Malaria pf/pv Antigen – Rapid Test Kit

The Malaria pf/pv Antigen Rapid Test Kit (Colloidal Gold Method) is a diagnostic tool designed to quickly and accurately detect the presence of Plasmodium falciparum and Plasmodium vivax antigens in human whole blood, either from fingertip or venous sources. Here’s an overview of its features and operation:

Product Overview

• Purpose: Qualitative in vitro detection of malaria antigens (P. falciparum and P. vivax).
• Principle: Double-antibody sandwich using colloidal gold labeling for antigen detection.
• Sample Types: Whole blood from fingertip or venous sources.

Testing Procedure

1. Preparation: Bring test components and samples to room temperature.
2. Test Application:
   • For Test Strips: Add 1 drop (10 μL) of blood and 3 drops (75 μL) of sample diluent.
   • For Test Cards: Same as above, with blood and diluent added sequentially.
3. Timing: Read results between 15-30 minutes. Results after 30 minutes are invalid.

Result Interpretation

• Positive:
  • P. falciparum: Red band on T1 and control (C) line.
  • P. vivax: Red band on T2 and control (C) line.
  • Both P. falciparum and P. vivax: Bands on T1, T2, and C lines.
• Negative: No band on T1 or T2 lines, red band only on the C line.
• Invalid: No red band on the C line; retesting is recommended.

Performance Characteristics

• Sensitivity: Detects down to 100 parasites/μL.
• Specificity: No cross-reactivity with other pathogens.
• Accuracy: Sensitivity >99.9%, specificity 99.4%, and accuracy 99.5%.

Storage and Handling

• Storage: 2–30°C, away from humidity and direct sunlight. Use within 1 hour of opening in high humidity or temperatures above 30°C.
• Sample Handling:
  • Immediate Testing: Fingertip blood.
  • Storage: Venous blood can be stored at 2–8°C for up to 3 days.
  • Preparation: Warm to room temperature and avoid hemolyzed or lipemic samples.

Precautions and Limitations

• Usage: In vitro diagnostic use only; for professional use.
• Limitations: For qualitative screening; confirmatory testing may be necessary.
• Disposal: Follow local biohazard disposal regulations for infectious waste.