Malaria Rapid Test

10 November, 2025

Intended Use

The Malaria Rapid Test (Pv/Pf) is an in-vitro diagnostic test designed for the simultaneous and differential detection of Plasmodium vivax (Pv) LDH and Plasmodium falciparum (Pf) HRP-II antigens in human whole blood samples.

Summary

Malaria is a serious infectious disease that occurs when Plasmodium parasites — including P. falciparum, P. vivax, P. ovale, and P. malariae — invade red blood cells. The infection causes fever, chills, headache, vomiting, fatigue, and anemia.

In severe cases, malaria may trigger convulsions, coma, or even death. Among these species, P. falciparum and P. vivax pose the greatest threat.

P. falciparum often leads to cerebral malaria and shows strong drug resistance. Meanwhile, P. vivax causes relapsing infections and has a high infectivity rate.

Traditional vs Modern Diagnosis

Traditionally, laboratories diagnosed malaria using microscopic blood film examinations. While effective, this method requires skilled technicians, time, and specialized equipment.

As a result, testing in remote or low-resource areas becomes challenging.

However, Rapid Diagnostic Tests (RDTs) now offer a faster and simpler solution. These tests deliver reliable results within minutes and are suitable for both clinical and field use.

In addition, the Malaria Antigen Test (Pv/Pf) combines:

Anti-Plasmodium vivax lactate dehydrogenase (pLDH) antibodies
Anti-Plasmodium falciparum histidine-rich protein II (HRP-II) antibodies

Principle of the Test

First, a blood sample is added to the sample well (S), followed by buffer in the buffer well (B). The detergent in the buffer breaks open red blood cells and releases Plasmodium antigens.

Next, these antigens bind to gold-conjugated antibodies specific to P. vivax and P. falciparum. As the mixture moves along the membrane:

A colored band in the Pv region indicates P. vivax infection.
A colored band in the Pf region indicates P. falciparum infection.
Bands in both regions confirm a mixed infection.
No test band means a negative result.
A control band (C) must always appear to validate the test.

Reagent Materials

1.Test Card
2.Capillary tube
3.Lancet
4.Alcohol swab
5.Buffer vial

Precautions & Specimen Collection

Use this test only for professional purposes under medical supervision.

Maintain room temperature for reagents and blood samples before use.
Avoid mouth pipetting or handling materials with your mouth.
Keep the testing area clean and hygienic.
Always wear protective gear — gloves, lab coat, and goggles.
Dispose of used materials in biohazard containers.
Never mix reagents from different kits.
Check expiration dates before use.

Specimen Handling

No fasting or special preparation is needed. Collect fresh whole blood via venipuncture or finger prick using standard aseptic techniques.

If immediate testing isn’t possible, store samples at 2–8°C for up to 72 hours or freeze at -20°C for long-term preservation.

Avoid repeated freezing and thawing (maximum two cycles). Additionally, reject clotted or contaminated samples to prevent invalid results.

Test Procedure

1️⃣ Bring the sealed test pouch to room temperature.
2️⃣ Label the card with the patient’s ID.
3️⃣ Add 5 µl of blood into the sample well (S).
4️⃣ Add 3 drops of buffer into the buffer well (B).
5️⃣ Read the results within 15–20 minutes (not after 20 minutes).
6️⃣ Dispose of all used materials safely in biomedical waste containers.

Interpretation of Result

✅ Negative Result: Only control line (C) visible → No malaria detected.
🩸 Positive for P. falciparum: Bands at Pf and C regions → Pf HRP-II antigen present.
🩸 Positive for P. vivax: Bands at Pv and C regions → Pv pLDH antigen present.
🩸 Mixed Infection: Bands at Pf, Pv, and C → Both species detected.
❌ Invalid Result: No control band (C) → Repeat test with new card.

Limitation

Always interpret results considering clinical and epidemiological context.

Moreover, confirm doubtful results with microscopy or molecular testing (ELISA, CLIA, PCR). Band intensity does not represent antigen quantity.

False negatives may occur in early infection or low antigen titers. Persistent positivity after treatment could indicate drug resistance.

Therefore, the final diagnosis must be made by a qualified physician after evaluating clinical findings and lab data.

Disclaimer & Warning

Every effort has been made to ensure the accuracy, reliability, and diagnostic performance of this test. However, storage conditions, environmental factors, and procedural variations may influence results.

Patients should not self-diagnose or self-treat based solely on rapid test results. Always consult a registered medical practitioner for confirmation and appropriate treatment.

Frequently Asked Questions

1. What is the Malaria Rapid Test (Pv/Pf)?

The Malaria Rapid Test (Pv/Pf) is a quick diagnostic test that detects antigens specific to Plasmodium falciparum and Plasmodium vivax in human blood. It helps identify malaria infection within 15–20 minutes without needing laboratory equipment.

2. How does the Malaria Rapid Test work?

The test uses the principle of immunochromatography. When a blood sample is placed on the test card, it reacts with malaria-specific antibodies. If malaria antigens are present, colored bands appear on the test window to indicate infection by P. falciparum, P. vivax, or both.

3. What type of sample is required for the Malaria Rapid Test?

A fresh whole blood sample collected via venipuncture or finger prick is required. EDTA or heparinized blood can also be used for accurate results.

4. How long does it take to get results?

Results are available within 15–20 minutes after adding the blood and buffer to the test card. Reading results after 20 minutes is not recommended.

5. How accurate is the Malaria Rapid Test?

The Malaria Rapid Test (Pv/Pf) is highly sensitive and specific when used correctly. However, accuracy can vary depending on the infection stage, parasite density, and test handling conditions. Microscopic confirmation is advised for final diagnosis.

10. Is it safe to perform the test at home?

Although the test is easy to use, it should be performed by or under the supervision of a medical professional. Incorrect handling or interpretation can lead to unreliable results.

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