Dengue – Rapid Test Kit

Product Name: Dengue IgG/IgM/NS1 Rapid Test Kit (Colloidal Gold Method)

Intended Use: This kit is designed for in vitro qualitative detection of dengue NS1 antigen and IgG/IgM antibodies in human blood (fingertip or venous), serum, or plasma. It serves as a preliminary tool for screening and diagnosing dengue virus infections.

Test Method & Principle

1. NS1 Antigen Detection: Utilizes a double-antibody sandwich method in which the dengue NS1 antigen, if present, binds with a colloidal gold-labeled antibody to form a complex that travels up the test strip to show a red band.
2. IgG/IgM Antibody Detection: Applies the indirect colloidal gold immunochromatography method. If IgG/IgM antibodies are present, they form complexes that are captured on specific test lines.
3. Result Reading:
   • NS1 Antigen Positive: Red bands on both control (C) and test (T) lines.
   • IgG/IgM Positive: Red bands on control (C) and either G or M lines, or both.
   • Negative: Red band only on control (C) line.
   • Invalid: No red band on control line (C); requires retesting.

Result Time: Read results within 15-30 minutes; results are invalid after 30 minutes.

Key Specifications

• Sample Requirements: Works with serum, plasma, or whole blood (fingertip or venous).
• Storage: 2-30°C, protected from sunlight and high humidity. Valid for 24 months.
• Performance: Sensitivity >99.9%, specificity 99.5%, accuracy 99.6%.

Limitations & Precautions

1. In vitro use only for preliminary screening; other tests may be needed to confirm results.
2. Single-use product; dispose of waste as per local biohazard protocols.
3. For best results, use under adequate lighting conditions.