Rapid malaria test

for antigensPlasmodiumblood

Product overview
The Malaria Pf/Pan Rapid Test Device (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale and Plasmodium malariae in whole blood. The test is designed for quick screening in clinical and field settings and provides visual results within minutes.

Key product information
Product Name: Malaria Pf/Pan Rapid Test Device (cassette or strip)
Specimen: Whole Blood
Method: Colloidal gold immunochromatographic assay
Form / Dosage Form: In Vitro Diagnostic rapid test cassette/strip
Reading Time: Read at 10 minutes (do not interpret after 20 minutes)
Accuracy: Manufacturer claim ~99%
Format: Strip or cassette
Certification: ISO9001 / ISO13485 / CE
Shelf Time: 24 months
Package: 25 tests/box

Intended use
The Malaria Pf/Pan Rapid Test Device (Whole Blood) is intended as a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium species (including P. falciparum, P. vivax, P. ovale and P. malariae) in whole blood as an aid in the diagnosis of malaria infection.

Operating steps

• Equilibrate test device, specimen, buffer and controls to room temperature (15–30°C) before testing.
• Open the foil pouch and use the test device promptly; best results if used within one hour of opening.
• Place the device on a clean, level surface. Transfer specimen using a pipette or disposable dropper.
• Using a pipette: add 5 µL whole blood to the specimen well, then add 3 drops of buffer (~180 µL) and start the timer.
• Using a disposable dropper: draw specimen to the fill line (~5 µL), transfer to the specimen well, then add 3 drops of buffer (~180 µL) and start the timer.
• Wait for the colored line(s) to appear. Read the result at 10 minutes. Do not interpret results after 20 minutes.

Product range / related formats
The product is available as strip or cassette formats for rapid infectious disease screening. Typical kit packaging is 25 tests per kit; alternative pack sizes may be available from the manufacturer.

Characteristics / technical specifications

• Test type: Rapid chromatographic immunoassay (colloidal gold)
• Target: Antigens of P. falciparum, P. vivax, P. ovale, P. malariae
• Specimen: Whole blood
• Sample volume: ~5 µL whole blood
• Buffer volume: ~180 µL (3 drops)
• Result time: Read at 10 minutes; do not read after 20 minutes
• Sensitivity/Accuracy: ~99% (manufacturer claim)
• Storage / Shelf life: 24 months
• Package: 25 tests per box
• Certifications: ISO9001, ISO13485, CE