Intended use

The rapid test kit is used for qualitative determination of IgG and IgM antibodies of novel coronavirus in human serum, plasma or whole blood in vitro. This kit is offered to clinical laboratories and healthcare workers for point-of-care testing, and not for at home testing, in compliance with Section IV.D. of the FDA’s Policy for COVID-19 Diagnostic Test.

Product principle

The product is based on the principle of colloidal gold technology. If the Coronavirus IgG/IgM antibodies are high enough, they will combine with the colloidal gold-labeled antigen to form a colloidal gold-antigen-antibody complex. If (IgG) G and (IgM) M lines are colored, the patient will be detected positive. If not colored, the patient will be detected negative. The quality control (C) line is always colored to indicate the test is effective.

Clinical Application

In human infected with a novel coronavirus (COVID-19), the body's immune system produces an immune response to the virus, producing specific antibodies. The determination of relevant antibodies can be used to screen for infection with novel coronavirus.

· 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.

Not for the screening of donated blood.

Applicable Department

Emergency Department

ICU

Pneumology Department

Cardio-Pulmonary Function Department

Result Reference

Except IgG/IgM rapid test, what else can manufacturer offer?

1) Virus Transport Medium (Room Temperature)

2) Sample Release Kit (Sample Collection in 5 Seconds, Directly Use on PCR)
3) Compatible RNA Extraction Reagent Kits (Same Quality, Lower Price)
4) Specimen Collection Swab (Flocked Swabs for both PCR and Rapid Test)
5) Covid-19 Antigen Rapid Test (Swab and Oral Fluid)