GHM Trichomonas Vaginalis Antigen Rapid Test US – Qualitative Detection of Trichomonas vaginalis Antigen with 10-Minute Results, Vaginal Swab Sample Compatibility, and Professional Point-of-Care Use

SKU: GHM Trichomonas Vaginalis Antigen Rapid Test US
Brand: Global Healthcare Medical

Product Overview

Global Healthcare Medical GHM Trichomonas Vaginalis Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Trichomonas 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 trichomoniasis.

Trichomonas vaginalis is a motile, flagellated protozoan parasite that resides in the human urogenital tract and is the causative agent of trichomoniasis—the most common curable, non-viral sexually transmitted infection (STI) worldwide. According to the World Health Organization, an estimated 156 million new cases of T. vaginalis infection occurred among people aged 15–49 years globally in 2020, with 73.7 million cases in females and 82.6 million in males. The infection is transmitted primarily through sexual contact and can infect the vagina, urethra, and paraurethral glands. While many infections are asymptomatic, symptomatic individuals may present with vaginal discharge, genital itching, dysuria, and discomfort during intercourse. The clinical presentation of trichomoniasis overlaps significantly with bacterial vaginosis and vulvovaginal candidiasis, making laboratory confirmation essential for accurate diagnosis and appropriate treatment selection.

Untreated trichomoniasis is associated with serious reproductive health complications. Trichomoniasis is associated with pelvic inflammatory disease (PID), adverse birth outcomes, and increased HIV transmission risk—early detection and treatment reduce these complications. Studies have reported a 2–3-fold increased risk of contracting HIV, a 30% increase in the risk of preterm birth, and increased risks of female infertility and pelvic inflammatory disease (PID). In pregnant individuals, trichomoniasis has been associated with premature rupture of membranes, preterm delivery, and delivery of a small for gestational age infant, as well as increased risk of HIV transmission. Because wet mount microscopy has a reported sensitivity of only 58% versus culture, rapid antigen detection offers a significant diagnostic advantage by detecting pathogen antigens directly from vaginal swabs with greater sensitivity and in a fraction of the time.

The GHM Trichomonas Vaginalis Antigen Rapid Test US delivers qualitative results in just 10 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 Trichomonas Vaginalis Antigen Rapid Test US is based on lateral flow immunochromatography technology, utilizing a double antibody sandwich method for specific detection of Trichomonas vaginalis antigen. The test strip contains colloidal gold-conjugated monoclonal antibodies specific to Trichomonas 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 Trichomonas vaginalis antigen is present in the specimen. The test specifically detects Trichomonas vaginalis antigen with no cross-reactivity with other STI-related microorganisms.

Fast Results – 10 Minutes

The GHM Trichomonas Vaginalis 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. Traditional wet mount microscopy requires immediate specimen processing and specialized equipment, while the rapid antigen test provides actionable results within minutes, enabling same-visit diagnosis and treatment.

Vaginal Swab Sample Compatibility – Simple and Non-Invasive Collection

The GHM Trichomonas 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.

Clinical Utility – Aid for Diagnosis of Trichomonas vaginalis Infection

The GHM Trichomonas Vaginalis Antigen Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of Trichomonas vaginalis infection and trichomoniasis. 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 Trichomonas vaginalis supports timely initiation of appropriate antimicrobial therapy and prevention of reproductive health complications. Early and accurate diagnosis of trichomoniasis is essential for reducing PID-related morbidity, adverse pregnancy outcomes, and HIV transmission risk. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited.

High Accuracy – Trusted Clinical Performance

The GHM Trichomonas Vaginalis Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. The product specifications report a sensitivity of 98.5%, specificity of 99.12%, and accuracy of 98.80%. A systematic review and meta-analysis of rapid antigen tests for trichomoniasis reported a pooled sensitivity of 87.0% and a pooled specificity of 98.3%, with a subgroup analysis of symptomatic individuals yielding a pooled sensitivity of 85% and a specificity of 99.9%.

Performance characteristics based on product specifications. A systematic review and meta-analysis of rapid antigen tests for trichomoniasis reported a pooled sensitivity of 87.0% and a pooled specificity of 98.3%. Subgroup analysis of symptomatic individuals yielded a pooled sensitivity of 85% and a specificity of 99.9%. Independent evaluations of rapid antigen-based point-of-care tests for T. vaginalis in antenatal settings have reported specificities ranging from 99.1% to 100.0%, with sensitivities varying by population and reference method. Detection is optimal in specimens collected from symptomatic patients, and the test is best suited for use as an aid in the diagnosis of trichomoniasis 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.

CE Marked – European Conformity

The GHM Trichomonas 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.

Product Specifications

Important Testing Notes:

• Collect a vaginal swab specimen using the provided sterile swab; ensure adequate specimen collection by rotating the swab for 10–15 seconds to absorb secretions.

• Test immediately after collection; if testing is delayed, store at 2–8°C for up to 72 hours or -20°C for 3 months. Do not freeze and thaw repeatedly.

• Any visible shade of color in the Test line (T) indicates a positive result, as intensity varies with antigen concentration.

• A negative result does not rule out Trichomonas vaginalis infection; confirmatory testing with culture or molecular methods is recommended.

• The test specifically detects Trichomonas vaginalis antigen with no cross-reactivity with other STI-related microorganisms.

Why Clinical Professionals Choose Global Healthcare Medical

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 Trichomonas 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.