30th September 2021  Content supplied by: Beijing Tigsun Diagnostics Co,.Ltd.

CE-Marked Detection Kit for COVID-19 IgM and IgG Antibodies


Tigsun COVID-19 Combo IgM/IgG Rapid Test (Lateral Flow Method) is an immunochromatographic CE-marked assay for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgM/IgG antibodies in human whole blood, serum, and plasma samples. 

Key Features:

  • Fast: Result in 15 minutes.
  • Convenient, flexible, no instrument needed.
  • IgM and IgG combined detection gives high sensitivity.
  • Highly specific without cross-reaction with common viruses.

Detection Principle:
SARS-CoV-2 IgG antibodies: When a positive sample is detected, the SARS-CoV-2 IgG antibodies in the sample are bound to colloidal gold-labeled SARS-CoV-2 antigens to form an immune complex.

When the complex passes the Test Line (T), it binds to the anti-human IgG monoclonal antibody immobilized in the Test Line (T) of the device to form a new complex. This generates a colored test band that indicates a positive result.

When the SARS-CoV-2 antibody level in the specimen is zero or below the target cutoff, there is not a visible colored band in the Test Line (T) of the device. This indicates a negative result. To serve as a procedure control, a colored line will appear at the Control Line (C), if the test has been performed properly.
 
SARS-CoV-2 IgM antibodies: When a positive sample is detected, the SARS-CoV-2 IgM antibodies in the sample bound with colloidal gold-labeled anti-human IgM (μ chain) monoclonal antibody to form an immune complex.

When the complex passes the Test Line (T), it binds to the SARS-CoV-2 antigen immobilized in the Test Line (T) of the device to form a new complex. This generates a colored test band that indicates a positive result.

When the SARS-CoV-2 antibody level in the specimen is zero or below the target cutoff, there is not a visible colored band in the Test Line (T) of the device. This indicates a negative result. To serve as a procedure control, a colored line will appear at the Control Line (C), if the test has been performed properly.

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Date Published: 30th September 2021

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