COVID-19 test kit

IgGIgMfor neutralizing antibody

Product description
The 2019-nCoV Neutralization Antibody Test Kit is a qualitative colloidal gold lateral flow immunoassay for detection of functional neutralizing antibodies to SARS-CoV-2 in human serum, plasma and whole blood. It provides a rapid visual result for use by healthcare professionals in point-of-care screening and clinical workflows.

Principle
The assay contains colloidal gold-labelled 2019-nCoV Spike Protein (RBD). Mouse anti-human IgG is immobilized at the G test area and mouse anti-human IgM at the M test area; a control line (C) verifies proper flow. Antibody-bound complexes generate visible colored lines for qualitative interpretation.

Key features

• Format: Colloidal gold lateral flow (visual qualitative)
• Target: Functional neutralizing antibodies to SARS-CoV-2
• Test lines: G (IgG) and M (IgM) with control (C)
• Sample types: Whole blood, serum, plasma

Operation steps

• Step 1: Add 20 µl whole blood or 10 µl serum/plasma to sample well A.
• Step 2: Add two drops (≈80 µl) of sample diluent into well B and start timing.
• Step 3: Read result at 15 minutes. Do not interpret after 20 minutes.

Result interpretation

• Positive: Colored band at control (C) and at G and/or M test area.
• Negative: Colored band only at control (C).
• Invalid: No colored band at control (C); repeat test with a new device.

Technical specifications

• Product name: 2019-nCoV Neutralization Antibody Test Kit (Colloidal Gold Immunochromatography)
• Assay principle: Colloidal gold immunochromatography; colloidal gold-labelled 2019-nCoV Spike Protein (RBD)
• Detection target: Functional neutralizing antibodies to SARS-CoV-2
• Test areas: G (IgG), M (IgM) and control (C)
• Sample types: Whole blood, serum, plasma
• Sample volume: 20 µl whole blood; 10 µl serum or plasma
• Diluent volume: Two drops (~80 µl)
• Time to result: Read at 15 minutes; do not read after 20 minutes
• Format: Rapid colloidal gold lateral flow assay
• Result: Visual qualitative (positive/negative/invalid)