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Global Healthcare Medical
GHM Rotavirus & Adenovirus Combo Rapid Test US – Dual-Pathogen Qualitative Detection of Rotavirus and Adenovirus Antigens with 10–15 Minute Results, Feces Sample Compatibility, and Professional Point-of-Care Use
GHM Rotavirus & Adenovirus Combo Rapid Test US – Dual-Pathogen Qualitative Detection of Rotavirus and Adenovirus Antigens with 10–15 Minute Results, Feces Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Rotavirus & Adenovirus Combo Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Rotavirus & Adenovirus Combo Rapid Test US is a lateral flow chromatographic immunoassay designed for the qualitative detection and differentiation of rotavirus and adenovirus antigens in human feces specimens. The kit is intended for use by healthcare professionals as a screening test and as an aid in the diagnosis of viral gastroenteritis.
Acute gastroenteritis is a leading cause of morbidity and mortality worldwide, particularly among children under five years of age. Rotavirus remains the most common cause of severe diarrheal disease in infants and young children globally, accounting for approximately 40% of diarrhoeal deaths in children younger than 5 years. Adenovirus, particularly serotypes F40 and F41, is also a significant cause of acute gastroenteritis in both children and adults, and is frequently detected alongside rotavirus in co-infection cases. Because the clinical presentations of rotavirus and adenovirus gastroenteritis overlap significantly—both typically presenting with watery diarrhea, vomiting, fever, and abdominal pain—differential diagnosis based on clinical symptoms alone is unreliable. Rapid antigen detection provides a practical solution for identifying the specific viral etiology, supporting appropriate clinical management, reducing unnecessary antibiotic use, and enabling timely infection control measures.
The GHM Rotavirus & Adenovirus Combo Rapid Test US delivers qualitative results in 10–15 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with human feces specimens, providing a simple and non-invasive sample collection method suitable for a wide range of clinical settings, including pediatric clinics, hospitals, and emergency departments.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including pediatric clinics, physician office laboratories, hospital laboratories, 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 lateral flow immunochromatography.
Key Features & Benefits
Dual-Pathogen Combo Detection – Rotavirus and Adenovirus in One Test
The GHM Rotavirus & Adenovirus Combo Rapid Test US utilizes a lateral flow chromatographic immunoassay capable of simultaneously detecting and differentiating rotavirus and adenovirus antigens from a single patient sample. The test incorporates separate test lines for rotavirus and adenovirus, enabling clear differentiation between the two pathogens in a single assay. This dual-pathogen design supports differential diagnosis of viral gastroenteritis and reduces the need for multiple specimen collections and separate testing procedures.
| Feature | Benefit |
|---|---|
| Dual-pathogen combo detection | Simultaneously detects rotavirus and adenovirus in one test |
| Separate test lines for each pathogen | Clear differentiation between rotavirus and adenovirus |
| Single-sample workflow | Reduces the need for multiple specimen collections and separate tests |
| Colloidal gold immunochromatography | Established and reliable detection method |
| Qualitative visual result | Clear and interpretable test outcome |
| Internal procedural control | Confirms proper test performance |
Fast Results – 10–15 Minutes
The GHM Rotavirus & Adenovirus Combo Rapid Test US provides qualitative results in 10–15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Rapid results enable immediate clinical assessment and timely initiation of appropriate management, including rehydration therapy and infection control measures.
| Feature | Benefit |
|---|---|
| 10–15 minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for pediatric clinics and emergency departments |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput testing environments |
Feces Sample Compatibility – Simple and Non-Invasive Collection
The GHM Rotavirus & Adenovirus Combo Rapid Test US is compatible with human feces specimens, providing a simple and non-invasive sample collection method. The test uses collection tubes with extraction buffer for convenient specimen processing. Fresh stool specimens are recommended for optimal results. Specimens may be stored at 2–8°C for up to 2 days if not tested immediately; for long-term storage, -20°C or colder is recommended.
| Feature | Benefit |
|---|---|
| Feces specimen | Simple and non-invasive sample collection |
| Collection tubes with extraction buffer | Convenient specimen processing |
| No dietary restrictions required | Simplified testing protocol |
| No special equipment required | Streamlined workflow in clinical settings |
| Flexible specimen storage | Convenient handling for delayed testing |
Clinical Utility – Aid for Differential Diagnosis of Viral Gastroenteritis
The GHM Rotavirus & Adenovirus Combo Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of rotavirus and adenovirus infection. The test provides rapid antigen detection, enabling timely clinical decision-making and supporting patient management.
