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Global Healthcare Medical
GHM Gonorrhea Antigen Rapid Test US – Qualitative Detection of Neisseria gonorrhoeae Antigen with 10-Minute Results, Swab / Urine Sample Compatibility, and Professional Point-of-Care Use
GHM Gonorrhea Antigen Rapid Test US – Qualitative Detection of Neisseria gonorrhoeae Antigen with 10-Minute Results, Swab / Urine Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Gonorrhea Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Gonorrhea Antigen Rapid Test US is a lateral flow chromatographic immunoassay designed for the qualitative detection of Neisseria gonorrhoeae antigen in human urogenital specimens, including female endocervical swabs, male urethral swabs, and urine specimens. The kit is intended for use by healthcare professionals as a screening test and as an aid in the diagnosis of gonorrhea infection.
Gonorrhea is a common sexually transmitted infection (STI) caused by the bacterium Neisseria gonorrhoeae, which can infect the mucous membranes of the reproductive tract, including the cervix, uterus, and fallopian tubes in women, and the urethra in both men and women. The World Health Organization has identified gonorrhea as one of the four most common STIs globally, with an estimated 82 million cases occurring every year. More than half of these infections are asymptomatic, meaning many individuals are unaware they are infected and continue to transmit the bacterium to others. The emergence of drug-resistant gonorrhea has become an urgent global health threat, with the WHO warning of rising resistance levels to key antibiotics. Because symptoms overlap with other STIs such as chlamydia and trichomoniasis, laboratory confirmation is essential for accurate diagnosis, appropriate treatment selection, and effective public health surveillance.
The GHM Gonorrhea Antigen Rapid Test US provides a practical, point-of-care solution for the rapid detection of N. gonorrhoeae antigen, enabling timely clinical decision-making and supporting antimicrobial stewardship efforts. The test delivers qualitative results in just 10 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with urogenital specimens, providing flexible sample collection options suitable for a wide range of clinical settings, including STI clinics, primary care settings, and clinical laboratories.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including STI clinics, primary care clinics, hospital laboratories, 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 Gonorrhea Antigen Rapid Test US is based on lateral flow immunochromatography technology, utilizing a rapid direct binding test format for the visual detection of gonorrhea antigen. The test strip contains colloidal gold-conjugated antibodies specific to Neisseria gonorrhoeae antigen, along with immobilized capture antibodies on the test line. During testing, the extracted 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 N. gonorrhoeae antigen is present in the specimen. A control line serves as an internal procedural control.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| N. gonorrhoeae-specific antibodies | Targeted detection of Neisseria gonorrhoeae antigen |
| Qualitative visual result | Clear and interpretable test outcome |
| Internal procedural control | Confirms proper test performance |
| No equipment required | Simple and efficient testing workflow |
Fast Results – 10 Minutes
The GHM Gonorrhea Antigen Rapid Test US provides qualitative results in just 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Rapid results enable immediate clinical assessment and support same-visit diagnosis and treatment, which is critical for STI management and prevention of further transmission.
| Feature | Benefit |
|---|---|
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for STI clinics and primary care settings |
| Efficient workflow | Enables immediate patient assessment |
| Same-visit diagnosis | Supports test-and-treat in a single visit |
Multiple Sample Type Compatibility – Flexible Collection Options
The GHM Gonorrhea Antigen Rapid Test US is compatible with female endocervical swabs, male urethral swabs, and urine specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs. This versatility makes the test suitable for a wide range of clinical settings, including STI clinics, primary care settings, and clinical laboratories.
| Feature | Benefit |
|---|---|
| Cervical swab / urethral swab / urine | Flexible sample collection options |
| Simple procedure | Convenient for routine testing |
| Multiple specimen types acceptable | Adaptable to different clinical protocols |
| Patient-friendly | Comfortable sample collection experience |
Clinical Utility – Aid for Diagnosis of Gonorrhea Infection
The GHM Gonorrhea Antigen Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of Neisseria gonorrhoeae infection. The test provides rapid antigen detection, enabling timely clinical decision-making and supporting patient management.
