Coronavirus (COVID-19) IgM/IgG Rapid Test Kit

Universal Services Foundation LLC is now carrying  COVID -19 IgM/IgG Rapid Test Cassettes, one of the world’s finest rapid point-of-care lateral flow chromatographic immunoassays for the qualitative detection of antibodies (lgG and lgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. The test has been used widely by the Chinese CDC to combat infections and is now available globally. This test detects both early marker and late marker, IgM/IgG antibodies in human finger-prick (capillary), serum, and plasma samples.

In this ever-growing pandemic, the in vitro diagnostic test can be used for the rapid screening of carriers of the virus that are symptomatic or asymptomatic. Recent studies suggest that a high percentage of patients show no clinical symptoms of the virus, thus screening patients is vitally important. The test is ideally suited for hospitals, clinics, and test laboratories. The test can also be effectively deployed via telehealth, or in businesses, schools, airports, seaports and train stations, etc., giving it the potential to become a compelling force in the fight against this global threat. The test must use under the supervision of a health care professional at the point of care. It is important to note that this test is not intended for home use.

Test Principle

The COVID-19 lgG/IgM Rapid Test Cassette is a qualitative membrane strip based immunoassay for the detection of antibodies (lgG and lgM ) to Novel coronavirus in human Whole Blood/Serum/Plasma. The test cassette consists of:

1. a burgundy-colored conjugate pad containing Novel coronavirus recombinant envelope antigens conjugated with Colloid gold (Novel coronavirus conjugates)
2. a nitrocellulose membrane strip containing two test lines (lgG and lgM lines) and a control line (C line)

The lgM line is pre-coated with the Mouse anti-Human lgM antibody, lgG line is coated with Mouse anti-Human lgG antibody. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. lgM anti-Novel coronavirus, if present in the specimen, will bind to the Novel coronavirus conjugates. The immunocomplex is then captured by the reagent pre-coated on the lgM band, forming a burgundy colored lgM line, indicating a Novel coronavirus lgM positive test result. lgG anti-Novel coronavirus if present in the specimen will bind to the Novel coronavirus conjugates. The immunocomplex is then captured by the reagent coated on the lgG line, fanning a burgundy colored lgG line, indicating a Novel coronavirus lgG positive test result. The absence of any T lines (lgG and lgM) suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

This product has CE-IVD registration and has a Certificate of Conformity and all Certifications that can be download along with the Instructions for Use and other relevant documents by submitting a PO.

• FDA Guidance Document