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Global Healthcare Medical
GHM Chlamydia Antigen Rapid Test US – Qualitative Detection of Chlamydia trachomatis Antigen with 10-Minute Results, Swab / Urine Sample Compatibility, and Professional Point-of-Care Use
GHM Chlamydia Antigen Rapid Test US – Qualitative Detection of Chlamydia trachomatis Antigen with 10-Minute Results, Swab / Urine Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Chlamydia Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Chlamydia Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Chlamydia trachomatis antigen in human urogenital specimens, including female cervical swabs, male urethral swabs, and male urine specimens. The kit is intended for use by healthcare professionals as a screening test and as an aid in the diagnosis of chlamydia infection.
Chlamydia trachomatis is the most common bacterial sexually transmitted infection (STI) worldwide, with an estimated 128.5 million new infections occurring globally among adults aged 15 to 49 years in 2020. The global prevalence among people aged 15–49 years was estimated to be 4.0% for women and 2.5% for men in 2020. The infection can affect the cervix, urethra, and other urogenital structures, and the majority of cases are asymptomatic, meaning many individuals are unaware they are infected and continue to transmit the bacterium to others. Untreated chlamydia can lead to serious reproductive health complications, including pelvic inflammatory disease (PID), ectopic pregnancy, and infertility in women, as well as epididymitis in men. Because symptoms overlap significantly with other STIs such as gonorrhea and trichomoniasis, laboratory confirmation is essential for accurate diagnosis and appropriate treatment selection.
The GHM Chlamydia Antigen Rapid Test US provides a practical, point-of-care solution for the rapid detection of C. trachomatis 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 Chlamydia Antigen Rapid Test US is based on lateral flow immunochromatography technology, utilizing a rapid direct binding test format for the visual detection of chlamydia antigen. The test strip contains colloidal gold-conjugated antibodies specific to Chlamydia trachomatis 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 Chlamydia trachomatis 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 |
| C. trachomatis-specific antibodies | Targeted detection of Chlamydia trachomatis 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 Chlamydia 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 Chlamydia Antigen Rapid Test US is compatible with female cervical swabs, male urethral swabs, and male urine specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs. For male urine specimens, collect 15–30 mL of clean first morning urine in a sterile urine cup. 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 / male 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 Chlamydia Infection
The GHM Chlamydia Antigen Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of Chlamydia trachomatis 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 chlamydia supports timely initiation of appropriate antimicrobial therapy and prevention of complications. Early and accurate diagnosis of chlamydia is essential for reducing chlamydia-related morbidity, including pelvic inflammatory disease (PID), ectopic pregnancy, and infertility in women. 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 C. trachomatis 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 Chlamydia Antigen Rapid Test US is designed to deliver reliable clinical performance with high specificity. A new point-of-care Chlamydia Rapid Test was evaluated against strand displacement amplification assay and demonstrated a sensitivity of 81.6% (40/49) and a specificity of 98.3% (578/588). A systematic review of point-of-care tests for urogenital Chlamydia trachomatis infections reported pooled specificity of antigen detection tests of 99% for cervical swabs, 97% for vaginal swabs, and 98% for male urine.
| Parameter | Specification |
|---|---|
| Sensitivity | 81.6% (vs. strand displacement amplification assay) |
| Specificity | 98.3% (vs. strand displacement amplification assay) |
| Specimen | Cervical Swab / Urethral Swab / Male 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 Chlamydia antigen tests. A point-of-care Chlamydia Rapid Test demonstrated a sensitivity of 81.6% (40/49) and a specificity of 98.3% (578/588) compared with strand displacement amplification assay. Systematic reviews of point-of-care antigen detection tests have reported pooled sensitivities of 53% for cervical swabs, 37% for vaginal swabs, and 63% for male urine, with specificities of 99%, 97%, and 98%, respectively. The CDC and WHO recommend that in resource-limited settings, rapid antigen tests offer a practical screening solution, though NAAT confirmation is required. Detection is optimal in specimens collected from symptomatic patients, and the test is best suited for use as an aid in the diagnosis of chlamydia in symptomatic patients. The test provides a preliminary result; confirmatory testing with 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 Chlamydia 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 Chlamydia Antigen Rapid Test US |
| Product Code | ICH-502 |
| Product Type | Chlamydia Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of Chlamydia trachomatis antigen in human urogenital specimens (female cervical swab, male urethral swab, and male urine); used as a screening test and as an aid in the diagnosis of Chlamydia trachomatis infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antigen | Chlamydia trachomatis antigen |
| Specimen | Female Cervical Swab / Male Urethral Swab / Male Urine |
| Time to Result | 10 minutes |
| Sensitivity | 81.6% (vs. strand displacement amplification assay) |
| Specificity | 98.3% (vs. strand displacement amplification assay) |
| 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 A, Extraction Buffer B, Extraction Tubes, Disposable Droppers, Polyester Swabs, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Chlamydia 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 male urine options |
| C. trachomatis-specific detection | Targeted detection of Chlamydia trachomatis antigen |
| High specificity | 98.3% specificity vs. strand displacement amplification assay |
| 81.6% sensitivity | Reliable detection in symptomatic patients |
| 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 Chlamydia 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.
