WhatsApp USA: +1 6032769350 | WhatsApp HK: +852 63697831
Global Healthcare Medical
GHM Strep A Antigen Rapid Test US – Qualitative Detection of Group A Streptococcus Antigen with 5-Minute Positive Results, Throat Swab Sample Compatibility, and Professional Point-of-Care Use
GHM Strep A Antigen Rapid Test US – Qualitative Detection of Group A Streptococcus Antigen with 5-Minute Positive Results, Throat Swab Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Strep A Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Strep A Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Group A Streptococcus (Strep A) antigen directly from human throat swab specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of Group A streptococcal pharyngitis in symptomatic individuals.
Group A Streptococcus (GAS) is a major bacterial pathogen responsible for a wide spectrum of clinical conditions, ranging from uncomplicated pharyngitis and skin infections to invasive diseases such as streptococcal toxic shock syndrome and necrotizing fasciitis. GAS is estimated to account for 15–30% of cases of pharyngitis in children and 5–10% of cases in adults. Rapid antigen detection tests (RADTs) are recommended by the Infectious Diseases Society of America (IDSA) as the first-line testing method for patients with clinical features of GAS pharyngitis, enabling prompt and appropriate antimicrobial therapy.
The GHM Strep A Antigen Rapid Test US delivers positive results in just 5 minutes, with negative results confirmed at 10 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with human throat swab specimens, providing a simple and efficient sample collection method 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 pediatric clinics, family practice, urgent care centers, emergency departments, 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 Strep A Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test uses antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen. During testing, the extracted throat swab specimen reacts with an antibody to Strep A that is coated onto particles. This mixture migrates up the membrane to react with an antibody to Strep A on the membrane, and a colored line (pink-red) is generated at the test line region.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Group A Streptococcus-specific antibodies | Targeted and accurate measurement |
| Qualitative visual result | Clear and interpretable test outcome |
| No cross-reactivity with other Streptococcus groups | Specific detection of Group A Streptococcus antigen |
Fast Results – Positive in 5 Minutes
The GHM Strep A Antigen Rapid Test US provides positive results in just 5 minutes, with negative results confirmed at 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings.
| Feature | Benefit |
|---|---|
| 5-minute positive result | Rapid turnaround for timely clinical decisions |
| 10-minute negative confirmation | Enables efficient patient assessment |
| Point-of-care compatibility | Suitable for pediatric clinics and family practice |
| Test-and-treat in one visit | Supports same-visit diagnosis and treatment |
Throat Swab Sample Compatibility – Simple and Efficient Collection
The GHM Strep A Antigen Rapid Test US is compatible with human throat swab specimens, providing a simple and efficient sample collection method. The test is compatible with transport swabs containing modified Stuart's or Amies medium.
| Feature | Benefit |
|---|---|
| Throat swab specimen | Simple and efficient sample collection |
| Transport swab compatibility | Compatible with modified Stuart's or Amies medium |
| No special equipment required | Streamlined workflow in clinical settings |
| Patient-friendly | Comfortable sample collection experience |
Clinical Utility – Aid for Diagnosis of Group A Streptococcal Pharyngitis
The GHM Strep A Antigen Rapid Test US is intended for use as an aid in the diagnosis of Group A streptococcal pharyngitis. Rapid antigen detection tests are recommended by IDSA guidelines as the first-line testing method for patients with clinical features of GAS pharyngitis. The test provides rapid etiological diagnosis, enabling timely initiation of appropriate antimicrobial therapy and supporting antibiotic stewardship efforts.
| Feature | Benefit |
|---|---|
| Rapid etiological diagnosis | Supports early identification of Group A Streptococcus |
| Guideline-aligned testing | Consistent with IDSA recommendations for RADT use |
| Antibiotic stewardship support | Helps reduce unnecessary antibiotic use |
| Clinical versatility | Useful across pediatric clinics, family practice, and urgent care settings |
High Accuracy – Trusted Clinical Performance
The GHM Strep A Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Published evaluations of rapid antigen detection tests for Group A Streptococcus have demonstrated strong performance across clinical settings, making them valuable tools for point-of-care diagnostics when correctly used.
| Parameter | Specification |
|---|---|
| Sensitivity | 97.6% |
| Specificity | 97.5% |
| Precision | >99% |
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 Strep A 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 Strep A Antigen Rapid Test US |
| Product Code | STA-502b |
| Product Type | Strep A Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of Group A Streptococcus antigen directly from human throat swab specimens; used as an aid in the diagnosis of Group A streptococcal pharyngitis |
| Detection Principle | Lateral flow immunochromatography; colloidal gold sandwich immunoassay |
| Target Antigen | Group A Streptococcus antigen |
| Specimen | Throat swab |
| Time to Result | Positive in 5 minutes; Negative in 10 minutes |
| Sensitivity | 97.6% |
| Specificity | 97.5% |
| Precision | >99% |
| Storage Temperature | 2–30°C |
| Shelf Life | 24 months |
| Application Scenario | Pediatric clinic, family practice, urgent care center, emergency department, 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 Size | 25 tests/kit |
| Kit Contents | Strep A Rapid Test Cassette, Extraction Tubes, Disposable Swabs, Dropper Tips, Strep A Reagent A, Strep A Reagent B, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Strep A Antigen Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 5-minute positive result | Rapid turnaround for timely clinical decisions |
| Throat swab compatibility | Simple and efficient sample collection |
| Rapid etiological diagnosis | Supports early identification of Group A Streptococcus |
| High sensitivity and specificity | 97.6% sensitivity and 97.5% specificity |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for pediatric clinics, family practice, and urgent care settings |
| Guideline-aligned testing | Consistent with IDSA recommendations for RADT use |
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 Strep A 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.
