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Global Healthcare Medical
GHM HBsAg Antigen Rapid Test US – Qualitative Detection of Hepatitis B Surface Antigen with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
GHM HBsAg Antigen Rapid Test US – Qualitative Detection of Hepatitis B Surface Antigen with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM HBsAg Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM HBsAg Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Hepatitis B Surface Antigen (HBsAg) 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 B virus (HBV) infection.
Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV), a member of the Hepadnaviridae family. HBV can cause chronic infection and puts people at high risk of death from cirrhosis and liver cancer. The WHO estimates that 254 million people were living with chronic hepatitis B infection in 2022, with 1.2 million new infections per year and 1.1 million deaths annually, mostly from cirrhosis and hepatocellular carcinoma. HBsAg is the earliest serologic marker of HBV infection, detectable weeks before symptoms appear, making it the primary marker for screening and diagnosis. The HBsAg Rapid Test provides a rapid, cost-effective screening solution that is comparable to ELISA in diagnostic accuracy, supporting its use in clinical and resource-limited settings.
The GHM HBsAg Antigen 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.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including physician office laboratories, hospital laboratories, blood donation screening programs, urgent care centers, 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 HBsAg Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test strip contains colloidal gold-conjugated monoclonal antibodies specific to HBsAg, along with immobilized capture antibodies on the test line. During testing, the specimen reacts with the antibody-coated particles and migrates up the membrane to react with the antibodies on the membrane. A colored line is generated at the test line region if HBsAg is present in the specimen. The test detects all 10 HBsAg subtypes that gave positive results on the rapid test cassette.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| HBsAg-specific monoclonal antibodies | Targeted detection of HBsAg |
| Detects all 10 HBsAg subtypes | Comprehensive coverage of circulating HBV strains |
| Qualitative visual result | Clear and interpretable test outcome |
| Internal procedural control | Confirms proper test performance |
Fast Results – 15 Minutes
The GHM HBsAg Antigen Rapid Test US provides qualitative results in just 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. HBsAg can be detected 2–4 weeks in advance of elevated ALT liver enzyme levels and 3–5 weeks prior to symptoms, making early detection critical for timely intervention.
| 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 HBsAg Antigen 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. Fingerstick whole blood sensitivity and specificity were 97.2% and 98.5% respectively at 15-minute reading. 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 Hepatitis B Virus Infection
The GHM HBsAg Antigen Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of hepatitis B viral infection. The test provides rapid serological diagnosis, enabling timely clinical decision-making and supporting patient management. HBsAg is the first serologic marker to appear in the blood of patients infected with hepatitis B, prior to the onset of symptoms, and is also present in patients with chronic infection.
The test is particularly valuable in settings where rapid identification of HBV infection supports timely clinical management and public health intervention. Early and accurate diagnosis of hepatitis B, supported by rapid laboratory assessment, is essential for reducing HBV-related morbidity and mortality through appropriate clinical management, including antiviral therapy where indicated. The test is also suitable for blood donor screening and in decentralized testing environments where laboratory infrastructure may be limited.
| Feature | Benefit |
|---|---|
| Acute and chronic infection detection aid | Supports identification of acute and chronic HBV infection |
| Screening utility | Suitable for use as a screening test in clinical and public health settings |
| Blood donor screening support | Suitable for screening blood donors and blood products |
| Infection control support | Enables prompt identification of cases and implementation of infection control measures |
| Clinical versatility | Useful across physician offices, hospitals, blood banks, and public health screening settings |
High Accuracy – Trusted Clinical Performance
The GHM HBsAg Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Clinical evaluation against ELISA methods has demonstrated strong performance, with independent studies reporting excellent diagnostic accuracy comparable to ELISA, supporting its use as a reliable and cost-effective screening tool in clinical and resource-limited settings.
| Parameter | Specification |
|---|---|
| Sensitivity | 99.3% |
| Specificity | 99.8% |
| Accuracy | 99.6% |
| Reference Method | ELISA |
| Cross-reactivity | No cross-reactivity observed with common bloodborne pathogens |
Performance characteristics based on comparison with ELISA methods using clinical whole blood, serum, and plasma samples. Published studies of rapid HBsAg assays report pooled sensitivity of 98.07% and specificity of 99.56% across 33 high-quality studies. The analytical sensitivity required for an HBsAg diagnostic test in the EU is 0.13 IU/mL.
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 HBsAg 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 HBsAg Antigen Rapid Test US |
| Product Code | IHBSG-402 |
| Product Type | HBsAg Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human whole blood, serum, or plasma specimens; used as a screening test and as an aid in the diagnosis of hepatitis B viral infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antigen | Hepatitis B Surface Antigen (HBsAg) |
| Specimen | Whole Blood (venipuncture or fingerstick) / Serum / Plasma |
| Time to Result | 15 minutes |
| Sensitivity | 99.3% |
| Specificity | 99.8% |
| Accuracy | 99.6% |
| Reference Method | ELISA |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Physician office laboratory, hospital laboratory, blood donation screening program, urgent care center, 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 | 40 tests/kit |
| Kit Contents | HBsAg Test Cassette, Sample Buffer, Disposable Droppers, Package Insert with Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM HBsAg Antigen 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 |
| HBsAg-specific detection | Targeted detection of Hepatitis B Surface Antigen |
| Detects all 10 HBsAg subtypes | Comprehensive coverage of circulating HBV strains |
| High sensitivity and specificity | 99.3% sensitivity and 99.8% specificity |
| ELISA-validated performance | Validated against ELISA methods in clinical studies |
| Acute and chronic infection detection | HBsAg is the earliest serologic marker of HBV infection |
| Blood donor screening support | Suitable for screening blood donors and blood products |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for physician offices, hospitals, blood banks, 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 HBsAg 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.
