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Global Healthcare Medical
GHM HIV/HCV/HBsAg Combo Rapid Test US – 3-in-1 Qualitative Detection of HIV-1/2 Antibodies, HCV Antibodies, and HBsAg with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
GHM HIV/HCV/HBsAg Combo Rapid Test US – 3-in-1 Qualitative Detection of HIV-1/2 Antibodies, HCV Antibodies, and HBsAg with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM HIV/HCV/HBsAg Combo Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM HIV/HCV/HBsAg Combo Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of antibodies to human immunodeficiency virus type 1 and type 2 (HIV-1/2), antibodies to hepatitis C virus (HCV), and 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 HIV, HCV, and HBV infections.
HIV, HCV, and HBV represent three of the most significant bloodborne infectious diseases worldwide, with substantial global health burdens. An estimated 39.9 million people were living with HIV globally, approximately 50 million people are living with chronic hepatitis C infection, and 254 million people were living with chronic hepatitis B infection as of 2022. These infections share common transmission routes—including blood exposure and sexual transmission—and frequently co-occur in at-risk populations, making integrated, multi-pathogen screening an increasingly important public health strategy. Because early-stage infections are often asymptomatic, screening is essential for identifying infected individuals, linking them to care, and preventing further transmission.
The GHM HIV/HCV/HBsAg Combo Rapid Test US combines three separate screening assays into a single test device, enabling simultaneous detection of all three markers from one patient sample. This triple-panel design reduces the need for multiple specimen collections and separate testing procedures, streamlining the screening workflow and supporting integrated, cost-effective testing strategies. 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 GHM HIV/HCV/HBsAg Combo Rapid Test US delivers qualitative results in just 15 minutes, supporting rapid clinical decision-making at the point of care. 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, prenatal screening settings, 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
3-in-1 Combo Detection – HIV, HCV, and HBsAg in One Test
The GHM HIV/HCV/HBsAg Combo Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting three major bloodborne infectious disease markers from a single patient sample. The test incorporates separate test lines for HIV-1/2 antibodies, HCV antibodies, and HBsAg, enabling clear differentiation of results for each pathogen in a single assay. This triple-panel design supports integrated, multi-pathogen screening and reduces the need for separate specimen collections and testing procedures.
| Feature | Benefit |
|---|---|
| 3-in-1 combo detection | Simultaneously detects HIV-1/2, HCV, and HBsAg in one test |
| Separate test lines for each marker | Clear differentiation of results for each pathogen |
| Single-sample workflow | Reduces the need for multiple specimen collections and separate tests |
| Colloidal gold immunochromatography | Established and reliable detection method |
| Recombinant antigen/antibody-coated test lines | Targeted detection of each analyte |
| Qualitative visual result | Clear and interpretable test outcome |
Fast Results – 15 Minutes
The GHM HIV/HCV/HBsAg Combo 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 public health screening settings |
| 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 HIV/HCV/HBsAg Combo 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 Integrated Screening of HIV, HCV, and HBV Infections
The GHM HIV/HCV/HBsAg Combo Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of HIV, HCV, and HBV infections. The test provides rapid serological and antigenic diagnosis, enabling timely clinical decision-making and supporting integrated linkage to care. Early and accurate identification of these infections is essential for reducing disease-related morbidity and mortality through appropriate clinical management, including linkage to confirmatory testing and initiation of appropriate therapy.