The dual-pathogen design provides comprehensive diagnostic value. Rapid identification of the specific viral etiology supports appropriate clinical management, including rehydration therapy and infection control measures. It also helps reduce unnecessary antibiotic prescriptions, as viral gastroenteritis does not respond to antibacterial therapy. The test is particularly valuable in pediatric settings, where rotavirus and adenovirus are leading causes of acute gastroenteritis, and in outbreak settings where rapid identification supports timely infection control measures.
| Feature | Benefit |
|---|---|
| Active infection detection aid | Supports identification of current rotavirus and/or adenovirus infection |
| Rapid etiological diagnosis | Enables timely initiation of appropriate management |
| Differential diagnosis support | Helps distinguish rotavirus from adenovirus gastroenteritis |
| Antibiotic stewardship support | Helps reduce unnecessary antibiotic use |
| Infection control support | Enables prompt isolation and cohorting decisions |
| Pediatric relevance | Particularly valuable in pediatric clinical settings |
| Clinical versatility | Useful across pediatric clinics, hospitals, and emergency departments |
High Accuracy – Trusted Clinical Performance
The GHM Rotavirus & Adenovirus Combo Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity for both rotavirus and adenovirus targets. Independent evaluations of rotavirus and adenovirus combo rapid tests have demonstrated strong performance, including a relative sensitivity of 99.1% and a relative specificity of 100% for rotavirus detection compared to reference methods. Studies of immunochromatographic assays for simultaneous detection of rotavirus and adenovirus in stool samples have reported overall agreement rates of 91.5% for rotavirus and 85.5% for adenovirus compared to ELISA.
| Target | Sensitivity | Specificity | Accuracy |
|---|---|---|---|
| Rotavirus Antigen | 98.0% | 97.0% | 98.0% |
| Adenovirus Antigen | 95.2% | 99.0% | 97.5% |
| Parameter | Specification |
|---|---|
| Limit of Detection | 10 ng/mL for both Rotavirus and Adenovirus |
| Precision | >99% |
Performance characteristics based on evaluations of rotavirus and adenovirus combo rapid tests. Published studies of rapid rotavirus/adenovirus combo tests have reported sensitivities ranging from 75% to 100% for rotavirus and 22% to 96% for adenovirus, and specificities ranging from 95% to 100% for rotavirus and 84% to 99% for adenovirus, depending on the product, population, and reference method used. The clinical performance of adenovirus antigen detection may be lower for non-F species adenoviruses, and detection is optimal in specimens with high viral loads. The test is best suited for use as an aid in the diagnosis of viral gastroenteritis 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 Rotavirus & Adenovirus 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 Rotavirus & Adenovirus Combo Rapid Test US |
| Product Type | Rotavirus & Adenovirus Combo Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection and differentiation of rotavirus and adenovirus antigens in human feces specimens; used as a screening test and as an aid in the diagnosis of rotavirus and/or adenovirus infection |
| Detection Principle | Lateral flow chromatographic immunoassay; colloidal gold |
| Target Antigens | Rotavirus antigen; Adenovirus antigen |
| Specimen | Feces |
| Time to Result | 10–15 minutes |
| Sensitivity | Rotavirus: 98.0%; Adenovirus: 95.2% |
| Specificity | Rotavirus: 97.0%; Adenovirus: 99.0% |
| Accuracy | Rotavirus: 98.0%; Adenovirus: 97.5% |
| Limit of Detection | 10 ng/mL for both Rotavirus and Adenovirus |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Pediatric clinic, physician office laboratory, hospital laboratory, 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 Sizes | 25 tests/kit; 40 tests/kit |
| Kit Contents | Combo Test Cassette, Collection Tubes with Extraction Buffer, Disposable Droppers, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Rotavirus & Adenovirus Combo Rapid Test US |
|---|---|
| Dual-pathogen combo detection | Simultaneous detection and differentiation of rotavirus and adenovirus |
| 10–15 minute test time | Rapid turnaround for timely clinical decisions |
| Feces sample compatibility | Simple and non-invasive sample collection |
| Separate test lines for each pathogen | Clear differentiation between rotavirus and adenovirus |
| High sensitivity and specificity | Rotavirus: 98.0% sensitivity and 97.0% specificity; Adenovirus: 95.2% sensitivity and 99.0% specificity |
| Low limit of detection | 10 ng/mL for both Rotavirus and Adenovirus |
| Pediatric relevance | Particularly valuable in pediatric clinical settings |
| Antibiotic stewardship support | Helps reduce unnecessary antibiotic use |
| Infection control support | Enables prompt isolation and cohorting decisions |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for pediatric clinics, hospitals, and emergency departments |
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 Rotavirus & Adenovirus 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.
