WhatsApp USA: +1 6032769350 | WhatsApp HK: +852 63697831
Global Healthcare Medical
GHM Candida Albicans Antigen Rapid Test US – Qualitative Detection of Candida albicans Antigen with 10–15 Minute Results, Vaginal Swab / Urine Sample Compatibility, and Professional Point-of-Care Use
GHM Candida Albicans Antigen Rapid Test US – Qualitative Detection of Candida albicans Antigen with 10–15 Minute Results, Vaginal Swab / Urine Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Candida Albicans Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Candida Albicans Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Candida albicans antigen in human vaginal swab, urine, male urethral swab, and female cervical swab specimens. The kit is intended for use by healthcare professionals as a screening test and as an aid in the diagnosis of Candida albicans infection.
Candida albicans is the most common fungal pathogen in humans and the primary causative agent of vulvovaginal candidiasis (VVC), the second most common cause of vaginitis among women of childbearing age worldwide. It is estimated that approximately three-quarters of women will experience at least one episode of VVC in their lifetime, and candidiasis can also manifest as oral thrush and, in severe cases, invasive candidiasis with bloodstream infections carrying a mortality rate near 40%. Accurate identification of Candida albicans is clinically important because treatment strategies may differ from those for non-albicans Candida species, which are increasingly prevalent and often exhibit reduced susceptibility to first-line antifungal agents.
The GHM Candida Albicans Antigen 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 vaginal swab, urine, male urethral swab, and female cervical swab specimens, providing flexible sample collection options 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 Candida Albicans Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test strip contains anti-Candida albicans antibody conjugated with colloidal gold particles, along with immobilized anti-Candida albicans antibodies coated on the membrane. 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 Candida albicans antigen is present in the specimen.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Candida albicans-specific antibodies | Targeted detection of Candida albicans 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 – 10–15 Minutes
The GHM Candida Albicans Antigen 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, supporting timely initiation of appropriate antifungal therapy and reducing the need for empirical treatment.
| Feature | Benefit |
|---|---|
| 10–15 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 |
Multiple Sample Type Compatibility – Flexible Collection Options
The GHM Candida Albicans Antigen Rapid Test US is compatible with vaginal swab, urine, male urethral swab, and female cervical swab 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.
| Feature | Benefit |
|---|---|
| Vaginal swab / urine / urethral swab / cervical swab | 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 Candida albicans Infection
The GHM Candida Albicans Antigen Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of Candida albicans 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 Candida albicans supports timely initiation of appropriate antifungal therapy and differentiation from non-albicans Candida species. Detection of Candida albicans antigen is significant because a positive result is associated with infection rather than colonization, and specimen collection from symptomatic women with a fungal load of 10² to 10⁴ CFU/mL yielded positive results with test line intensities correlating with infection severity. 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 Candida albicans infection |
| Rapid etiological diagnosis | Enables timely initiation of appropriate antifungal therapy |
| Screening test utility | Suitable for use as a screening test in clinical settings |
| Species differentiation support | Helps distinguish Candida albicans from other Candida species |
| Clinical versatility | Useful across gynecology clinics, primary care clinics, and clinical laboratories |
High Accuracy – Trusted Clinical Performance
The GHM Candida Albicans Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Published evaluations of rapid Candida albicans antigen tests have demonstrated strong performance, including a point-of-care lateral flow immunochromatographic assay that achieved 100% sensitivity, 89.9% specificity, and 90.32% accuracy against Candida spp. culture for the diagnosis of vulvovaginal candidiasis.
| Parameter | Specification |
|---|---|
| Sensitivity | 100% (POCT LFIA vs. culture) |
| Specificity | 89.9% (POCT LFIA vs. culture) |
| Accuracy | 90.32% (POCT LFIA vs. culture) |
| Cut-off Value | 10⁵ CFU/mL |
| Specimen | Vaginal Swab / Urine / Urethral Swab / Cervical Swab |
| Time to Result | 10–15 minutes |
Performance characteristics based on published evaluations of rapid Candida albicans antigen tests. A point-of-care lateral flow immunochromatographic assay for Candida albicans achieved a sensitivity of 100%, specificity of 89.9%, accuracy of 90.32%, positive likelihood ratio of 9, negative likelihood ratio of 0, positive predictive value of 50%, and negative predictive value of 100% against Candida spp. culture. An immunochromatography test using a monoclonal antibody to Candida mannan achieved a sensitivity of 96.6% and a specificity of 98.6%, with significantly higher sensitivity than microscopic examination (61.6%) and higher specificity than fungal culture (82%). Detection is optimal in specimens collected from symptomatic patients, as specimens from asymptomatic women with positive cultures containing 10² to 10³ CFU/mL were negative. The test provides a preliminary result; confirmatory testing with culture is recommended to definitively identify and distinguish Candida albicans from other Candida species.
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 Candida Albicans 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 Candida Albicans Antigen Rapid Test US |
| Product Type | Candida Albicans Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of Candida albicans antigen in human vaginal swab, urine, male urethral swab, and female cervical swab specimens; used as a screening test and as an aid in the diagnosis of Candida albicans infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antigen | Candida albicans antigen |
| Specimen | Vaginal Swab / Urine / Male Urethral Swab / Female Cervical Swab |
| Time to Result | 10–15 minutes |
| Cut-off Value | 10⁵ CFU/mL |
| Sensitivity | 100% (POCT LFIA vs. culture) |
| Specificity | 89.9% (POCT LFIA vs. culture) |
| Accuracy | 90.32% (POCT LFIA vs. culture) |
| 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 | 20 tests/kit; 25 tests/kit |
| Kit Contents | Test Cassette, Extraction Buffer, Disposable Droppers, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Candida Albicans Antigen Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 10–15 minute test time | Rapid turnaround for timely clinical decisions |
| Multiple sample type compatibility | Vaginal swab, urine, urethral swab, and cervical swab options |
| Candida albicans-specific detection | Targeted detection of Candida albicans antigen |
| High sensitivity and specificity | 100% sensitivity and 89.9% specificity vs. culture |
| 90.32% overall accuracy | Strong concordance with Candida spp. culture |
| Species differentiation support | Helps distinguish Candida albicans from other Candida species |
| 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 Candida Albicans 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.
