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Global Healthcare Medical
GHM Malaria P.f. Antigen Rapid Test US – Qualitative Detection of Plasmodium falciparum HRP-II Antigen with 10-Minute Results, Whole Blood Sample Compatibility, and Professional Point-of-Care Use
GHM Malaria P.f. Antigen Rapid Test US – Qualitative Detection of Plasmodium falciparum HRP-II Antigen with 10-Minute Results, Whole Blood Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Malaria P.f. Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Malaria P.f. Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Plasmodium falciparum histidine-rich protein II (HRP-II) antigen in human whole blood specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of Plasmodium falciparum malaria infection.
Malaria is an acute mosquito-borne infectious disease caused by Plasmodium parasites, which invade human red blood cells and seriously endanger human health. It is characterized by fever with chills and anemia, and is transmitted from one person to another by the bite of infected Anopheles mosquitoes. There are four kinds of Plasmodium parasites that can infect humans: P. falciparum, P. vivax, P. ovale, and P. malariae. Of these, P. falciparum causes more severe disease than the other plasmodial species and accounts for most malaria deaths. Although six Plasmodium species cause malaria, P. falciparum accounted for approximately 97% of malaria cases worldwide in 2023 and is highly endemic in sub-Saharan Africa.
The vast majority of malaria rapid diagnostic tests (RDTs) target the histidine-rich protein 2 (HRP2) antigen, with approximately 450 million RDTs sold in 2023 and 90% distributed in sub-Saharan Africa. HRP2 is a falciparum-specific protein produced by the asexual and sexual forms of the parasite and is expressed on the surface of infected erythrocytes. It is liberated into the blood upon maturation of the schizont and serves as a good diagnostic and prognostic marker as it represents parasite burden. HRP2 is a stable, heat-resistant protein that is highly expressed, conferring good sensitivity for the detection of P. falciparum infection. Because malaria symptoms are nonspecific and overlap with other febrile illnesses, laboratory confirmation is essential for accurate diagnosis and appropriate treatment.
The GHM Malaria P.f. Antigen Rapid Test US delivers qualitative results in just 10 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with whole blood specimens collected by venipuncture or fingerstick, providing flexible sample collection options suitable for a wide range of clinical settings, including resource-limited environments where microscopy may not be readily available.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including primary care clinics, hospitals, emergency departments, and malaria screening programs in endemic areas. The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system covering in vitro diagnostic test kits and analyzers based on immunochromatography.
Key Features & Benefits
Colloidal Gold Immunochromatography – Reliable Qualitative Detection
The GHM Malaria P.f. Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test strip contains colloidal gold-conjugated monoclonal antibodies specific to the Plasmodium falciparum histidine-rich protein II (HRP-II) antigen, along with immobilized capture antibodies on the test line. During testing, the specimen reacts with the antibody-coated particles and migrates up the membrane to react with the antibodies on the membrane. A colored line is generated at the test line region if P. falciparum HRP-II antigen is present in the specimen.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| P. falciparum HRP-II-specific monoclonal antibodies | Targeted detection of P. falciparum antigen |
| Qualitative visual result | Clear and interpretable test outcome |
| No instrumentation required | Simple and efficient testing workflow in resource-limited settings |
| Internal procedural control | Confirms proper test performance |
Fast Results – 10 Minutes
The GHM Malaria P.f. Antigen Rapid Test US provides qualitative results in just 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Early symptoms of P. falciparum malaria may overlap with other febrile illnesses, making rapid P. falciparum-specific testing essential for accurate diagnosis and prompt treatment initiation.
| Feature | Benefit |
|---|---|
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for primary care clinics and emergency departments |
| Efficient workflow | Enables immediate patient assessment |
| No complex equipment or processing steps | Supports decentralized testing environments |
Whole Blood Sample Compatibility – Simple and Efficient Collection
The GHM Malaria P.f. Antigen Rapid Test US is compatible with whole blood specimens collected by venipuncture or fingerstick, providing simple and efficient sample collection methods suitable for a wide range of clinical settings. The test requires only a small sample volume, making it practical for use in both clinical and field settings.
| Feature | Benefit |
|---|---|
| Whole blood specimen | Simple and efficient sample collection |
| Venipuncture or fingerstick | Flexible collection options for different clinical settings |
| Small sample volume required | Practical for field and decentralized testing |
| No special equipment required | Streamlined workflow in resource-limited settings |
Clinical Utility – Aid for Diagnosis of Plasmodium falciparum Malaria
The GHM Malaria P.f. Antigen Rapid Test US is intended for use as an aid in the diagnosis of Plasmodium falciparum malaria infection. The test provides rapid etiological diagnosis, enabling timely initiation of appropriate antimalarial therapy and supporting patient management. Early and accurate diagnosis of P. falciparum malaria, supported by rapid laboratory assessment, is essential for reducing malaria mortality through prompt and appropriate clinical management.
