Principle

The test is an immunochromatographic assay on a membrane strip pre-coated with antibodies specific to P.f. antigen.

The specimen reacts with a dye conjugate pre-coated on the strip.

The mixture migrates by capillary action and binds to antibodies in the test line (T) area if P.f. antigen is present, producing a colored line.

A control line (C) always appears to indicate proper specimen volume and correct procedural technique.

Kit Components

Individually packed test devices.

Disposable droppers.

Buffer solution.

Package insert.

Directions for Use

1. Allow the test device, specimen, and buffer to reach room temperature (15-30°C).

2. Remove the test device from the sealed pouch just before use.

3. Add 5 µL of whole blood to the specimen well.

4. Add 3 drops (≈180 µL) of buffer to the buffer well.

5. Read results at 10 minutes. Do not interpret results after 20 minutes.
Interpretation of Results

Positive: Colored lines appear in both the control (C) and test (T) regions.

Negative: A colored line appears only in the control (C) region.

Invalid: No line appears in the control (C) region.

Performance

Sensitivity: >99% compared to microscopic blood smear analysis.

Specificity: 99.7% compared to microscopic blood smear analysis.

Accuracy: 99.7%.

Precautions

For professional use only.

For qualitative detection only; not for quantitative measurement or sole diagnostic criteria.

Handle all specimens as potentially infectious.

Dispose of used materials according to local regulations. .