Livzon Diagnostic Kit

Please follow all FDA guidelines regarding the use of this test.
If you have any questions please refer to the FAQs on Diagnostic Testing for SARS-CoV-2.
Livzon COVID-19 Order Form

We are proud to offer 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. Livzon’s test was the first one used in China has been used widely in the top tier Chinese hospitals to combat infections and is now available globally.  It is currently being used by many governments and countries around the world, such as: Denmark, Sweden, France, Spain, Russia, and the US. 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 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 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 be 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

This product contains one lgM test cassette and one lgG test cassette. The lgM test uses colloidal gold immunochromatography technology to detect the Coronavirus (SARS-CoV-2) lgM antibody. The anti-human lgM antibody labeled by colloidal gold is coated on the conjugate pad. Meanwhile, on the cellulose nitrate membrane, the antigens of Coronavirus (SARS-CoV-2) are coated in the test area, and goat anti-mouse antibody is coated in the control area. While testing, the lgM antibody in the test sample (the specific lgM antibody to Coronavirus (SARS-CoV-2) and non-specific lgM antibody) binds with the colloidal gold labeled anti-human lgM antibody and forms an immune complex. The immune complex moves along the membrane through chromatography. If there is specific lgM antibody to Coronavirus (SARS-CoV-2) in the test sample, it will be captured by the antigens coated in the test area, forming a visible band (test line); The free colloidal gold conjugate or immune complex continues to move forward, and binds specifically with the goat anti-mouse antibody coated in the control area, forming a visible band (control line). If the test sample doesn· t contain any Coronavirus (SARS-CoV-2) lgM antibody, only a control line will appear. The lgG test uses colloidal gold immunochromatography technology to detect the Coronavirus (SARS-CoV-2) lgG antibody. The anti-human lgG antibody labeled by collo idal gold is coated on the conjugate pad. Meanwhile, on the cellulose nitrate membrane, the antigens of Coronavirus (SARS-CoV-2) are coated in the test area, and goat anti-mouse antibody is coated in the control area. While testing, the lgG antibody in the test sample (the specific lgG antibody to Coronavirus (SARS-CoV-2) and non-specific lgG antibody) binds with the colloidal gold labeled anti-human lgG antibody and forms an immune complex. The immune complex moves along the membrane through chromatography. If there is specific lgG antibody to Coronavirus (SARS-CoV-2) in the test sample, it will be captured by the antigens coated in the test area, forming a visible band (test line); The free colloidal gold conjugate or immune complex continues to move forward, and binds specifically with the goat anti-mouse antibody coated in the control area, forming a visible band (control tine). If the test sample doesn’t contain any Coronavirus (SARS-CoV-2) lgG antibody, only a control line will appear.

This product is CFDA/NMPA approved and CE labeled.  The Certificate of Conformity can be down load along with the Instructions for Use and other relevant documents from the manufacturer.  Please find these documents in the document library:

1. IFU
2. Livzon brochure
3. Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia
4. Certificate of Conformity
5. FDA guidance
6. ISO 13495 Certificate
7. Letter of Authorization

Features & Benefits

Diagnostic Kit for lgM/lgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow) is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.

Easy, Fast & Precise

 

Performance Report

The COVID-19 lgG/IgM Rapid Test developed by ZHUHAI LIVZON DIAGNOSTICS INC. is for qualitative detection of antibodies (lgG and lgM) to Novel coronavirus in  human Whole Blood/Serum/Plasma. By studying on the statistical coincident rate, they could validate if it could be used for detection of antibodies (IgG and lgM) to Novel coronavirus in human Whole Blood/Serum/Plasma.

Method

Livzon Evaluation Report

Result