The test is particularly valuable in malaria-endemic areas, where rapid identification of cases supports timely clinical management and infection control measures. The test is also suitable for use in decentralized testing environments where microscopy is sometimes not feasible.
| Feature | Benefit |
|---|---|
| Active infection detection aid | Supports identification of current P. falciparum infection |
| Rapid etiological diagnosis | Enables timely initiation of appropriate antimalarial therapy |
| Endemic area screening support | Suitable for screening programs in malaria-endemic regions |
| Field-friendly testing | No instrumentation required, suitable for decentralized settings |
| Clinical versatility | Useful across primary care clinics, hospitals, and emergency departments |
High Accuracy – Trusted Clinical Performance
The GHM Malaria P.f. Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Clinical evaluation against microscopy and other reference methods has demonstrated strong performance, making this assay a reliable tool for point-of-care diagnostics when correctly used.
| Parameter | Specification |
|---|---|
| Sensitivity | 95.92% |
| Specificity | >99.99% |
| Overall Accuracy | 99.19% |
| Limit of Detection | 100 parasites/µL |
| Cross-reactivity | No cross-reactivity observed with Influenza A/B, RSV, Adenovirus, HIV, HCV, HBsAg, Helicobacter pylori, or other tested pathogens |
Performance characteristics based on comparison with microscopy using clinical whole blood samples. Detection is optimal in specimens with adequate parasite density. Published evaluations of HRP2-based malaria RDTs report detection rates of 94.0% at 200 parasites/µL in WHO product testing round 8 (2018).
ISO 13485 Certified – Quality and Safety Compliance
The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system, demonstrating compliance with stringent international standards for the design, development, manufacture, and distribution of in vitro diagnostic test kits and analyzers.
| Feature | Benefit |
|---|---|
| EN ISO 13485 certification | Quality management system compliance |
| IVD scope | Certified for in vitro diagnostic test kits |
| Quality assurance | Meets high standards of quality and safety |
| Professional-grade | Designed for healthcare professional use |
CE Marked – European Conformity
The GHM Malaria P.f. Antigen Rapid Test US is CE marked for professional in vitro diagnostic use, demonstrating conformity with applicable European regulatory requirements for diagnostic medical devices.
| Feature | Benefit |
|---|---|
| CE marking | Regulatory compliance for professional use |
| Professional IVD use | Designed for trained healthcare personnel |
| Quality compliance | Meets European regulatory standards |
Product Specifications
| Specification | Detail |
|---|---|
| Model / SKU | GHM Malaria P.f. Antigen Rapid Test US |
| Product Code | MPF-502b |
| Product Type | Malaria P.f. Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of Plasmodium falciparum histidine-rich protein II (HRP-II) antigen in human whole blood specimens; used as an aid in the diagnosis of Plasmodium falciparum malaria infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antigen | Plasmodium falciparum histidine-rich protein II (HRP-II) |
| Specimen | Whole Blood (venipuncture or fingerstick) |
| Sample Volume | 5 µL whole blood |
| Time to Result | 10 minutes |
| Sensitivity | 95.92% |
| Specificity | >99.99% |
| Overall Accuracy | 99.19% |
| Limit of Detection | 100 parasites/µL |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Primary care clinic, hospital, emergency department, malaria screening program in endemic areas, decentralized testing, point-of-care |
| Regulatory Status | Manufactured under EN ISO 13485 certified quality management system; CE marked |
| Intended User | Professional healthcare use only |
| Kit Sizes | 1T / 5T / 25T |
| Kit Contents | Malaria P.f. Test Cassette, Sample Buffer, Sterile Lancet, Alcohol Swab, Plastic Dropper, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Malaria P.f. Antigen Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Whole blood sample compatibility | Simple and efficient sample collection |
| P. falciparum HRP-II-specific detection | Targeted detection of P. falciparum antigen |
| High sensitivity and specificity | 95.92% sensitivity and >99.99% specificity |
| 99.19% overall agreement | Strong concordance with microscopy |
| No instrumentation required | Suitable for decentralized and resource-limited settings |
| No cross-reactivity | No cross-reactivity with common respiratory and bloodborne pathogens |
| WHO guideline-aligned testing | Consistent with WHO product testing standards for malaria RDTs |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for primary care clinics, hospitals, and emergency departments |
About Global Healthcare Medical
Global Healthcare Medical is dedicated to connecting healthcare providers, retailers, and distributors with high-quality medical devices designed for reliable performance. The GHM Malaria P.f. Antigen Rapid Test US is part of our professional diagnostic line, developed to support accurate, efficient, and accessible point-of-care testing in clinical environments.
Our focus is on dependable performance, clear documentation, and responsive support for professional healthcare settings.
