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Global Healthcare Medical
GHM Syphilis Rapid Test US – Qualitative Detection of Treponema pallidum Antibodies with 10-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
GHM Syphilis Rapid Test US – Qualitative Detection of Treponema pallidum Antibodies with 10-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Syphilis Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Syphilis Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of antibodies to Treponema pallidum (TP), the causative agent of syphilis, in human whole blood, serum, or plasma specimens. The kit is intended for use by healthcare professionals as a screening test and as an aid in the diagnosis of syphilis infection.
Syphilis is a systemic, sexually transmitted infection caused by the spirochete bacterium Treponema pallidum. The disease progresses through distinct stages, including primary syphilis (characterized by painless ulcers and highly infectious lesions), secondary syphilis (skin rashes, mucocutaneous lesions, lymphadenopathy), and latent or tertiary stages (which can lead to organ damage including the central nervous system, cardiovascular system, and bones). Congenital syphilis occurs when the bacterium crosses the placenta during pregnancy, leading to severe complications in neonates. Due to its often asymptomatic nature in latent stages, syphilis is frequently underdiagnosed, making early and accurate diagnosis critical for preventing disease progression and transmission.
Rapid treponemal tests detect antibodies specific to Treponema pallidum and are recommended for use in screening algorithms for syphilis. These tests enable same-day results, facilitate immediate linkage to care, and are suitable for use in decentralized and community-based testing settings. The GHM Syphilis Rapid Test US detects total antibodies (IgG, IgM, and IgA) against Treponema pallidum, supporting the identification of both recent and latent infections.
The GHM Syphilis Rapid Test US delivers qualitative results in 10 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options suitable for a wide range of clinical settings.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including sexual health clinics, primary care settings, public health screening programs, 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 Syphilis Rapid Test US is based on lateral flow immunochromatography technology. The test strip contains recombinant Treponema pallidum antigens coated on the test line, along with colloidal gold-conjugated Treponema pallidum antigens and control antibodies. During testing, the specimen reacts with the antigen-coated particles and migrates up the membrane to react with the antigens on the membrane. A colored line is generated at the test line region if Treponema pallidum antibodies are present in the specimen.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Recombinant Treponema pallidum antigen-coated test line | Targeted detection of anti-TP antibodies |
| Detects anti-TP IgG, IgM, and IgA | Comprehensive antibody detection across immunoglobulin classes |
| Qualitative visual result | Clear and interpretable test outcome |
| Internal procedural control | Confirms proper test performance |
Fast Results – 10 Minutes
The GHM Syphilis Rapid Test US provides qualitative results in 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. Rapid point-of-care tests for syphilis antibodies provide results in a short timeframe and allow same-day linkage to care, particularly for difficult-to-reach populations.
| Feature | Benefit |
|---|---|
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for sexual health clinics and primary care settings |
| Efficient workflow | Enables immediate patient assessment |
| Same-day results | Supports immediate linkage to care |
Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection
The GHM Syphilis Rapid Test US is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs. The test requires only a small sample volume, making it suitable for both clinic-based and field-based testing scenarios.
| Feature | Benefit |
|---|---|
| Whole blood / serum / plasma | Flexible sample collection options |
| Fingerstick or venipuncture whole blood | Suitable for different clinical settings |
| Small sample volume required | Practical for field and decentralized testing |
| No special equipment required | Streamlined workflow in resource-limited settings |
Clinical Utility – Aid for Diagnosis of Syphilis Infection
The GHM Syphilis Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of syphilis infection. The test provides rapid serological diagnosis, enabling timely clinical decision-making and supporting linkage to care. Early and accurate identification of syphilis infection is essential for reducing syphilis-related morbidity and preventing congenital syphilis transmission.
The test is particularly valuable in settings where rapid identification of syphilis infection supports public health screening and linkage to care. Rapid syphilis testing enables same-day results, facilitates immediate linkage to care, and is critical for achieving global sexually transmitted infection testing and treatment targets. The test is designed for professional use in screening for Treponema pallidum antibodies in clinics, outreach programs, primary care, and public health settings.
| Feature | Benefit |
|---|---|
| Syphilis antibody detection aid | Supports identification of individuals with syphilis exposure |
| Screening utility | Suitable for use as a screening test in clinical and public health settings |
| Linkage to care support | Enables rapid referral for confirmatory testing and clinical management |
| Public health screening support | Suitable for outreach and community screening programs |
| Congenital syphilis prevention support | Valuable for screening pregnant women at delivery |
| Clinical versatility | Useful across sexual health clinics, primary care, and public health settings |
High Accuracy – Trusted Clinical Performance
The GHM Syphilis Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Clinical evaluation against reference methods has demonstrated strong performance, making this assay a reliable tool for point-of-care diagnostics when correctly used.
| Parameter | Specification |
|---|---|
| Sensitivity | 99.3% |
| Specificity | 99.5% |
| Reference Method | TPHA |
| Cross-reactivity | No cross-reactivity observed with common infectious disease antibodies |
Performance characteristics based on clinical evaluation of rapid syphilis antibody tests. Published evaluations of rapid treponemal antibody assays report specificities of 99% or higher and sensitivities that increase considerably (≥92%) among specimens with higher RPR titres (RPR ≥ 1:8). Independent evaluations of rapid syphilis tests have reported sensitivities ranging from 92.3% to 100% and specificities of 100% when compared with reference methods.
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 Syphilis 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 Syphilis Rapid Test US |
| Product Code | SYP-402a |
| Product Type | Syphilis Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of antibodies to Treponema pallidum (TP) in human whole blood, serum, or plasma specimens; used as a screening test and as an aid in the diagnosis of syphilis infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antibodies | Anti-Treponema pallidum antibodies (IgG, IgM, IgA) |
| Specimen | Whole Blood (venipuncture or fingerstick) / Serum / Plasma |
| Sample Volume | 20 µL of whole blood, serum, or plasma |
| Time to Result | 10 minutes (do not interpret after 30 minutes) |
| Sensitivity | 99.3% |
| Specificity | 99.5% |
| Reference Method | TPHA |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Sexual health clinic, primary care setting, public health screening program, outreach program, 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 | Syphilis Test Cassette, Assay Diluent, Disposable Droppers, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Syphilis Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Whole blood / serum / plasma compatibility | Flexible and convenient sampling options |
| Anti-TP IgG, IgM, and IgA detection | Comprehensive antibody detection across immunoglobulin classes |
| High sensitivity and specificity | 99.3% sensitivity and 99.5% specificity |
| Screening test utility | Suitable for use as a screening test in clinical and public health settings |
| Same-day results | Supports immediate patient management and linkage to care |
| Public health screening support | Suitable for outreach and community screening programs |
| Congenital syphilis prevention support | Valuable for screening pregnant women |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for sexual health clinics, primary care, and public health settings |
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 Syphilis 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.
