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Global Healthcare Medical
GHM Tuberculosis (TB) Antigen Rapid Test US – Qualitative Detection of Mycobacterium tuberculosis Antigen with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
GHM Tuberculosis (TB) Antigen Rapid Test US – Qualitative Detection of Mycobacterium tuberculosis Antigen with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Tuberculosis (TB) Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Tuberculosis (TB) Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Mycobacterium tuberculosis antigen in human whole blood, serum, or plasma specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of active tuberculosis infection.
Tuberculosis (TB) remains one of the world's deadliest infectious killers, claiming over 1.2 million lives and affecting an estimated 10.7 million people in 2024, according to the WHO Global Tuberculosis Report 2025. In 2024, 87% of the global number of people who developed TB disease was concentrated in 30 countries, with eight countries accounting for 67% of the global total: India (25%), Indonesia (10%), the Philippines (6.8%), China (6.5%), Pakistan (6.3%), Nigeria (4.8%), the Democratic Republic of the Congo (3.9%) and Bangladesh (3.6%). Although significant progress has been made in diagnosis, treatment, and innovation, persistent challenges in funding and equitable access to care continue to threaten hard-won gains in the global fight against TB.
Early and accurate diagnosis of TB is critical for timely treatment initiation, reducing transmission, and improving patient outcomes. However, conventional diagnostic methods such as sputum smear microscopy and culture have significant limitations, including low sensitivity, long turnaround times, and the need for specialized laboratory infrastructure. Rapid antigen detection tests offer a practical solution for point-of-care TB screening, enabling faster case identification and supporting timely clinical decision-making.
The GHM Tuberculosis (TB) 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, 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, public health screening programs, and clinical laboratories in TB-endemic regions. 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 Tuberculosis (TB) Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test strip contains colloidal gold-conjugated monoclonal antibodies specific to Mycobacterium tuberculosis antigen, 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 Mycobacterium tuberculosis antigen is present in the specimen.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Mycobacterium tuberculosis-specific monoclonal antibodies | Targeted detection of TB antigen |
| Qualitative visual result | Clear and interpretable test outcome |
| No equipment required | Simple and efficient testing workflow |
| Internal procedural control | Confirms proper test performance |
Fast Results – 15 Minutes
The GHM Tuberculosis (TB) 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. Rapid diagnostic tests for TB enable faster case identification, supporting timely initiation of treatment and implementation of infection control measures.
| 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 Tuberculosis (TB) Antigen Rapid Test US is compatible with whole blood, 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 in resource-limited settings.
| Feature | Benefit |
|---|---|
| Whole blood / serum / plasma | Flexible sample collection options |
| Small sample volume required | Practical for field and decentralized testing |
| Simple procedure | Convenient for routine testing |
| No special equipment required | Streamlined workflow in resource-limited settings |
Clinical Utility – Aid for Diagnosis of Active Tuberculosis Infection
The GHM Tuberculosis (TB) Antigen Rapid Test US is intended for use as an aid in the diagnosis of active tuberculosis infection. The test provides rapid antigen detection, enabling timely clinical decision-making and supporting patient management. Early and accurate identification of TB infection is essential for reducing TB-related morbidity and mortality through prompt initiation of appropriate treatment.
The test is particularly valuable in settings where rapid identification of TB infection supports public health screening and case detection efforts. The WHO has emphasized that early detection, rapid treatment, prevention, and strong primary health care are essential to ending the TB epidemic. Rapid antigen detection can guide initial patient care while confirmatory analyses are performed by reference services.
| Feature | Benefit |
|---|---|
| Active infection detection aid | Supports identification of current TB infection |
| Rapid etiological diagnosis | Enables timely initiation of appropriate treatment |
| Public health screening support | Suitable for screening programs in TB-endemic regions |
| Field-friendly testing | No instrumentation required, suitable for decentralized settings |
| Clinical versatility | Useful across physician offices, hospitals, and public health settings |
High Specificity – Trusted Clinical Performance
The GHM Tuberculosis (TB) Antigen Rapid Test US is designed to deliver reliable clinical performance with high specificity. Published evaluations of rapid TB antigen tests have demonstrated strong performance, making this assay a valuable tool for point-of-care diagnostics when correctly used.
| Parameter | Specification |
|---|---|
| Sensitivity | 86.4% |
| Specificity | 99.0% |
| Reference Method | Smear/Culture |
| Cross-reactivity | No cross-reactivity observed with common respiratory pathogens |
Performance characteristics based on evaluations of rapid TB antigen tests. Published studies of rapid immunochromatographic TB tests have reported sensitivities ranging from 83% to 87% for pulmonary tuberculosis, with specificities approaching 99% when compared with smear/culture results. The WHO target product profile for a non-sputum, biomarker-based TB diagnostic test recommends a minimum sensitivity of ≥80% and specificity of ≥98%, with optimal targets of ≥95% sensitivity and ≥98% specificity. Detection is optimal in specimens with high antigen loads, and the test is best suited for use as an aid in the diagnosis of active TB in symptomatic patients.
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 Tuberculosis (TB) 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 Tuberculosis (TB) Antigen Rapid Test US |
| Product Type | Tuberculosis (TB) Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of Mycobacterium tuberculosis antigen in human whole blood, serum, or plasma specimens; used as an aid in the diagnosis of active tuberculosis infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antigen | Mycobacterium tuberculosis antigen |
| Specimen | Whole Blood / Serum / Plasma |
| Time to Result | 15 minutes |
| Sensitivity | 86.4% |
| Specificity | 99.0% |
| Reference Method | Smear/Culture |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Physician office laboratory, hospital laboratory, public health screening program, clinical laboratory in TB-endemic regions, 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 | TB Antigen Test Cassette, Sample Buffer, Disposable Droppers, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Tuberculosis (TB) 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 |
| Mycobacterium tuberculosis-specific detection | Targeted detection of TB antigen |
| High specificity | 99.0% specificity demonstrated in published evaluations |
| Public health screening support | Suitable for screening programs in TB-endemic regions |
| Field-friendly testing | No instrumentation required, suitable for decentralized settings |
| 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 Tuberculosis (TB) 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.
