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Global Healthcare Medical
GHM HAV IgM Rapid Test US – Qualitative Detection of Hepatitis A Virus IgM Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
GHM HAV IgM Rapid Test US – Qualitative Detection of Hepatitis A Virus IgM Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM HAV IgM Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM HAV IgM Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of 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 acute or recent hepatitis A virus infection.
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 presence of specific HAV IgM antibody in blood samples suggests acute or recent HAV infection. At the onset of symptoms, HAV IgM antibody becomes detectable, rapidly increases in titer over a period of 2–6 weeks, and then declines to non-detectable levels within 3–6 months in most patients. Because of the transient production of anti-HAV IgM, its presence in serum indicates ongoing or recent infection and is the most useful serological marker for diagnosing acute HAV infection.
The GHM HAV 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, 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
Colloidal Gold Immunochromatography – Reliable Qualitative Detection
The GHM HAV IgM Rapid Test US is based on lateral flow immunochromatography technology. The membrane is immobilized with anti-human IgM antibody on the test region. During the assay, the specimen reacts with gold particles coated with recombinant HAV antigen. As the specimen/particle mixture migrates chromatographically on the membrane by capillary action, the complex is captured by the test band located in the result window, causing a visible line. The appearance of any color in the test region is considered positive for HAV IgM antibody. A colored line at the control region serves as a procedural control and always appears in the viewing window, confirming proper test performance.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Recombinant HAV antigen-coated gold particles | Targeted detection of HAV IgM antibodies |
| Anti-human IgM capture antibody | Specific and accurate detection |
| Qualitative visual result | Clear and interpretable test outcome |
| Internal procedural control | Confirms proper test performance |
Fast Results – 15 Minutes
The GHM HAV 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 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 of Acute or Recent Hepatitis A Infection
The GHM HAV IgM Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of acute or recent infection with hepatitis A virus. The test provides rapid serological diagnosis, enabling timely clinical decision-making and supporting patient management. 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 test is particularly valuable in settings where rapid identification of HAV infection supports timely clinical management and public health intervention. Because symptomatic hepatitis A viral infections cannot be clinically distinguished from hepatitis B or C viral infections, serological testing is important for proper diagnosis. The detection of HAV IgM antibody in blood samples suggests acute or recent HAV infection (usually within the past 6 months).
| Feature | Benefit |
|---|---|
| Acute/recent infection detection aid | Supports identification of acute or recent HAV infection |
| 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 |
| Clinical versatility | Useful across physician offices, urgent care, and public health screening settings |
High Accuracy – Trusted Clinical Performance
The GHM HAV IgM Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Clinical evaluation against ELISA methods has demonstrated strong performance across multiple independent studies, making this assay a reliable tool for point-of-care diagnostics when correctly used.
| Parameter | Specification |
|---|---|
| Sensitivity | 95.7% |
| Specificity | 99.1% |
| Reference Method | ELISA |
Performance characteristics based on clinical evaluation of 377 specimens (96 HAV IgM positive and 281 HAV IgM negative, confirmed by ELISA with clinical symptoms or asymptomatic) using commercial ELISA as the reference method. In an additional evaluation of 151 specimens (50 positive and 101 negative) using another rapid test as the reference method, the assay also demonstrated high relative sensitivity and specificity. Published studies of rapid HAV IgM assays report sensitivities ranging from 66–100% and specificities ranging from 97.7–>99.9%, depending on the product and population evaluated.
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 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 IgM Rapid Test US |
| Product Code | IHA-402 |
| Product Type | HAV IgM Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of 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 acute or recent HAV infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antibody | IgM antibodies to hepatitis A virus (HAV) |
| Specimen | Whole Blood / Serum / Plasma |
| Time to Result | 15 minutes |
| Sensitivity | 95.7% |
| Specificity | 99.1% |
| 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, 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; 50 tests/kit |
| Kit Contents | HAV IgM Test Cassette, Sample Buffer, Disposable Droppers, Sterile Lancet (optional), Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM HAV IgM Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Whole blood / serum / plasma compatibility | Flexible and convenient sampling options |
| HAV IgM-specific detection | Targeted detection of HAV IgM antibodies |
| High sensitivity and specificity | 95.7% sensitivity and 99.1% specificity |
| ELISA-validated performance | Validated against ELISA methods in clinical studies |
| Acute/recent infection detection aid | Supports identification of acute or recent HAV infection |
| Differential diagnosis support | Helps distinguish HAV from hepatitis B and C infections |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for physician offices, urgent care, 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 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.
