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The EZER™ Malaria Pf/Pv Antigen Rapid Test Device is a fast, reliable lateral flow immunoassay designed for the qualitative detection of the two most common malaria parasites—Plasmodium falciparum and Plasmodium vivax—in human whole blood samples.
This test simultaneously identifies P. falciparum–specific HRP-II antigen (T1) and P. vivax–specific lactate dehydrogenase, pv-LDH (T2), enabling clear differentiation between Pf, Pv, and mixed infections in a single assay. When evaluated against microscopy, the test demonstrates high diagnostic performance, with a relative sensitivity of 95.92% for Pf and 97.62% for Pv, and a specificity exceeding 99.99%.
The test delivers visual results within 10 minutes using only 5 µL of whole blood and three drops of buffer, with no instrumentation required. Each kit includes test devices, sample buffer, disposable droppers, and instructions, making it ready for immediate use in point-of-care and laboratory settings.
With its dual-species detection capability, ease of use, and high accuracy, the EZER™ Malaria Pf/Pv Antigen Rapid Test supports early diagnosis, appropriate treatment selection, and effective malaria control. It is an essential frontline tool for laboratory professionals and healthcare providers involved in malaria diagnostics and surveillance.
The EZER™ Malaria Pf/Pv Antigen Rapid Test Device includes all materials required for use in clinical and decentralized testing environments:
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 tested immediately after collection or stored at 2–8°C if testing is delayed (do not freeze). Both venous and fingerstick whole blood samples are compatible, supporting point-of-care use.
EZER™ Malaria Pf/Pv Rapid Test device detecting Plasmodium falciparum and Plasmodium vivax antigens in a whole blood sample
Malaria is a serious mosquito-borne infectious disease caused by Plasmodium parasites transmitted by infected Anopheles mosquitoes. The most common human malaria pathogens include:
P. falciparum — the most severe form, responsible for the majority of malaria-related deaths
P. vivax — widely distributed and associated with recurrent malaria episodes
Malaria is typically characterized by fever, chills, anemia, headache, and fatigue. Without timely diagnosis and treatment, especially in P. falciparum infections, the disease can progress rapidly to severe complications.
Accurate and early differentiation between P. falciparum, P. vivax, and mixed infections is essential for appropriate treatment selection and effective disease control, particularly in endemic and outbreak-prone regions.
Manufactured by Genesis Biotech, the EZER™ Malaria Pf/Pv Antigen Rapid Test demonstrates strong diagnostic performance when compared with microscopy:
For Plasmodium falciparum:
Sensitivity: 95.92%
Specificity: >99.99%
Accuracy: 99.19%
For Plasmodium vivax:
Sensitivity: 97.62%
Specificity: >99.99%
Accuracy: 99.58%
The minimum detection threshold is 100 parasites/µL for both species. No cross-reactivity was observed with Influenza A/B, RSV, Adenovirus, HIV, HCV, HBsAg, Syphilis, or Helicobacter pylori. The test also showed no interference from common endogenous substances such as hemoglobin, bilirubin, triglycerides, cholesterol, or ascorbic acid.
Its reliability, clarity of interpretation, and high analytical specificity make the EZER™ device a dependable tool for malaria-targeted diagnostics.
The test employs monoclonal antibodies targeting two malaria-specific antigens:
HRP-II antigen (T1) — specific to Plasmodium falciparum
pv-LDH antigen (T2) — specific to Plasmodium vivax
Test Procedure:
Add 1 drop (approximately 5 µL) of whole blood to the sample well
Add 3 drops of buffer
Read the result after 10 minutes (do not interpret after 20 minutes)
Result Interpretation:
C + T1 + T2: Mixed P. falciparum and P. vivax infection
C + T1: Plasmodium falciparum positive
C + T2: Plasmodium vivax positive
C only: Negative
No C line: Invalid — repeat test with a new device
This streamlined cassette format ensures consistent and unambiguous result interpretation, even in high-throughput or resource-limited settings.
The EZER™ Malaria Pf/Pv Antigen Rapid Test is well suited for:
Clinical laboratories evaluating febrile patients
Tropical and travel medicine clinics
Emergency and triage settings requiring rapid malaria confirmation
Public health surveillance and outbreak response programs
Its rapid turnaround time, dual-species differentiation, and ease of use make it particularly valuable for deployment in remote clinics, mobile healthcare units, and field hospitals.
As a CE-certified diagnostic solution, the EZER™ Malaria Pf/Pv Antigen Rapid Test enhances diagnostic efficiency and supports informed clinical decision-making where access to microscopy or advanced laboratory infrastructure is limited.
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