COVID-19 RAPID IgM/IgG ANTIBODY TEST

In response to the COVID-19 Coronavirus pandemic, Global Health Sourcing has made it our goal to source and distribute the best COVID-19 Rapid Point of Care Test Kits available within the United States and Internationally. As with any disease state, early detection is key. The IgG/IgM rapid test looks for Immunoglobin G and Immunoglobin M, to aid in the detection of the novel coronavirus. IgM looks for the virus in its acute state within the body, and IgG detects the antibodies that determine whether the patient had the virus in the past. Virus antibodies are detected in blood within 1-3 weeks after infection, and results of the IgG/IgM rapid COVID-19 test are provided in less than 15 minutes.  

Coronavirus dual IgG and IgM rapid point of care testing can be done virtually anywhere, and is a great option for employers, entertainment venues, senior care facilities, and healthcare organizations. Testing must be conducted by a licensed healthcare professional, similar to the flu shot, and is performed by obtaining 10 ul of blood from a simple finger stick or venipuncture.

Health professionals are practitioners, including physicians, nurses, pharmacists, dentists, respiratory therapists, physical therapists, technologists, or any other practitioners or allied health professionals that have a role in using a device for human use.

Global Health Sourcing is located in the United States of America, and we are proud to be sourcing COVID-19 rapid test kits from American companies.

We look forward to facilitating our communities return to work, the lifestyles they love, along with reuniting families, friends and loved ones.  

REGULATORY DISCLOSURES

● This test has not been reviewed by the FDA.
● Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection 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.

The Manufacturer will track adverse events and report to FDA under 21 CFR Part 803. A website will be available to report on adverse events, and this website will be referenced in the Fact Sheet for Health Care providers as well as through the “COVID-19 (Sars Cov-2) IgM/IgG test”. Each report of an adverse event will be processed according to The Domestic Manufacturer Non-Conformance Reporting Requirements, and Medical Device Reports will be filed with the FDA as required. Through a process of inventory control, The Domestic Manufacturer will also maintain records of device usage/purchase. The Domestic Manufacturer will collect information on the performance of the test, and report to FDA any suspected occurrence of false positive or false negative results of which The Domestic Manufacturer becomes aware. The Domestic Manufacturer will maintain records associated with this EUA and ensure these records are maintained until notified by FDA. Records will be made available to FDA for inspection upon request.