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Global Healthcare Medical
GHM Filariasis IgG/IgM Rapid Test US – Dual-Target Qualitative Detection of Filarial IgG & IgM Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
GHM Filariasis IgG/IgM Rapid Test US – Dual-Target Qualitative Detection of Filarial IgG & IgM Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Filariasis IgG/IgM Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Filariasis IgG/IgM Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection and differentiation of IgG and IgM antibodies to lymphatic filarial parasites (Wuchereria bancrofti and Brugia malayi) in human whole blood, serum, or plasma specimens. The kit is intended for use by healthcare professionals as a screening test and as an aid in the diagnosis of lymphatic filariasis infection.
Lymphatic filariasis (LF), commonly known as elephantiasis, is a neglected tropical disease caused by parasitic nematodes transmitted through the bites of infected mosquitoes. The disease remains a significant public health challenge in many endemic countries, with over 657 million people in 39 countries worldwide threatened by lymphatic filariasis and requiring preventive chemotherapy to stop the spread of this parasitic infection. Globally, an estimated 129 million people were infected with LF, of which 43 million had clinical disease, including 25 million men with hydrocele and over 15 million people with lymphoedema. India bears the highest LF burden globally, accounting for approximately 62% (404.3 million) of the at-risk population.
The definitive parasitologic diagnosis is the demonstration of microfilariae in blood samples. However, this gold standard test is restricted by the requirement for nocturnal blood collection and lack of adequate sensitivity. Antibody detection provides an early means to detect filarial parasite infection. The presence of IgM to the parasite antigens suggests current infection, whereas IgG corresponds to late-stage infection or past infection. The GHM Filariasis IgG/IgM Rapid Test uses conserved recombinant antigens to simultaneously detect antibodies to both W. bancrofti and B. malayi parasites without the restriction on specimen collection timing.
The GHM Filariasis IgG/IgM Rapid Test US delivers qualitative results in just 15 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options suitable for a wide range of clinical settings, including decentralized and resource-limited environments where laboratory infrastructure may be limited.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including physician office laboratories, hospital laboratories, public health screening programs in endemic areas, tropical medicine clinics, and clinical laboratories. 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
2-in-1 Detection – IgG and IgM in One Test
The GHM Filariasis IgG/IgM Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting and differentiating filarial IgG and IgM antibodies from a single patient sample. The test incorporates separate test lines for IgG and IgM, enabling clear differentiation between current/recent infection and past or chronic exposure in a single assay. This dual-target design provides a comprehensive diagnostic picture that supports appropriate clinical decision-making and effective patient management.
| Feature | Benefit |
|---|---|
| 2-in-1 detection | Simultaneously detects filarial IgG and IgM antibodies in one test |
| Separate test lines for IgG and IgM | Clear differentiation between current/recent infection and past exposure |
| Single-sample workflow | Reduces the need for multiple specimen collections and separate tests |
| Colloidal gold immunochromatography | Established and reliable detection method |
| Recombinant antigen-coated particles | Targeted detection of antibodies to both W. bancrofti and B. malayi |
| Qualitative visual result | Clear and interpretable test outcome |
Fast Results – 15 Minutes
The GHM Filariasis IgG/IgM Rapid Test US provides qualitative results in just 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Rapid diagnostic tests for filariasis enable faster case identification and support timely public health intervention in endemic areas.
| Feature | Benefit |
|---|---|
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for physician office laboratories and tropical medicine clinics |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput screening environments |
Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection
The GHM Filariasis IgG/IgM Rapid Test US is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs. Unlike traditional parasitological diagnosis that requires nocturnal blood collection, this antibody-based test can be performed at any time of day, overcoming a major barrier to filariasis diagnosis in field settings. The test requires only a small sample volume, making it suitable for both clinic-based and field-based testing scenarios.
| Feature | Benefit |
|---|---|
| Whole blood / serum / plasma | Flexible sample collection options |
| Any time of day collection | No requirement for nocturnal blood collection |
| Fingerstick or venipuncture whole blood | Suitable 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 Lymphatic Filariasis
The GHM Filariasis IgG/IgM Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of infection with lymphatic filarial parasites. The test provides rapid serological diagnosis, enabling timely clinical decision-making and supporting patient management. Early and accurate identification of filarial infection is essential for reducing LF-related morbidity and preventing disease progression to chronic lymphedema and hydrocele.
