The Malaria P.f. Rapid Test is a qualitative membrane-based immunoassay. During testing, the whole blood specimen reacts with the dye conjugate pre-coated on the test device. The mixture migrates through the membrane by capillary action. If P.f. antigen is present, a colored line appears in the test region.

A separate control line serves as an internal procedural control, confirming appropriate specimen volume and membrane wicking.

Step 1 - Prepare the Test: Allow the test device, specimen and buffer to reach room temperature (15–30°C). Remove the device from the foil pouch and use as soon as possible; best results are obtained when the assay is performed within 1 hour.

Step 2 - Add Sample: Transfer 5 μL of whole blood to the specimen well, then add 3 drops of buffer (approximately 180 μL) and start the timer. With the disposable dropper, draw to the fill line (approximately 5 μL), transfer to the specimen well, then add 3 drops of buffer to the buffer well.

Step 3 - Read the Result: Read at 10 minutes. Do not interpret after 20 minutes.

Positive: C line + T line. Two colored bands appear, one in the control region (C) and one in the test region (T).

Negative: C line only. One colored band appears in the control region (C), with no band in the test region (T).

Invalid: No C line. Repeat the test using a new test device.

Note: T-line intensity may vary with P.f. antigen concentration. Any visible color in the test region should be considered positive according to the package insert.

• P.f. Antigen Detection - Qualitative detection of Plasmodium falciparum antigen in whole blood.

• Whole Blood Compatible - Supports fingerstick and venipuncture whole blood.

• Rapid Results - Visual result interpretation at 10 minutes.

• Simple Operation - Requires a small whole-blood sample and buffer.

• Built-in Procedural Control - Control line checks specimen volume and membrane migration.

• Professional IVD Use - Intended for professional in vitro diagnostic use.

Fingerstick Whole Blood: Clean and dry the hand, puncture with a sterile lancet, wipe away the first drop, and gently massage to obtain a blood drop. Test immediately after collection.

Venipuncture Whole Blood: Store at 2–8°C for up to 2 days if needed. For longer-term storage, keep below −20°C. Frozen specimens should be completely thawed and mixed well. Do not freeze and thaw repeatedly more than three times.

• Store the kit at 2–30°C.

• Keep the test device sealed in the original foil pouch until use.

• Do not freeze.

• Humidity and temperature can adversely affect results.

• Do not use beyond the expiration date printed on the sealed pouch.

The package insert reports comparison with traditional thick or thin blood smear microscopic analysis, using 367 clinical specimens.

Precision: Intra-assay testing used 10 replicates of twelve negative, low-positive and high-positive specimens; negative and positive values were correctly identified >99% of the time. Inter-assay precision was evaluated using the same specimen groups across independent assays and different lots.

Important: This is a qualitative test and should not be used to determine quantitative P.f. antigen concentration or its rate of increase. Results should be interpreted with other available clinical information.

OEM & Customized Solutions Available

As an IVD manufacturer, we can discuss customized product solutions according to your market and project requirements.

• Private Label / OEM Branding

• Customized product packaging

• Customized artwork and label design

• Customized product name and catalog information

• Customized package configuration

• Customized documentation and language versions

For OEM projects, please contact us with your required test target, market, packaging configuration and estimated order quantity.