and vaccine development. He was a post-doctorate fellow in the Reproductive Biology department of The University of Texas Medical School and a post-doctorate fellow in the Division of Laboratory Medicine, M.D. Anderson Cancer Center at The University of Texas.
About COVIDSignals™ COVIDSignals™ (Bailey Island, Maine, US) is the global distributor of the Global WholeHealth Partners RDT IgG/IgM Antibody Test, the first COVID-19 serology test made wholly in the US, including its reagent and membrane. COVIDSignals™’s test delivers a 98+% accuracy via blood draw or a simple finger prick sample. To learn more, visit www.covidsignals.com.
About Clinical Laboratory Improvement Amendments (CLIA) The United States Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing authority to promulgate standards for certain laboratory testing to ensure the accuracy, reliability, and timeliness of test results regardless of where or by whom the test was performed. The CLIA requirements are based on the complexity of the test and the type of laboratory where the testing is performed. To learn more, visit: FDA.gov - CLIA Amendments
Media Inquiries: Contact Julie R. Manley, at [email protected] and at (646) 981-3342.