The dual-target design provides comprehensive diagnostic value. IgM antibodies typically indicate recent or current infection, while IgG antibodies reflect past or ongoing exposure to filarial parasites. The test is particularly valuable in settings where rapid identification of filarial infection supports public health surveillance and mass drug administration (MDA) program monitoring. The WHO has set a goal of eliminating LF by 2030 as a public health problem, and robust diagnostic tools are critical to achieving this target.
| Feature | Benefit |
|---|---|
| Current/recent infection detection aid | Supports identification of active filarial infection via IgM detection |
| Past or chronic exposure detection support | Identifies past filarial infection or ongoing exposure via IgG detection |
| Screening utility | Suitable for use as a screening test in clinical and public health settings |
| Any-time sample collection | Overcomes nocturnal blood collection barrier |
| Public health surveillance support | Suitable for MDA program monitoring and epidemiological surveys |
| Clinical versatility | Useful across physician offices, hospitals, tropical medicine clinics, and public health settings |
High Accuracy – Trusted Clinical Performance
The GHM Filariasis IgG/IgM Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity for both IgG and IgM targets. Published evaluations of rapid filariasis antibody tests have demonstrated excellent diagnostic accuracy.
| Target | Sensitivity | Specificity |
|---|---|---|
| Filarial IgG Antibody | 92.3% | 100% |
| Filarial IgM Antibody | 98.5% | 100% |
| Parameter | Specification |
|---|---|
| Specimen | Whole Blood / Serum / Plasma |
| Time to Result | 15 minutes |
| Cross-reactivity | Recombinant proteins eliminate cross-reaction with individuals having other parasitic diseases |
| Storage Temperature | 2–30°C |
Performance characteristics based on published evaluations of rapid filariasis antibody tests. A study conducted in the Kamwenge District, Western Uganda, using the Abbexa Filariasis IgG/IgM Rapid Test reported a sensitivity of 92.3% for IgG and 98.5% for IgM, with a specificity of 100% for both IgG and IgM, indicating a high level of reliability in detecting both positive and negative cases. Independent evaluations of the BLF Rapid™ test showed 100% diagnostic sensitivity and specificity in in-house evaluations, with 84–100% diagnostic sensitivity and 100% specificity in independent evaluations (excluding non-lymphatic filarial infections).
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 Filariasis IgG/IgM 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 Filariasis IgG/IgM Rapid Test US |
| Product Type | Filariasis IgG/IgM Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection and differentiation of IgG and IgM antibodies to lymphatic filarial parasites (Wuchereria bancrofti and Brugia malayi) in human whole blood, serum, or plasma specimens; used as a screening test and as an aid in the diagnosis of lymphatic filariasis infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antibodies | Filarial IgG and IgM antibodies |
| Target Parasites | Wuchereria bancrofti, Brugia malayi |
| Specimen | Whole Blood (venipuncture or fingerstick) / Serum / Plasma |
| Time to Result | 15 minutes |
| Sensitivity | IgG: 92.3%; IgM: 98.5% |
| Specificity | IgG: 100%; IgM: 100% |
| Cross-reactivity | Recombinant proteins eliminate cross-reaction with other parasitic diseases |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Physician office laboratory, hospital laboratory, tropical medicine clinic, public health screening program in endemic areas, clinical laboratory, 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; 40 tests/kit |
| Kit Contents | Filariasis IgG/IgM Test Cassette, Sample Buffer, Disposable Droppers, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Filariasis IgG/IgM Rapid Test US |
|---|---|
| 2-in-1 detection | Simultaneous detection and differentiation of filarial IgG and IgM antibodies |
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Whole blood / serum / plasma compatibility | Flexible and convenient sampling options |
| Separate test lines for IgG and IgM | Clear differentiation between current/recent infection and past exposure |
| High sensitivity and specificity | IgG: 92.3% sensitivity and 100% specificity; IgM: 98.5% sensitivity and 100% specificity |
| Any-time sample collection | Overcomes nocturnal blood collection barrier |
| Recombinant antigen technology | Eliminates cross-reaction with other parasitic diseases |
| Covers both major LF parasites | Detects antibodies to W. bancrofti and B. malayi |
| Public health surveillance support | Suitable for MDA program monitoring and epidemiological surveys |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for physician offices, tropical medicine clinics, and public health settings |
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 Filariasis IgG/IgM 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.
