Malaria Pf/Pan Antigen Rapid Test – EZER™ Diagnostic Kit

What is in the Malaria Rapid Test?

The EZER™ Malaria Pf/Pan Antigen Rapid Test Device includes all materials needed for field and clinical testing:

Kit Contents:

• 20 test cassettes

• 20 sterile plastic droppers

• 1 vial of sample buffer

• 1 package insert

All components are CE-marked and optimized for whole blood testing. Specimens should be processed immediately or refrigerated at 2–8°C (not frozen). Fingerstick samples are also compatible and ideal for point-of-care use.

Role of Malaria Parasites in Disease

Malaria is a life-threatening, mosquito-borne disease caused by Plasmodium species. The main human pathogens include:

• P. falciparum, causes the most severe disease; responsible for most malaria-positive deaths globally

• P. vivax, associated with relapsing fever and widespread tropical prevalence

• P. ovale and P. malariae, less common but contribute to persistent and recurring infections

Symptoms include cyclical fever, chills, anemia, headache, and fatigue. If untreated, especially with P. falciparum, malaria can progress rapidly to organ failure or death.

Accurate and early detection of both P. falciparum-positive and mixed infections is vital for effective treatment and containment strategies, particularly in endemic or outbreak-prone regions.

About the EZER™ Malaria Pf/Pan Antigen Rapid Test Device

Manufactured by Genesis Biotech, the EZER™ Malaria Rapid Test delivers excellent diagnostic performance:

• For P. falciparum:

  • Sensitivity: 95.92%

  • Specificity: >99.99%

  • Accuracy: 99.19%

• For non-falciparum species:

  • Sensitivity: 97.62%

  • Specificity: >99.99%

  • Accuracy: 99.58%

Minimum detection threshold is 100 parasites/μL for all species. The test showed no cross-reactivity with HIV, HCV, influenza A/B, RSV, syphilis, or H. pylori specimens. It also remained stable with common interfering substances like hemoglobin, bilirubin, triglycerides, and ascorbic acid.

Its robustness, combined with high confidence level and clear result interpretation, makes the EZER™ device a standout tool in malaria-targeted diagnostics.

Principle and Workflow

The test uses dual monoclonal antibodies targeting:

• HRP-II antigen (test line T1) specific to P. falciparum

• pLDH antigen (test line T2) common to all Plasmodium species

Test Procedure:

1. Add 1 drop (5 µL) of whole blood to the sample well

2. Add 3 drops of buffer

3. Read the result after 10 minutes (no later than 20 min)

Result Interpretation:

• Two lines (C + T1 + T2): Mixed infection or P. falciparum with another species

• Two lines (C + T1): P. falciparum-positive

• Two lines (C + T2): P. vivax, P. ovale, or P. malariae

• One line (C only): Negative

• No C line: Invalid – retest with a new device

This streamlined format supports clear, consistent reporting even in remote or high-throughput settings.

Clinical Application

The EZER™ Malaria Pf/Pan Antigen Rapid Test is ideal for:

• Clinical microbiology labs diagnosing febrile patients with travel history

• Tropical medicine units managing high-risk populations

• Emergency and triage centers needing immediate malaria-positive confirmation

• Public health response teams during outbreaks or seasonal surveillance

Its quick time-to-result, species differentiation, and portability make it particularly suited for use in remote clinics, refugee health programs, and field hospitals.

As a trusted, CE-certified solution, the EZER™ device enhances diagnostic efficiency and reduces reliance on microscopy, especially where trained personnel or equipment are limited.