Malaria Rapid Test

10 November, 2025 jambir sk 0 Comments 1 category

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 develops when Plasmodium parasites — such as P. falciparum, P. vivax, P. ovale, and P. malariae — enter red blood cells. The disease triggers fever, chills, headache, vomiting, fatigue, and anemia.

In severe cases, malaria progresses to convulsions, coma, or even death. Among all species, P. falciparum and P. vivax create the highest risk.

P. falciparum often causes cerebral malaria and shows strong resistance to many drugs. Meanwhile, P. vivax creates repeated infections and spreads quickly. Overall, both species demand urgent attention because they increase complications and worsen disease severity.

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

You don’t need fasting or any special preparation before sample collection. Collect fresh whole blood through venipuncture or a finger prick while following standard aseptic techniques.

If you cannot perform the test immediately, store the sample at 2–8°C for up to 72 hours. For longer storage, freeze the sample at –20°C. However, don’t freeze and thaw the sample more than twice because repeated temperature changes damage its quality.

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 malaria test results within the clinical and epidemiological context. Additionally, confirm doubtful results using microscopy or molecular tests such as ELISA, CLIA, or PCR. Band intensity only shows the presence of antigens; it does not measure their quantity.

False negatives may appear in early infection or when antigen levels stay very low. In some cases, you may also notice persistent positive results after treatment, which often suggests drug resistance.

Therefore, a qualified physician should review all clinical findings and lab data to reach the final diagnosis.

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.

Category: Uncategorized