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Global Healthcare Medical
GHM Malaria P.f./P.v. Antigen Rapid Test US – Dual-Species Qualitative Detection of Plasmodium falciparum HRP-II and Plasmodium vivax pLDH Antigens with 10-Minute Results, Whole Blood Sample Compatibility, and Professional Point-of-Care Use
GHM Malaria P.f./P.v. Antigen Rapid Test US – Dual-Species Qualitative Detection of Plasmodium falciparum HRP-II and Plasmodium vivax pLDH Antigens with 10-Minute Results, Whole Blood Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Malaria P.f./P.v. Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Malaria P.f./P.v. Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection and differentiation of Plasmodium falciparum histidine-rich protein II (HRP-II) antigen and Plasmodium vivax lactate dehydrogenase (Pv-LDH) antigen in human whole blood specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of Plasmodium falciparum and Plasmodium vivax 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. P. vivax, while generally less severe, is the most widely distributed Plasmodium species outside of sub-Saharan Africa and is associated with recurrent malaria episodes due to its ability to form dormant liver-stage hypnozoites. In 2023, P. falciparum accounted for approximately 97% of malaria cases worldwide, while P. vivax is the dominant species in many regions of Asia, Latin America, and the Horn of Africa. 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.
Malaria RDTs rely on the detection of parasite antigens. P. falciparum-specific HRP2 is a stable, heat-resistant protein that is highly expressed and confers good sensitivity for the detection of P. falciparum infection. For P. vivax detection, lactate dehydrogenase (Pv-LDH) is the target antigen, with LDH-based assays capable of detecting viable parasites across all Plasmodium species. Dual-species tests that combine Pf HRP2 and Pv pLDH detection provide a comprehensive diagnostic solution for regions where both species are co-endemic.
The GHM Malaria P.f./P.v. 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
Dual-Species Detection – P. falciparum and P. vivax in One Test
The GHM Malaria P.f./P.v. Antigen Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting and differentiating Plasmodium falciparum and Plasmodium vivax antigens from a single patient sample. The test incorporates two separate test lines: T1 for P. falciparum-specific HRP-II antigen and T2 for P. vivax-specific pLDH antigen, enabling clear differentiation between P. falciparum, P. vivax, and mixed infections in a single assay.
| Feature | Benefit |
|---|---|
| Dual-species detection | Simultaneously detects P. falciparum and P. vivax antigens in one test |
| Two separate test lines (T1 & T2) | Clear differentiation between Pf, Pv, and mixed infections |
| Covers over 95% of global malaria cases | Comprehensive coverage of the two most common malaria pathogens |
| Colloidal gold immunochromatography | Established and reliable detection method |
| No instrumentation required | Simple and efficient testing workflow in resource-limited settings |
Fast Results – 10 Minutes
The GHM Malaria P.f./P.v. 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 malaria may overlap with other febrile illnesses, making rapid species-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./P.v. 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 (5 µL of whole blood), 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 (5 µL) | Practical for field and decentralized testing |
| No special equipment required | Streamlined workflow in resource-limited settings |
Clinical Utility – Aid for Diagnosis of P. falciparum and P. vivax Malaria
The GHM Malaria P.f./P.v. Antigen Rapid Test US is intended for use as an aid in the diagnosis and differentiation of malaria infections caused by P. falciparum and P. vivax. The test provides rapid etiological diagnosis, enabling timely initiation of appropriate antimalarial therapy and supporting patient management. Early and accurate diagnosis of 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. Dual-species detection enables healthcare providers in co-endemic regions to rapidly differentiate between P. falciparum and P. vivax infections, supporting species-appropriate treatment selection, including the use of primaquine for radical cure of P. vivax. 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 Pf and/or Pv infection |
| Rapid etiological diagnosis | Enables timely initiation of appropriate antimalarial therapy |
| Species differentiation support | Helps distinguish Pf, Pv, and mixed infections for targeted treatment |
| 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./P.v. Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Clinical evaluation against microscopy has demonstrated strong performance for both species, making this assay a reliable tool for point-of-care diagnostics when correctly used.
| Target | Sensitivity | Specificity | Accuracy |
|---|---|---|---|
| Plasmodium falciparum (HRP-II) | 95.92% | >99.99% | 99.19% |
| Plasmodium vivax (pLDH) | 97.62% | >99.99% | 99.58% |
| Parameter | Specification |
|---|---|
| Limit of Detection | 100 parasites/µL for both Pf and Pv |
| Precision | >98% |
Performance characteristics based on comparison with microscopy using clinical whole blood samples. Published field evaluations of HRP2/pLDH-based Pf/Pv combination RDTs have demonstrated sensitivities of >96% for P. falciparum and >92% for P. vivax at densities >20 parasites/µL by qPCR, with specificities exceeding 98% for both species. The WHO recommends RDTs for P. vivax detection to have sensitivities ≥75.0% and specificities ≥90.0% at densities of 200 parasites/µL.
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./P.v. 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./P.v. Antigen Rapid Test US |
| Product Code | MALV-422b |
| Product Type | Malaria P.f./P.v. Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection and differentiation of Plasmodium falciparum HRP-II antigen and Plasmodium vivax pLDH antigen in human whole blood specimens; used as an aid in the diagnosis of P. falciparum and P. vivax malaria infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antigens | Plasmodium falciparum histidine-rich protein II (HRP-II); Plasmodium vivax lactate dehydrogenase (Pv-LDH) |
| Specimen | Whole Blood (venipuncture or fingerstick) |
| Sample Volume | 5 µL whole blood |
| Time to Result | 10 minutes |
| Sensitivity | Pf: 95.92%; Pv: 97.62% |
| Specificity | Pf: >99.99%; Pv: >99.99% |
| Accuracy | Pf: 99.19%; Pv: 99.58% |
| Precision | >98% |
| Limit of Detection | 100 parasites/µL for both Pf and Pv |
| 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 | 25T / 40T |
| Kit Contents | Malaria P.f./P.v. Test Cassette, Sample Buffer, Disposable Specimen Dropper, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Malaria P.f./P.v. Antigen Rapid Test US |
|---|---|
| Dual-species detection | Simultaneous detection and differentiation of Pf and Pv antigens |
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Whole blood sample compatibility | Simple and efficient sample collection |
| Two separate test lines (T1 & T2) | Clear differentiation between Pf, Pv, and mixed infections |
| Covers over 95% of global malaria cases | Comprehensive coverage of the two most common malaria pathogens |
| High sensitivity and specificity | Pf: 95.92% sensitivity; Pv: 97.62% sensitivity; >99.99% specificity |
| 99.19% and 99.58% overall agreement | Strong concordance with microscopy for Pf and Pv respectively |
| Precision >98% | Reliable and consistent test performance |
| No instrumentation required | Suitable for decentralized and resource-limited settings |
| WHO guideline-aligned testing | Consistent with WHO performance benchmarks 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./P.v. 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.
