Malaria Pf Antigen Rapid Test – EZER™ Diagnostic Kit

What is in the Malaria Pf Antigen Rapid Test?

The EZER™ Malaria Pf Antigen Rapid Test is a CE-marked lateral flow diagnostic device that utilizes monoclonal antibodies specific to Plasmodium falciparum histidine-rich protein II (HRP-II). It is designed for the qualitative detection of P. falciparum antigens in human whole blood samples.

Kit contents

• 20 test devices

• 1 vial of sample buffer

• 20 plastic droppers

• 1 package insert

Whole blood specimens should be tested immediately after collection. If testing is delayed, venous whole blood may be stored at 2–8 °C for up to 48 hours. No specialized equipment is required for test execution or result interpretation.

Role of Plasmodium falciparum in Disease

Malaria is a mosquito-borne infectious disease caused by Plasmodium parasites that invade red blood cells. Of the four species known to infect humans, Plasmodium falciparum causes the most severe disease and accounts for the majority of malaria-related deaths worldwide.

The disease is characterized by fever, chills, anemia, and may progress to severe complications if untreated. Transmission occurs through the bite of infected Anopheles mosquitoes. Because malaria symptoms are nonspecific, laboratory confirmation is essential for accurate diagnosis and appropriate treatment.

About the EZER™ Malaria Pf Antigen Rapid Test

The EZER™ Malaria Pf Antigen Rapid Test has been evaluated against microscopy using clinical whole blood samples and demonstrated strong diagnostic performance:

• Relative Sensitivity: 95.92%

• Relative Specificity: >99.99%

• Overall Accuracy: 99.19%

The minimum detection level for P. falciparum is 100 parasites/µL.

Cross-reactivity

No cross-reactivity was observed with Influenza A/B, RSV, Adenovirus, HIV, HCV, HBsAg, Helicobacter pylori, or other tested pathogens, supporting high analytical specificity.

Principle and Workflow

The test is based on an immunochromatographic assay principle:

Sample collection

• Collect whole blood using standard venipuncture or fingerstick procedures

Sample preparation

• Add approximately 5 µL of whole blood to the sample well

• Add 3 drops of sample buffer

Test application

• Allow the reaction to proceed

• Read results at 10 minutes (do not interpret after 20 minutes)

Result interpretation

• Two lines (C + T): Plasmodium falciparum positive

• One line (C): Negative

• No control line: Invalid

Each test includes an internal procedural control to confirm correct test performance.

Clinical Application

The EZER™ Malaria Pf Antigen Rapid Test is suitable for use in:

• Clinical and reference laboratories

• Hospitals and emergency departments

• Travel and tropical medicine clinics

• Field diagnostics and outbreak response settings

When used alongside clinical findings and confirmatory testing, this Pf-specific rapid test supports early diagnosis, timely treatment, and effective malaria control strategies.