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The EZER™ Malaria Pf Antigen Rapid Test is a lateral flow immunoassay for the qualitative detection of Plasmodium falciparum antigens in human whole blood. It is designed to support timely clinical decision-making by aiding in the diagnosis of P. falciparum malaria.
Malaria caused by Plasmodium falciparum is associated with severe clinical manifestations and a higher risk of complications compared to other Plasmodium species. Early symptoms may overlap with other febrile illnesses, making Pf-specific testing essential for accurate diagnosis.
By detecting P. falciparum histidine-rich protein II (HRP-II), the EZER™ test provides rapid results within 10 minutes, enabling prompt clinical assessment without complex equipment or processing steps. This makes the test suitable for routine laboratory use and decentralized testing environments.
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.
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.
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.
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.
No cross-reactivity was observed with Influenza A/B, RSV, Adenovirus, HIV, HCV, HBsAg, Helicobacter pylori, or other tested pathogens, supporting high analytical specificity.
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.
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.
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