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Global Healthcare Medical
GHM Gardnerella Vaginalis Antigen Rapid Test US – Qualitative Detection of Gardnerella vaginalis Antigen with 15-Minute Results, Vaginal Swab Sample Compatibility, and Professional Point-of-Care Use
GHM Gardnerella Vaginalis Antigen Rapid Test US – Qualitative Detection of Gardnerella vaginalis Antigen with 15-Minute Results, Vaginal Swab Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Gardnerella Vaginalis Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Gardnerella Vaginalis Antigen Rapid Test US is a lateral flow chromatographic immunoassay designed for the qualitative detection of Gardnerella vaginalis antigen in human vaginal swab specimens. The kit is intended for use by healthcare professionals as a screening test and as an aid in the diagnosis of Gardnerella vaginalis infection and bacterial vaginosis (BV).
Gardnerella vaginalis is a Gram-variable anaerobic bacterium commonly colonizing the human vagina and is the primary pathogen linked to bacterial vaginosis, the most common cause of vaginal discharge worldwide. In healthy women, beneficial lactobacilli dominate the vaginal flora and suppress its overgrowth; when the microbial balance breaks down, this bacterium multiplies rapidly, causing symptoms such as abnormal grayish discharge, fishy odor, and mild vaginal irritation. Bacterial vaginosis affects approximately one in four women globally, with global prevalence estimates ranging from 23% to 29%. The condition is associated with significant complications, including pelvic inflammatory disease, postabortion and postpartum endometritis, and increased risk of preterm birth and spontaneous abortion.
Because clinical symptoms of bacterial vaginosis overlap significantly with vulvovaginal candidiasis and trichomoniasis, laboratory confirmation is essential for accurate diagnosis and appropriate treatment selection. The GHM Gardnerella Vaginalis Antigen Rapid Test US provides a practical, point-of-care solution for the rapid detection of Gardnerella vaginalis antigen, enabling timely clinical decision-making and supporting antimicrobial stewardship efforts.
The GHM Gardnerella Vaginalis Antigen Rapid Test US delivers qualitative results in 15 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with human vaginal swab specimens, providing a simple and non-invasive sample collection method suitable for a wide range of clinical settings, including gynecology 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 gynecology 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 Gardnerella Vaginalis Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test strip contains colloidal gold-conjugated antibodies specific to Gardnerella vaginalis antigen, along with immobilized capture antibodies on the test line. During testing, the extracted swab 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 Gardnerella vaginalis 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 |
| Gardnerella vaginalis-specific antibodies | Targeted detection of Gardnerella vaginalis antigen |
| Qualitative visual result | Clear and interpretable test outcome |
| Internal procedural control | Confirms proper test performance |
| No special equipment required | Streamlined workflow in clinical settings |
Fast Results – 15 Minutes
The GHM Gardnerella Vaginalis 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 results enable immediate clinical assessment, supporting timely initiation of appropriate antimicrobial therapy and reducing the need for empirical treatment.
| Feature | Benefit |
|---|---|
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for gynecology clinics and primary care settings |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput testing environments |
Vaginal Swab Sample Compatibility – Simple and Non-Invasive Collection
The GHM Gardnerella Vaginalis Antigen Rapid Test US is compatible with human vaginal swab specimens, providing a simple and non-invasive sample collection method. Vaginal swab collection is a standard, well-tolerated procedure that can be performed during routine gynecological examination. The test requires only a small sample volume and uses extraction tubes with buffer for convenient specimen processing.
| Feature | Benefit |
|---|---|
| Vaginal swab specimen | Simple and non-invasive sample collection |
| Extraction tubes with buffer | Convenient specimen processing |
| No dietary restrictions required | Simplified testing protocol |
| No special equipment required | Streamlined workflow in clinical settings |
| Patient-friendly | Comfortable sample collection experience |
Clinical Utility – Aid for Diagnosis of Gardnerella vaginalis Infection and Bacterial Vaginosis
The GHM Gardnerella Vaginalis Antigen Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of Gardnerella vaginalis infection and bacterial vaginosis. 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 Gardnerella vaginalis supports timely initiation of appropriate antimicrobial therapy. Early and accurate diagnosis of bacterial vaginosis is essential for reducing BV-related complications, including pelvic inflammatory disease, postabortion and postpartum endometritis, and adverse pregnancy outcomes such as preterm birth. 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 Gardnerella vaginalis 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 BV-related complications including PID and preterm birth |
| Clinical versatility | Useful across gynecology clinics, primary care clinics, and clinical laboratories |
High Accuracy – Trusted Clinical Performance
The GHM Gardnerella Vaginalis Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Published evaluations of rapid Gardnerella vaginalis antigen tests have demonstrated strong performance across multiple clinical studies.
| Parameter | Specification |
|---|---|
| Sensitivity | ≥80% |
| Specificity | ≥90% |
| Concordance | ≥90% |
| Specimen | Vaginal Swab |
| Time to Result | 15 minutes |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
Performance characteristics based on published evaluations of rapid Gardnerella vaginalis antigen tests. A validation study of an immunologic diagnostic kit for Gardnerella vaginalis reported clinical sensitivity ≥80%, clinical specificity ≥90%, and concordance ≥90% between samples evaluated in parallel by different methods. A multiplex recombinase polymerase amplification combined with lateral flow strips platform demonstrated a sensitivity of 97.1%, specificity of 90%, and accuracy of 95.9% compared to conventional culture and microscopy. Direct probe assays for Gardnerella vaginalis nucleic acids reported sensitivity of 90% and specificity of 97% compared with detection of clue cells on vaginal wet mounts. Detection is optimal in specimens collected from symptomatic patients, and the test is best suited for use as an aid in the diagnosis of Gardnerella vaginalis infection in symptomatic patients. The test provides a preliminary result; confirmatory testing with culture or molecular methods is recommended.
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 Gardnerella Vaginalis 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 Gardnerella Vaginalis Antigen Rapid Test US |
| Product Code | IGV-502 |
| Product Type | Gardnerella Vaginalis Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of Gardnerella vaginalis antigen in human vaginal swab specimens; used as a screening test and as an aid in the diagnosis of Gardnerella vaginalis infection and bacterial vaginosis |
| Detection Principle | Lateral flow chromatographic immunoassay; colloidal gold |
| Target Antigen | Gardnerella vaginalis antigen |
| Specimen | Vaginal Swab |
| Time to Result | 15 minutes |
| Sensitivity | ≥80% |
| Specificity | ≥90% |
| Concordance | ≥90% |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Gynecology 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 | 10 tests/kit; 20 tests/kit; 25 tests/kit |
| Kit Contents | Test Cassette, Extraction Tubes with Buffer, Disposable Droppers, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Gardnerella Vaginalis Antigen Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Vaginal swab sample compatibility | Simple and non-invasive sample collection |
| Gardnerella vaginalis-specific detection | Targeted detection of Gardnerella vaginalis antigen |
| High sensitivity and specificity | ≥80% sensitivity and ≥90% specificity |
| ≥90% concordance | Strong concordance with reference methods |
| Complication prevention support | Helps reduce risk of BV-related complications including PID and preterm birth |
| 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 gynecology 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 Gardnerella Vaginalis 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.
