Flu AB – Rapid Test Kit - Results at Home

FluA/FluB Antigen Rapid Test Kit (Colloidal Gold Method)

Intended Use

The kit is for in vitro qualitative detection of influenza A and B (FluA/FluB) antigens in human nasal and oropharyngeal swab samples, designed for professional use only. It serves as an auxiliary diagnostic tool to differentiate influenza types, supporting epidemiological data on influenza outbreaks.

Test Principle

This kit utilises the double-antibody sandwich principle in colloidal gold immunochromatography. It detects influenza A/B antigens by capturing antibody-antigen complexes and rendering visual lines for positive or negative results.

Sample Requirements & Collection

• Sample Types: Nasal and oropharyngeal swabs.
• Swab Tip Material: Nylon flocking, absorbent cotton, or polyester fiber.
• Collection Guidelines:
  • Nasal Swab: Insert 1-1.5 cm, rotate four times per cavity.
  • Oropharyngeal Swab: Swab each pharyngeal tonsil area and posterior pharyngeal wall at least three times.

Storage & Handling

• Storage Conditions: Store at 2-30°C; avoid high humidity and direct sunlight.
• Shelf Life: 24 months.
• Sample Storage:
  • Room Temperature: 24 hours max.
  • Refrigerated (2-8°C): 72 hours max.
  • Frozen (-20°C): Up to 3 months; -70°C for long-term storage.

Test Method Overview

1. Preparation: Check kit components, bring to room temperature, wash hands.
2. Sample Processing: Mix swab in lysis buffer for at least 30 seconds.
3. Testing: Place test pad on flat surface, apply sample. Read results in 15-30 minutes.

Interpretation of Results

• Flu A Positive: Red bands at test line (A) and control line (C).
• Flu B Positive: Red bands at test line (B) and control line (C).
• Flu A+B Positive: Red bands on both test lines (A and B) and control line (C).
• Negative: Red band only on control line (C).
• Invalid: No red band on control line (C).

Limitations & Precautions

• Intended Use: For qualitative analysis only; confirm with clinical history and additional tests.
• False Results: May occur due to poor sampling, low virus levels, or antigenic variations.
• Precautions: Use within the validity period; avoid contamination and follow all safety guidelines.

Performance Characteristics

• Positive Reference: 100% agreement for both influenza A and B.
• Negative Reference: 100% agreement for negative results.
• Analytical Sensitivity: Test sensitivities vary by sample concentration; consistent results across specified dilution levels.