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Global Healthcare Medical
GHM HCV Rapid Test US – Qualitative Detection of Hepatitis C Virus Antibodies with 10-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
GHM HCV Rapid Test US – Qualitative Detection of Hepatitis C Virus Antibodies with 10-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM HCV Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM HCV Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of antibodies to hepatitis C virus (HCV) 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 C virus infection.
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), a bloodborne pathogen that can lead to chronic infection, cirrhosis, and hepatocellular carcinoma. Globally, an estimated 50 million people are living with chronic hepatitis C infection, with approximately 1.0 million new infections occurring annually. The WHO has set a target to eliminate hepatitis C as a public health threat by 2030, and achieving this goal depends on expanding access to rapid diagnostic testing, particularly in decentralized and resource-limited settings where laboratory infrastructure may be limited.
HCV antibody testing is the recommended first-line screening approach for detecting HCV exposure. Antibodies to HCV typically become detectable within 4–10 weeks after infection and persist for life in most individuals. Rapid point-of-care tests for HCV antibodies provide results in a short timeframe and allow linkage to care, particularly for difficult-to-reach populations.
The GHM HCV Rapid Test US delivers qualitative results in 10 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, harm reduction programs, 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 HCV Rapid Test US is based on lateral flow immunochromatography technology. The test strip contains recombinant HCV antigens coated on the test line, along with colloidal gold-conjugated recombinant HCV antigens and control antibodies. During testing, the specimen reacts with the antigen-coated particles and migrates up the membrane to react with the antigens on the membrane. A colored line is generated at the test line region if HCV antibodies are present in the specimen.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Recombinant HCV antigen-coated test line | Targeted detection of anti-HCV antibodies |
| Detects anti-HCV IgG, IgM, and IgA | Comprehensive antibody detection across immunoglobulin classes |
| Qualitative visual result | Clear and interpretable test outcome |
| Internal procedural control | Confirms proper test performance |
Fast Results – 10 Minutes
The GHM HCV Rapid Test US provides qualitative results in 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Rapid point-of-care tests for HCV antibodies provide results in a short timeframe and allow linkage to care, particularly for difficult-to-reach populations.
| Feature | Benefit |
|---|---|
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for physician office laboratories and harm reduction programs |
| 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 HCV 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. 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 |
| 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 Hepatitis C Virus Infection
The GHM HCV Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of hepatitis C virus infection. The test provides rapid serological diagnosis, enabling timely clinical decision-making and supporting linkage to care. Early and accurate identification of HCV infection is essential for reducing HCV-related morbidity and mortality through appropriate clinical management, including linkage to confirmatory testing and antiviral therapy where indicated.
The test is particularly valuable in settings where rapid identification of HCV infection supports public health screening and harm reduction efforts. Rapid point-of-care HCV antibody testing is a critical tool for expanding access to diagnosis and achieving WHO hepatitis C elimination targets.
| Feature | Benefit |
|---|---|
| HCV antibody detection aid | Supports identification of individuals with HCV exposure |
| Screening utility | Suitable for use as a screening test in clinical and public health settings |
| Linkage to care support | Enables rapid referral for confirmatory testing and clinical management |
| Public health screening support | Suitable for harm reduction and community screening programs |
| Clinical versatility | Useful across physician offices, hospitals, and public health settings |
High Accuracy – Trusted Clinical Performance
The GHM HCV Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Clinical evaluation against reference methods has demonstrated strong performance, making this assay a reliable tool for point-of-care diagnostics when correctly used.
| Parameter | Specification |
|---|---|
| Sensitivity | 98.8% |
| Specificity | 99.1% |
| Detectable Limit | 0.410 S/CO |
| Reference Method | Immunochromatographic assay |
Performance characteristics based on clinical evaluation of rapid HCV antibody tests. Published evaluations of rapid HCV antibody assays report pooled sensitivity of 98% and specificity of 100% when compared to enzyme immunoassay reference methods. Independent WHO prequalification evaluations of rapid HCV antibody tests have demonstrated sensitivity of 100% and specificity of 100% in some products.
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 HCV 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 HCV Rapid Test US |
| Product Code | IHC-402-WC |
| Product Type | HCV Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of antibodies to Hepatitis C Virus (HCV) in human whole blood, serum, or plasma specimens; used as a screening test and as an aid in the diagnosis of HCV infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antibodies | Anti-HCV antibodies (IgG, IgM, IgA) |
| Specimen | Whole Blood (venipuncture or fingerstick) / Serum / Plasma |
| Sample Volume | 50 µL (2 drops) of serum, plasma, or venous whole blood |
| Time to Result | 10 minutes |
| Sensitivity | 98.8% |
| Specificity | 99.1% |
| Detectable Limit | 0.410 S/CO |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Physician office laboratory, hospital laboratory, harm reduction program, 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 | HCV Test Cassette, Buffer, Disposable Droppers, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM HCV Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Whole blood / serum / plasma compatibility | Flexible and convenient sampling options |
| Anti-HCV IgG, IgM, and IgA detection | Comprehensive antibody detection across immunoglobulin classes |
| High sensitivity and specificity | 98.8% sensitivity and 99.1% specificity |
| Detectable limit 0.410 S/CO | Reliable detection at low antibody concentrations |
| Screening test utility | Suitable for use as a screening test in clinical and public health settings |
| Linkage to care support | Enables rapid referral for confirmatory testing |
| Public health screening support | Suitable for harm reduction and community screening programs |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for physician offices, hospitals, 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 HCV 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.
