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Global Healthcare Medical
GHM HAV IgG/IgM Rapid Test US – Dual-Target Qualitative Detection of Hepatitis A Virus IgG & IgM Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
GHM HAV IgG/IgM Rapid Test US – Dual-Target Qualitative Detection of Hepatitis A Virus IgG & IgM Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM HAV IgG/IgM Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM HAV IgG/IgM Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection and differentiation of IgG and IgM antibodies to hepatitis A virus (HAV) 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 hepatitis A virus infection and immunity assessment.
Hepatitis A is caused by infection with the hepatitis A virus (HAV), a positive-sense RNA virus belonging to the Picornaviridae family. Its transmission primarily depends on the fecal-oral route from person to person, and infection occurs mainly due to contaminated food or poor sanitary conditions. Globally, there were an estimated 159 million acute HAV infections in 2019, with 39,000 deaths from acute hepatitis A. The clinical presentation of hepatitis A is often indistinguishable from hepatitis B or C, making serological testing essential for accurate diagnosis. The HAV IgG/IgM Rapid Test provides a dual-target solution that simultaneously detects both IgG and IgM antibodies, enabling accurate differentiation between acute/recent infection and past infection or immunity.
The GHM HAV 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, serum, and plasma specimens, providing flexible sample collection options suitable for a wide range of clinical settings.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including physician office laboratories, urgent care centers, hospital laboratories, travel clinics, public health screening programs, 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 HAV IgG/IgM Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting and differentiating HAV IgG and IgM antibodies from a single patient sample. The test incorporates two separate test lines: T1 for IgG and T2 for IgM, enabling clear differentiation between acute/recent infection, past infection, and immunity 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 HAV IgG and IgM antibodies in one test |
| Two separate test lines (T1 & T2) | Clear differentiation between acute/recent infection and past infection/immunity |
| Single-sample workflow | Reduces the need for multiple specimen collections and separate tests |
| Colloidal gold immunochromatography | Established and reliable detection method |
| Recombinant HAV antigen-coated gold particles | Targeted detection of HAV antibodies |
| Qualitative visual result | Clear and interpretable test outcome |
Fast Results – 15 Minutes
The GHM HAV 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.
| Feature | Benefit |
|---|---|
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for physician office laboratories and urgent care centers |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput testing environments |
Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection
The GHM HAV IgG/IgM Rapid Test US is compatible with whole blood (fingerstick or venipuncture), serum, and plasma specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs. The test requires only a small sample volume, making it suitable for both pediatric and adult patient populations.
| Feature | Benefit |
|---|---|
| Whole blood / serum / plasma | Flexible sample collection options |
| Fingerstick or venipuncture whole blood | Suitable for different clinical settings |
| Small sample volume required | Practical for pediatric and adult patients |
| No special equipment required | Streamlined workflow in clinical settings |
Clinical Utility – Aid for Diagnosis and Immunity Assessment
The GHM HAV IgG/IgM Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of infection with hepatitis A virus. The test provides rapid serological diagnosis, enabling timely clinical decision-making and supporting patient management.
The dual-target design provides comprehensive diagnostic value. A positive IgM result (with or without IgG) indicates acute or recent HAV infection, typically detectable within 2–4 weeks after infection and persisting for up to 3–6 months. A positive IgG result with a negative IgM result suggests past infection or vaccination, indicating immunity to HAV. Concurrent positive IgG and IgM results may indicate a recent infection in a later stage. Because HAV IgM antibody becomes detectable at or prior to the onset of clinical illness and declines over 3–6 months, its presence in serum is the most useful serological marker for diagnosing acute HAV infection. Anti-HAV IgG antibodies appear soon after IgM, persist for years after infection, and confer lifelong immunity.
The test is particularly valuable in settings where rapid identification of HAV infection and immunity status supports clinical management and public health intervention. Early and accurate diagnosis of HAV infection is essential for appropriate clinical management, including supportive care, identification of close contacts who may benefit from post-exposure prophylaxis, and implementation of infection control measures. The ability to simultaneously assess immunity status is also valuable for pre-vaccination screening and travel medicine consultations.
| Feature | Benefit |
|---|---|
| Acute/recent infection detection aid | Supports identification of acute or recent HAV infection via IgM detection |
| Immunity assessment support | Determines past infection or vaccination status via IgG detection |
| Screening utility | Suitable for use as a screening test in clinical and public health settings |
| Differential diagnosis support | Helps distinguish HAV from hepatitis B and C infections |
| Infection control support | Enables prompt identification of cases and close contacts |
| Travel medicine relevance | Valuable for pre-travel immunity screening and vaccination decisions |
| Clinical versatility | Useful across physician offices, urgent care, travel clinics, and public health screening settings |
High Accuracy – Trusted Clinical Performance
The GHM HAV IgG/IgM Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity for both IgG and IgM targets. Clinical evaluation against ELISA methods has demonstrated strong performance across large specimen panels, making this assay a reliable tool for point-of-care diagnostics when correctly used.
| Target | Sensitivity | Specificity | Accuracy |
|---|---|---|---|
| HAV IgG Antibody | 97.9% | 99.1% | 98.4% |
| HAV IgM Antibody | 95.7% | 99.1% | 98.6% |
Performance characteristics based on clinical evaluation of 698 specimens for IgG (379 HAV IgG positive and 319 HAV IgG negative) and 697 specimens for IgM (116 HAV IgM positive and 581 HAV IgM negative), confirmed by ELISA with clinical symptoms or asymptomatic. Commercial ELISA served as the reference method. In an additional evaluation of 151 specimens (50 positive and 101 negative), the assay also demonstrated high relative sensitivity and specificity.
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 HAV 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 HAV IgG/IgM Rapid Test US |
| Product Code | HAV-422a |
| Product Type | HAV IgG/IgM Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection and differentiation of IgG and IgM antibodies to hepatitis A virus (HAV) in human whole blood, serum, or plasma specimens; used as a screening test and as an aid in the diagnosis of HAV infection and immunity assessment |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antibodies | HAV IgG and IgM antibodies |
| Specimen | Whole Blood / Serum / Plasma |
| Time to Result | 15 minutes |
| Sensitivity | HAV IgG: 97.9%; HAV IgM: 95.7% |
| Specificity | HAV IgG: 99.1%; HAV IgM: 99.1% |
| Accuracy | HAV IgG: 98.4%; HAV IgM: 98.6% |
| Reference Method | ELISA |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Physician office laboratory, urgent care center, hospital laboratory, travel clinic, public health screening program, 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 | HAV IgG/IgM Test Cassette, Buffer, Disposable Dropper, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM HAV IgG/IgM Rapid Test US |
|---|---|
| 2-in-1 detection | Simultaneous detection and differentiation of HAV IgG and IgM antibodies |
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Whole blood / serum / plasma compatibility | Flexible and convenient sampling options |
| Two separate test lines (T1 & T2) | Clear differentiation between acute/recent infection and past infection/immunity |
| High sensitivity and specificity | IgG: 97.9% sensitivity; IgM: 95.7% sensitivity; 99.1% specificity |
| 98.4% and 98.6% overall agreement | Strong concordance with ELISA for IgG and IgM respectively |
| Dual diagnostic and immunity assessment | Supports both acute infection detection and immunity status evaluation |
| ELISA-validated performance | Validated against ELISA methods in large clinical studies |
| Travel medicine relevance | Valuable for pre-travel immunity screening and vaccination decisions |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for physician offices, urgent care, travel clinics, and public health screening 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 HAV 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.