The triple-panel design is particularly valuable in settings where integrated screening for multiple bloodborne pathogens is recommended, including prenatal screening, sexual health clinics, harm reduction programs, and bloodborne pathogen screening initiatives. The test is designed for professional use in screening for HIV-1/2 antibodies, HCV antibodies, and HBsAg in clinical, outreach, and public health settings.
| Feature | Benefit |
|---|---|
| Integrated screening aid | Supports simultaneous identification of HIV, HCV, and HBV 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 outreach and community screening programs |
| Prenatal screening relevance | Valuable for screening pregnant women for multiple bloodborne pathogens |
| Clinical versatility | Useful across physician offices, hospitals, and public health settings |
High Accuracy – Trusted Clinical Performance
The GHM HIV/HCV/HBsAg Combo Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity across all three targets. Independent evaluations of triple-panel rapid tests have reported excellent diagnostic performance with sensitivities and specificities comparable to individual tests.
| Target | Sensitivity | Specificity | Accuracy |
|---|---|---|---|
| HIV-1/2 Antibodies | 99.70% | 100% | 99.9% |
| HCV Antibodies | 98.71% | 99.33% | 99.0% |
| HBsAg | 98.97% | 99.78% | 99.5% |
Performance characteristics based on independent evaluations of combination rapid diagnostic test kits. Published studies of HIV/HCV/HBsAg combination ICT kits have reported sensitivities of 97.8% for HBsAg and 98.8% for anti-HCV antibodies, with specificities of 99.8% and 99.6%, respectively. The analytical sensitivity required for an HBsAg diagnostic test in the EU is 0.13 IU/mL. A systematic review of multiplex immunochromatographic rapid tests reported high sensitivity, high specificity, and excellent concordance with reference methods.
CLIA-Waived Testing Support – Expanded Point-of-Care Access
The GHM HIV/HCV/HBsAg Combo Rapid Test US supports integrated screening in CLIA-waived settings. Individual rapid HIV and HCV antibody tests have been granted CLIA-waived status by the FDA and are suitable for use in non-clinical settings, including outreach and community-based testing programs. This triple-panel test is designed to support integrated screening workflows in similar point-of-care environments. Healthcare providers should verify local regulatory requirements regarding CLIA certification before performing testing in their facility.
| Feature | Benefit |
|---|---|
| CLIA-waived setting compatibility | Supports testing in non-clinical and outreach settings |
| Integrated screening workflow support | Streamlines multi-pathogen testing in a single visit |
| Point-of-care focused design | Suitable for community screening and outreach programs |
| Room temperature storage | Convenient storage and transport conditions |
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 HIV/HCV/HBsAg Combo 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 HIV/HCV/HBsAg Combo Rapid Test US |
| Product Type | HIV/HCV/HBsAg Combo Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of antibodies to HIV-1/2, antibodies to HCV, and HBsAg in human whole blood, serum, or plasma specimens; used as a screening test and as an aid in the diagnosis of HIV, HCV, and HBV infections |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Analytes | HIV-1/2 antibodies; HCV antibodies; Hepatitis B Surface Antigen (HBsAg) |
| Specimen | Whole Blood / Serum / Plasma |
| Time to Result | 15 minutes |
| Sensitivity | HIV: 99.70%; HCV: 98.71%; HBsAg: 98.97% |
| Specificity | HIV: 100%; HCV: 99.33%; HBsAg: 99.78% |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Physician office laboratory, hospital laboratory, public health screening program, prenatal screening setting, 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 | 20 tests/kit; 25 tests/kit |
| Kit Contents | Combo Test Cassette, Sample Buffer, Disposable Droppers, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM HIV/HCV/HBsAg Combo Rapid Test US |
|---|---|
| 3-in-1 combo detection | Simultaneous detection of HIV-1/2, HCV, and HBsAg |
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Whole blood / serum / plasma compatibility | Flexible and convenient sampling options |
| Separate test lines for each marker | Clear differentiation of results for each pathogen |
| High sensitivity and specificity | HIV: 99.70% sensitivity and 100% specificity; HCV: 98.71% sensitivity and 99.33% specificity; HBsAg: 98.97% sensitivity and 99.78% specificity |
| Integrated screening support | Streamlines multi-pathogen testing in a single visit |
| CLIA-waived setting compatibility | Supports testing in non-clinical and outreach settings |
| Public health screening support | Suitable for prenatal screening and community outreach 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 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 HIV/HCV/HBsAg Combo 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.