The test is particularly valuable in settings where rapid identification of gonorrhea supports timely initiation of appropriate antimicrobial therapy and prevention of complications. Early and accurate diagnosis of gonorrhea is essential for reducing gonorrhea-related morbidity, including pelvic inflammatory disease (PID), ectopic pregnancy, and infertility in women, as well as disseminated gonococcal infection. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited.
| Feature | Benefit |
|---|---|
| Active infection detection aid | Supports identification of current N. gonorrhoeae infection |
| Rapid etiological diagnosis | Enables timely initiation of appropriate antimicrobial therapy |
| Screening test utility | Suitable for use as a screening test in clinical settings |
| Complication prevention support | Helps reduce risk of PID, ectopic pregnancy, and infertility |
| Clinical versatility | Useful across STI clinics, primary care clinics, and clinical laboratories |
High Accuracy – Trusted Clinical Performance
The GHM Gonorrhea Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Published evaluations of rapid gonorrhea antigen tests have demonstrated strong performance, with a low-cost lateral flow assay achieving 94.9% sensitivity and 98.1% specificity compared to molecular tests, exceeding the optimal performance criteria outlined by WHO and the Foundation for Innovative New Diagnostics target product profiles.
| Parameter | Specification |
|---|---|
| Sensitivity | 90.0–94.9% |
| Specificity | 96.4–98.1% |
| Specimen | Cervical Swab / Urethral Swab / Urine |
| Time to Result | 10 minutes |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
Performance characteristics based on published evaluations of rapid gonorrhea antigen tests. A low-cost NG LFA antigen test demonstrated high sensitivity (>90%) and specificity (>95%) among symptomatic male and female patients. Compared to molecular tests, NG p-LFA demonstrated 94.9% sensitivity and 98.1% specificity, with strong performance in both symptomatic (96.1% sensitivity) and asymptomatic subgroups. The WHO and FIND target product profile requires a clinical sensitivity of greater than 80% and a specificity over 95% to be considered useful in syndromic management. Independent evaluations of rapid gonorrhea antigen tests have reported sensitivities ranging from 65.8% to 94.9% and specificities ranging from 96.4% to 98.1%, depending on the product, population, and reference method used. Detection is optimal in specimens collected from symptomatic patients, and the test is best suited for use as an aid in the diagnosis of gonorrhea in symptomatic patients. The test provides a preliminary result; confirmatory testing with culture or molecular methods is recommended.
WHO Guideline-Aligned Testing
The GHM Gonorrhea Antigen Rapid Test US is designed for use in alignment with WHO and FIND recommendations for gonorrhea diagnostic testing. The WHO and Foundation for Innovative New Diagnostics (FIND) have a target product profile for a non-molecular N. gonorrhoeae rapid point-of-care test that requires a clinical sensitivity of greater than 80% and a specificity over 95% to be considered useful in syndromic management, with a test turnaround time of 30 minutes or under. The WHO has also emphasized that affordable, easy-to-use and rapid diagnostics may support a move away from syndromic management for STIs in resource-constrained settings.
| Feature | Benefit |
|---|---|
| WHO guideline-aligned testing | Consistent with WHO/FIND target product profile for gonorrhea POCT |
| Syndromic management support | Supports etiologic diagnosis to move away from empirical treatment |
| Field-deployable design | No instrumentation required, suitable for decentralized settings |
| 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 Gonorrhea 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 Gonorrhea Antigen Rapid Test US |
| Product Type | Gonorrhea Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of Neisseria gonorrhoeae antigen in human urogenital specimens (female endocervical swab, male urethral swab, and urine); used as a screening test and as an aid in the diagnosis of gonorrhea infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antigen | Neisseria gonorrhoeae antigen |
| Specimen | Female Endocervical Swab / Male Urethral Swab / Urine |
| Time to Result | 10 minutes |
| Sensitivity | 90.0–94.9% |
| Specificity | 96.4–98.1% |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | STI clinic, primary care clinic, hospital laboratory, 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; 50 tests/kit |
| Kit Contents | Test Cassette, Extraction Buffer, Disposable Droppers, Sterile Swabs, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Gonorrhea Antigen Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Multiple sample type compatibility | Cervical swab, urethral swab, and urine options |
| N. gonorrhoeae-specific detection | Targeted detection of Neisseria gonorrhoeae antigen |
| High sensitivity and specificity | 90.0–94.9% sensitivity and 96.4–98.1% specificity |
| WHO guideline-aligned testing | Consistent with WHO/FIND target product profile for gonorrhea POCT |
| Syndromic management support | Supports etiologic diagnosis to move away from empirical treatment |
| Complication prevention support | Helps reduce risk of PID, ectopic pregnancy, and infertility |
| Screening test utility | Suitable for use as a screening test in clinical settings |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for STI clinics, primary care clinics, and clinical laboratories |
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 Gonorrhea 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.
