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Global Healthcare Medical
GHM Malaria P.f./Pan Antigen Rapid Test US – Dual-Target Qualitative Detection of Plasmodium falciparum HRP-II and Pan-Plasmodium pLDH Antigens with 10-Minute Results, Whole Blood Sample Compatibility, and Professional Point-of-Care Use
GHM Malaria P.f./Pan Antigen Rapid Test US – Dual-Target Qualitative Detection of Plasmodium falciparum HRP-II and Pan-Plasmodium pLDH Antigens with 10-Minute Results, Whole Blood Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Malaria P.f./Pan Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Malaria P.f./Pan Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection and differentiation of Plasmodium falciparum histidine-rich protein II (Pf HRP-II) antigen and pan-Plasmodium lactate dehydrogenase (Pan pLDH) antigen in human whole blood specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of malaria infection, including both P. falciparum and non-falciparum species.
Malaria remains one of the world's most serious infectious diseases. According to the World Health Organization, there were an estimated 282 million malaria cases and 610,000 malaria deaths globally in 2024, representing roughly 9 million more cases than the previous year. The WHO African Region continues to bear the greatest burden, accounting for 95% of cases and 95% of deaths. Malaria is caused by Plasmodium parasites, which invade human red blood cells. Four species of Plasmodium parasites are responsible for malaria infections in humans: P. falciparum, P. vivax, P. ovale, and P. malariae. Of these, P. falciparum causes the most severe disease and accounts for most malaria-related deaths, while non-falciparum species contribute to persistent and recurring infections.
Malaria rapid diagnostic tests (RDTs) are essential tools for the prompt diagnosis of malaria, particularly in settings where quality microscopy is not available. The WHO recommends that all suspected cases of malaria be confirmed using parasite-based diagnostic testing. The dual-target design of this test simultaneously detects P. falciparum-specific HRP-II antigen and pan-Plasmodium pLDH antigen, which is expressed by all four human-infecting Plasmodium species. This enables rapid differentiation between P. falciparum infection, non-falciparum infection, and mixed infections, supporting appropriate treatment selection and case management.
The GHM Malaria P.f./Pan 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-Target Detection – Pf HRP-II and Pan pLDH in One Test
The GHM Malaria P.f./Pan Antigen Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting and differentiating P. falciparum-specific HRP-II antigen and pan-Plasmodium pLDH antigen from a single patient sample. The test incorporates two separate test lines: T1 for P. falciparum-specific HRP-II antigen and T2 for pan-Plasmodium pLDH antigen, enabling clear differentiation between P. falciparum infection, non-falciparum infection, and mixed infections in a single assay.
| Feature | Benefit |
|---|---|
| Dual-target detection | Simultaneously detects Pf HRP-II and Pan pLDH antigens in one test |
| Two separate test lines (T1 & T2) | Clear differentiation between Pf, non-falciparum, and mixed infections |
| Covers all four human-infecting Plasmodium species | Comprehensive coverage of P. falciparum, P. vivax, P. ovale, and P. malariae |
| 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./Pan 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./Pan 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 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 Malaria Infection
The GHM Malaria P.f./Pan Antigen Rapid Test US is intended for use as an aid in the diagnosis and differentiation of malaria infections. 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-target detection enables healthcare providers to rapidly differentiate between P. falciparum and non-falciparum infections, supporting species-appropriate treatment selection. 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 malaria infection |
| Rapid etiological diagnosis | Enables timely initiation of appropriate antimalarial therapy |
| Species differentiation support | Helps distinguish Pf, non-falciparum, 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./Pan 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 P. falciparum and pan-Plasmodium targets, 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% |
| Pan-Plasmodium (pLDH) | 97.62% | >99.99% | 99.58% |
| Parameter | Specification |
|---|---|
| Limit of Detection | 100 parasites/µL for all species |
| Precision | >98% |
| Cross-reactivity | No cross-reactivity observed with HIV, HCV, Influenza A/B, RSV, Syphilis, or H. pylori |
Performance characteristics based on comparison with microscopy using clinical whole blood samples. Published field evaluations of HRP2/pLDH-based Pf/Pan combination RDTs have demonstrated high sensitivity for P. falciparum detection, with specificities exceeding 98% for both targets.
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./Pan 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./Pan Antigen Rapid Test US |
| Product Code | MALP-402b |
| Product Type | Malaria P.f./Pan Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection and differentiation of Plasmodium falciparum HRP-II antigen and pan-Plasmodium pLDH antigen in human whole blood specimens; used as an aid in the diagnosis of malaria infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antigens | Plasmodium falciparum histidine-rich protein II (HRP-II); Pan-Plasmodium lactate dehydrogenase (pLDH) |
| Specimen | Whole Blood (venipuncture or fingerstick) |
| Sample Volume | 5 µL whole blood |
| Time to Result | 10 minutes |
| Sensitivity | Pf: 95.92%; Pan: 97.62% |
| Specificity | Pf: >99.99%; Pan: >99.99% |
| Accuracy | Pf: 99.19%; Pan: 99.58% |
| Precision | >98% |
| Limit of Detection | 100 parasites/µL for all species |
| 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 | 25 tests/kit; 50 tests/kit |
| Kit Contents | Malaria P.f./Pan Test Cassette, Sample Diluent, Dropper, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Malaria P.f./Pan Antigen Rapid Test US |
|---|---|
| Dual-target detection | Simultaneous detection of Pf HRP-II and Pan pLDH 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, non-falciparum, and mixed infections |
| Covers all four human-infecting Plasmodium species | Comprehensive coverage of malaria pathogens |
| High sensitivity and specificity | Pf: 95.92% sensitivity; Pan: 97.62% sensitivity; >99.99% specificity |
| 99.19% and 99.58% overall agreement | Strong concordance with microscopy for Pf and Pan 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 recommendations for parasite-based diagnostic testing |
| 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./Pan 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.
